bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 oral capsules.; SAGE-217 matched-placebo oral capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: SAGE-217; Postpartum depression

Summary:

      The purpose of this study is to determine if treatment with SAGE-217 reduces depressive
      symptoms in females with severe postpartum depression (PPD) as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has ceased lactating or agrees not to provide breastmilk to her infant(s)
             from just prior to receiving the investigational product (IP) on Day 1 until 7 days
             after the last dose of IP.

          -  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 DSM-5 Clinical Trial Version
             (SCID-5-CT).

          -  Participant is ≤12 months postpartum at screening and Day 1.

        Exclusion Criteria:

          -  Participant is at significant risk of suicide or has attempted suicide associated with
             the current episode of PPD.

          -  Participant has active psychosis per investigator assessment.

          -  Participant has a medical history of nonfebrile seizures.

          -  Participant has a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.

          -  Participant has a history of sleep apnea.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Liraglutide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Liraglutide 1.8mg; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2
      diabetes, however, these have not been studied prospectively in subjects with type 1
      diabetes. The investigators have, therefore, designed this study to investigate the central
      hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect.
      A major secondary objective of this study is to elucidate the mechanisms responsible for its
      glucose lowering effects and those involved in reducing the insulin dose. The specific aims
      of this proposal are:

      Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c,
      fasting, postprandial and the overall mean glucose concentrations while decreasing the dose
      of insulin required.

      Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and
      postprandial glucagon concentrations and increases basal and postprandial C-peptide
      concentrations.

      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric
      emptying.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as
             insulin pump) or multiple (four or more) injections of insulin per day.

          2. Regularly measuring blood sugars four times daily.

          3. HbA1c of less than 8.5%.

          4. Well versed with carbohydrate counting.

          5. Age 18-75 years.

          6. BMI 20-40 kg/m2

        Exclusion Criteria:

          1. Type 1 diabetes for less than 6 months;

          2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
             bypass, surgery or coronary angioplasty) in the previous four weeks;

          3. Hepatic disease (transaminase > 3 times normal) or cirrhosis;

          4. Renal impairment (serum eGFR < 30ml/min/1.73m2);

          5. HIV or Hepatitis B or C positive status;

          6. Participation in any other concurrent clinical trial;

          7. Any other life-threatening, non-cardiac disease;

          8. Use of an investigational agent or therapeutic regimen within 30 days of study.

          9. history of pancreatitis

         10. pregnancy

         11. inability to give informed consent

         12. history of gastroparesis

         13. history of medullary thyroid carcinoma or MEN 2 syndrome.
Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant
Intervention description: Atogepant Tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 685.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Migraine; Aura

Summary:

      The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once
      a day for the prevention of migraine in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and participant privacy information (eg, written
             authorization for use and release of health and research study information) obtained
             from the participant prior to initiation of any study-specific procedures.

          -  Participants must be using a medically acceptable and effective method of birth
             control during the course of the entire study.

          -  Eligible participants who completed the double-blind treatment period (Visit 7) and
             the follow-up period (Visit 8), if applicable, depending on the timing of study
             initiation, of Study 3101-301-002 (NCT03777059) without significant protocol
             deviations (eg, noncompliance to protocol-required procedures).

        Exclusion Criteria:

          -  Female participant is pregnant, planning to become pregnant during the course of the
             study, or currently lactating. Women of childbearing potential must have a negative
             urine pregnancy test at Visit 1.

          -  Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP >
             100 mm Hg at Visit 1.

          -  Participants with clinically significant hematologic, endocrine, cardiovascular,
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: Celecoxib; Celecoxib; celecoxib; placebo
Intervention description: dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg; dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo; dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg; dose 1 placebo followed 6-12 hours later by dose 2 placebo
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: sore throat; acute pain

Summary:

      We are proposing a study in which we utilize and augment the sore throat pain model to assess
      the analgesic effectiveness of celecoxib compared to placebo in patients with painful
      pharyngitis under randomized, double-blind, placebo-controlled conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must have a diagnosis of pharyngitis with objective findings of
             tonsillo-pharyngitis.

          -  The patient is willing to take "nothing by mouth" including inhaled treatments except
             trial medication during the two hours while at the site and following trial drug
             administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The
             patient will be allowed food and drink between hours 2 and 24, but no other oral or
             inhaled treatments such as smoking, lozenges, chewing gum. After the two hour
             assessment, the patients will be allowed food and drink within one half-hour following
             any hourly evaluations sore throat.

        Exclusion Criteria:

          -  The patient has used any analgesic/antipyretic within 1 dosing interval preceding
             administration of the first dose of trial medication.

          -  The patient anticipates using any inhaled therapy including beta-agonists (e.g.,
             ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy
             on an intermittent basis in the week prior to the screening visit.
The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Condition: Acetabular Fractures
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Placebo
Intervention description: Tranexamic acid: anti-fibrinolytic agents; Placebo
Intervention MeSH terms: Fibrinolytic Agents; Tranexamic Acid; Antifibrinolytic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if patients undergoing acetabular ORIF (open
      reduction with internal fixation) who receive tranexamic acid have a reduced risk of
      allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for
      thromboembolic events compared to patients who receive placebo. Investigators want to
      determine the cost-effectiveness related to allogenic blood transfusion as a blood loss
      management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic
      surgery carries with it a significant risk for blood loss. Current management of
      perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood
      transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse
      reactions. There have been significant efforts to reduce the use of allogenic blood
      transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been
      used in management of blood during surgery. In order to determine the impact of tranexamic
      acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will
      conduct a prospective randomized study. Patients undergoing acetabular surgery will be
      screened for this study. Patients will be then randomized to placebo or tranexamic acid which
      will be administered during and after surgery. The following data will be collected: patient
      characteristics, surgery information, blood loss, blood transfusions, wound complication
      within 30 days of surgery, and cost.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients aged 18 or above undergoing acetabular ORIF.

