bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of intravenous Mircera,
      administered with pre-filled syringes, for the treatment of anemia in patients with chronic
      kidney disease who are on dialysis, and who have previously received treatment with epoetin
      alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of
      Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin
      they were receiving in the week preceding study start. The anticipated time on study
      treatment is 3-12 months, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  longterm hemodialysis for >=12 weeks before screening;

          -  baseline Hb between 10 and 13g/dL;

          -  iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing
             interval for >=4 weeks before screening.

        Exclusion Criteria:

          -  acute or chronic bleeding within 8 weeks prior to screening;

          -  transfusion of red blood cells within 8 weeks prior to screening;

          -  poorly controlled hypertension necessitating interruption of erythropoetin treatment
             in previous 6 months;

          -  previous treatment with Mircera.
A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Carboxymethylcellulose Based Eye Drop Formulation A; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
Intervention description: Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop
      formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops
      (OPTIVE™) in subjects with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used artificial tears for dry eye

        Exclusion Criteria:

          -  Start date of over the counter, herbal, prescription or nutritional supplements that
             may affect dry eye or vision within 3 months prior to study start or an anticipated
             change in dosage during the study

          -  History of eye surgery or trauma in the 6 months prior to study start

          -  Current use or use within 2 weeks of study start, of topical eye medications.
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Iptacopan (LNP023)
Intervention description: Taken orally b.i.d. Dosage supplied: 200mg Dosage form: Hard gelatin capsule Route of Administration: oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paroxysmal nocturnal hemoglobinuria; Hemoglobin; Anemia; LNP023; Iptacopan

Summary:

      The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe
      for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to
      complement inhibitor therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants ≥ 18 years of age with a diagnosis of PNH confirmed by
             high-sensitivity flow cytometry with clone size ≥ 10%

          -  Mean hemoglobin level <10 g/dL

          -  LDH > 1.5 x Upper Limit of Normal (ULN)

          -  Vaccination against Neisseria meningitidis infection is required prior to the start of
             study treatment

          -  If not received previously, vaccination against Streptococcus pneumoniae and
             Haemophilus influenzae infections should be given

        Exclusion Criteria:

          -  Prior treatment with a complement inhibitor, including anti-C5 antibody

          -  Known or suspected hereditary complement deficiency

          -  History of hematopoietic stem cell transplantation

          -  Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L;
             platelets <30x109/L; neutrophils <0.5x109/L).

          -  Active systemic bacterial, viral (incl. COVID-19)or fungal infection within 14 days
             prior to study drug administration.

          -  History of recurrent invasive infections caused by encapsulated organisms, e.g.
             meningococcus or pneumococcus.

          -  Major concurrent comorbidities including but not limited to severe kidney disease
             (e.g., dialysis), advanced cardiac disease (e.g., NYHA class IV heart failure), severe
             pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV)), or hepatic
             disease (e.g., active hepatitis) that in the opinion of the investigator precludes
             participant's participation in the study.
A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
Condition: Carcinoma, Non-Small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib; sunitinib; erlotinib; placebo
Intervention description: plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity; Sunitinib 37.5 mg daily by oral capsules in a continuous regimen; plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity; Placebo daily by oral capsules in a continuous regimen
Intervention MeSH terms: Erlotinib Hydrochloride; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 960.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; sunitinib; erlotinib; Phase 3

Summary:

      This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib
      alone in patients with advanced/metastatic lung cancer who have received previous treatment
      with a platinum-based regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced/metastatic non-small cell lung cancer

          -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based
             regimen

        Exclusion Criteria:

          -  Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the
             exception of bevacizumab) or other angiogenesis inhibitors

          -  History of or known brain metastases
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams
      (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major
      depressive disorder (MDD) who have a partial response to ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Condition: Pain; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Buprenorphine; Placebo
Intervention description: buccal soluble film; applied to the buccal mucosa twice daily; buccal soluble film; applied to the buccal mucosa twice daily
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: buccal soluble film; enriched enrollment; randomized withdrawal

Summary:

      The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal
      film is effective and safe in the treatment of chronic low back pain (CLBP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant and non-nursing female aged 18 or older

          -  History of moderate to severe chronic low back pain for ≥3 months with a pain
             intensity ≥5 [11 point numerical rating scale] reported at the open-label titration
             period Day 0/1 visit following a washout period (opioids, nonsteroidal
             anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24
             hours

          -  Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid
             (including opioid naïve) for 1 week or longer

          -  Stable health, as determined by the Investigator, on the basis of medical history,
             physical examination, and screening laboratory results so as to comply with all study
             procedures

          -  Female subjects of childbearing potential must be using a recognized effective method
             of birth control

          -  Written informed consent obtained at Screening, prior to any procedure being performed

        Exclusion Criteria:

          -  Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute
             spinal cord compression, cauda equina compression, acute nerve root compression,
             meningitis, and discitis

          -  Surgical procedure for back pain within 2 months prior to screening or nerve/plexus
             block within 4 weeks of screening

          -  Hypokalemia or clinically unstable cardiac disease, including: unstable atrial
             fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active
             myocardial ischemia

          -  Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram
             (ECG)

          -  History of long QT syndrome, or an immediate family member with this condition

          -  Diagnosis of moderate to severe hepatic impairment.

