bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor
      (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who
      are homozygous for F508del.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX18-445-109); or had study drug
             interruption(s) in parent study but completed study visits up to the last scheduled
             visit of the Treatment Period in the parent study

        Key Exclusion Criteria:

          -  History of study drug intolerance in parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: rituximab; interferon-a-2a
Intervention description: 375 mg/m2 rituximab i.v. weekly for 4 weeks; 3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5
Intervention MeSH terms: Interferons; Interferon alpha-2; Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan
      (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with
      follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either
      MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day
      subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375
      mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle
      of treatment. The anticipated time on study treatment is up to 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >18 years of age

          -  CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small
             lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise
             specified

          -  Stage II (with bulky disease), III, or IV lymphoma

          -  No previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide

          -  Indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma
             manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or
             thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general
             symptoms (weight loss, night sweats or fever)

          -  WHO performance status 0-2

        Exclusion Criteria:

          -  Prior treatment with rituximab or an interferon

          -  B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or
             central nervous system lymphoma

          -  Indolent lymphoma transformed into aggressive lymphoma

          -  Indolent lymphoma with bulky tumor requiring urgent therapy

          -  Prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or
             curative surgery >5 years ago

          -  Positive for HIV infection

          -  Uncontrolled asthma or allergy requiring corticosteroids
Liraglutide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Liraglutide 1.8mg; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2
      diabetes, however, these have not been studied prospectively in subjects with type 1
      diabetes. The investigators have, therefore, designed this study to investigate the central
      hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect.
      A major secondary objective of this study is to elucidate the mechanisms responsible for its
      glucose lowering effects and those involved in reducing the insulin dose. The specific aims
      of this proposal are:

      Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c,
      fasting, postprandial and the overall mean glucose concentrations while decreasing the dose
      of insulin required.

      Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and
      postprandial glucagon concentrations and increases basal and postprandial C-peptide
      concentrations.

      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric
      emptying.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as
             insulin pump) or multiple (four or more) injections of insulin per day.

          2. Regularly measuring blood sugars four times daily.

          3. HbA1c of less than 8.5%.

          4. Well versed with carbohydrate counting.

          5. Age 18-75 years.

          6. BMI 20-40 kg/m2

        Exclusion Criteria:

          1. Type 1 diabetes for less than 6 months;

          2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
             bypass, surgery or coronary angioplasty) in the previous four weeks;

          3. Hepatic disease (transaminase > 3 times normal) or cirrhosis;

          4. Renal impairment (serum eGFR < 30ml/min/1.73m2);

          5. HIV or Hepatitis B or C positive status;

          6. Participation in any other concurrent clinical trial;

          7. Any other life-threatening, non-cardiac disease;

          8. Use of an investigational agent or therapeutic regimen within 30 days of study.

          9. history of pancreatitis

         10. pregnancy

         11. inability to give informed consent

         12. history of gastroparesis

         13. history of medullary thyroid carcinoma or MEN 2 syndrome.
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo; Tamsulosin
Intervention description: by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks; PO, QD (30 min after meal) for 12 weeks; PO, QD (30 min after meal) for 12 weeks
Intervention MeSH terms: Tadalafil; Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 612.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design,
      multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12
      weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to
             initiation and IPSS score greater than or equal to 13 at the beginning of the
             treatment

          -  Agree not to use any other approved or experimental pharmacologic BPH, erectile
             dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.

          -  Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any
             other BPH therapy, ED or OAB therapy for specified duration of time prior to the
             beginning of the treatment

        Exclusion Criteria:

          -  Prostate specific antigen (PSA) score beyond acceptable range defined for study at
             initiation

          -  History of urinary retention or lower urinary tract (bladder) stones within 6 months
             of initiation

          -  History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor
             at initiation

          -  Clinical evidence of prostate cancer at initiation

          -  Clinical evidence of any of the bladder or urinary tract conditions, which may affect
             lower urinary tract symptom at initiation

          -  History of cardiac conditions, including Angina requiring certain treatment with
             nitrates, unstable angina defined for study, positive cardiac stress test before
             starting the study

          -  History of significant central nervous system injuries (including stroke or spinal
             cord injury within 6 months of initiation)

          -  Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens,
             luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids
             at initiation
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Remdesivir; Standard of Care
Intervention description: Administered as an intravenous infusion; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4891.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV)
      regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent, or with a legal representative
             who can provide informed consent, or enrolled under International Conference on
             Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
             investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18,
             where locally and nationally approved) prior to performing study procedures

          -  Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg
             (where permitted according to local law and approved nationally and by the relevant
             institutional review board (IRB) or independent ethics committee (IEC))

          -  Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
             polymerase chain reaction (PCR) test ≤ 4 days before randomization

          -  Currently hospitalized

          -  Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen
             at screening

        Key Exclusion Criteria:

          -  Participation in any other clinical trial of an experimental treatment for COVID-19

          -  Concurrent treatment with other agents with actual or possible direct acting antiviral
             activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing

          -  Evidence of multiorgan failure

          -  Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane
             oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.

