bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Valbenazine
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of
      optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with
      Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have participated in and completed Study NBI-98854-TS2003

          2. Have a clinical diagnosis of Tourette Syndrome (TS)

          3. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          4. Be in good general health

          5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          6. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2
             (VMAT2) inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline

          7. Have a known history of substance (drug) dependence, or substance or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
Condition: Inherited Erythromelalgia
MeSH terms: Erythromelalgia
Intervention: PF-05089771; Placebo
Intervention description: A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered.; Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of single doses of
      PF-05089771 against placebo in treatment of pain in patients with primary, inherited
      erythromelalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and or female subjects between the ages of 18-78 years

          -  Subject has clinical signs of IEM

          -  Minimum BMI 17.5kg/m2 and total body weight >50kg

        Exclusion Criteria:

          -  Other severe pain conditions, e.g. rheumatologic, that may impair subject's
             self-assessment of pain due to IEM.

          -  Evidence of clinically significant hypertension, clinically significant hematological,
             dermatological, renal, endocrine (except diabetes mellitus), pulmonary,
             gastrointestinal, cardiovascular, hepatic, neurological (other than IEM), or allergic
             disease (including drug allergies but excluding untreated asymptomatic seasonal
             allergies).

          -  Subjects with severe obesity.
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MEDI3506; Placebo
Intervention description: multiple doses; multiple doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MEDI3506; Safety; Efficacy; Atopic Dermatitis; Eczema

Summary:

      This is a research study to determine the efficacy and safety of investigational drug
      MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years inclusive at the time of consent.

          -  Body mass index between 19.0 and 40.0 kg/m2 inclusive.

          -  Documented history of chronic AD, for at least 1 year prior to screening Visit 1.

          -  Meets at minimum 1 of the criteria, as follows:

               -  History of inadequate response to topical medications for AD

               -  Subject intolerance to treatment with topical medications for AD, or

               -  Topical medications are otherwise medically inadvisable

          -  AD that affects ≥ 10% of the body surface area (BSA).

          -  An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).

          -  An IGA score of ≥ 3.

        Exclusion Criteria:

          -  Any active medical or psychiatric condition, or other reason, that would interfere
             with evaluation of the investigational product or interpretation of subject safety or
             study results.

          -  Any other clinically relevant abnormal findings from physical examination (including
             vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.

          -  Active dermatologic conditions that might confound the diagnosis of AD or would
             interfere with the assessment of the skin.

          -  Known active allergic or irritant contact dermatitis.
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ETC-1002; Placebo
Intervention description: Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day; Placebo once daily for 8 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: lipid-lowering drugs; statin intolerance

Summary:

      This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and
      safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of
      statin intolerance.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A history of statin intolerance that began during statin treatment and resolved within
             4 weeks of stopping the statin treatment

          -  For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per
             deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all
             lipid-regulating drugs and supplements)

          -  For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and
             fasting TG <400 mg/dL

        Key Exclusion Criteria:

          -  Acute significant cardiovascular disease

          -  Poorly controlled hypertension
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: rituximab [MabThera/Rituxan]; chlorambucil
Intervention description: 375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).; 8mg/m2 po on days 1-7 of courses 1-8
Intervention MeSH terms: Rituximab; Chlorambucil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of MabThera + chlorambucil as
      induction therapy, followed in responders by maintenance therapy or observation in elderly
      patients with previously untreated chronic lymphocytic leukemia. During the induction phase
      patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses
      of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses
      of MabThera given every 8 weeks, or no further treatment. The anticipated time on study
      treatment is 2+ years, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=60 years of age;

          -  CD20+ chronic lymphocytic leukemia (CLL);

          -  no previous treatment for CLL;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  co-morbid conditions requiring long term use of systemic corticosteroids during study
             treatment;

          -  history of severe cardiac disease;

          -  transformation to aggressive B-cell malignancy.
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: bevacizumab [Avastin]; fotemustine
Intervention description: 15 mg/kg intravenously on day 1 of every 3 week cycle; 100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles
Intervention MeSH terms: Bevacizumab; Fotemustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients
      with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic
      disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week
      cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks
      rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study
      treatment is until disease progression, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  cutaneous malignant melanoma;

          -  advanced, inoperable stage IV melanoma;

          -  measurable and/or evaluable sites of metastases.

        Exclusion Criteria:

          -  prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;

          -  prior malignancies within past 5 years, with the exception of cured non-melanoma skin
             cancer, or in situ cancer of cervix;

          -  clinically significant cardiovascular disease;

          -  ongoing treatment with aspirin (>325mg/day) or other medications known to predispose
             to gastrointestinal ulceration.
Research Study of Treatment for Winter Depression With Different Colors of Light
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Intervention: Blue Light Box 467 nm; Red Light Box 657 nm
Intervention description: 467 nm Blue LED Light; 657 nm Red LED Light
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Seasonal Affective Disorder

Summary:

      The specific aim of this study is to test the hypothesis that light stimuli concentrated
      around 467 nm will evoke a significantly stronger therapeutic response in SAD patients
      compared to light stimuli concentrated around 657 nm at an equal photon density.

