bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Condition: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo Matched to Alirocumab
Intervention description: Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody; Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to assess the long-term safety and tolerability of
      alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl
      glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other
      lipid-modifying therapies (LMTs).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Prior participation in and the successful completion of the R727-CL-1003 study
             (NCT01266876).

          2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to
             entry into the study

          3. A negative urine pregnancy at the screening/baseline visit for women of childbearing
             potential

        Key Exclusion Criteria:

          1. Reported a drug-related serious adverse event (SAE) or drug-related clinical or
             laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early
             termination or withdrawal

          2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the
             investigator or patient

          3. Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline
             visit

        Note: Other exclusion criteria applied
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: AIN457
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Crohns; Bowel disease; digestive disorders; auto immune; diarrhea; Inflammatory Bowel Disease (IBD); gastrointestinal diseases; digestive system diseases; Antibody; IL 17; anti IL-17; monoclonal antibody; Crohn's Disease (Chron's, CD)

Summary:

      This study will assess the safety and tolerability of AIN457 in patients with moderate to
      severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participate and complete the core CAIN457A2202 study up to and including
             Visit 11 (end of study), may enter the extension study upon signing informed consent.

        Exclusion Criteria:

          -  Patients for whom continued treatment with AIN457 is not considered appropriate by the
             treating physician.

          -  Patients who were non-compliant or who demonstrated a major protocol violation in the
             core CAIN457A2202 study

          -  Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).

        Other protocol-defined inclusion/exclusion criteria may apply
6-week Safety and PD Study in Adults With NAFLD
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-06835919 Low Dose; PF-06835919 High Dose
Intervention description: 0 mg; 75 mg once daily; 300 mg once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY,
      SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS
      WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI at least 28 kg/m2

          -  Type 2 diabetes and/or metabolic syndrome

        Exclusion Criteria:

          -  Liver disease

          -  Type 1 diabetes

          -  Recent heart attack or stroke

          -  Inability to have an MRI scan
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Elidel; Ketoconazole Cream
Intervention MeSH terms: Ketoconazole; Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: seborrheic dermatitis

Summary:

      This is an exploratory study to determine effectiveness of Elidel for the treatment of
      seborrheic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 or older and sign written informed consent.

          -  Must be wiling and able to comply with protocol.

          -  Must have active seborrheic dermatitis of the face.

        Exclusion Criteria:

          -  No history of overt bacterial, viral or fungal infection of the head/neck.

          -  No history or presence of compromising dermatosis elsewhere on the skin

          -  No Parkinson's disease, HIV, infections or disorders of the central nervous system

          -  No actinically damaged skin
CoQ10 and D-ribose in Patients With Diastolic Heart Failure
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: CoQ10; D-Ribose Oral Powder; Placebo pills; Placebo powder
Intervention description: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.; Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.; Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.; Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Intervention MeSH terms: Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: heart failure with preserved ejection fraction

Summary:

      The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by
      patients who have diastolic heart failure, or heart failure with preserved ejection fraction
      (HFpEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with HFpEF within a 6-month period

          -  New York Heart Association (NYHA) Classification II-III HF

          -  Have left ventricular ejection fraction (EF) ≥ 50% documented by an echocardiogram

          -  Have a telephone or reliable phone contact

          -  Have their own means of transportation to the study site

        Exclusion Criteria:

          -  Acute coronary syndrome in the past 12 weeks

          -  Significant valvular heart disease

          -  Severe cardiac fibrosis (galectin-3 level > 26 ng/ml)

          -  Constrictive pericardium

          -  Pulmonary fibrosis

          -  Congenital heart disease

          -  Hypertrophic or infiltrative cardiomyopathy

          -  Heart transplant

          -  Left ventricular assist device

          -  Heart failure (HF) associated hospital admission or emergency room visit within past
             30 days

          -  Recent percutaneous coronary intervention

          -  Significant renal and/or hepatic dysfunction

          -  Severe cognitive impairment

          -  Consumption of any CoQ10 (ubiquinol) or D-ribose supplements
Acamprosate Safe to Use in Individuals With Liver Disease.
Condition: Alcohol-related Liver Disease
MeSH terms: Liver Diseases
Intervention: Acomprosate
Intervention description: Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Is acamprosate safe to use in individuals with liver disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Aged 21 or over

          -  Diagnosis of alcohol-related liver disease and AUD.

               -  The diagnosis of alcohol-related liver disease will be determined by a
                  hepatologist based on history of regular and excessive alcohol consumption in the
                  absence of other causes of liver cirrhosis or acute hepatitis, compatible
                  clinical, imaging and laboratory findings and typical histology on liver biopsy,
                  if performed. Underlying liver disease may include alcoholic hepatitis, advanced
                  (F3-F4) fibrosis, and/or portal hypertension.

