bioihbjkbjnl/mcl2 huggingface dataset:
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
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Intervention: asfotase alfa; asfotase alfa
Intervention description: 2 mg/kg subcutaneous injection three times per week for 6 months.; 3 mg/kg subcutaneous injection three times per week for 6 months.
Intervention MeSH terms: Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia

Summary:

      This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP
      compared to a historical control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent from parent or legal guardian prior to participation

          2. Patients > 5 and < 12 years of age with open growth plates at time of enrollment

          3. Tanner stage of 2 or less indicating pre-pubescence

          4. Documented history of HPP, as evidenced by:

               -  Presence of HPP-related rickets on skeletal radiographs of the wrist and knee

               -  Serum alkaline phosphatase (ALP) below age-adjusted normal range

               -  Plasma PLP at least twice the upper limit of normal

          5. 25(OH) vitamin D level > 20 ng/mL

          6. Ability of patient and parent/guardian to comply with study requirements

        Exclusion Criteria:

          1. Serum calcium or phosphorus below age-adjusted normal range

          2. History of sensitivity to any study drug constituent

          3. Medical condition, serious intercurrent illness, or other extenuating circumstance
             that, in the opinion of the Investigator, may significantly interfere with study
             compliance, including all prescribed evaluations and follow-up activities

          4. Treatment with an investigational drug within 1 month before start of study drug

          5. Current enrollment in any other study involving an investigational new drug, device,
             or treatment for HPP (e.g., bone marrow transplantation)

          6. Current evidence of a treatable form of rickets

          7. Prior treatment with bisphosphonates

          8. Bone fracture or orthopedic surgery within the past 12 months that, in the opinion of
             the Investigator would interfere with the ability of study patient to comply with
             study protocol

          9. Major congenital abnormality other than those associated with HPP
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Condition: Pandemic H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Adjuvanted H5N1 pandemic influenza vaccine
Intervention description: Comparison of two doses of aH5N1c vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 979.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, Pandemic, H5N1, Adults

Summary:

      Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived
      Influenza Vaccine in Adult Subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult subjects 18 to 64 years of age,

          2. Individuals willing to provide written informed consent,

          3. Individuals in good health,

          4. Individuals willing to allow for their serum samples to be stored beyond the study
             period.

        Exclusion Criteria:

          1. Individuals not able to understand and follow study procedures,

          2. History of any significant illness,

          3. History of any chronic medical condition or progressive disease,

          4. Presence of medically significant cancer,

          5. Known or suspected impairment/alteration of immune function,

          6. Presence of any progressive or severe neurologic disorder,

          7. Presence of any bleeding disorders or conditions that prolongs bleeding time,

          8. History of allergy to vaccine components,

          9. Receipt of any other investigational product within 30 days prior to entry into the
             study,

         10. History of previous H5N1 vaccination,

         11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into
             the study,

         12. Receipt of any other vaccine within 2 weeks prior to entry into the study

         13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended
             study vaccination,

         14. Pregnant or breast feeding,

         15. Females of childbearing potential refusing to use acceptable method of birth control,

         16. Body mass index (BMI) ≥ 35 kg/m2,

         17. History of drug or alcohol abuse,

         18. Any planned surgery during study period,

         19. Individuals conducting the study and their immediate family members,

         20. Individuals with behavioral or cognitive impairment or psychiatric diseases.
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Lixivaptan
Intervention description: Oral vasopressin V2 receptor antagonist
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the
      pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan
      in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease (CKD) in
      stages CKD1, CKD2 or CKD3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, between 18 and 65 years of age at the time of screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 with eGFR calculated
             by the CKD EPI equation

          -  Diagnosed with ADPKD by modified Ravine criteria

          -  Considered by Investigator to be in good health relative to underlying CKD status and
             clinically stable with respect to underlying CKD

        Exclusion Criteria:

          -  Known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such
             as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine),
             or any compound listed as being present in the study formulation

          -  Women who are pregnant or breast feeding

          -  Subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational
             drug or used an investigational device within 30 days or 5 half-lives, whichever is
             longer, prior to first study dose

          -  Subject has a transplanted kidney, or absence of a kidney

          -  Subjects with clinically significant incontinence, overactive bladder, or urinary
             retention (e.g., benign prostatic hyperplasia)

          -  Subjects with clinically significant liver disease, or clinically significant liver
             function abnormalities or serology other than that expected for ADPKD with cystic
             liver disease at baseline

          -  Subjects with any clinically significant concomitant disease or condition other than
             ADPKD (including treatment for such conditions) that, in the opinion of the
             Investigator, could either interfere with the study drug or pose an unacceptable risk
             to the subject
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
Condition: Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation; Recurrent Uterine Corpus Carcinoma; Stage I Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer
MeSH terms: Carcinoma; Adenocarcinoma; Carcinoma, Endometrioid; Carcinoma, Adenosquamous
Intervention: Laboratory Biomarker Analysis; Medroxyprogesterone; Therapeutic Conventional Surgery
Intervention description: Correlative studies; Given IM; Undergo surgical hysterectomy
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well medroxyprogesterone works in treating patients with
      endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not
      including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating
      endometrioid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus

               -  All histologic grades and stages eligible

               -  Diagnosis by endometrial curettage or biopsy within the past 8 weeks

                    -  Must have the initial tissue block or 16 unstained sections of 5 micron
                       thickness available

          -  Performance status - GOG 0-3

          -  No history of thrombophlebitis or thromboembolic disorders

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No prior therapeutic progesterone or anti-estrogen therapy within 3 months before
             diagnosis

          -  No concurrent aminoglutethimide

          -  No prior cancer treatment that would preclude study therapy

          -  No concurrent bosentan

          -  No concurrent rifampin
A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bevacizumab
Intervention description: Bevacizumab was provided as a concentrate in vials.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously
      every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines
      of prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 19-75 years of age

          -  Multiple myeloma.