      The secondary objective of this study is to determine the efficacy of different colors and
      levels of light in order to optimize therapeutic benefit, while also minimizing side effects
      and maintaining safety of light exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Seasonal Affective Disorder

          -  Over 18 years old

          -  Stable sleeping pattern with a bedtime no later than 1 a.m.

        Exclusion Criteria:

          -  Pregnant women

          -  Concurrent psychiatric illness that would preclude compliance with the protocol

          -  active suicidal or homicidal ideation or plan

          -  variable psychiatric illness (i.e. rapid cycling disorder or severe premenstrual
             syndrome)

          -  individuals with substance abuse or dependence who have not been in remission for at
             least one year

          -  individuals taking photosensitizing medications

          -  individuals with macular degeneration or other ocular conditions which might be
             adversely affected by light

          -  less then six weeks after onset of psychotherapeutic treatment
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Intervention: atorvastatin; Placebo
Intervention description: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.; oral drug of similar appearance to atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: early diffuse scleroderma; Raynaud

Summary:

      The purpose of this study is to learn about the effect atorvastatin on blood vessel function
      and Raynaud symptoms in patients with early diffuse systemic sclerosis.

      Systemic sclerosis is a disease characterized by blood vessel injury, immune system
      activation and fibrosis. Blood vessel injury is thought to be important early in the disease.
      Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe
      ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized
      to have many effects beyond cholesterol reduction. These include improvement of blood vessel
      function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16
      weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse
      systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood
      vessel changes and improve Raynaud symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. early diffuse scleroderma (< 3 years from the first scleroderma-related symptom)

          2. Raynaud phenomenon

          3. no use of lipid-lowering medication within 60 days

        Exclusion Criteria:

          1. pregnancy

          2. renal or kidney dysfunction (creatinine < 2.0 mg/dL or creatinine clearance < 60
             c/min)

          3. diabetes mellitus

          4. known cardiovascular disease or a prior history of stroke

          5. history of liver disease

          6. new or changed dose of calcium channel blockers (CCB) and angiotensin receptor
             blockers (ARBs) in the last 4 weeks

          7. known allergy or adverse reaction to the atorvastatin or another statin drug
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABBV-3373; Placebo for ABBV-3373; Adalimumab; Placebo for adalimumab
Intervention description: ABBV-3373 is administered as intravenous (IV) infusion; Placebo for ABBV-3373 is administered as IV infusion; Adalimumab is administered as subcutaneous (SC) injection; Placebo for adalimumab is administered as subcutaneous (SC) injection
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis (RA); ABBV-3373; Adalimumab

Summary:

      This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants
      with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX)
      compared with adalimumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American
             College of Rheumatology (ACR) classification criteria or 2010 ACR/European League
             against Rheumatism (EULAR) criteria.

          -  Participant meets the following disease activity criteria: >= 4 swollen joints (based
             on 28 joint count) and >= 4 tender joints (based on 28 joint count) at Screening and
             Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein
             (CRP) >= 3.2 at Screening.

          -  Participant has an incomplete response to methotrexate. Participants must have been on
             oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25
             mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week)
             for >= 4 weeks prior to the first dose of study drug. Participant must be expected to
             be able to continue on stable dose of MTX for the duration of study participation.

        Exclusion Criteria:

          -  Participants previously exposed to adalimumab or other anti-tumor necrosis factor
             (TNF) biologics.

          -  Participants previously exposed to non-anti-TNF biologics or targeted synthetic
             disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants
             exposed for less than 3 months and terminated not due to lack of efficacy or
             intolerability.
A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations
Condition: Autosomal Dominant Hypocalcemia (ADH)
MeSH terms: Arthrogryposis; Hypocalcemia
Intervention: NPSP795
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autosomal Dominant Hypocalcemia; Hypocalcemia; ADH; Hypoparathyroidism

Summary:

      This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor
      antagonist) on activating mutations of the Calcium-sensing receptor in patients with
      Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an
      inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and
      hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV
      infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary
      depending on measured levels of ionized calcium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not
             previously confirmed, genetic testing will be performed at the screening visit

          -  At least 18 years of age

          -  Body mass index (BMI) ≥ 18.5 to < 39 kg/m2

        Exclusion Criteria:

          -  Diseases or conditions that might compromise any major body system or interfere with
             the pharmacokinetics of NPSP795

          -  History of treatment with PTH 1-84 or 1-34 within the previous 6 months

          -  History of hypocalcemia requiring frequent IV calcium infusions

          -  History of hypocalcemic seizure within the past 3 months

          -  Blood 25-hydroxy vitamin D level < 25 ng/mL. If subjects have a blood 25-hydroxy
             vitamin D level < 25 ng/mL at the outpatient screening visit, they will be prescribed
             vitamin D replacement. Once the 25-hydroxy vitamin D level is > 25 ng/mL, the subject
             will be eligible to continue on to the treatment phase of the study

          -  Estimated glomerular filtration rate (GFR) < 25 mL/minute, and/or abnormal hepatic,
             hematologic, and/or clotting function

          -  12 lead resting electrocardiogram (ECG) with clinically significant abnormalities

          -  Concomitant medications with the potential to interfere with NPSP795 metabolism

          -  History of thyroid or parathyroid surgery