bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; MDD; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: TC-5214; Placebo
Intervention description: Tablet, oral, twice daily for 52 weeks; Tablet, oral, twice daily for 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 813.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy

Summary:

      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      for 52 weeks with another antidepressant medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Outpatient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder, psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  Patients with significant liver, kidney, lung, heart, neurological, or any other
             medical conditions that might confound the study or put the patient at greater risk
             during study participation.
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Condition: Possible Fungal Infection
MeSH terms: Mycoses
Intervention: voriconazole (Vfend); voriconazole (Vfend)
Intervention description: voriconazole, early treatment; voriconazole, deferred treatment
Intervention MeSH terms: Voriconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neutropenia; Fever of unknown origin; Empirical treatment; Voriconazole

Summary:

      A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the
      number of white blood cells, especially of the so-called neutrophil granulocytes, which are
      very important for the defense against infections. Hence their decrease (called
      "neutropenia") leads to a predisposition to infections.

      Since infections during neutropenia can be very dangerous, the patients are treated with
      antibiotics from the very first signs of such an infection (usually fever). If the
      antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature
      within four days, a drug against fungi is added.

      In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as
      usual) only in case the antibiotics alone do not lead to a normalization of the body
      temperature (current standard of care). The other half of the patients receive voriconazole
      immediately after onset of fever (concomitantly with the antibiotics).

      The research question is, whether in the "early-treatment" group fewer manifest fungal
      infections will be observed than in the "late-treatment" group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;

          -  Neutropenia (<500 neutrophils/µL) of at least 10 days;

          -  Newly diagnosed fever;

          -  Positive panfungal polymerase chain reaction assay

        Exclusion Criteria:

          -  Documented bacterial infection during screening or at randomization

          -  Fungemia or other documented invasive fungal infection during screening or at
             randomization.
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Condition: Spinal Cord Injury; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Intervention: Fampridine-SR; Placebo
Intervention description: 25mg bid (twice daily); Placebo
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: spinal cord injury; muscle spasticity

Summary:

      Normally, nerve fibers carry electrical impulses through the spinal cord, providing
      communication between the brain and the arms and legs. In people with spinal cord injury,
      some fibers may be destroyed at the site of injury, while others remain connected but do not
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as
      bladder control, bowel function and sexual function. The study will also examine the possible
      risks of taking Fampridine-SR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6
             months)

          -  Moderate to severe lower-limb spasticity

          -  Able to give informed consent and willing to comply with protocol

        Exclusion Criteria:

          -  Pregnancy

          -  History of seizures

          -  Existing or history of frequent Urinary Tract Infections

          -  History of drug or alcohol abuse

          -  Allergy to pyridine-containing substances

          -  Received a botox injection 4 months prior to study

          -  Received an investigational drug within 30 days

          -  Previously treated with 4-aminopyridine (4-AP)

          -  Not on stable medication dosing in 3 weeks prior to study

          -  Abnormal ECG or laboratory value at screening
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AGN-229666
Intervention description: One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal
      or perennial allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients living in Japan with allergic conjunctivitis with itching and
             redness

          -  Able and willing to discontinue wearing any contact lenses during the study period.

        Exclusion Criteria:

          -  Eye surgical intervention and/or a history of refractive surgery within 6 months

          -  History of retinal detachment, diabetic retinopathy, or progressive retinal disease

          -  Presence of active eye infection (bacterial, viral, or fungal)

          -  History of an eye herpetic infection

          -  Use of corticosteroids within 6 months or anticipated use during the study.
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101
Intervention description: AR101 powder
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen (CPNA); (Characterized Peanut Allergen) OIT; Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adolescents; Desensitization; Quality of Life; OIT (oral immunotherapy); CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)

Summary:

      To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in
      combination with standard of care (peanut avoidance, education) versus standard of care alone
      in peanut-allergic subjects aged 4 to 17 years.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 4 through 17 years

          -  History of physician diagnosed IgE mediated peanut allergy with characteristic signs
             and symptoms

          -  Positive SPT for peanut

          -  Positive serum IgE to peanut

          -  Written informed consent from the subject's parent/guardian

          -  Written assent from the subject as appropriate

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  Uncertain clinical diagnosis of peanut allergy

          -  History of severe or life threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of screening

          -  Severe persistent asthma or uncontrolled mild or moderate asthma

          -  History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease,
             severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent
             gastrointestinal symptoms of undiagnosed etiology

          -  History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and
             hereditary or idiopathic angioedema

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of chronic disease (other than asthma, atopic dermatitis, or allergic
             rhinitis) that is, or is at significant risk of becoming, unstable or requiring a
             change in chronic therapeutic regimen
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Placebo comparator; risedronate
Intervention description: oral weekly for one year; 35 mg risedronate, once a week for one year
Intervention MeSH terms: Risedronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: Female
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral
      Quantitative Computed Tomography) technology to detect minute changes in bone
      microarchitecture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  cessation of menstruation (surgical or natural) between 6 and 36 months prior to study
             enrollment;

          -  osteopenic

          -  must have at least 1 evaluable radius and tibia, without history of fracture
             (traumatic or atraumatic)

          -  BMI (body mass index) between 18 and 28 kg/m2 inclusive;

        Exclusion Criteria:

          -  history of any generalized bone disease, including hyperparathyroidism, Paget's
             disease of bone, renal osteodystrophy, or any other acquired or congenital bone
             disease; or any known condition that would interfere with the assessment of DXA
             (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar
             vertebrae at lumbar spine L1 - L4) or the femoral neck.

