bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Safety Study of AXS-05 in Subjects With Depression
Condition: Major Depressive Disorder; Treatment Resistant Depression; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: AXS-05 (dextromethorphan and bupropion) oral tablets
Intervention description: Oral tablets, taken twice daily for up to 12 months.
Intervention MeSH terms: Dextromethorphan; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 876.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; AXS-05; Dextromethorphan; Bupropion; Dopamine Reuptake Inhibitor; NMDA Receptor Antagonist; Nicotinic Acetylcholine Receptor Antagonist; Serotonin Reuptake Inhibitor; Axsome Therapeutics; Norepinephrine Reuptake Inhibitor; Sigma-1 Receptor Agonist; Glutamate Modulator; Antidepressant

Summary:

      An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder
      (MDD), including treatment resistant depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of major depressive disorder, including treatment resistant depression

          -  Body mass index (BMI) between 18 and 40 kg/m^2, inclusive

          -  Agree to use adequate method of contraception for the duration of the study

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Suicide risk

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

          -  Additional criteria may apply
An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes
Condition: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome
MeSH terms: Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Intervention: GWP42003-P
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 681.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Cannabidiol; CBD; GWP42003-P; GWPCARE5

Summary:

      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and adults with Dravet or Lennox-Gastaut syndromes.
    

Eligibility criteria:

        Key Inclusion Criteria:

        • Participant has completed the treatment phase of their Core Studies: GWEP1332A
        [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560],
        GWEP1424 [NCT02224703], and GWEP1423 [NCT02224690].

        Key Exclusion Criteria:

          -  Participant is currently using or has in the past used recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3
             months prior to study entry other than the investigational medicinal product (IMP)
             received during the Core Study and are unwilling to abstain for the duration for the
             study.

          -  Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the
             Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.

          -  Participant has been part of a clinical trial involving an IMP during the inter-study
             period.

          -  Female participant is of child bearing potential or male participant's partner is of
             child bearing potential, unless willing to ensure that they or their partner use
             highly effective contraception, for example, hormonal contraceptives, intrauterine
             devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or
             sexual abstinence, during the study and for 3 months thereafter (however, a male
             condom should not be used in conjunction with a female condom).

          -  Participant has significantly impaired hepatic function at the 'End of Treatment'
             visit of their Core Study or at Visit 1 if re-assessed: i) Alanine aminotransferase
             (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN); ii) ALT or
             AST >3 × ULN and (total bilirubin [TBL] >2 × ULN or international normalized ratio
             [INR] >1.5); iii) ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
             right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). This
             criterion must be confirmed prior to entering the study.
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: tozadenant; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor fluctuations; Off time; On time; Dyskinesia

Summary:

      Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient understands study requirements and has given his/her written informed consent
             on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved
             consent form.

          -  Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain
             Bank Diagnostic criteria

          -  Minimum of 3 years since diagnosis.

          -  Meet Hoehn and Yahr PD stage

          -  Good response to levodopa

          -  Stable regimen of anti-PD medications

          -  Patients must have been taking a levodopa-containing anti-PD medication continuously
             for at least the previous 12 months

          -  Patient has documented a minimum amount of Off time.

          -  If of childbearing potential (male and female) must use an acceptable method of
             contraception

        Exclusion Criteria:

          -  Previous tozadenant study participation

          -  Current or recent participation in another study.

          -  Secondary or atypical parkinsonism

          -  Neurosurgical intervention for PD

          -  Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®

          -  Treatment with excluded medications

          -  Untreated or uncontrolled hyperthyroidism or hypothyroidism

          -  Clinically significant out-of-range laboratory

          -  MMSE out of range

          -  Current episode of major depression (stable treatment for depression is permitted).

          -  Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide
             Severity Rating Scale (C-SSRS)

          -  Women lactating or pregnant

          -  Hypersensitivity to any components of tozadenant or excipients

          -  Abnormal findings on the physical or neurological examination, or medical history that
             would make the patient unsuitable for the study

          -  History of hepatitis or cholangitis
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Condition: Partial Epilepsies
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: lacosamide
Intervention description: 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 308.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Adjunctive treatment in epilepsy; add-on treatment for epilepsy; partial seizures; AEDs; antiepileptic drugs; seizures

Summary:

      The purpose of this trial is to determine whether lacosamide is safe and effective for
      long-term use in patients with partial-seizures from epilepsy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of parent clinical trial for treatment of partial seizures

        Exclusion Criteria:

          -  Receiving any study drug or experimental device other than lacosamide

          -  Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse
             event
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
Condition: Infantile Refsum's Disease; Zellweger Syndrome; Adrenoleukodystrophy; Peroxisomal Disorders; Cholestasis
MeSH terms: Cholestasis; Zellweger Syndrome; Adrenoleukodystrophy; Refsum Disease; Refsum Disease, Infantile; Peroxisomal Disorders
Intervention: Cholic Acids
Intervention description: 10-15 mg/kg body weight/day taken orally.
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Healthy volunteers: No

Summary:

      OBJECTIVES:

      I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate
      treatment to patients with identified inborn errors of bile acid synthesis and metabolism

      II. To assess the safety and tolerability of cholic acid
    

Eligibility criteria:

        PROTOCOL ENTRY CRITERIA:

        --Disease Characteristics--

        Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin
        malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis

        Inclusion criteria for enrollment were:

          -  Infants < age 3 months

          -  Children presenting for evaluation of cholestasis defined as a conjugated bilirubin >
             2mg/dl or increased serum bile acids

          -  Older subjects of any age with cholestatic liver disease if urine screens suggested
             that they had inborn errors of bile acid metabolism

          -  Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine
             analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis
             are indicated

          -  The patient and/or parent/legal guardian must have signed the written informed consent
             document before study start.

