bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Condition: Mantle Cell Lymphoma; Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Lenalidomide; Investigators choice single agent
Intervention description: For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.; Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; Lymphoma; MCL

Summary:

      To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients
      with relapsed or refractory mantle cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven mantle cell lymphoma

          -  Patients who are refractory to their regimen or have relapsed once, twice or up to
             three times and who have documented progressive disease

          -  Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2

          -  Willing to follow pregnancy precaution

        Exclusion Criteria:

          -  Any of the following laboratory abnormalities

          -  Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L)

          -  Platelet count < 60,000/mm^3 (60 x 10^9/L)

          -  Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or
             alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >3.0 x upper limit
             or normal (ULN), except patients with documented liver involvement by lymphoma

          -  Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented
             liver involvement by lymphoma.

          -  Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

          -  History of active central nervous system (CNS) lymphoma within the previous 3 months

          -  Subjects not willing to take deep venous thrombosis (DVT) prophylaxis

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
             sero-positive because of hepatitis B virus vaccine are eligible
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
Condition: Kaposi Sarcoma; Human Immunodeficiency Virus; Immune Reconstitution Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sarcoma, Kaposi; Sarcoma; Immune Reconstitution Inflammatory Syndrome
Intervention: Valganciclovir; Antiretroviral Combinations
Intervention description: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.; Patients will receive standard antiretroviral treatment as recommended
Intervention MeSH terms: Anti-Retroviral Agents; Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Kaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting
      combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a
      severe clinical presentation and high mortality (severe-IRIS-KS). The objective of this study
      is to evaluate the presence of Severe IRIS-KS and it´s attributable mortality in patients
      with AIDS and disseminated KS with the use of valganciclovir prior to the initiation of cART
      compared with the standard management of immediate cART initiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who
             accept to participate and who sign the letter of informed consent.

          -  The following are the KS severity criteria: pulmonary compromise, and/or digestive
             tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise
             with generalized lymphedema.

        Exclusion Criteria:

          -  Patients with another synchronic malignant neoplasm

          -  Patients receiving corticosteroids

          -  Patients with active hepatitis B and/or hepatitis C

          -  Patients with KS limited to skin with less than 30 lesions.

          -  Patients with APACHE II score ≥15 points.
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Condition: Acute Pain; Post Operative Pain; Pain
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: MR-107A-02; Placebo
Intervention description: MR-107A-02 oral tablet; Placebo oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double blind, placebo controlled
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after
      dental surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥18 years of age.

          2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which
             involves partial or complete mandibular bony impaction.

          3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours
             following the end of surgery in the eligibility assessment as well as in the baseline
             assessment immediately pre-dosing.

          4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,
             none, mild, moderate, severe) during the 5 hours following the end of surgery.

        Exclusion Criteria:

          1. Previously dosed with MR-107A-02.

          2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).

          3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel
             disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may
             affect coagulation.

          4. Moderate or severe hypertension, prior stroke or transient ischemic attack.

          5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent
             whichever is longer.

          6. Use of medications with the potential to interact with MR-107A-02.

          7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator.
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in
      Japanese participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine as defined by International Headache Society (IHS)
             International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or
             1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to Galcanezumab or other antibodies to CGRP or its
             receptor.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to Galcanezumab and the excipients in the investigational product.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Open-Label Study of OTO-201 for Treatment of AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Intervention: OTO-201
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute otitis media with tympanostomy tubes

Summary:

      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible
      subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is
      designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with AOMT.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of sensorineural hearing loss

          -  Subject has tympanic membrane perforation other than the surgical tympanostomy tube
             perforation

          -  Subject has a history of known immunodeficiency disease
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: S42909 100 mg; S42909 200 mg; S42909 400 mg; S42909 800 mg; S42909 1200 mg; Placebo Oral Tablet
Intervention description: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dose-response relationship study of S42909 on leg ulcer healing after oral repeated
      administration in patients with active venous leg ulcer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian (defined for this study as having 2 Caucasian parents), men or women

          -  Age ≥ 18 years old

          -  18.5 kg/m2 ≤ BMI ≤ 45.0 kg/m2 (= Weight (kg) / height² (m²))

          -  Patients with chronic venous disease documented by imaging to detect a venous disorder
             in one or both the sub- and extra-fascial venous systems. The examination performed
             within 6 months before selection can be used.

          -  Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP
             C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection
             and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple
             ulcerations on one or both legs are eligible for selection.

