bioihbjkbjnl/mcl2 huggingface dataset:
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
Condition: CML
Intervention: nilotinib
Intervention description: Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl

Summary:

      To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in
      patients who achieve MR4.5
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of CML

          -  Treated with at least 1 year of imatinib

          -  Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by
             PCR reported on the International scale confirmed during screening

          -  Written informed consent obtained prior to any screening procedures performed

        Exclusion Criteria:

          -  T315I mutation

          -  Prior imatinib failure or had accelerated phase or blast crisis CML

          -  Impaired cardiac function

          -  Pregnant or lactating women
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Sargramostim (GM-CSF); Pneumococcal Vaccine
Intervention description: Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.; Subcutaneously on Day 0
Intervention MeSH terms: Molgramostim; Sargramostim; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Leukemia; Sargramostim; Pneumococcal Pneumonia; Pneumococcal Vaccine; Prevnar; GM-CSF; CLL

Summary:

      The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the
      effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia,
      in patients with chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Inclusion Criteria:

        1) Patients in complete / partial remission or those with active Chronic lymphocytic
        leukemia (CLL) with Rai stage 0 to 4.

        Exclusion Criteria:

          1. Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having
             received Rituximab within 6 months.

          2. Patients will not be entered while febrile (Temperature > 38 degrees C) within 1 week.

          3. Active infection.

          4. Patients with known Human immunodeficiency virus (HIV) infection.

          5. Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF)
             or pneumococcal vaccine.

          6. Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.

          7. Patients who have previously received pneumococcal vaccine within the preceding 12
             months.

          8. Absolute lymphocyte count less than 500 cells/mm3.
Lidocaine Patches Prior to Intravenous Insertion
Condition: Need for Intravenous Catheter
Intervention: Lidocaine tetracaine; Placebo
Intervention description: Lidocaine 70 mg/tetracaine 70 mg; Placebo patch identical in appearance to Synera
Intervention MeSH terms: Lidocaine; Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 45.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: intravenous catheter; emergency department; pain

Summary:

      This study will determine whether application of a patch containing a topical anesthetic
      (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an
      intravenous catheter in Emergency Department patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 3,

          -  Need for non-emergent intravenous catheter

        Exclusion Criteria:

          -  Unstable patients,

          -  Allergy to lidocaine or tetracaine
Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Yohimbine
Intervention description: Yohimbine capsule
Intervention MeSH terms: Yohimbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: genetics; type 2 diabetes; insulin secretion

Summary:

      The investigators have recently discovered a genetic variant in an adrenergic receptor that
      leads to increased risk for type 2 diabetes. The investigators have also seen that blockers
      of that receptor improves impaired insulin secretion in animals. The investigators will now
      test the blocker in patients with type 2 diabetes with or without the risk variant in an
      effort to make diabetes treatment more individualized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  informed consent

          -  age 18-70, for females only postmenopausal

        Exclusion Criteria:

          -  heart disease

          -  anxiety disorder

          -  antidiabetic treatment other than metformin

          -  adrenergic blockers

          -  ulcus

          -  allergy to any component in the capsules
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Condition: Spinal Cord Injury; Bone Loss; Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: Alendronate; Calcium; Vitamin D
Intervention description: Weekly oral alendronate 70 mg for 12 months; Daily oral 1000 mg Calcium; Daily oral 1000 IU
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Alendronate; Vitamins; Calcium Carbonate; Antacids; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Teriparatide; Alendronate; Alendronic Acid; Osteoporosis; Bone Fracture; Bone Loss; Spinal Cord Injury; Bone Diseases; Metabolic Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Nervous System; Wounds and Injuries; Bone Density Conservation Agents; Physiological Effects of Drugs; Pharmacologic Actions

Summary:

      The purpose of this study is to determine if a year of alendronate treatment will maintain or
      increase bone mass density (BMD) compared to baseline BMD values in people with chronic
      spinal cord injury (SCI).

      This study will also investigate 1) if alendronate therapy will increase bone strength in
      people with chronic SCI, 2) the number of participants with adverse events from alendronate,
      and 3) the effects of alendronate on serum markers of bone metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on
             Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for 90 days following completion of therapy.

          -  Ability to understand and the willingness to sign a written informed consent.

        Exclusion Criteria:

          -  Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).

          -  Individuals who are not able to sit or stand upright for at least 30 minutes after
             taking their medication.

          -  Individuals with poor dental hygiene.

          -  Individuals with esophageal abnormalities.

          -  Individuals who are not able to tolerate alendronate treatment.

          -  Individuals who will not be able to return for all study visits.

          -  Patients may not be receiving any other investigational agents.

          -  Other medical conditions that in the opinion of the investigator would preclude the
             subject from completing the study
Evaluate SAGE-547 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Intervention: SAGE-547; Placebo
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,
      tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female
      participants with essential tremor in the upper limb.

