bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Condition: Chorea, Huntington
MeSH terms: Huntington Disease; Chorea
Intervention: Valbenazine; Placebo
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Huntington's; Huntington; Chorea; Movement disorder; Valbenazine; HD; Tetrabenazine; VMAT2-Inhibitor

Summary:

      This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the
      efficacy, safety, and tolerability of valbenazine to treat chorea in participants with
      Huntington disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Huntington Disease (HD) with chorea

          2. Be able to walk, with or without the assistance of a person or device

          3. Participants of childbearing potential who do not practice total abstinence must agree
             to use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently while participating in the study until 30 days (females) or 90 days
             (males) after the last dose of the study drug

          4. Be able to read and understand English

        Exclusion Criteria:

          1. Have a history of previously established therapy with a VMAT2 inhibitor, in the
             judgement of the investigator

          2. Have difficulty swallowing

          3. Are currently pregnant or breastfeeding

          4. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch
             block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure

          5. Have an unstable or serious medical or psychiatric illness

          6. Have a significant risk of suicidal behavior

          7. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1
             year of screening

          8. If taking antidepressant therapy, be on a stable regimen

          9. Have received gene therapy at any time

         10. Have received an investigational drug in a clinical study within 30 days of the
             baseline visit or plan to use such investigational drug (other than valbenazine)
             during the study

         11. Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the
             baseline visit

         12. Had a medically significant illness within 30 days before baseline, or any history of
             neuroleptic malignant syndrome
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo matching with Saxagliptin; Metformin IR; Metformin XR; Saxagliptin
Intervention description: Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52; Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52; Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52; Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination
      with Metformin in pediatric patients with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of
             age at the time of screening

          -  Previously diagnosed as having type 2 diabetes

          -  HbA1c ≥7.0% and ≤10.5%

          -  Body weight ≥ 30 kg

          -  Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months

          -  Women must have a negative serum or urine pregnancy test

          -  Women must not be breastfeeding

        Exclusion Criteria:

          -  Current use of anti-diabetic medications or use within the specified timeframe prior
             to screening (Exception: Metformin)

          -  Fasting plasma glucose (FPG) > 255 mg/dL

          -  Diabetic ketoacidosis (DKA) within 6 months of study entry

          -  Abnormal renal function

          -  Active liver disease

          -  Anemia

          -  An abnormal Thyroid Stimulating Hormone (TSH)

          -  Creatinine kinase (CK) ≥ 3X ULN
A Comparison of Once a Day Dose Compared to 2 Doses/Day
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mesalamine Once-Daily; Mesalamine Twice-Daily
Intervention description: Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks; Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1027.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy in maintaining remission of ulcerative
      colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol
      dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of ulcerative colitis that has been successfully maintained in
             remission for at least 3 months prior to study entry

          -  At least one flare in the past 18 months

          -  Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day
             (stable dose is defined as the same dose for the past 3 months)

          -  Females must be postmenopausal or surgically sterile or have a negative urine
             pregnancy test and practice acceptable contraception

        Exclusion Criteria:

          -  History of or current renal disease

          -  History of hepatic disease

          -  History of allergy or hypersensitivity to salicylates, aminosalicylates

          -  Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90
             days of screening

          -  Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ribavirin
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule; Capsule
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Interferon-Free; Hepatitis C Genotype 1b; Chronic Hepatitis C; Hepatitis C Virus; Hepatitis C; Treatment-Naive; Paritaprevir; Ombitasvir; Dasabuvir; Viekira PAK; Ribavirin

Summary:

      The purpose of this study is to evaluate the safety and antiviral activity of
      ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without
      cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to
             10,000 IU/mL at screening)

          -  Subject has never received antiviral treatment for hepatitis C infection

          -  No evidence of liver cirrhosis

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

          -  Positive screen for drugs or alcohol

          -  Significant sensitivity to any drug

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Abnormal laboratory tests
Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3
Condition: Oxidative Stress; Endothelial Dysfunction
Intervention: valsartan (ARB); ramipril (ACE inhibitor); Placebo
Intervention MeSH terms: Valsartan; Ramipril; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hemodialysis; fibrinolysis; oxidative stress; systemic inflammatory reaction; endothelial dysfunction; carotid intima media thickness (IMT; angiotensin receptor blockade; angiotensin converting enzyme inhibition

Summary:

      The purpose of the study is to see how two classes of blood pressure
      medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin
      receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body
      and on the carotid arteries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  On thrice weekly chronic hemodialysis for at least 6 months

          -  Clinically stable, adequately dialyzed [single-pool Kt/V > 1.2 or Urea Reduction Ratio
             (URR) > 65%] thrice weekly, with polysulphone membrane for at least 3 consecutive
             months prior to study

        Exclusion Criteria:

          -  History of functional transplant less than 6 months prior to study

          -  Use of immunosuppressive drugs within 1 month prior to study

          -  History of active connective tissue disease

          -  History of acute infectious disease within one month prior to study

          -  AIDS (HIV seropositivity is not an exclusion criteria)