          -  Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area
             selection criteria) should be ≥ 5 cm2 and ≤ 100 cm2 at the selection visit and ≥ 4.5
             cm2 and ≤ 100 cm2 at the inclusion visit (measured by transparent sheet and confirmed
             with the digital 3D imaging device).

          -  Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.

        Exclusion Criteria:

          -  Unlikely or unwilling to be compliant to standardized compression recommendation,
             study medication and visits, previous records of poor compliance to compression
             stockings.

          -  Inadequately controlled type 1 and type 2 diabetes with an HbA1c > 8%.
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
Condition: HIV; Pregnancy Malaria; Sexually Transmitted Infection
MeSH terms: Infections; Malaria; Sexually Transmitted Diseases
Intervention: Azithromycin/TMPS; Placebo/TMPS
Intervention description: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit; 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Intervention MeSH terms: Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: Female
Minimum age: 16 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: STI Prevention; Cameroon; sub-Saharan Africa; HIV pregnancy; Malaria in pregnancy

Summary:

      More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women
      living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of
      preventing malaria and other common perinatal infections would have great potential to
      improve adverse birth outcomes. The purpose of this randomized controlled trial is to
      evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to
      determine its efficacy and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed HIV-infection (documented in medical record)

          -  Age ≥16 years

          -  Confirmed pregnancy, <28 weeks estimated gestational age (by best obstetric estimate
             which may include ultrasound or fundal height and LMP)

          -  Live singleton pregnancy

          -  Receiving prenatal care at Mboppi Hospital or Mutengene Hospital

          -  Plan to receive follow up prenatal care and deliver at study facility

          -  Capable of providing written informed consent

          -  Able and agree to come to facility for febrile episodes or acute illness during
             pregnancy (with reimbursement of transportation costs).

          -  Agree to avoid antimalarial medications outside of study protocol.

        Exclusion Criteria:

          -  Severe anemia (last hemoglobin <6)

          -  History of severe adverse reaction to co-trimoxazole or azithromycin

          -  Active medical problem requiring inpatient evaluation at the time of screening

          -  Intention of moving far away from the facility during pregnancy or not likely to
             return for follow up care or delivery

          -  Signs or symptoms of early or active labor

          -  History of severe cardiac disease (including congestive heart failure, severe valvular
             disease or arrhythmias).
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Condition: Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7
MeSH terms: Carcinoma; Breast Neoplasms
Intervention: Laboratory Biomarker Analysis; Nab-paclitaxel; Questionnaire Administration
Intervention description: Correlative studies; Given IV; Ancillary studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects of nab-paclitaxel in treating older patients
      with breast cancer that has spread from where it started to nearby tissue or lymph nodes
      (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy,
      such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by
      killing the cells, by stopping them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic breast cancer

          -  Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth
             factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel
             alone

          -  First or second line chemotherapy treatment for metastatic disease

          -  Karnofsky performance status (KPS) >= 70%

          -  Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)

          -  Peripheral neuropathy =< grade 1

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelets >= 100,000 cells/mm^3

          -  Hemoglobin (Hb) >= 9.0 g/dl

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x
             institutional upper limit of normal

          -  Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present
             in the absence of liver metastases

          -  Bilirubin =< 1.5 mg/dl

          -  Creatinine clearance (calculated or 24 hour) >= 30 ml/min

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents

          -  Untreated central nervous system (CNS) metastases or symptomatic CNS metastases
             requiring escalating doses of corticosteroids

          -  Known history of allergic reactions to paclitaxel

          -  Presence of any serious or uncontrolled infection

          -  Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Dysport in Vulvodynia Phase II Study
Condition: Vulvodynia
MeSH terms: Vulvodynia
Intervention: Botulinum toxin type A; Placebo
Intervention description: Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.; The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to define optimal doses of Dysport and evaluate its efficacy and
      safety compared with placebo for the treatment of vulvodynia.

      The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage
      2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1;
      Dysport or placebo) followed by an open label treatment period. One or two optimally safe and
      effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal

          -  Have vulvodynia for at least 6 months and for no more than 15 years

          -  Have provoked pain at the vestibule on a Q tip test

        Exclusion Criteria:

          -  Deep pain during intercourse

          -  Have genitourinary or gastrointestinal conditions which may interfere with the study

          -  Previous surgery that according to investigator's judgement may impact on study
             outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery,
             perianal surgery) or genital trauma or mutilation/cutting