               -  The diagnosis of AUD will be determined by a hepatologist and/or addiction
                  psychiatrist based on history obtained that is consistent with DSM-5 diagnostic
                  criteria for AUD (all categories of mild, moderate and severe considered
                  eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).

          -  Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to
             initiating acamprosate treatment.

          -  At study enrollment, initial MELD-Na score must be less than 20 for the five
             individuals enrolling in the first phase of the pilot safety assessment. The second
             phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or
             more at enrollment.

          -  Have capacity to provide consent themselves

        Exclusion criteria:

          -  Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min

          -  Congestive heart failure (NYHA class II or higher)

          -  Hypotension, requiring the use of vasoconstrictors (i.e. midodrine)

          -  Pregnancy, lactation or refusal to use a reliable method of birth control if a
             sexually active female of childbearing potential. Although no human trial data is
             available, animal studies suggest possible teratogenic effects of acamprosate (Merck,
             2005).
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
Condition: Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: ALD518; 0.9% saline
Intervention description: IV; IV Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the
      course of oral mucositis in subjects with head and neck cancer receiving concomitant
      chemotherapy and radiotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have recently diagnosed (< than 6 months prior to screening visit date),
             pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx,
             hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects
             with a history of surgical management (approximately 4-6 weeks before RT with
             sufficient time for post-surgical healing) are eligible

          -  Have a plan to receive a continuous course of conventional external beam irradiation
             delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
             to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.

          -  Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to
             100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin
             regimen administered weekly (100 mg/m2)

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  CRP < 80 mg/L

          -  Have adequate hematopoietic, hepatic, and renal function at the screening visit

        Exclusion Criteria:

          -  Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor

          -  Metastatic disease (M1) Stage IV C

          -  Any prior history of head and neck cancer

          -  Prior radiation to the head and neck

          -  Have had a major surgical procedure, other than for HNC, or significant traumatic
             injury within 4 weeks prior to the initiation of RT; or anticipation of need for a
             major surgical procedure during the clinical trial

          -  Active infectious disease, excluding oral candidiasis

          -  Have OM at the screening visit

          -  Have a history of hypersensitivity to monoclonal antibody
ToRsemide for pOstpartum HYpertension
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension
Intervention: Torsemide; Placebo
Intervention MeSH terms: Torsemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preeclampsia, puerperium

Summary:

      Currently there is no intervention to prevent persistent postpartum hypertension in
      preeclamptic women. Physiologically, the use of a pharmacokinetically predictable
      loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated
      secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the
      incidence of persistent postpartum hypertension in preeclamptic women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women at ≥ 18 years of age

          -  Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:

          -  Preeclampsia

          -  Preeclampsia with severe features

          -  Preeclampsia superimposed to chronic hypertension

        Exclusion Criteria:

          -  Chronic hypertension without superimposed preeclampsia

          -  Gestational hypertension

          -  Urine output < 30 cc/h at time of randomization

          -  Heart failure or pulmonary edema

          -  Hypersensitivity to Torsemide or sulfonylureas

          -  Hypokalemia (serum potassium < 3 mEq/L)

          -  Preexisting diuretic use within 24 hours prior to randomization
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: NOV03; Placebo
Intervention description: Perfluorohexyloctane; Saline solution (0.9% sodium chloride solution)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane
      (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye
      Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of Drye Eye Disease (DED) in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/peri-ocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study

          -  Ongoing ocular or systemic infection

          -  Wear contact lenses within 1 month prior to screening or anticipated use of contact
             lenses during the study

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or saline components

          -  Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears
             or topical anti-glaucoma medication within 2 months prior to screening
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Intervention: Clostridium difficile Vaccine; Placebo
Intervention description: 0.5 mL intramuscular injection.; 0.5 mL intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile, Vaccine.

Summary:

      This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85
      years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination
      schedules. The study will assess the safety and tolerability of the vaccine as well as the
      subjects' immune response to the vaccine. One year after the third dose subjects that did not
      receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up
      to 4 years after their third vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects

          -  Aged 65 to 85 years

        Additional Inclusion Criteria for the extension Stage:

          -  Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in
             the original portion of the study.

        Exclusion Criteria:

          -  Proven or suspected prior episode of Clostridium difficile associated diarrhea

          -  Unstable chronic medical condition

          -  Disease requiring significant change in therapy or hospitalization for worsening
             disease within 8 weeks before receipt of study vaccine

          -  Serious chronic disorders

          -  Congenital or acquired immunodeficiency disorders

          -  Rheumatologic disorders or other illnesses requiring chronic treatment with known
             immunosuppressant medications.

          -  Active or treated leukemia or lymphoma or bone marrow disorder

          -  Any contraindication to vaccination or vaccine components including previous
             anaphylactic reaction to any vaccine or vaccine-related components

        Additional Exclusion Criteria for the Extension Stage:

          -  Subjects originally randomized to placebo during the original portion of the study.

          -  Subjects who have already completed Visit 9 prior to study unblinding.