bioihbjkbjnl/mcl2 huggingface dataset:
The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients
Condition: Abdominal Obesity; Hypertension
MeSH terms: Obesity, Abdominal
Intervention: Carvedilol CR + Lisinopril; Lisinopril + HCTZ
Intervention description: Participants were given Carvedilol CR + Lisinopril for three months. Oral medication. Carvedilol CR and Lisinopril combination therapy was initiated at 20 mg and 10 mg, respectively. Patients returned one week later and doses of carvedilol CR and lisinopril were increased to 40 mg and 20 mg, respectively, depending on blood pressure.; Participants were given Lisinopril + HCTZ for three months. Oral medication. Lisinopril + HCTZ combination therapy was initiated at 12.5 mg and 10 mg, respectively. Patients returned 1 week later and doses of hydrochlorothiazide and lisinopril were increased to 25 mg and 20 mg, respectively, depending on blood pressure levels.
Intervention MeSH terms: Hydrochlorothiazide; Carvedilol; Lisinopril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of two different combination therapies
      for high blood pressure on vascular health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years old

          -  Systolic blood pressure (SBP) >130 and/or diastolic blood pressure (DBP) >85 (or
             currently taking anti-hypertensive medication)

          -  Waist circumference >102 cm (men) and >88 cm (women)

          -  Stable cardiovascular medication regimen (or other medications known to affect
             endothelial function) at least 1 month prior to enrollment and throughout the study

        Exclusion Criteria:

          -  Use of anti-hypertensive medications within one month of randomization (patients may
             be washed-out from anti-hypertensive medications)

          -  Unstable angina

          -  History of angina symptoms within 3 months of screening

          -  Decompensated heart failure

          -  History of myocardial infarction

          -  Stroke or coronary artery bypass graft within 3 months of screening

          -  Standard clinical contraindications to beta-blocker therapy

          -  Standard clinical contraindications to ACE-I therapy

          -  Women who are currently pregnant or planning to become pregnant (pregnancy testing
             will occur at specific intervals throughout study and women will be informed of
             potential risks during the consenting process; information specific to this risk will
             be detailed in the consent form)

          -  Breastfeeding women

          -  Clinically significant liver disease

          -  Creatinine > 2.5 mg/dL

          -  Hepatic function greater than 3 times upper limit of normal
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Condition: Cholera
MeSH terms: Cholera
Intervention: PXVX0200 Lot A; PXVX0200 Lot B; PXVX0200 Lot C; Placebo
Intervention description: Lot P700-1CA03; Lot P700-3CA03; Lot P700-6BA03; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3146.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men or women,

          -  age 18 to 45 years inclusive;

          -  normal medical history and physical examination

          -  Women must have a negative pregnancy test.

        Exclusion Criteria:

          -  travel to a cholera endemic area in the previous 5 years;

          -  abnormal stool pattern or regular use of laxatives;

          -  Currently active unstable or undiagnosed medical conditions

          -  current or recent antibiotic use;

          -  pregnancy or nursing;

          -  Previously received a licensed or investigational cholera vaccine

          -  History of cholera or enterotoxigenic E. coli infection

          -  History of Guillain-Barré Syndrome

          -  Received or plans to receive any other licensed vaccines, except for seasonal
             influenza

          -  Recipient of bone marrow or solid organ transplant

          -  Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders
             diagnosed or treated during the past 5 years

          -  Use of systemic chemotherapy in the previous 5 years prior to the study

          -  any immunosuppressive medical condition
Open Label Study of Long Term Safety Evaluation of Alirocumab
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering
      therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had
      completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and
      LTS11717 (NCT01507831).

      Secondary Objectives:

        -  To evaluate the long-term efficacy of alirocumab on lipid parameters.

        -  To evaluate the long-term immunogenicity of alirocumab.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with heFH who had completed one of the four parent studies (EFC12492,
        R727-CL-1112, EFC12732 and LTS11717).

        Exclusion criteria:

        Significant protocol deviation in the parent study; Any permanent treatment discontinuation
        from the parent study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Olmesartan; Placebo; LCZ696
Intervention description: 10 mg, 20 mg, 40 mg capsules; Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule; 100 mg, 200 mg tablets
Intervention MeSH terms: Olmesartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 588.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor

Summary:

      The purpose of this study is to access the efficacy and safety of LCZ696 compared to
      olmesartan in elderly Asian patients for the treatment of hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give written informed consent before any assessment is performed

          -  Patients with essential hypertension, untreated or currently taking antihypertensive
             therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg

          -  Patients must be able to communicate and comply with all study requirements and
             demonstrate good medication compliance

        Exclusion criteria:

          -  Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients
             with history of angioedema, drug-related or otherwise

          -  Patients with history or evidence of a secondary form of hypertension

          -  Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any
             history of stroke

          -  History of myocardial infarction, coronary bypass surgery or any percutaneous coronary
             intervention (PCI) during the 12 months prior to Visit 1.

          -  Current angina pectoris requiring medication (other than patients on a stable dose of
             oral or topical nitrates).

          -  Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are
             not on a stable dose of antidiabetic medication

          -  Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).

          -  Patients with a clinically significant valvular heart disease at the time of screening

          -  Women of child-bearing potential, who do not use adequate birth control methods Other
             protocol-defined inclusion/exclusion criteria may apply
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CT-P13 SC (Infliximab); Placebo SC
Intervention description: Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years, inclusive.

