bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: NBI-98854; Placebo
Intervention description: NBI-98854 40 mg capsules; NBI-98854 placebo capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment and follow-up periods of the study.

          2. Female subjects must not be pregnant.

          3. Have one of the following clinical diagnoses for at least 3 months prior to screening:
             Schizophrenia or Schizoaffective Disorder, or Mood Disorder.

          4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to
             screening.

          5. Have moderate or severe TD.

          6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or
             mood disorder, be on stable doses.

          7. Be in good general health.

          8. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

          9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines,
             phencyclidine, cocaine, opiates, or cannabinoids

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          2. Have a known history of substance dependence, or substance (drug) or alcohol abuse

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

          6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)

          7. Have received an investigational drug within 30 days prior to screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

         10. Have had previous exposure with NBI-98854 or had previously participated in an
             NBI-98854 clinical study.

         11. Are currently pregnant or breastfeeding.
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids; Anemia
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex 25 mg; Proellex 50 mg; Placebo
Intervention description: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months; Proellex 50 mg, 2 - 25 mg capsules daily for 3 months; Placebo, 2 capsules daily for 3 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Uterine fibroids; Anemia

Summary:

      Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg
      elemental iron) iron supplements twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and
             39, inclusive;

          -  Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine
             fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;

          -  Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned
             or anticipated after the study;

          -  Willing to comply with all study procedures, including the endometrial biopsies and
             blood draws for all visits, including Follow-up Visits

        Exclusion Criteria:

          -  Post-menopausal women or women likely to become post-menopausal during the study,
             defined as one or more of the following:

               -  Six months or more (immediately prior to Screening Visit) without a menstrual
                  period, or

               -  Prior hysterectomy, or

               -  Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if
                  regular menstruation is occurring);

          -  Females who have undergone a uterine arterial embolization, or endometrial ablation
             therapy (previous myomectomy is acceptable) for any cause;

          -  Documented endometriosis or active pelvic inflammatory disease (PID);

          -  Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive
             organs;

          -  Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

          -  Use of prohibited concomitant medications:

               1. Depo-Provera use must cease ten months prior to first dose of study drug, or

               2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose
                  of study drug, or

               3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior
                  to the start of the study
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: lenalidomide; Placebo; Rituximab; Cyclophosphamide; Doxorubicin; prednisone; vincristine
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 570.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: R-CHOP chemotherapy; DLBCL front line therapy; gene expression profiling (GEP) activated B-cell (ABC) type DLBCL biomarkers; Activated B-Cell (ABC) type; Diffuse Large B-Cell Lymphoma, not otherwise specified; Diffuse Large B-Cell Lymphoma, associated with chronic inflammation; Diffuse Large B-Cell Lymphoma, Epstein-Barr virus positive (EBS+) of the elderly; Diffuse Large B-Cell Lymphoma, T-cell / histiocyte-rich

Summary:

      To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide,
      doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,
      cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in
      patients who have previously untreated ABC type DLBCL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type

          2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma

          3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) /
             Magnetic Resonance Imagining (MRI) scans

          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

          5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ≤
             1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)

        Exclusion Criteria:

          1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma

          2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient
             has been disease free for 5 years or more

          3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
             Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

          4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left
             Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles
Condition: Bilateral Nasolabial Fold Wrinkles
Intervention: Autologous Human Fibroblasts (azficel-T); Placebo
Intervention description: Collection of 3 mm post auricular skin punch biopsies.
Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.; Collection of 3 mm post auricular skin punch biopsies.
Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles

Summary:

      The purpose of this study is to evaluate the safety profile and the treatment effect of
      Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold
      wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is at least 18 years of age

          -  Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as
             per protocol

          -  Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol

          -  Ability to comply with the study requirements

          -  Negative pregnancy test (Females)

          -  Healthy post-auricular skin for biopsy

        Exclusion Criteria:

          -  Excessive dermatochalasis of the treatment area

          -  Inability to lessen the nasolabial fold wrinkles by physically spreading the area
             apart

          -  Total area to be treated exceeds 20 cm in length

          -  Physical attributes which may prevent assessment or treatment as judged by the
             evaluator

          -  Use of an investigational product/procedure within 30 days prior to enrollment or
             plans for use during the study

          -  Previous treatment with the sponsor's product

          -  History of active autoimmune disease or organ transplantation

          -  Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma
             is excluded)

          -  Active or chronic skin disease

          -  Known genetic disorders affecting fibroblasts or collagen

          -  Active systemic infection

          -  Requires chronic antibiotic or steroidal therapy

          -  Use of certain commercial products/procedures to the treatment area prior to study
             enrollment or plans for use during the study

          -  Use of systemic agents that increase bleeding or clotting, or disorders equated with
             these effects

          -  Known allergic reactions to agents used in preparation of treatment

          -  Excessive exposure to sun without adequate sun protection
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
Condition: Cancer of Cervix
MeSH terms: Uterine Cervical Neoplasms
Intervention: Gemcitabine; Cisplatin; Brachytherapy; Pelvic radiation
Intervention description: Brachytherapy, 30-35 Gy over 1 week; Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Intervention MeSH terms: Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 515.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effectiveness of two methods of treating cancer
      of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing
      radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will
      receive cisplatin along with radiation therapy without adjuvant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with cancer of cervix

          -  tumor that can be measured

          -  no previous treatment with chemotherapy or radiation for this cancer

          -  Karnofsky Performance Status Score >=70

          -  able to give written consent

          -  willing and able to participate in the study, both during the active treatment and the
             follow-up period.

