bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: LDE225
Intervention description: LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: locally advanced basal cell carcinoma; metastatic basal cell carcinoma; LDE225; sonidegib; Basel Cell Carcinoma (BCC); skin cancer; Basel Cell Carcinoma; BCC

Summary:

      This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225
      in patients with locally advanced or metastatic BCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced BCC and metastatic BCC

          -  Patients with adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          -  Patients who had had major surgery within 4 weeks of initiation of study medication

          -  Patients unable to take oral drugs or with lack of physical integrity of the upper
             gastrointestinal tract, or known malabsorption syndromes.

          -  Patients with concurrent medical conditions that may interfere or potentially affect
             the interpretation of the study.

          -  Patients with neuromuscular disorders or are on concurrent treatment with drugs that
             may cause muscle damage.

          -  Patients who were on concurrent therapy with other anti-neoplastic agents.

          -  Patients who had taken part in an experimental drug within 4 weeks of initiation of
             study medication.

          -  Pregnant or nursing (lactating) women

          -  Women of child bearing potential unwilling to use 2 forms of highly effective
             contraception throughout the study and for 3 months after the last treatment

          -  Fertile males not willing to use condoms throughout the study and for 3 months after
             the last treatment.

          -  Patients who were unwilling or unable to comply with the protocol.
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GLPG0634; Placebo
Intervention description: GLPG0634 capsules.; Placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      -  Participants suffering from active rheumatoid arthritis who had an inadequate response
           to methotrexate were evaluated for improvement of disease activity (efficacy) when
           taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg
           once daily) or matching placebo for 24 weeks.

        -  During the course of the study, patients were also examined for any side effects that
           could occur (safety and tolerability), and the amount of GLPG0634 present in the blood
           (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
           action-related parameters in the blood (Pharmacodynamics) were determined. Also, the
           effects of different doses of GLPG0634 administration on participants' disability,
           fatigue and quality of life were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects who are ≥18 years of age on the day of signing informed
             consent,

          -  have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria
             of RA and ACR functional class I-III,

          -  have ≥6 swollen joints (from a 66-joint count) and

             ≥8 tender joints (from a 68-joint count) at Screening and at Baseline,

          -  Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range
             (ULN),

          -  have shown an inadequate response in terms of either lack of efficacy or toxicity to
             MTX,

          -  have agreed to be washed out from MTX for a period of at least 4 weeks before or
             during the Screening period.

        Exclusion Criteria:

          -  current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD),
             with the exception of antimalarials, which must be at a stable dose for at least 12
             weeks prior to Screening,

          -  current or previous RA treatment with a biologic DMARD, with the exception of biologic
             DMARDs: administered in a single clinical study setting, and; more than 6 months prior
             to Screening (12 months for rituximab or other B cell depleting agents), and; where
             the biologic DMARD was effective, and if discontinued, this should not be due to lack
             of efficacy,

          -  previous treatment at any time with a cytotoxic agent, other than MTX, before
             Screening.
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: DUR-928
Intervention description: oral suspension daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a research trial testing DUR-928 (an experimental medication). The purpose of the
      trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary
      Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months,
             with or without inflammatory bowel disease (IBD).

          -  Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no >15% fluctuation in the
             past 3 months.

          -  In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be
             stable for at least 3 months and at a dose not greater than 20 mg/kg/day.

          -  Subjects of childbearing potential must agree to use a medically acceptable method of
             contraceptive to prevent pregnancy in the subject and/or the partner for the duration
             of their participation in the trial up to 2 months after the last study drug dosing.

        Exclusion Criteria:

          -  Presence of documented secondary sclerosing cholangitis or small duct PSC

          -  Bacterial cholangitis within 30 days prior to Screening

          -  Presence of percutaneous drain or endoscopic bile duct stent

          -  History of, or suspicion of cholangiocarcinoma.