          -  Patient who has moderately to severely active CD with a score on the CDAI of 220 to
             450 points

        Exclusion Criteria:

          -  Patient who has previously received either a TNFα inhibitor or biological agent within
             5 half-lives

          -  Patient who has previously demonstrated inadequate response or intolerance to TNFα
             inhibitors for the treatment of CD.
A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; Methotrexate
Intervention description: 8 mg/kg intravenous infusion every 4 weeks.; methotrexate as per standard of care in clinical practice.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label, multicenter study evaluated the safety and tolerability and the
      efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in
      combination with methotrexate in patients with active moderate to severe rheumatoid arthritis
      (RA). Patients were eligible to participate in this study if they are currently experiencing
      an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic
      drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous
      infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment
      was 24 weeks. The target sample size was 50-200 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥ 18 years of age

          -  Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a
             Disease Activity Score (DAS28) > 3.2 at screening)

          -  Patients with active RA after more than 12 weeks of treatment with DMARDs

          -  Patients with inadequate response to a stable dose of non-biologic DMARD

        Exclusion Criteria:

          -  Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and
             able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are
             permitted

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following enrollment

          -  Prior history of or current inflammatory joint disease other than RA
Phase III Cat-PAD Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Intervention: Cat-PAD; Placebo
Intervention description: 1 dose every 4 weeks; 1 dose every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1408.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cat allergy; Rhinoconjunctivitis

Summary:

      The purpose of this study is to compare the treatment effect of two treatment regimens of
      Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue
      medication usage and Quality of Life.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female, aged 12-65 years.

          -  Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.

          -  Subjects may optionally also have GINA Step 1 controlled asthma.

          -  Positive skin prick test to cat hair.

          -  Cat dander specific IgE ≥0.35 kU/L.

        Exclusion Criteria

          -  Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or
             Steps 2 to 5.

          -  FEV1 <80% of predicted.

          -  Clinically significant confounding symptoms of allergy to seasonal allergens during
             the final evaluation period.

          -  Skin prick test 5 mm greater than the negative control to perennial allergens or
             animal dander (other than cat) which cannot be avoided during the study.

          -  Significant symptoms of another clinically relevant illness that is likely to affect
             scoring of rhinoconjunctivitis symptoms.

          -  Clinically relevant abnormalities detected on physical examination.

          -  History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
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
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo; Lumacaftor Plus Ivacaftor Combination; Ivacaftor
Intervention description: Matching placebo tablet; Fixed dose combination tablet; Film-coated tablet
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 563.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the efficacy of lumacaftor in combination
      with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)
      who are homozygous for the F508del mutation on the CF transmembrane conductance regulator
      (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF

          -  Homozygous for the F508del CFTR mutation

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent
             (%) and less than or equal to (=<) 90% of predicted normal for age, sex, and height

          -  Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
             the Safety Follow up Visit

        Exclusion Criteria:

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose
             of study drug

          -  History of solid organ or hematological transplantation

          -  History of alcohol or drug abuse in the past year

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating lumacaftor and/or ivacaftor) within 30 days of screening.

          -  Use of strong inhibitors, moderate inducers, or strong inducers of Cytochrome P450 3A
             (CYP3A) within 14 days before Day 1 of dosing
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Condition: Cardiovascular Disease; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Intervention: Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
Intervention description: Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 125.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiovascular disease; Inflammation; Fish Oil; Omega-3 Fatty Acids; LPS; Endotoxin

Summary:

      The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600,
      900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the
      inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the
      production over time of several inflammatory markers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and non-pregnant/lactating women between the ages of 20 and 45

          -  BMI >19.9 and <30.0

          -  Able to give written informed consent and willing to comply with all study- related
             procedures.

        Exclusion Criteria:

          -  Previous history of heart disease or diabetes

          -  Renal Insufficiency

          -  Chronic anti-inflammatory use

          -  Systolic blood pressure < 90

          -  Individuals currently using tobacco products or have done so in the previous 30 days

          -  Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is
             greater than 3-4 servings per month.
Study of Pharmacotherapy of Psychotic Depression
Condition: Major Depressive Disorder With Psychotic Features
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Intervention: Olanzapine; Sertraline; placebo
Intervention description: 10-20mg/day; 150-200mg/day; tablet that ressembles sertraline but contains no medication
Intervention MeSH terms: Olanzapine; Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major depressive disorder with psychotic features; Delusional Depression; Randomized Trial; Combination Treatment; SSRI; Atypical Antipsychotic

Summary:

      This study will determine the effectiveness of combining selective serotonin reuptake
      inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major depressive disorder, single or recurrent, with psychotic features

        Exclusion Criteria:

          -  History of substance abuse or dependence within the 3 months prior to enrollment

          -  Acute or unstable medical illness

          -  Diagnosis of schizophrenia or other psychotic disorders

          -  Pregnant

          -  Intolerance to SSRIs or olanzapine
Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth
Condition: Surgery
Intervention: 2% CHG Cloth solution; Vehicle Cloth; Active Comparator; Saline; SLS
Intervention description: Investigational CHG; Excipients from CHG cloth only; Active comparator; Negative control; Provides a slight irritation for a positive control
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 249.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product
      applied to see if they become sensitized to repeated applications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Free of skin disorders

          -  Signed consent

        Exclusion Criteria:

          -  Allergies to latex

          -  Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or
             during testing

          -  severe illness

          -  Pregnant (females)