bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant; Tranexamic Acid; Oral Placebo; S.C. Placebo
Intervention description: Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.; over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.; hard capsule matched to tranexamic acid; solution for injection, matched to icatibant for injection
Intervention MeSH terms: Icatibant; Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Outcome Measures:

      The primary endpoint was the time to onset of symptom relief of the first attack in the
      double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic
      acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid
      refers to the hazard rate under tranexamic acid.

      Secondary Outcome Measures:

        -  Additional efficacy assessments (Time to Almost Complete Symptom Relief)

        -  Safety and tolerability

        -  Pharmacoeconomics
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age above 18 years;

          -  Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);

          -  Current edema in the cutaneous, abdominal and/or laryngeal areas;

          -  Current edema moderate to severe according to the investigator's Symptom Score.

        Exclusion Criteria:

          -  Diagnosis of angioedema other than HAE,

          -  Participation in a clinical trial of another investigational medicinal product
             (IMP)within the past month

          -  Treatment with any pain medication since onset of the current angioedema attack

          -  Treatment with replacement therapy, including C1-INH products, less than 3 days before
             onset of the current angioedema attack

          -  Treatment with Tranexamic acid replacement therapy within a week before onset of the
             current angioedema attack

          -  Treatment with ACE inhibitors

          -  Contraindications for Tranexamic acid

          -  Evidence of coronary artery disease based on medical history or Screening examination
             in particular unstable angina pectoris or severe coronary heart disease

          -  Congestive heart failure (class 3 and 4)

          -  Serum creatinine level of ≥ 250 μmol/L

          -  Serious concomitant illness that the investigator considered to be a contraindication
             for participation in the trial

          -  Pregnancy (as assessed prior to treatment) and/or breast-feeding
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab
Intervention description: Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2282.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the long-term safety and tolerability of dupilumab in participants with asthma
      who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579,
      EFC13691).

      Secondary Objectives:

      To evaluate the long-term efficacy of dupilumab in participants with asthma who participated
      in a previous dupilumab asthma clinical study.

      To evaluate dupilumab in participants with asthma who participated in a previous dupilumab
      asthma clinical study, with regards to:

        -  Systemic exposure

        -  Anti-drug antibodies

        -  Biomarkers
    

Eligibility criteria:

        Inclusion criteria:

        - Participants with asthma who completed the treatment period in a previous dupilumab
        asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma
        who completed the treatment and follow-up periods in previous dupilumab asthma Study
        DRI12544.

        Exclusion criteria:

        - Participants who experienced any hypersensitivity reactions to Investigational Medicinal
        Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the
        Investigator, could indicate that continued treatment with dupilumab, may present an
        unreasonable risk for the participant.

        The above information was not intended to contain all considerations relevant to a
        Participant's potential participation in a clinical trial.
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Letrozole; Anastrozole
Intervention description: 2.5 mg tablets; 1 mg tablets
Intervention MeSH terms: Letrozole; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4172.0
Sex: Female
Minimum age: 33 Years
Maximum age: 96 Years
Healthy volunteers: No
Keywords: Breast cancer; letrozole; anastrozole; adjuvant; postmenopausal; FACE

Summary:

      Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females
      who recently underwent primary surgery for breast cancer. Patients will be randomized to
      letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up
      will occur for 5 years after the completion of enrollment for survival and disease status
      updates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent primary surgery for breast cancer

          -  Early stage breast cancer

          -  Postmenopausal

          -  Hormone receptor positive

          -  Positive lymph node involvement

        Exclusion Criteria:

          -  Metastatic disease

          -  Presence of contralateral breast cancer including DCIS

          -  Progression

        Other protocol-defined inclusion/exclusion criteria may apply.
Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Condition: Colorectal Surgery
Intervention: liposomal Bupivacaine; Bupivacaine Hydrochloride
Intervention description: 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group; 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: LB group (Liposomal Bupivacaine)
SB group (Standard Bupivacaine)
Masking: Double (Participant, Investigator)
Masking description: Both the patients and the research staff doing assessments will be blinded to the randomization.
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the difference between two different pain control
      methods in patients who will be having a colorectal surgery
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients undergoing colorectal surgery at Indiana University Hospital

          -  American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4

          -  Age 18 or older, male or female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion criteria:

          -  Any contraindication for QL block.

          -  History of substance abuse in the past 6 months.

          -  Patients on more than 30mg morphine equivalents of opioids daily.

          -  Any physical, mental or medical conditions which in the opinion of the investigators,
             may confound quantifying postoperative pain resulting from surgery.

          -  Known allergy or other contraindications to the study medications (Acetaminophen,
             Gabapentin, Bupivacaine).

          -  Postoperative intubation.

          -  Any BMI greater than 40.0.
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
Condition: Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuralgia
Intervention: pregabalin; placebo
Intervention description: Pregabalin 75 mg-300mg twice daily during the course of the study.; Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathy; pain; HIV-1; HIV Infections

Summary:

      The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in
      reducing neuropathic pain associated with HIV neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages of 18 or greater

          -  Documented evidence of HIV-1 infection

          -  Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with
             subjective sensory symptom of pain

          -  Pain starts in the feet

        Exclusion Criteria:

          -  Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if
             treated B12 deficiency -treatment is less than 6 months of B12 supplementation
             (injection or intranasal B12) prior to screening

          -  Diabetes mellitus requiring regular medical treatment (other than diet and exercise)
             or HbA1C >6.9

          -  Subjects with peripheral neuropathic pain that is not associated with HIV infection;
             including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic
             Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy,
             radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related
             to: metabolic abnormalities; nutritional factors; vascular insults; inflammation;
             autoimmune disease; and malignancy
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Condition: Guillain-Barre Syndrome
MeSH terms: Guillain-Barre Syndrome; Syndrome
Intervention: Eculizumab; Placebo
Intervention description: Eculizumab will be administered via IV infusion once a week for 4 weeks.; Placebo will be administered via IV infusion once a week for 4 weeks.
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eculizumab; Soliris; Alexion; C5 Inhibition Therapy

Summary:

      This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized
      study to investigate the efficacy and safety of eculizumab in participants with severe GBS,
      defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or
      FG4/FG5 within 2 weeks from onset of weakness due to GBS.

      This study will be conducted only at sites in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet the GBS criteria.

          -  Participants who were able to run prior to onset of GBS symptoms.

          -  Participants with onset of weakness due to GBS < 2 weeks before screening.

          -  Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or
             FG4 to FG5).

          -  Participants who are already on IVIg or deemed eligible for and who will start IVIg.

          -  Participants who can start their first dose of study drug before the end of the IVIg
             treatment period.

        Exclusion Criteria:

          -  Participants who have previously received or are currently receiving treatment with
             complement modulators.

          -  Participants who have been administered another investigational product within 30 days
             or 5 half-lives (whichever is longer) prior to providing consent or are currently
             participating in another interventional study.

          -  Participants who have received rituximab within 12 weeks prior to screening.

          -  Participants who are being considered for or are already on plasmapheresis.

          -  Participants who have received immunosuppressive treatment during the 4 weeks prior to
             providing consent.