          -  clinical or radiological evidence of osteoporosis, such as atraumatic vertebral
             compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior
             height ratio; or 20% reduction of the anterior, middle, and/or posterior height as
             compared with the adjacent vertebrae) documented by spinal X ray or a history of
             osteoporosis-related atraumatic fracture of the hip or of the wrist;

          -  glucocorticoid-induced osteopenia;

          -  previous bisphosphonate therapy;
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Condition: Non-obstructive Azoospermia
MeSH terms: Azoospermia; Pain, Postoperative
Intervention: Gabapentin; Placebo
Intervention description: Gabapentin 600mg tablet; Placebo tablet
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 74.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative
      and post-operative period to reduce or potentially eliminate narcotic usage following scrotal
      surgery. Research study results have shown that the use of anti-inflammatories in the
      peri-operative period reduces both pain and narcotic use. The hypothesis is that adding
      another agent in the multi-modal pathway will further reduce pain and potentially reduce
      narcotic usage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants undergoing microsurgical testicular sperm extraction.

          -  Participants over 18 years of age who can provide informed consent

          -  Participants with no contraindication to the consumption gabapentin or documented
             allergy/intolerance

          -  Participants not currently using opiates for another reason

        Exclusion Criteria:

          -  Contraindication to the consumption of celecoxib or gabapentin

          -  History of substance abuse (including prior opiate abuse)

          -  Narcotic use within last 3 months

          -  Any of the following comorbidities: renal failure, heart disease, peptic ulcer
             disease, cerebrovascular disease, significant liver disease, untreated depression,
             chronic pain disorder, or bleeding diatheses

          -  Medical history or concurrent illness that the investigator considers sufficiently
             serious to interfere with the conduct, completion, or results of this trial, or
             constitutes an unacceptable risk to the subject
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in
      participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

        Key Exclusion Criteria:

          -  Any other chronic liver disease

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Clinical hepatic decompensation

          -  Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
             inhibitor

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: NPSP558
Intervention description: 50, 75, 100 μg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PTH 1-84; Hypoparathyroidism; NPSP558; Parathyroid Hormone 1-84

Summary:

      This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in
      reducing requirements for supplemental oral calcium and active vitamin D, while maintaining
      stable total serum calcium levels in adult subjects with hypoparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who meet all the following inclusion criteria can be enrolled into this study:

          1. Signed and dated informed consent form (ICF) before any study-related procedures are
             performed

          2. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE
             study, OR Enrolled in REPLACE and dropped out during optimization, but currently meet
             inclusion/exclusion criteria for REPLACE

          3. Able to perform daily SC self-injections of study medication (or have a designee
             perform injection) via a multidose injection pen into the thigh

          4. Willingness and ability to understand and comply with the protocol

          5. Women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate
             serum follicle stimulating hormone (FSH) levels (> 40 IU/L); (2) surgically
             sterilized; OR (3) of childbearing potential with a negative pregnancy test at
             screening and who consent to use two acceptable methods of contraception for the
             duration of the study, with pregnancy testing at every scheduled visit during the
             treatment period . Female partners (who are of childbearing potential) of male study
             patients must also use acceptable forms of contraception during their partner's
             participation

        Exclusion Criteria:

        Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not
        eligible for enrollment in this study:

          1. Any condition that, in the investigator's opinion after consultation with the sponsor,
             would preclude the safe use of NPSP558

          2. Any disease or condition in the opinion of the investigator that has a high
             probability of precluding the patient from completing the study or where the patient
             cannot or will not appropriately comply with study requirements

          3. Pregnant or lactating woman
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: Lorazepam
Intervention description: intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to < 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.
Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study.
Intervention MeSH terms: Lorazepam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Lorazepam; Status Epilepticus

Summary:

      The purpose of this study is to determine the efficacy, safety and pharmacokinetics of
      Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with status epilepticus or repetitive status epilepticus / cluster seizure
             who have seizures that can be evaluated by investigator's visual observations based on
             motor symptoms or who have seizures that can be evaluated by EEG.

          -  Subjects with status epilepticus accompanied by generalized seizure, partial seizure
             or secondarily generalized seizure lasting 5 minutes or longer

          -  Subjects with repetitive status epilepticus / cluster seizure accompanied by not less
             than 3 consecutive episodes of generalized seizure, partial seizure or secondarily
             generalized seizure in 1 hour.

          -  Subjects not younger than 3 months (either gender is eligible for the study)

        Exclusion Criteria:

          -  Subjects with known or suspected recurrent seizures due to illegal drug or alcohol
             withdrawal

          -  Subjects with known history of hypersensitivity to lorazepam or benzodiazepine

          -  Subjects with a known history of benzodiazepine abuse.

          -  Subjects currently receiving lorazepam

          -  Subjects with angle-closure glaucoma

          -  Subjects with myasthenia gravis

          -  Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin,
             blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of
             normal of the institutional reference value (if the data is available)

          -  Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than
             1500/mm3 at screening visit (if the data is available)