          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
             of normal (ULN)

          -  Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥
             18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
             age

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Condition: Glabellar Lines; Lateral Canthal Lines
Intervention: botulinum toxin neuromodulator
Intervention description: A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Intervention MeSH terms: Botulinum Toxins; Neurotransmitter Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the
      long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal
      Lines (Crow's Feet and LCL).
    

Eligibility criteria:

        Inclusion Criteria:

        - Male or female at least 18 years of age.

        Exclusion Criteria:

          -  Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than the investigational product).

          -  Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          -  Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
Condition: Unresectable or Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab; Placebo for Nivolumab; Placebo for Ipilimumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with
      Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab
      alone.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed stage III (unresectable) or stage IV melanoma

          -  Treatment naïve patients

          -  Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per
             RECIST 1.1 criteria

          -  Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Ocular melanoma

          -  Subjects with active, known or suspected autoimmune disease

          -  Subjects with a condition requiring systemic treatment with either corticosteroids
             (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
             days of treatment

          -  Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
             Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated
             antigen-4 (anti-CTLA-4) antibody
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear; Postoperative Pain
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries
Intervention: Ketorolac
Intervention description: Oral Ketorolac
Intervention MeSH terms: Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Rotator Cuff Tear; Postoperative Pain

Summary:

      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following
           arthroscopic rotator cuff repair.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           arthroscopic rotator cuff repair.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients between the ages of 18 and 89 years old, male or female

          2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

        Exclusion Criteria

          1. Patients below the age of 18 or above the age of 89

          2. Illiterate or non-English speaking patients

          3. Patients with contraindications to Ketorolac

          4. History of alcohol of drug abuse

          5. Chronic use of analgesic or psychotropic drugs

          6. Known peptic ulcer disease or bleeding diathesis

          7. Renal dysfunction
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin detemir; insulin aspart
Intervention description: Injected s.c. (under the skin) once daily. Dose was individually adjusted.; Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.; Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 456.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to
      compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with
      insulin detemir (IDet), both combined with insulin aspart.

      The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension
      period is registered as NN1250-3725.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus for at least 12 months

          -  Current treatment with any basal bolus insulin for at least 12 months

          -  HbA1c below or equal to 10.0%

          -  Body Mass Index (BMI) below or equal to 35.0 kg/m^2

          -  For Japan only: Minimum age is 20 years

          -  For the extension trial only: Completed the six-month treatment period in trial
             NN1250-3585 (NCT01074268)

        Exclusion Criteria:

          -  Use of any other antidiabetic drug than insulin within the last 3 months

          -  Cardiovascular disease within the last 6 months

          -  Uncontrolled treated/untreated severe hypertension

          -  Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for
             diabetic ketoacidosis during the previous 6 months

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures

          -  Cancer and medical history of cancer
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Condition: Partial Epilepsies; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: lacosamide
Intervention description: Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Epilepsy; seizures; antiepileptic; Lacosamide; Vimpat; safety; adjunctive

Summary:

      The purpose of this study is to allow eligible subjects from the parent study, SP925
      [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects who participated in SP925 [NCT00655551] for treatment of
             partial-onset seizures

        Exclusion Criteria:

          -  Receiving any study drug or experimental device other than lacosamide

          -  Meets withdrawal criteria for parent study SP925 [NCT00655551]

          -  Experiencing ongoing serious adverse event
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Condition: Cardiac Surgery; Cardiopulmonary Bypass
Intervention: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution; Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Intervention description: Peri-operative fluid replacement therapy (max 40ml/kg/day); Peri-operative fluid replacement therapy (max 40ml/kg/day)
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 28 Days
Maximum age: 3 Years
Healthy volunteers: No

Summary:

      This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during
      elective open-heart surgery in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 28 days to 3 years old

          -  Planned cardiac surgery with cardiopulmonary by-pass

          -  signed informed consent

        Exclusion Criteria:

          -  Moribund patients (ASA 5)

          -  Jehovah Witnesses

          -  Pre-operative coagulation disorders

          -  Pre-operative renal insufficiency

          -  Pre-operative hepatic disorders

          -  Intra-cranial hemorrhage

          -  hypernatremia