bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Fremanezumab
Intervention description: Fremanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in
      participants with cluster headache (CH). Participants who complete the pivotal studies
      TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the
      current study will visit the investigational center for investigational medicinal product
      (IMP) administration, safety and efficacy assessments, and blood and urine collections for
      pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses.
      Participants will return to the investigational center for a follow-up visit to evaluate
      ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant
      medications) approximately 7.5 months after the last dose of IMP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant completes either the Phase 3 pivotal study for ECH (Study
             TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057)
             without important protocol deviations related to participant safety and participant
             compliance.

          -  Prior to 15 June 2018, participants from the ECH study and the CCH study were
             enrolled. After 15 June 2018, only participants who participated in the ECH study
             (Study TV48125-CNS-30056) will be enrolled for active treatment.

          -  In addition, participants who do not complete the pivotal efficacy studies, and
             participants who complete the pivotal efficacy studies but will not continue treatment
             during this long-term safety study, will be offered to enroll in this study for the
             purpose of evaluating ADAs, and safety (adverse events and concomitant medications)
             approximately 7.5 months after administration of the last dose of the IMP.

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Any finding that, in the judgment of the investigator, is a clinically significant
             abnormality, including serum chemistry, hematology, coagulation, and urinalysis test
             values (abnormal tests may be repeated for confirmation)

               -  Additional criteria apply, please contact the investigator for more information
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: NDL-PDT; c-PDT; placebo c-PDT
Intervention description: Metvix natural daylight photodynamic therapy; Metvix conventional photodynamic therapy; Metvix placebo conventional photodynamic therapy
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 2 intra-individual groups:
Metvix NDL-PDT / Metvix c-PDT
Metvix NDL-PDT / Placebo c-PDT
Masking: Single (Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratoses; photodynamic therapy; natural daylight

Summary:

      This study was to be conducted as a multi-centre, randomized, investigator-blinded, active
      and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding
      efficacy) and superiority (regarding pain) study.

      The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared
      to c-PDT in terms of lesion complete response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the
             scalp on treated areas

          -  Subject with two symmetrical treated areas half scalps or two half faces excluding
             ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no
             more than a twofold difference in terms of total number of lesions between the two TAs

        Exclusion Criteria:

          -  Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas

          -  Subject with pigmented AK on the treated areas

          -  Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons

          -  Subject with porphyria,
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Beclomethasone dipropionate; Flunisolide
Intervention description: Beclomethasone dipropionate; Flunisolide
Intervention MeSH terms: Beclomethasone; Flunisolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: questionnaire; nasal spray; Seasonal allergic rhinitis; nasal spray questionnaire; allergic rhinitis

Summary:

      The Protocol section needs to be updated using the following text "The main goal of the study
      was to validate the Preference Module of the EARNS-Q and to test the reliability using
      Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for
      determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an
      Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen
      attribute rating items followed by fourteen importance weighing questions. The Preference
      Module includes the same items along with preference questions related to each item as well
      as a global preference question.
    

Eligibility criteria:

        Inclusion criteria:

          -  Seasonal allergic rhinitis.

          -  Nasal allergy symptoms during the spring allergy season.

        Exclusion Criteria:

          -  Prior use of beclomethasone dipropionate or flunisolide.

          -  Significant concomitant medical conditions.

          -  Use of corticosteroids.

          -  Use of allergy and other identified medications during the study.

          -  Current tobacco use or tobacco use within the past year.
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
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Condition: Chronic Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of chronic allergic conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a positive history of ocular allergies and a positive skin test reaction to a
             perennial allergen and a seasonal allergen

          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of
             instillation

        Exclusion Criteria:

          -  History of refractive surgery (including LASIK procedures) within the past 2 years

          -  History of retinal detachment, diabetic retinopathy, or active retinal disease

          -  Presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit

          -  Use any of the disallowed medications during the period indicated

          -  History of IOP increase as a result of steroid treatment
Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Condition: Video Assisted Thoracoscopic Surgery; Pain, Postoperative; Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion); US Guided Paravertebral Catheter (0.2% ropivicaine bolus); Thoracic Epidural (0.125% bupivicaine/hydromorphone)
Intervention description: Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.; Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.; Epidural catheter will be placed in the thoracic region prior to surgery.
Intervention MeSH terms: Hydromorphone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VATS; pain

Summary:

      The purpose of this study is to compare three different pain control methods on subjects who
      are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study
      will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic
      side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pt undergoing VATS procedure at Indiana University Hospital

          -  ASA 1,2,3 or 4

          -  Age 18 or older, male or female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion Criteria:

          -  Any contraindication for Thoracic Epidural or Paravertebral block

          -  History of substance abuse in the past 6 months

          -  Patient staying intubated after surgery

          -  Known allergy or other contraindications to the study medications , which include
             dilaudid, bupivacaine, ropivacaine
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide
Intervention description: Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to evaluate the long-term safety and tolerability of
      teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who
      completed Study SHP633-302 (NCT02980666).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent by a parent or guardian prior to any study-related procedures.

