bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Condition: Glabellar Frown Lines (GL); Lateral Canthal Lines (LCL)
Intervention: botulinum toxin neuromodulator; Placebo
Intervention description: QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL; Placebo will be injected into either the LCL, GL, or both the LCL and GL
Intervention MeSH terms: Botulinum Toxins; Neurotransmitter Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for
      the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe LCL at maximum smile as assessed by the Investigator.

          3. Moderate to severe LCL at maximum smile as assessed by the subject.

          4. Moderate to severe GL at maximum frown as assessed by the Investigator.

          5. Moderate to severe GL at maximum frown as assessed by the subject

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP).
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Condition: Chronic Kidney Disease (CKD); Hyperkalemia (HK)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Intervention: Patiromer; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Treatment of Hyperkalemia; Hyperkalemia

Summary:

      The purpose of this study was to evaluate the efficacy and safety of patiromer
      (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study
      also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic
      treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer
      treatment was also evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 18 - 80

          -  Chronic kidney disease (CKD) - eGFR 15 to < 60 mL/min/1.73m2 at screening

          -  Hyperkalemia, defined as a serum potassium value of 5.1 to < 6.5 mEq/L at screening

          -  Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II
             receptor blocker (ARB), or an aldosterone antagonist (AA) medication

          -  Informed consent given

        Exclusion Criteria:

          -  Participants with auto-immune related chronic kidney disease such as lupus nephritis
             or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with
             renal involvement

          -  Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c > 10.0 %, or
             hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the
             previous 6 months in participants with Type 2 diabetes

          -  Participants with severe heart failure, defined as NYHA (New York Heart Association)
             class IV

          -  Participants with major surgery including thoracic and cardiac, in the past 3 months,
             or participants with heart or kidney transplant

          -  Participants with significant cardiovascular or cerebrovascular events in the past 2
             months, such as cardiac arrest, myocardial infarction, or stroke

          -  Participants with BMI ≥ 40 kg/m2
Scleroderma Lung Disease
Condition: Lung Diseases; Pulmonary Fibrosis; Systemic Scleroderma; Scleroderma, Systemic
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Fibrosis
Intervention: Cyclophosphamide; Placebo
Intervention description: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.; Matching gelcaps 25 mgs
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Diseases; Pulmonary Fibrosis; Systemic Scleroderma; Scleroderma, systemic

Summary:

      To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and
      progression of symptomatic pulmonary disease in patients with systemic sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with limited or diffuse systemic scleroderma if they had evidence of active
             alveolitis on examination of bronchoalveolar-lavage (BAL) fluid (defined as
             neutrophilia of ≥3 percent, eosinophilia of ≥2 percent, or both)on thoracic
             high-resolution computed tomography (CT), any ground-glass opacity,

          2. Onset of the first symptom of scleroderma other than Raynaud's phenomenon within the
             previous seven years,

          3. An FVC between 45 and 85 percent of the predicted value

          4. Grade 2 exertional dyspnea according to the baseline instrument of the Mahler Dyspnea
             Index (as measured with the use of the magnitude-of-task component).

        Exclusion Criteria:

          1. A single-breath carbon monoxide diffusing capacity (DlCO) that was less than 30
             percent of the predicted value,

          2. A history of smoking within the preceding six months, other clinically significant
             pulmonary abnormalities,

          3. Clinically significant pulmonary hypertension requiring drug therapy.

          4. Patients taking prednisone at a dose of more than 10 mg per day, those who had
             previously been treated for more than four weeks with oral cyclophosphamide or had
             received two or more intravenous doses,