          -  Prior liver transplantation, or currently listed for liver transplantation

          -  Presence of other concomitant liver diseases

          -  Moderate to Severe active IBD or flare in colitis activity within the last 3 months

          -  Any severe and/or untreated concomitant cardiovascular, renal, endocrine or
             psychiatric disorder

          -  Any active malignant disease (within 3 years), other than non-melanomatous skin cancer

          -  Human immunodeficiency virus (HIV) infection

          -  Existing or intended pregnancy, or breast feeding

          -  Has received medication from another clinical trial within the past 30 days
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: MS1819; Porcine PERT
Intervention description: MS1819, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.; Porcine PERT is being used as a comparator to MS1819 as a second drug/intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2x2 Crossover
Masking: None (Open Label)
Masking description: Unblinded
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exocrine pancreatic insufficiency; EPI; Cystic Fibrosis; CF; Pancreatic enzyme replacement therapy (PERT); Lipase

Summary:

      The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs
      porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic
      insufficiency (EPI) due to cystic fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial
             diagnostic sweat chloride ≥ 60 mmol/L

          2. Under stable dose of porcine PERT

          3. A fair or better nutritional status

          4. Fecal elastase <100 µg/g

          5. Standard-of-care medications including Cystic Fibrosis Transmembrane Conductance
             Regulator (CFTR) modulators are allowed

        Exclusion Criteria:

          1. History or diagnosis of fibrosing colonopathy

          2. Any chronic diarrheal illness unrelated to pancreatic insufficiency

          3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper
             limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit

          4. Feeding via an enteral tube during 6 months before screening

          5. Forced expiratory volume ≤30% at the Screening visit
Treatment of Rett Syndrome With Recombinant Human IGF-1
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Intervention: Recombinant Human Insulin Growth Factor 1 (rhIGF-1); Placebo
Intervention description: Subjects will receive twice daily subcutaneous injections of IGF-1.; Subjects will receive twice daily subcutaneous injections of a saline solution (placebo).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Mitogens; Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Rett syndrome; RTT; IGF-1; autism spectrum disorder

Summary:

      Investigators are recruiting children for a clinical trial using the medication recombinant
      human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with
      Rett syndrome (RTT). While IGF-1 is approved by the Food & Drug Administration (FDA) for
      certain use in children, it is considered an investigational drug in this trial because it
      has not previously been used to treat RTT. Information from this study will help determine if
      IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a
      treatment for RTT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of "classic" (or "typical") Rett Syndrome

          -  Genetic documentation of MECP2 mutation

          -  Subject must be post-regression (Hagberg Stage 2)

          -  Subject and caregiver's primary language must be English

          -  Subject must reside in North America (US and Canada)

          -  Caregiver must have internet access and be able to complete questionnaires online and
             communicate via email

          -  Subject is stable on current medications for at least 4 weeks

          -  Subject's regimen of non-pharmacological interventions (physical therapy, speech
             therapy, etc.) is stable for at least 90 days

        Exclusion Criteria:

          -  Severe scoliosis (curvature >40 degrees)

          -  Bone-age greater than 11 years

          -  Cardiomegaly (enlarged heart)

          -  Tanner stage 2 or higher breast development

          -  Allergy to IGF-1

          -  Prior use of IGF-1, growth hormone, or sex steroids
Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
Condition: Cushing Disease
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion
Intervention: Pasireotide
Intervention description: Pasireotide 600 μg or 900 μg was administered as an SC injection.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cushing's disease; ACTH; Cortisol; ACTH dependent Cushing's disease

Summary:

      Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic
      hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and
      efficacy of pasireotide in participants with Cushing's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed the 15 days of Pasireotide treatment in the
             CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol.
             Participants who did not achieve normalization of 24 -hour urinary free cortisol may
             be enrolled if in the opinion of the investigator the participant is getting
             significant clinical benefits from treatment with Pasireotide .

          -  The participant did not experience any unacceptable adverse events of tolerability
             issues during the original 15 day treatment.