          -  History of myocardial infarction or cerebrovascular event within 3 months

          -  Advanced liver disease

          -  Gastrointestinal dysfunction requiring parental nutrition

          -  Active malignancy excluding basal cell carcinoma of the skin

          -  History of ACE inhibitor-associated cough (intolerable) or angioedema

          -  Ejection fraction less than 30%

          -  Inability to discontinue ACE inhibitor or ARB

          -  Predialysis potassium repeatedly higher than 6.0 mmol/L (confirmed on a repeated blood
             draw)

          -  Anticipated live donor kidney transplant

          -  Pregnancy or breast-feeding

          -  History of poor adherence to hemodialysis or medical regimen

          -  Inability to provide consent
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: ceftaroline; vancomycin plus aztreonam; Placebo
Intervention description: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days; vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.; Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil; Aztreonam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Antibacterial; Antibiotic; Antimicrobial; Bacterial infection, skin; Ceftaroline; Ceftaroline acetate; Cellulitis; Cephalosporin; Complicated skin and skin structure infection (cSSSI); cSSSI; Intravenous; Methicillin-resistant Staphylococcus Aureus (MRSA); PPI-0903; Prodrug; Skin disease, bacterial; Skin infection; Staphylococcal skin infection; Staphylococcus aureus; Streptococcal skin infection; Surgical site infection; TAK-599

Summary:

      The purpose of this study is to determine whether ceftaroline is effective and safe in the
      treatment of complicated skin infections in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires
             significant surgical intervention, or cellulitis or abscess on lower extremity which
             occurs in subjects with diabetes mellitus or well-documented peripheral vascular
             disease.

        Exclusion Criteria:

          -  Prior treatment of current complicated skin and skin structure infection (cSSSI) with
             an antimicrobial.

          -  Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior
             isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Condition: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy
Intervention: IgPro20
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose
      of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with
      regard to safety and efficacy.

      Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a
      CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will
      have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for
      up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose
      IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.
      Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed
      a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP
      relapse within 4 weeks, they will be withdrawn.

      The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
             rescued from a CIDP relapse during the SC Treatment Period of pivotal study
             IgPro20_3003 (NCT01545076).

          -  Written informed consent for study participation obtained before undergoing any
             study-specific procedures.

        Exclusion Criteria:

          -  Subject is unable to directly transition from study IgPro20_3003.

          -  New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
             during participation in study IgPro20_3003 that in the judgment of the investigator
             could increase risk to the subject, interfere with the evaluation of investigational
             medicinal product, and/or conduct of the study.
Promoting Heart Health in Preschool Children
Condition: Cardiovascular Health
Intervention: Children-Multicomponent intervention
Intervention description: The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a "Healthy family day" workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide.
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2279.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: behavioral modification; health communication; prevention

Summary:

      As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular
      Institute, a multidisciplinary team design and implemented a pedagogic and communication
      strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included
      educational materials, pedagogical activities and the use of Sesame Workshop healthy habits
      for life materials. For Colombia, the latter were largely developed in collaboration with the
      Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery,
      Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children attending one of the 14 H.I. in Usaquén

          -  Children who are 3, 4, or 5 years of age at the time of the beginning of the
             intervention

        Exclusion Criteria:

          -  Unwillingness to provide informed consent

          -  Children who have received formal training in healthy habits in nutrition and / or
             physical activity in the 6 months prior to the start of the follow-up period of the
             study.

          -  Children who plan to receive formal training in healthy habits in nutrition and / or
             physical activity during the follow-up study period.
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: tirasemtiv
Intervention description: Oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; tirasemtiv

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in
      patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv
      in ALS (CY 4031).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal
             consent is given, a Legal Designee of the patient must sign the ICF form

          -  Completed participation on study drug and the Follow-Up Visit in the CY 4031 study

          -  Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree
             for the duration of their participation in the study to either:

               -  Use a condom during sexual intercourse with female partners who are of
                  childbearing potential AND to have female partners use a highly effective means
                  of contraception OR

               -  Abstain from sexual intercourse during participation in the study

          -  Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:

               -  Not be breastfeeding

               -  Have a negative pregnancy test

               -  Have no intention to become pregnant during participation in the study AND

               -  Practice sexual abstinence, defined as refraining from intercourse during the
                  duration of the study OR if male partners are not vasectomized with a confirmed
                  zero sperm count, require use of a condom AND use of a highly effective
                  contraceptive measure

        Exclusion Criteria:

          -  Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during
             the course of the study

          -  Has taken an investigational study drug (other than tirasemtiv) prior to dosing,
             within 30 days or five half-lives of the prior agent, whichever is greater

          -  Use of tizanidine and theophylline-containing medications during study participation

          -  Participation or planning to participate in any form of stem cell therapy for the
             treatment of ALS or another investigational drug
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: AXS-07
Intervention description: AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Axsome; AXS-07; MoSEIC™ meloxicam; rizatriptan

Summary:

      MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to
      evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect
      of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has participated in a prior study with AXS-07 for the treatment of migraine

        Exclusion Criteria:

          -  Has previously received any investigational drug or device or investigational therapy
             within 30 days before Screening, other than AXS-07

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study