bioihbjkbjnl/mcl2 huggingface dataset:
Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Azithromycin; Placebos
Intervention description: Participants will be shipped a single 1.2 g dose of oral azithromycin; Participants will be shipped a dose of matching placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This individually randomized telemedicine-based trial aims to evaluate the efficacy of a
      single dose of azithromycin for prevention of progression of COVID-19 in patients with a
      recent positive SARS-CoV-2 test who are not currently hospitalized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a positive SARS-CoV-2 test and test results received within the previous
             seven days

          -  Not currently hospitalized

          -  Willing and able to receive study drug by mail

          -  Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via
             email or over the phone

          -  No known allergy or other contraindication to macrolides

          -  Age 18 years or older at the time of enrollment

          -  No known history of prolongation of the QT interval (eg. History of torsades de
             pointes, congenital long QT syndrome, bradyarrhthmia)

          -  No recent use of hydroxychloroquine within the past 7 days for participants >55 years
             of age

          -  Not currently taking nelfinavir or warfarin (Coumadin)

          -  Provision of informed consent

          -  Not currently pregnant
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema (DME)
MeSH terms: Macular Edema; Edema
Intervention: CT-P42; Eylea
Intervention description: 2mg/0.05 mL by Intravitreal injection; 2mg/0.05 mL by Intravitreal injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to
      Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic
      Macular Edema
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient aged ≥18 years.

          -  Patient with DME secondary to DM involving the center of the macula (defined as the
             Optical Coherence Tomography [OCT] central subfield) in the study eye.

        Exclusion Criteria:

          -  Patient who has only one functional eye.

          -  Patient who currently has, or has a history (where indicated) of active proliferative
             diabetic retinopathy
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate
Intervention description: Telotristat etiprate tablet (250 mg)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      orally administered telotristat etiprate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS
             (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS
             (NCT02063659)] study

          -  Patients of childbearing potential must agree to use an adequate method of
             contraception (defined as having a failure rate of <1% per year) during the study and
             for 12 weeks after the Follow-up visit.

          -  Ability and willingness to provide written informed consent

        Exclusion Criteria:

          -  Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS,
             LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study

          -  Positive pregnancy test

          -  Presence of any clinically significant findings at entry for medical history,
             laboratory values, or physical examination
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone tablets; Risperidone tablets
Intervention description: Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo); Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 388.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; Lurasidone; LATUDA

Summary:

      This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose,
      non-inferiority and multicentre study designed to evaluate the efficacy and safety of
      lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and aged between 18 and 65 years of age.

          -  Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total
             score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at
             Screening and Baseline.

          -  Not pregnant, if of reproductive potential agrees to use adequate and reliable
             contraception for duration of study.

          -  Able and agrees to remain off prior antipsychotic medication for the duration of
             study.

          -  Willing and able to comply with the protocol, including the inpatient requirements and
             outpatient visits.

        Exclusion Criteria:

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others or property.

          -  Any chronic organic disease of the CNS(other than schizophrenia)

          -  Subjects are participating or participated in other clinical studies including
             marketed drugs or medical devices within 30 days before signing the informed consent
             form.

          -  Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence
             within the last 6 months.
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Condition: Periodic Fevers Syndrome
MeSH terms: Familial Mediterranean Fever; Amyloidosis; Syndrome; Fever; Hyperthermia
Intervention: Canakinumab (AIN457)
Intervention description: Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Healthy volunteers: No
Keywords: Canakinumab,; interleukin-1; Periodic Fevers Syndrome; TRAPS; HIDS; crFMF; auto-inflammatory diseases; extension study

Summary:

      The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this
      extension study. This extension study offered the opportunity for participants who completed
      Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with
      ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development
      of ACZ885 in Periodic Fever Syndromes was suspended.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of
             canakinumab in Japan

          -  Written informed consent. Parent or legal guardian's written informed consent and
             child's assent, if appropriate, are required before any assessment is performed for
             patients < 20 years of age

        Exclusion Criteria:

          -  Any conditions or significant medical problems in which the investigator judges the
             patient should not enter this extension study
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736; PLACEBO
Intervention description: MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).; PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Intervention MeSH terms: Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 713.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Locally advanced; Unresectable Non-Small Cell Lung Cancer; MEDI4736; PD-L1; Stage III Non-Small Cell Lung Cancer; Chemoradiation; Immune-mediated cancer therapy

Summary:

      A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in
      Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age at least 18 years.

          2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)

          3. Patients must have received at least 2 cycles of platinum-based chemotherapy
             concurrent with radiation therapy.