          5. Patients who recently received other potentially disease-modifying medications.
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin glargine; insulin aspart
Intervention description: Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.; Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.; Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 501.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of the
      trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine
      (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Subjects fulfilling at least one of the below criteria: a)
        Experienced at least one severe hypo episode within the last year (according to the ADA
        (American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure,
        defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney
        disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes
        mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by
        symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70
        mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1
        (screening) - Male or female, age at least 18 years at the time of signing informed consent
        - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 -
        Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH)
        insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4
        daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin)
        for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to
        10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2
        Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit
        1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior
        to screening) - Use of any other anti-diabetic agent than those stated in the inclusion
        criteria within the last 26 weeks prior to Visit 1
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
Preoperative Alpha Blockade for Pheochromocytoma
Condition: Pheochromocytoma; Paraganglioma
MeSH terms: Pheochromocytoma; Paraganglioma
Intervention: Phenoxybenzamine; Doxazosin
Intervention description: Non-selective alpha blocker; Selective alpha blocker
Intervention MeSH terms: Doxazosin; Phenoxybenzamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires
      preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby
      reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a
      non-selective alpha blocker that is significantly more expensive and is associated with
      increased adverse effects in comparison with selective alpha blockers such as doxazosin.
      Retrospective studies show minimal differences in hemodynamic instability and no differences
      in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.
      This study is a randomized controlled trial that will compare hemodynamic instability,
      morbidity, mortality, cost, and quality of life between patients blocked with
      phenoxybenzamine vs. doxazosin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with pheochromocytoma / paraganglioma undergoing surgical resection

        Exclusion Criteria:

          -  Children < 18 years
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 611.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the effectiveness and safety of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to placebo, a treatment without activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study
Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: MP-424; Ribavirin; Peginterferon Alfa-2b
Intervention description: 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b
      (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after
      previous treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1, chronic hepatitis C

          -  Relapsers (patient who relapsed after previous treatment)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia; or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Enoxaparin; Rivaroxaban placebo; Enoxaparin placebo
Intervention description: Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days; Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days; Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days; Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Intervention MeSH terms: Enoxaparin; Rivaroxaban; Enoxaparin sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8101.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Acute medical illnesses with increased risk for VTE.; Deep vein thrombosis (DVT); Pulmonary embolism (PE),; Venous Thromboembolic disease (VTE),; Medical illness

Summary:

      This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in
      the leg and lung that can occur with patients hospitalized for acute medical illness, and
      compare these results with those of the standard enoxaparin dose and duration regimen. The
      safety of rivaroxaban will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients aged 40 years or more

          -  Patients at risk of venous thromboembolic events being hospitalized for acute medical
             conditions as follows:

               -  Heart failure, New York Heart Association (NYHA) class III or IV

               -  Active cancer

               -  Acute ischemic stroke

               -  Acute infectious and inflammatory diseases, including acute rheumatic diseases

               -  Acute respiratory insufficiency

               -  Additional risk factor for VTE, including reduced mobility

        Exclusion Criteria:

          -  Conditions that contraindicate the use of antithrombotic therapy with the Low
             Molecular-Weight Heparin (LMWH) enoxaparin

          -  Conditions that may increase the risk of bleeding, including intracranial hemorrhage

          -  Required drugs or procedures which may interfere with the study treatment

          -  Concomitant conditions or diseases which may increase the risk of study subjects or
             interfere with the study outcome

          -  General conditions in which subjects are not suitable to participate in the study
A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550
Intervention description: 5 mg oral BID; 10 mg oral BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2867.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic; severe; treatment; safety; CP-690,55; Plaque Psoriasis; Psoriasis Vulgaris; Xeljanz; Tofacitinib

Summary:

      The main objective of this study is to evaluate the long-term safety of CP-690,550 in
      patients being treated for moderate to severe chronic plaque psoriasis. This is an open label
      extension study available to patients who participated in one of the qualifying studies with
      CP-690,550 providing entry criteria is met.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have participated in qualifying study with CP-690,550 and are 18 years or older with
             diagnosis of plaque-type psoriasis (psoriasis vulgaris).

        Exclusion Criteria:

          -  Non-plaque or drug induced forms of psoriasis;

          -  Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot
             discontinue phototherapy (PUVA or UVB).

          -  Any uncontrolled significant medical condition.
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: fluticasone propionate/salmeterol combination DISKUS
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Bronchitis; COPD; Emphysema

Summary:

      This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease).
      This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects
      will be given breathing tests, and will record their breathing symptoms daily on diary cards.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of COPD.

        Exclusion criteria:

          -  Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other
             than COPD.

          -  Other inclusion and exclusion criteria will be evaluated at the first study visit.