          -  The patient must be willing and able to comply with all study assessments and
             procedures.
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Condition: Iron Deficiency Anemia; Iron Deficiency Anaemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Iron isomaltoside/ferric derisomaltose
Intervention description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion.
Intervention MeSH terms: Iron isomaltoside 1000
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency Anemia; Iron Deficiency Anaemia; IDA; Intravenous iron replacement therapy; Chronic Kidney Disease; CKD; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Summary:

      Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose
      re-dosing, in subjects who were previously treated with iron isomaltoside/ferric
      derisomaltose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed one of the lead-in trials

          2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in
             trials.

          3. Haemoglobin (Hb) of ≤ 11 g/dL

          4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin
             saturation (TSAT) ≤ 30 %

          5. Willingness to participate and signing the informed consent form (ICF)

        Exclusion Criteria:

          1. Intravenous (IV) iron treatment between the lead-in trial and screening

          2. During 30-day period prior to screening or during the trial period; has or will be
             treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy

          3. Received an investigational drug within 30 days of screening

          4. Decompensated liver cirrhosis or active hepatitis

          5. Pregnant or nursing women.

          6. Any other laboratory abnormality, medical condition, or psychiatric disorders which,
             in the opinion of the Investigator, will put the subject's disease management at risk
             or may result in the subject being unable to comply with the trial requirements
Additive Homeopathy in Cancer Patients
Condition: Malignant Tumors
MeSH terms: Neoplasms
Intervention: Additive classical homeopathy; Homeopathic Placebo globules
Intervention description: Homeopathic remedies every 2 to 3 months; Homeopathic placebo globules every 2 to 3 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; additive homeopathy; patients with advanced malignant tumors

Summary:

      The investigators aim to investigate the validity of their previous results in a randomized
      prospective, placebo-controlled, double-blind, multicenter controlled evaluation of
      questionnaires in patients with advanced malignant tumors. The investigators plan to compare
      the treatment outcome (quality of life and survival) in tumor patients, receiving standard or
      "add-on" homeopathic treatment.

      The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for
      cancer patients. In addition the investigators evaluate survival time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC)
             IIIB, IIIC, IV.

        Exclusion Criteria:

          -  sensitizing mutation of the EGFR gene or translocation of the ALK gene

          -  refusal to sign informed consent

          -  pregnancy

          -  hematological, hepatic, or renal pathology

          -  coronary heart disease

          -  history of secondary tumor

          -  major surgery within 4 weeks prior to study entry

          -  active infection and symptomatic peripheral neuropathy

          -  central nervous system metastases unless the metastases were treated and stable

          -  active autoimmune disease

          -  use of systemic immunosuppressive treatment

          -  use of systemic treatment during the previous 2 years

          -  active interstitial lung disease, or a history of pneumonitis for which
             glucocorticoids were prescribed

          -  previous systemic therapy for metastatic disease or previous irradiation

          -  use of any complementary and/or alternative therapy, including homeopathy other than
             the research treatment during the trial
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
Condition: Herpes Zoster; Pneumococcal Infection
MeSH terms: Herpes Zoster; Pneumococcal Infections
Intervention: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Comparator: placebo (concomitant-vaccine matched); Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
Intervention description: 0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period; Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.; Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 473.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal
      Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given
      together (in different body sites), as when they are given alone, in adults 60 years of age
      and older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  Stable underlying conditions

          -  Postmenopausal if female

          -  Afebrile

        Exclusion Criteria:

          -  Previously vaccinated with either vaccine

          -  Immune deficiency

          -  History of allergy to components in either vaccine

          -  Concomitant antiviral therapy
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin 100mg; Canagliflozin 300mg; Metformin; Sulphonylurea
Intervention description: Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; The participant's stable dose of background therapy of metformin should be continued throughout the study.; The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 678.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Canagliflozin; Placebo; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to assess the safety, tolerability, and efficacy of the addition
      of canagliflozin relative to the addition of placebo in patients with inadequate glycemic
      control on metformin alone or in combination with a sulphonylurea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM with inadequate glycemic control on metformin monotherapy or on
             metformin in combination with an SU at protocol-specified doses and having HbA1c
             >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study.

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or
             fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L)
             during the pre-treatment phase, despite reinforcement of diet and exercise counseling

          -  History of a severe hypoglycemic episode within 6 months before screening

          -  History of or current illness considered to be clinically significant by the
             investigator
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
Condition: Post-ischemic Stroke
MeSH terms: Ischemic Stroke
Intervention: dalfampridine-ER 7.5 mg; dalfampridine-ER 10 mg
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an extension study to evaluate the long-term safety, tolerability, and efficacy of
      two dose strengths of dalfampridine-ER.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the DALF-PS-1016 study

          -  Providing informed consent to continue into the DALF-PS-1029 long-term extension study

          -  Sufficient ambulatory ability to independently complete the Two Minute Walk Test
             (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension
             study

        Key Exclusion Criteria:

          -  Seizures, new onset strokes (or other significant neurological event precluding
             long-term continuation) occurring during the antecedent DALF-PS-1016 study

          -  Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the
             long-term extension study