          4. World Health Organisation (WHO) Performance Status of 0 to 1.

          5. Estimated life expectancy of more than 12 weeks.

        Exclusion Criteria:

          1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.

          2. Active or prior autoimmune disease or history of immunodeficiency.

          3. Evidence of severe or uncontrolled systemic diseases, including active bleeding
             diatheses or active infections including hepatitis B, C and HIV.

          4. Evidence of uncontrolled illness such as symptomatic congestive heart failure,
             uncontrolled hypertension or unstable angina pectoris.

          5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

          6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
             colitis).
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DFD01 Spray
Intervention description: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Intervention MeSH terms: Betamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the
      hypothalamic-pituitary-adrenal (HPA) axis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must weigh at least 55 pounds

          2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
             psoriasis.

          3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin,
             axillae and other intertriginous areas..

          4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.

          5. Subjects whose results from the screening ACTH stimulation test are considered normal
             (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of
             abnormal HPA axis function or adrenal response.

        Exclusion Criteria:

          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          2. History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.

          4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,
             tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate,
             cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab,
             adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).

          5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs
             (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic
             anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine),
             or 4) UVB therapy.

          6. Use within 30 days prior to the Screening Visit of any product containing
             corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.

          7. Subjects who have an abnormal sleep schedule or work overnight.

          8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased
             adrenal output, low pituitary function or pituitary tumors.

          9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar
             test reagents.
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: budesonide and montelukast; Placebo
Intervention description: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks; sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Intervention MeSH terms: Budesonide; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: OSA; Medical treatment

Summary:

      In children with mild apnea combined therapy with an inhaled nasal steroid and a medication
      that decreased nasal congestion (montelukast) was shown to be effective. We are testing to
      see if this combination works in adults with mild apnea as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 - 100 years

          -  RDI between 5 - 15

          -  all races

          -  both sexes

        Exclusion Criteria:

          -  craniofacial, syndromic, neurological abnormalities

          -  current or previous use of Singular, Rhinocort within last 6 months

          -  acute upper respiratory infections

          -  recent nasal trauma, nasal surgery, nasal septum perforation

          -  known immunodeficiency or under going immunosuppressant therapy

          -  current therapy with drugs that interact with Montelukast or Budesonide
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lumateperone (ITI-007); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 529.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate
      in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in
      patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

          -  treatment with either lithium or valproate and inadequate therapeutic response of
             depressive symptoms

        Exclusion Criteria:

          -  any subject unable to provide informed consent

          -  any female subject who is pregnant or breastfeeding

          -  any subject judged to be medically inappropriate for study participation
Propranolol Rescue of Prolonged Labor
Condition: Pregnancy, Prolonged
MeSH terms: Pregnancy, Prolonged
Intervention: Propranolol Hydrochloride; Saline
Intervention description: 2mg/mL vials; 0.9% saline in vials matching the vials of the active drug
Intervention MeSH terms: Propranolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 164.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Propranolol; Cesarean

Summary:

      A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women
      given IV propranolol versus placebo for treatment of prolonged labor.
    

Eligibility criteria:

        Inclusion Criteria:

        English-speaking

        >= 36 weeks gestation

        Singleton pregnancy

        Vertex presentation

        No contraindication to a vaginal delivery

        Meets at least one study criteria for prolonged labor:

          1. cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin
             OR

          2. cervical dilation >=6 cm and <1 cm dilation change over ≥2 hours with ruptured
             membranes and receiving oxytocin

        Exclusion Criteria:

        Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for
        hypertension control

        Receiving other beta blocker

        Maternal heart rate < 70 beats per minute, systolic blood pressure <90 mmHg, or diastolic
        blood pressure <50 mmHg on two sets of vital signs in the 1 hour prior to study drug
        administration: given that bradycardia and hypotension are possible side effects of
        propranolol

        History of any form of asthma: as this is a contraindication to beta blocker use

        Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in
        the neonate

        Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus
        bradycardia, and greater than first degree heart block)

        Known hypersensitivity to propranolol

        Intrauterine fetal demise since different labor protocols are used in these women

        Major fetal congenital anomaly since rate of cesarean may be inherently different in these
        women, unrelated to labor
Staccato Loxapine in Agitated Patients With Schizophrenia
Condition: Patients With Schizophrenia and Acute Agitation
MeSH terms: Psychomotor Agitation; Schizophrenia
Intervention: Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Intervention description: Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Intervention MeSH terms: Loxapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE

Summary:

      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      schizophrenic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients with schizophrenia and acute agitation

        Exclusion Criteria:

          -  Agitation caused primarily by acute intoxication

          -  History of drug or alcohol dependence

          -  Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug
             administration