        Exclusion Criteria:

          -  All patients aged below 18 years undergoing acetabulum surgery

          -  Patients with color-blindness (color vision changes used to assess toxicity)

          -  Patients with subarachnoid hemorrhage.

          -  Patients with active intravascular coagulation.

          -  Patients with a previous history of venous thromboembolism or with a history of
             hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).

          -  Prisoners

          -  Pregnant women
ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
Condition: Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC); Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related; Familial Transthyretin Cardiac Amyloidosis
MeSH terms: Amyloid Neuropathies; Amyloid Neuropathies, Familial; Cardiomyopathies; Amyloidosis, Familial; Amyloidosis
Intervention: Revusiran (ALN-TTRSC); Sterile Normal Saline (0.9% NaCl)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cardiomyopathy; Heart Failure; FAC; Amyloid; Transthyretin; TTR; RNAi therapeutic

Summary:

      The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in
      patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has
      been discontinued; patients are being followed-up for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented TTR mutation

          -  Amyloid deposits in cardiac or non-cardiac tissue

          -  Medical history of heart failure

          -  Evidence of cardiac involvement by echocardiogram

        Exclusion Criteria:

          -  Has known primary amyloidosis (AL), leptomeningeal amyloidosis, non-FAC hereditary
             cardiomyopathy, hypertensive cardiomyopathy, or cardiomyopathy due to valvular heart
             disease

          -  Has known peripheral vascular disease affecting ambulation

          -  Has a Polyneuropathy Disability score >2

          -  Has a New York Heart Association (NYHA) classification of IV
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Condition: Thromboembolism
MeSH terms: Sinus Thrombosis, Intracranial; Thrombosis; Thromboembolism
Intervention: Dabigatran etexilate; Warfarin
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      This is a multi-center, prospective, international, randomized (1:1), open-label study with
      two parallel groups. This phase III study is planned to investigate the efficacy and safety
      of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of
      major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with
      blinded endpoint adjudication.
    

Eligibility criteria:

        Inclusion criteria:

          -  Written informed consent in accordance with International Conference on Harmonization
             (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

          -  Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or
             without intracranial haemorrhage

          -  Completion of anticoagulation therapy for 5-15 days which has been administered until
             randomisation; anticoagulation must include full-dose low molecular weight heparin or
             unfractionated heparin

          -  Eligibility for treatment with an oral anticoagulant

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system
             infection or due to head trauma

          -  Planned surgical treatment for CVT

          -  Conditions associated with increased risk of bleeding

          -  History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence
             according to Investigator judgment

          -  Treatment with an antithrombotic regimen for an indication other than CVT and
             requiring continuation of that treatment for the original diagnosis without change in
             the regimen

          -  Severe renal impairment

          -  Active liver disease

          -  Pregnancy, nursing or planning to become pregnant while in the trial

          -  Further exclusion criteria apply
EZN-2279 in Patients With ADA-SCID
Condition: ADA-SCID; Adenosine Deaminase Deficiency; Severe Combined Immunodeficiency
MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Intervention: EZN-2279; Adagen
Intervention description: Weekly administration of EZN-2279 via IM injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of
      EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated
      with Adagen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of ADA-deficient combined immunodeficiency

          2. Stable clinical status while receiving therapy with Adagen®. Patients previously
             receiving gene therapy or undergoing hematopoietic stem cell transplantation who still
             require Adagen® treatment are eligible. The dose of Adagen® must be stable for at
             least 6 months prior to study entry.

          3. Have both of the following during the Adagen® Lead-in phase of the study prior to
             EZN-2279 transition:

               1. Trough plasma ADA activity >15 μmol/h/mL while receiving Adagen® and

               2. Total erythrocyte dAXP ≤0.02 μmol/mL from a trough blood sample

          4. Patients or parent/guardian must be capable of understanding the protocol requirements
             and risks and providing written informed assent/consent

        Exclusion Criteria:

          1. Autoimmunity requiring immunosuppressive treatment

          2. Patients with detectable neutralizing anti-Adagen® antibodies at screening evaluation

          3. Severe thrombocytopenia (platelet count <50 x 10^9/L)

          4. Current participation in other therapeutic protocols for ADA-deficient combined
             immunodeficiency

          5. Current or prior participation in another clinical study with an investigational agent
             and/or use of an investigational drug in the 30 days before study entry

          6. Known planned participation in a gene-therapy study for the planned duration of this
             study

          7. Any condition that, in the opinion of the PI, makes the patient unsuitable for the
             study

          8. Inability or unwillingness to administer Adagen® or EZN-2279 on a one-time-per-week
             regimen

          9. Inability to comply with the study protocol

         10. Female patients who are pregnant or lactating

         11. Female patients who are breast-feeding

         12. Female subjects of childbearing potential who are not using an FDA approved birth
             control method
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Gel (BID); Vehicle Gel (BID)
Intervention description: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days; One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      (LE) ophthalmic gel, 0.38% (BID)
    

Eligibility criteria:

        Inclusion Criteria:

        Visit 1 (Screening Visit)

          -  Be willing and able to comply with all treatment and follow-up/study procedures.

          -  Be a candidate for routine, uncomplicated cataract surgery.

        Visit 3 (Postoperative Day 1)

          -  Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with
             posterior chamber intraocular lens (IOL) implantation, not combined with any other
             surgery) in the study eye.

          -  Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

        Exclusion Criteria:

          -  Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          -  Have known hypersensitivity or contraindication to the study drug(s) or their
             components.