          -  When applicable, informed assent (as deemed appropriate by the Institutional Review
             Board [IRB]) by the participant prior to any study-related procedures.

          -  Participant completed Study SHP633-302 (NCT02980666).

          -  Participant (and/or parent/guardian) understands and is willing and able to fully
             adhere to study requirements as defined in this protocol.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
Perioperative Pregabalin in Ureteroscopy: a Pilot
Condition: Nephrolithiasis; Urolithiasis; Perioperative/Postoperative Complications; Pain, Postoperative; Pain, Acute; Anesthesia; Urologic Diseases; Anesthesia Morbidity
MeSH terms: Urolithiasis; Urinary Calculi; Nephrolithiasis; Kidney Calculi; Urologic Diseases; Pain, Postoperative; Postoperative Complications; Acute Pain
Intervention: Pregabalin 300mg
Intervention description: One 300mg capsule will be administered PO 1 hour before surgery
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants will receive 300mg PO pregabalin one hour before procedure start
Masking: None (Open Label)
Masking description: There will be no blinding for this pilot
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin; Perioperative medicine; Opioid sparing; Urolithiasis; Ureteroscopy

Summary:

      The investigators propose a pilot clinical trial on the use of perioperative pregabalin in
      order to decrease ureteral stent related symptoms and decrease opioid usage after
      ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will
      receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess
      safety and feasibility of studying this regimen at our institution, with the aim of
      performing a randomized, placebo-controlled, double-blinded study in the future.
    

Eligibility criteria:

        Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at
        University of Missouri Hospital and affiliated facilities

        Subject Inclusion

        Age >= 18 years

        Subject Exclusion

          -  Renal insufficiency (eGFR < 30 mL/minute/1.73 m2)

          -  Chronic indwelling ureteral stent

          -  Chronic opioid use

          -  History of opioid abuse

          -  Chronic gabapentinoid use

          -  Plan for inpatient hospitalization

          -  Pregnancy

          -  Inability of the patient to consent for themselves in English

          -  Allergy to gabapentinoid

          -  Liver failure or hepatic dysfunction
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 20mg; Placebo; Metformin ≥ 1000 mg
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed as a prospective, multi-centre, parallel group, double-blind
      randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of
      MP-513 (Teneligliptin) in combination with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form obtained from the subject, in accordance.

          -  The subject is aged ≥18 years at signature of the informed consent form.

          -  Hospitalization status: outpatient.

          -  The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3
             months at the screening visit (Day -28).

          -  The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000
             mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and
             diet and exercise regimen has not been changed for at least 8 consecutive weeks at the
             screening visit (Day -28). Subjects who cannot do exercise due to complication are not
             limited to this criteria.

          -  The subject's HbA1c is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day
             -14.

        Exclusion Criteria:

          -  The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.

          -  The subject has received insulin within 1 year prior to the screening visit (Day -28),
             with the exception of insulin therapy during hospitalization or insulin therapy for
             medical conditions not requiring hospitalization (< 2 weeks' duration).

          -  The subject has received an anti-diabetic drug within 8 weeks prior to the screening
             visit (Day -28).
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261
Intervention description: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure cluster; acute repetitive seizures; open-label; intranasal Midazolam; USL261; Upsher-Smith

Summary:

      The purpose of this study is to examine the long-term safety and tolerability of USL261 in
      the treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's
             seizure cluster episodes

          2. Has an established diagnosis of partial or generalized epilepsy that includes all the
             following:

               -  A documented history of seizure clusters lasting a minimum of 10 minutes, seizure
                  cluster pattern is observable, stereotyped, and recognizably different from the
                  subject's other non-cluster seizure activity (if any)

               -  A second seizure in the seizure cluster typically occurs within 6 hours from the
                  time of recognition

               -  A seizure cluster pattern composed of multiple (≥ 2) partial or generalized
                  seizures

               -  A seizure cluster pattern established >3 months before Visit 1

               -  A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1

               -  At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1

          3. Currently on a stable regimen of AED(s) that includes a benzodiazepine

          4. Weight is 40 kg to 125 kg, inclusive

        Exclusion Criteria:

          1. Has a neurological disorder that is likely to progress in the next year

          2. Has a severe chronic cardio-respiratory disease

          3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

          4. Has a history of their stereotypical seizure cluster progressing to status epilepticus
             within 2 years before Visit 1

          5. Has a history of acute narrow-angle glaucoma

          6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before
             Visit 1 or a suicide attempt in the past 5 years
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo; Sotagliflozin
Intervention description: Placebo once daily, before first meal of the day.; Sotagliflozin once daily, before first meal of the day.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 793.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose
      or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when
      used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have
      inadequate glycemic control with insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants had given written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of T1D made at least 1 year
             prior to informed consent.

          -  Participants were being treated with insulin or insulin analog delivered. via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  Willing and able to perform self-monitored blood glucose (SMBG) and complete the study
             diary as required per protocol.

          -  At the Screening Visit, A1C must be between 7.0% to 11.0%.

          -  Females of childbearing potential must use an adequate method of contraception and
             have a negative pregnancy test .

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             randomization.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the
             Investigator.