bioihbjkbjnl/mcl2 huggingface dataset:
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Long-Term Follow-Up of Patients who Received Engensis (VM202); Long-Term Follow-Up of Patients who Received Placebo
Intervention description: No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.; No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long term, prospective, non-interventional, safety extension study of phase 3 trial. Double blind, randomized, placebo-controlled, multicenter study/
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetic; neuropathy; shooting pain; burning pain; pins and needles pain; foot pain; ViroMed; Helixmith; Engensis; VM202

Summary:

      The purpose of this study is to explore the overall safety profile and durability of efficacy
      of Engensis (VM202) in painful diabetic peripheral neuropathy.

      All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270
      visit within the prior 90 days will be approached to enroll in the long-term safety extension
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Were randomized and dosed in the VMDN-003 study

          2. Received all IM injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003
             study

          3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90
             days prior to signing consent

        Exclusion Criteria:

          1. Were using an investigational drug or treatment

          2. Were unable or unwilling to give informed consent
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Brexanolone
Intervention description: Administered as IV infusion.
Intervention MeSH terms: Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 15 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of
      brexanolone in the treatment of adolescent female participants with postpartum depression
      (PPD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Participant has had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders (DSM-5) Axis I Disorders (SCID-5).

          2. Participant is ≤6 months postpartum at screening.

        Key Exclusion Criteria:

          1. Active psychosis

          2. Attempted suicide during current episode of PPD

          3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

        Note: Other protocol-defined inclusion/exclusion criteria may apply.
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Intravitreal aflibercept injection [IAI]; Sham
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy of intravitreal (IVT)
      aflibercept compared to sham treatment in the improvement of moderately severe to severe
      nonproliferative diabetic retinopathy (NPDR).

      The secondary objectives of the study are:

        -  To characterize the safety of IVT aflibercept in patients with moderately severe to
           severe NPDR

        -  To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and
           reduce the incidence of DME

        -  To determine the anatomic effects of IVT aflibercept in patients with moderately severe
           to severe NPDR
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately
             severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy
             severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in
             whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months
             per the investigator

          2. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS)
             letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40
             or better)

        Key Exclusion Criteria:

          1. Presence of diabetic macular edema (DME) threatening the center of the macula in the
             study eye

          2. Evidence of retinal neovascularization on clinical examination or Fluorescein
             Angiography (FA)

          3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye

          4. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or
             intravitreal (IVT) anti-VEGF treatment in the study eye

          5. Any prior intraocular steroid injection in the study eye

          6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional
             retinal detachment visible at the screening assessments in the study eye

        Note: Other inclusion/ exclusion criteria apply
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor
      (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic
      fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently participating in study VX17-659-105 (NCT03447262)

        Exclusion Criteria:

          -  History of drug intolerance in study VX17-659-105 that would pose an additional risk
             to the participant in the opinion of the investigator

          -  Current participation in an investigational drug trial (other than study VX17-659-105)

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Gantenerumab
Intervention description: Gantenerumab was administered as SC injection Q4W.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Healthy volunteers: No

Summary:

      The main purpose of the study was to evaluate the safety and tolerability of long-term
      administration of gantenerumab in participants with AD. All participants who have completed
      the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of
      this study. Of these, participants who completed Week 104 visit in Part 1. Participants
      received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the
      same dose as administered in the parent studies (part 1)/ Week 104 visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203
             or WN28745 will be eligible to participate in Part 1 of the study

          -  Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible
             for Part 2 of the study

          -  For Part 1 and Part 2:

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods that result in a failure rate
             of <1% per year during the treatment period and for at least 16 weeks after the last
             dose of study drug

          -  Agreement to not donate blood or blood products for transfusion for the duration of
             the study and for 1 year after final dose of study drug

          -  Availability of a person ('caregiver') who in the investigator's judgement, has
             frequent and sufficient contact with the participant

        Exclusion Criteria:

          -  Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study
             drug for any reason

          -  Any medical condition that may jeopardize the participant's safety if he or she
             continues to receive study treatment

          -  If the participant is unlikely to benefit from gantenerumab therapy, based on disease
             progression or other factors, or if study participation is otherwise not in the
             participant's best interest

          -  Any investigational treatment other than gantenerumab during or since completion of
             the OLEs of studies WN25203 or WN28745

          -  Pregnancy

          -  Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal
             leptomeningeal hemosiderosis)