      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and
      effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who
      completed Stage 1 were invited to participate in Stage 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms
             clearly present in at least 1 upper limb; participant has had tremor present for at
             least 2 years prior to Screening

          -  Off medication, or on a stable dose of medication for their tremor for at least 28
             days prior to Screening

        Exclusion Criteria:

          -  Recent history or active clinically significant manifestations of metabolic, hepatic,
             renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
             dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological
             (other than essential tremor) disorders

          -  Medical history of seizures
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Active treatment with a high dose of BGS649; Active treatment with a low dose of BGS649; Placebo treatment to blind study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Endometriosis; Infertility; Pain; Vaginal Diseases; Uterine Diseases

Summary:

      This study will assess the safety and tolerability of BGS649 in women with moderate to severe
      endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women with documented moderate to severe endometriosis. Occurrence of
             three sequential menstrual cycles of 24-35 days duration prior to enrollment.

          -  Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed
             within the past 10 years before screening).

          -  Patients not planning to become pregnant within one year after the screening visit and
             willing to use two effective methods of non-hormonal, barrier birth control for the
             duration of the study or who are surgically sterile.

          -  Patients must have a score of at least 4 on the numerical rating scale (NRS) for one
             of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia

        Exclusion Criteria:

          -  Estrogen replacement therapy using either prescription medications or
             estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical
             estrogens.

          -  Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or
             Arimidex (anastrozole) within the past 12 months.

          -  Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or
             intravenous bisphosphonate (i.e., Reclast, pamidronate) < 15 months from screening.

          -  Systemic glucocorticoid therapy within the past 4 weeks.

          -  Contra-indications to oral contraceptive use.

        Other protocol-defined inclusion/exclusion criteria may apply
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Condition: Hypogonadal Males
Intervention: Testosterone Gel (FE 999303)
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum
      testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the
      pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand
      application
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-75

          -  History of hypogonadism

          -  In good health based on medical history, physical examination, and clinical laboratory
             tests

          -  Serum testosterone deficiency

          -  One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or
             reduced sexual functioning)

          -  Body mass index (BMI) between 18 and 35 kg/m^2

          -  All screening lab tests within 20% of the normal range (exceptions are liver function
             tests)

          -  HIV, Hepatitis B and C negative

        Exclusion Criteria:

          -  Previous use of FE 999303

          -  Prostate cancer

          -  Breast carcinoma, patient or partner

          -  Palpable prostatic mass(es)

          -  Serum PSA levels ≥3 ng/dL

          -  Chronic use of any drug of abuse

          -  Lower urinary tract obstruction

          -  Clinically significant anemia or renal dysfunction

          -  Cardiovascular disease

          -  Hyperparathyroidism or uncontrolled diabetes

          -  Generalized skin irritation or significant skin disease

          -  Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
             (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone,
             5-alfa-reductase-inhibitors, ketoconazole, abiraterone)

          -  Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous
             12 months of screening)

          -  Use of testosterone products (within 8 weeks of screening for parenteral products, or
             6 weeks of screening for other preparations)

          -  Sleep apnea

          -  Untreated depression

          -  Subject with a partner who is pregnant or will not use contraception
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Condition: Obesity; Overweight and Obesity
MeSH terms: Obesity; Overweight
Intervention: LY3502970; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of the study was to assess the effect of LY3502970 in participants who have
      obesity or are overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)

          -  Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related
             comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]

          -  Have had a stable body weight for the 3 months prior to randomization (not more than
             5% body weight gain and/or loss)

        Exclusion Criteria:

          -  Have any prior diagnosis of diabetes

          -  Have a prior or planned surgical treatment for obesity

          -  Have obesity induced by other endocrinological disorders or diagnosed monogenetic or
             syndromic forms of obesity

          -  Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30
             milliliter (mL)/minute (min)/1.73 m²

          -  Have a history of acute chronic pancreatitis

          -  Have a history of significant active or unstable Major Depressive Disorder (MDD) or
             other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or
             other serious mood or anxiety disorder) within the last 2 years Note: Participants
             with MDD or generalized anxiety disorder whose disease state is considered stable for
             the past 2 years and expected to remain stable throughout the course of the study, may
             be considered for inclusion if they are not on excluded medications.

        Within 3 months prior to screening:

          -  Have poorly controlled hypertension

          -  Have history of acute myocardial infarction

          -  Have history of cerebrovascular accident (stroke)

          -  Had hospitalization due to congestive heart failure (CHF)

          -  Have cancer

          -  Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or
             at screening

          -  Have hepatitis B and/or positive hepatitis B surface antigen
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Condition: Kaposi´s Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Intervention: Bevacizumab
Intervention description: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Kaposi sarcoma; HIV; Bevacizumab

Summary:

      Kaposi sarcoma remains the most common malignancy among persons with HIV.

      Lesions localized to the airway may cause bleeding, pain and dyspnea.

      New therapeutic approaches for local disease are needed.

      The purpose of this study is to compare the effectiveness of intralesional bevacizumab +
      HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with
      AIDS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  KS of the oral cavity, pharynx and larynx, histopathologically confirmed

          -  HIV treatment-naïve

        Exclusion Criteria:

          -  Airway obstructive lesions

          -  Actively bleeding lesions

          -  Tumor-associated oedema or ulceration

          -  Gastrointestinal KS

          -  KS in other nonnodal viscera
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Valbenazine; Placebo oral capsule
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's
      optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric
      subjects with TS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence 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

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study