          -  History of severe emesis with opioids

          -  Clinically significant sleep apnea
PIE II: Pharmacological Intervention in the Elderly II
Condition: Diastolic Heart Failure; Heart Failure, Congestive
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: Spironolactone; Placebo
Intervention description: 25mg tablet daily for 9 months; Placebo tablet daily for 9 months
Intervention MeSH terms: Spironolactone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether spironolactone will improve exercise
      tolerance and quality of life in elderly patients with heart failure preserved ejection
      fraction (HFPEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory

          -  Medically stable

          -  Ages 60 or older

          -  Diagnosis of diastolic heart failure

        Exclusion Criteria:

          -  Valvular heart disease

          -  Significant change in cardiac medication within the past 4 weeks

          -  Uncontrolled hypertension

          -  Recent or debilitating stroke

          -  Cancer or other noncardiovascular conditions with life expectancy less than 2 years

          -  Anemia

          -  Elevated serum potassium

          -  Renal insufficiency

          -  Psychiatric disease (uncontrolled major psychoses, depression, dementia, or
             personality disorder)

          -  Allergy to spironolactone; currently taking spironolactone or any aldosterone
             antagonist

          -  Plans to leave area within 1 year

          -  Refuses informed consent

          -  Failure to pass screening tests: pulmonary function, echocardiogram, or exercise

          -  Contra-indications to magnetic resonance imaging [MRI] (indwelling metal-containing
             prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable
             claustrophobia)
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human-cl rhFVIII
Intervention description: Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to study the long-term efficacy, safety and tolerability of
      Human-cl rhFVIII in previously treated patients with severe hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months
             study participation and immediate enrollment into GENA-11

        Exclusion Criteria:

          -  Development of FVIII inhibitors (<=0.6 BU), during the course of the GENA-01 study

          -  Development of any severe liver or kidney disease (ALT and AST level > 5 times of
             upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01
             study
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Sofosbuvir; RBV
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2)

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)
      plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV)
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic genotype 2 HCV-infection

          -  Male or female, age ≥ 20 years

          -  Body weight ≥ 40 kg

          -  HCV RNA ≥ 10,000 IU/mL at screening

        Exclusion Criteria:

          -  Current or prior history of clinically significant illness other than HCV

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non-HCV etiology

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Enhancing Adaptations to Exercise
Condition: Inflammation
MeSH terms: Inflammation
Intervention: n3-PUFA; Placebo; Biopsy; Body Composition Scan
Intervention description: The DHA/EPA softgels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (~381 mg) and poloxamer 237, NF (~8.8 mg).; Looks exactly like the study drug but contains soybean oil with no active ingredient.; Two muscle biopsies from the upper part of one leg. A small (~1cm) incision will be made through the skin, and a needle will then be used to remove the muscle.; Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exercise; muscle function

Summary:

      Researchers are trying to understand how chronic inflammation affects muscle function and
      responses to exercise.They are also trying to determine if suppressing chronic inflammation
      using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise
      responsiveness in older adults.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women between the ages of 20-35 years

          -  Men and women between the ages of 65-85 years

        Exclusion criteria:

          -  Regular use of omega-3 nutritional supplements

          -  Diabetes or fasting plasma glucose > or equal to 126 mg/dL

          -  Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl)

          -  Active coronary artery disease or history of unstable macrovascular disease (unstable
             angina, myocardial infarction, stroke, and revascularization of coronary, peripheral
             or carotid artery within 3 months of recruitment)

          -  Renal failure (serum creatinine > 1.5mg/dl)

          -  Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L)

          -  Oral warfarin group medications or history of blood clotting disorders.

          -  international normalized ratio (INR) >2.01.5

          -  Smoking

          -  Pregnancy or breastfeeding

          -  Alcohol consumption greater than 2 glasses/day or other substance abuse

          -  Untreated or uncontrolled hypothyroidism

          -  Debilitating chronic disease (at the discretion of the investigators)

          -  Fish or shellfish allergy