          -  Female participants of childbearing potential who have not undergone clinically
             documented total hysterectomy and/or ovariectomy or tubal ligation must agree to use
             barrier contraception throughout the course of the extension study, and for one month
             after the study has ended.

        Exclusion Criteria:

          -  Participant who have developed poorly controlled diabetes mellitus as indicated by
             ketoacidosis or hemoglobin (Hgb) A1C (HgbA1C) > 10 since starting [study
             CSOM230B2208].

          -  Participant with persistent alanine aminotransferase (ALT)/ aspartate transaminase
             (AST) or alkaline phosphatase levels more than 2.5X upper limit of normal (ULN), serum
             creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN.

          -  Participant with abnormal coagulation (Prothrombin time (PT) and partial
             thromboplastin time (PTT) elevated by 30% above normal limits), white blood cells
             (WBC) <3.0x1'000'000'000/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT
             <100x1'000'000'000/L.

        Other protocol-defined inclusion / exclusion criteria may apply.
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
Condition: Neuromuscular Blockade
Intervention: MK-8616; Zemuron®
Intervention description: MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight.; Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight.
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to explore the dose-response relation of MK-8616 (Org
      25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both
      Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study
      is to evaluate the safety of single doses of MK-8616 administered to participants of American
      Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy
      participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant
      with a severe systemic disease that limits activity, but is not incapacitating).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has an ASA Class of 1 to 3

          -  Is scheduled for surgical procedures (excluding dental and neck surgeries) with an
             anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron®

        Exclusion Criteria:

          -  Is undergoing dental or neck surgery

          -  Has anatomical malformation that would impede intubation

          -  Has or is suspected to have neuromuscular disorders impairing neuromuscular block
             and/or significant renal dysfunction

          -  Is known or suspected to have a family history of malignant hyperthermia

          -  Is known or suspected to have an allergy to narcotics, muscle relaxants, or other
             medications used during general anesthesia

          -  Is pregnant

          -  Is a female of childbearing potential not using 1 of the following methods of birth
             control: condom or diaphragm with spermicide, vasectomized partner (<6 months),
             intrauterine device (IUD), or abstinence

          -  Is breast-feeding

          -  Has already participated in the study

          -  Has participated in another clinical trial, not pre-approved by Organon
             Pharmaceuticals USA within 30 days of entering this study
Omega-3 for Depression and Other Cardiac Risk Factors - 2
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Omega-3 supplement; Placebo
Intervention description: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks; Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Antidepressive agents; Coronary disease; Depression; Depressive disorder; Fatty Acids, Omega-3

Summary:

      The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to
      determine whether antidepressant augmentation with two grams of EPA omega-3 per day is
      superior to antidepressant therapy alone for major depression in patients with coronary heart
      disease (CHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented coronary heart disease

          -  Diagnosis of major depression based on structured interview

        Exclusion Criteria:

          -  Moderate to severe cognitive impairment

          -  Meets DSM-5 criteria for depressive disorder due to a general medical condition or
             medication

          -  Major Axis I psychiatric disorder other than unipolar depression or an anxiety
             disorder, a high risk of suicide, or current substance abuse other than tobacco;

          -  Not expected to survive one year or physically unable to tolerate the study protocol

          -  Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish

          -  Taking an antidepressant or an omega-3 supplement at baseline

          -  Exempted by their cardiologist or primary care physician

          -  Refuses to provide informed consent

          -  Participating in a competing protocol or trial
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal ABCWY; Placebo
Intervention description: One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1); One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No

Summary:

      This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the
      effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6
      month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as
      measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be
      invited at the time of their last study visit to participate in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescents who completed V102_16 study and received the study vaccines as assigned in
             the protocol (either two doses of the MenABCWY or one dose each of MenACWY and
             Placebo).

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
             meningitidis.

          -  History of any meningococcal vaccine administration other than vaccination given in
             the parent V102_16 protocol.