          -  Progressive disease after at least 2 lines of prior therapy.

        Exclusion Criteria:

          -  Non-secretory myeloma.

          -  History of malignancy, other than squamous cell cancer, basal cell cancer, or cancer
             in situ of the cervix within the last 5 years.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study treatment start.

          -  Clinically significant cardiac disease.
Safety of Urate Elevation in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; inosine; inosine
Intervention description: 500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms; 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL; 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Parkinson disease; PD; inosine; urate; uric acid; cerebrospinal fluid

Summary:

      The purpose of this study is to determine the safety and tolerability of inosine and its
      ability to raise urate levels in blood and cerebral spinal fluid in individuals with early
      Parkinson disease. This will determine whether it is appropriate to proceed with a larger
      study of inosine's ability to modify the rate of disability progression in PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic PD with at least two of the cardinal signs of PD (resting tremor,
             bradykinesia, rigidity)

          -  Currently not taking or needing any treatment for PD other than an monoamine oxidase-B
             (MAO-B) inhibitor

          -  Age 30 or older at the time of PD diagnosis

          -  Diagnosis of PD made within past 3 years

          -  Serum urate ≤ 5.8 mg/dL at initial screening

        Exclusion Criteria:

          -  History of kidney stones, gout, stroke, or heart attack

          -  History of renal disease or certain cardiovascular problems within the past year

          -  Acidic urine (pH ≤ 5.0), uric acid, or urate crystalluria at screening

          -  Use of certain medications including co-enzyme Q, creatine, more than 50 IU of vitamin
             E daily, and more than 300 mg of vitamin C daily. (A standard daily multivitamin is
             permitted.)

          -  Use of anti-PD and other medications targeting central nervous system dopamine
             transmission

          -  Known unstable medical or psychiatric condition that may compromise participation in
             the study

          -  Women who are pregnant or lactating
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
Condition: Healthy Volunteers; Norovirus
Intervention: NoV Vaccine
Intervention description: NoV vaccine injection administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate descriptively the long-term immunogenicity of at
      least 1 NoV vaccine administration.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male and female participants who previously received at least 1 dose of NoV vaccine in
        trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have
        baseline and post-vaccination data, and completed the primary vaccination trial protocol as
        initially described.

        Exclusion Criteria:

          1. Participation in any clinical trial is allowed, on condition that no investigational
             product is administered within 30 days prior to blood sampling.

          2. In the opinion of the investigator, the participant is not medically eligible to
             provide blood specimens.

          3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the participant's ability to
             participate in the trial.
6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AZD2066; Placebo; Duloxetine
Intervention description: 18 mg once daily; 60 mg once daily
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in
      patients with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed, written, and dated Informed Consent

          -  Documented primary clinical diagnosis of Major Depressive Disorder

        Exclusion Criteria:

          -  Patients with a secondary psychiatric disorder including bipolar disorder, psychotic
             disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic
             features), GAD and social anxiety disorder

          -  Patients whose current episode of depression started less than 4 weeks before
             enrollment

          -  History of inadequate response of antidepressants during current depressive episode
Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Exercise
Intervention description: After obtaining daily medical clearance, patients will be approached 4-5 days per week to perform 30-45 minutes of supervised exercise with a Canadian Society for Exercise Physiology (CSEP) - Certified Exercise Physiologist. All exercise sessions will be as tolerated, based on patient symptoms.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute myeloid leukemia; AML; chemotherapy; exercise; quality of life; cancer-related fatigue; elderly; physical fitness; muscular strength; Feasibility; Efficacy; Safety

Summary:

      Fatigue, reduced quality of life and declines in physical function are common in patients
      undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients
      undergoing treatment have shown that exercise improves these symptoms, but there are limited
      studies in AML. This study of a hospital-based exercise program will help determine if
      exercise is both feasible and helpful in improving symptoms among for AML patients undergoing
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years old

          -  newly diagnosed AML, or relapsed AML after having been in complete remission for at
             least 6 months

          -  initiating induction chemotherapy

          -  ambulatory without need for human assistance

          -  has consented to study

          -  is medically cleared for participation by attending physician

        Exclusion Criteria:

          -  has another active malignancy

          -  has life expectancy < 1 month, physician determined

          -  has significant comorbidity

          -  has uncontrolled pain

          -  has haemodynamic instability

          -  lacks fluency in reading and writing English and there is no translator available for
             each visit