        Exclusion Criteria:

          -  impairment such as hearing loss from prior cisplatin therapy

          -  damage to nerves such as being unable to distinguish hot and cold to touch

          -  used other experimental medication in past 30 days

          -  lab test results are not within the limits required for this study

          -  pregnancy or breast-feeding or possibility of becoming pregnant during this study and
             not using an approved method of birth control.
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Condition: Pain; Low Back Pain; Osteoarthritis; Neuropathic Pain
MeSH terms: Neuralgia; Low Back Pain; Chronic Pain
Intervention: BEMA Buprenorphine
Intervention description: buccal soluble film; applied to the buccal mucosa twice daily
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: buccal soluble film

Summary:

      The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment
      of chronic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant and non-nursing female aged 18 or older

          -  History of moderate to severe chronic pain:

               1. Subjects completing study BUP-301 (low back pain) or

               2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low
                  back pain), pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported
                  at the titration period Day 0/1 visit following a washout period (opioids,
                  NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently
                  taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or
                  longer

          -  Stable health, as determined by the Investigator, on the basis of medical history,
             physical examination, and 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 prior to any procedure being performed

        Exclusion Criteria:

          -  Cancer related pain

          -  Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute
             spinal cord compression, cauda equina compression, acute nerve root compression,
             meningitis, or discitis

          -  Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks,
             prior to titration period Day 0/1 visit

          -  History of severe emesis with opioids

          -  Clinically significant sleep apnea in the judgment of the investigator
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Japanese Encephalitis purified inactivated vaccine
Intervention description: IC51 6 mcg i.m. injection on Day 0 and Day 28
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 389.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to demonstrate equivalence of three commercial IC51 batches in terms of
      geometric mean titers for anti-JEV neutralizing antibody
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male and female healthy adults aged at least 18 years, with written informed consent
             and either no childbearing potential or negative pregnancy test

        Main Exclusion Criteria:

          -  History of immunodeficiency or immunosuppressive therapy,

          -  Known Human Immunodeficiency Virus (HIV); OR

          -  Drug addiction including alcohol dependence
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
Condition: Cardiac Transplant; Patent Ductus Arterious; Atrial Septal Defect; Bidirectional Cavopulmonary Anastomosis
MeSH terms: Heart Diseases; Heart Defects, Congenital; Heart Septal Defects, Atrial
Intervention: Dexmedetomidine
Intervention description: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Congenital heart disease; pharmacokinetics; pharmacodynamics; pediatric; Bidirectional cavopulmonary anastomosis; Fontan physiology; Cardiac transplant

Summary:

      The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and
      pharmacogenomics of dexmedetomidine in the following three pediatric patient populations:
      patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who
      have had a cardiac transplant, and patients with otherwise normal physiology who are
      undergoing closure of a patent ductus arteriosis or atrial septal defect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age is birth to 18 years

          -  > or = 6 kg.

          -  American Society of Anesthesiology (ASA) I, II, or III

          -  undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial
             septal defect.

          -  scheduled for cardiac catheterization

        Exclusion Criteria:

          -  subject or family history of malignant hyperthermia

          -  known hepatic disorder determined by history physical exam or laboratory tests

          -  pregnant or lactating female

          -  receiving inotropic agents or has a pacemaker

          -  weighs less than 6 kg.
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Condition: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
MeSH terms: Amyloid Neuropathies, Familial; Cardiomyopathies; Amyloidosis
Intervention: Placebo; Patisiran
Intervention description: Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.; Patisiran will be administered by intravenous (IV) infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; Transthyretin; TTR; Amyloidosis; Cardiomyopathy; ATTR

Summary:

      The purpose of this study is to evaluate the efficacy and safety of patisiran in participants
      with ATTR amyloidosis with cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either
             hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with
             cardiomyopathy

          -  Medical history of heart failure with at least 1 prior hospitalization for heart
             failure, or current clinical evidence (signs and symptoms of heart failure)

          -  Clinically stable with no cardiovascular related hospitalizations within 6 weeks of
             study start

          -  Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6
             months with evidence of disease progression while on tafamidis treatment

          -  Able to complete ≥150 m on the 6-minute walk test

          -  Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of
             heart failure severity, >300 ng/L and <8500 ng/L; in participants with permanent or
             persistent atrial fibrillation, screening NT-proBNP> 600 ng/L and <8500 ng/L

        Exclusion Criteria:

          -  Known primary amyloidosis (AL) or leptomeningeal amyloidosis.

          -  Received prior TTR lowering treatment

          -  New York Heart Association heart failure classification of III and at high risk

          -  New York Heart Association heart failure classification of IV

          -  Neuropathy requiring cane or stick to walk, or is wheelchair bound

          -  Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2

          -  Abnormal liver function

          -  Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

          -  Has non-amyloid disease that significantly affects ability to walk (e.g., severe
             chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular
             disease affecting ambulation)

          -  Prior or planned heart, liver, or other organ transplant

          -  Other cardiomyopathy not related to ATTR amyloidosis