          -  Evidence of intracerebral macrohemorrhage

          -  Part 2: Participants who have been discontinued from Part 1 of the study
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Condition: Stroke, Acute; Neurological Impairment
MeSH terms: Stroke; Ischemic Stroke
Intervention: EGb761; Placebo; Acetylsalicylic acid
Intervention description: EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.; Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.; Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association
      with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following
      ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient having had a single infarct in the carotid artery territory 3 to 8 days before
             inclusion

          -  Patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5)

          -  Patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time)
             test in the normal values of the laboratory

        Exclusion Criteria:

          -  Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8
             days prior

          -  Patient with known pre-existent cerebral infarction

          -  Infarct damaged area bigger than 1/3 hemisphere

          -  Patient having a score below the cut-off point at Frenchay Aphasia Short Test
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase Powder for Oral Solution
Intervention description: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 28 Days
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Liprotamase; Pancreatic Enzyme Replacement Therapy (PERT)

Summary:

      Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and
      amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be
      formulated without enteric coating for administration either as a capsule or as a dosing
      solution dissolved in water or juice. The purpose of the present study is to provide efficacy
      and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral
      Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Part A: males or females ≥7 years of age

          -  For Part B: males or females 28 days to <7 years

          -  Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride

          -  Low fecal elastase

          -  Fair-to-good nutritional status

        Exclusion Criteria:

          -  History or diagnosis of fibrosing colonopathy

          -  Distal intestinal obstruction syndrome in 6 months prior to screening

          -  Receiving enteral tube feedings

          -  Chronic diarrheal illness unrelated to pancreatic insufficiency

          -  Liver abnormalities, or liver or lung transplant, or significant bowel resection
Lubiprostone in Children With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1; 0 mcg soft capsules of placebo for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled
Masking: Double (Participant, Investigator)
Masking description: While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
Enrollment: 606.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Study to determine if children (6-17 years old) with functional constipation will respond to
      being treated with lubiprostone for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic
             Criteria for Childhood Functional Constipation

          -  At least 6 years of age but less than 18 years of age at the time of randomisation

          -  Only stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors are allowed if subject is taking antidepressants

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel
             syndrome (IBS), affecting GI motility or defecation

          -  Untreated faecal impaction at the time of screening

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Condition: Seizures
MeSH terms: Seizures; Epilepsy
Intervention: Cannabidiol Oral Solution
Intervention description: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Lennox-Gastaut syndrome; Dravet syndrome; Treatment-resistant seizures

Summary:

      This is a multicenter, open-label trial to assess the long-term safety and efficacy of
      Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with
      treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet
      syndrome (DS). All participants have rolled over from previous trials: INS011-14-029
      (NCT02324673) and INS011-15-054 (NCT02551731).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054

          -  Informed consent/assent (as applicable) was voluntarily provided by the participant
             and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and
             local requirements

          -  Is medically stable with no anticipated changes in chronic medications in the opinion
             of the Investigator

          -  Continues to meet protocol-specified criteria for qualification and contraception,
             including treatment-resistant seizure disorder

          -  In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able
             to continue keeping accurate seizure diaries

        Exclusion Criteria:

          -  Inadequate supervision by parent(s)/caregiver(s)

          -  History or current use of dietary supplements, drugs or over-the counter medications
             outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding)

               3. the analysis of results
Regional Anesthesia and Breast Cancer Recurrence
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Recurrence
Intervention: General anesthesia and opioids; Regional analgesia and propofol
Intervention description: General anesthesia, usually with sevoflurane, and opioid analgesia; Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
Intervention MeSH terms: Anesthetics; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2108.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Breast Cancer; Anesthesia; regional; cancer recurrence; Anesthesia; inhalational; Analgesia; opioid

Summary:

      In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy
      with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral
      anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be
      followed for up to 10 years to determine the rate of cancer recurrence or metastasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary breast cancer without known extension beyond the breast and axillary nodes
             (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)

          -  Scheduled for unilateral or bilateral mastectomy with or without implant (isolated
             "lumpectomy" will not qualify)

          -  Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least
             five nodes)

          -  Written informed consent, including willingness to be randomized to morphine or
             regional analgesia

        Exclusion Criteria:

          -  Previous surgery for breast cancer (except diagnostic biopsies)

          -  Inflammatory breast cancer

          -  Age < 18 or > 85 years old

          -  Scheduled free flap reconstruction

          -  ASA Physical Status ≥ 4

          -  Any contraindication to epidural or paravertebral anesthesia and analgesia (including
             coagulopathy, abnormal anatomy)

          -  Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine

          -  Other cancer not believed by the attending surgeon to be in long-term remission

          -  Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality