bioihbjkbjnl/mcl2 huggingface dataset:
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: GRASPA
Intervention description: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 30.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic leukemia; Elderly patient; Asparaginase

Summary:

      The main purpose of this study is to determine the maximum tolerated and efficient dose of
      GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years
      and over, Philadelphia chromosome-negative (ALL Ph-).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient aged ≥55 years old

          -  With newly diagnosed ALL without prior treatment

          -  Capable to receive polychemotherapy (World Health Organization (WHO) performance
             status ≤2)

          -  With or without meningeal disease

          -  Having signed an Informed Consent Form

          -  Subscribed to social security insurance

        Exclusion Criteria:

          -  ALL translocation(9;22) and/or BCR-ABL (Breakpoint Cluster Region-Abelson) positive

          -  Performance status incompatible with chemotherapy treatment (WHO score >2)

          -  Patient presenting with a general or visceral contraindication to intensive treatment
             including :

               -  Cardiac insufficiency defined as Left Ventricular Ejection Fraction <50% of the
                  theoretical value

               -  Plasma creatinine concentration 2 times greater than the upper limit of
                  laboratory ranges, except if related to ALL

               -  Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) levels 5
                  times greater than the upper limit of laboratory ranges, except if related to ALL

               -  Patient with another evolutive cancer other than ALL

               -  Severe evolutive infection, or Human Immunodeficiency Virus (HIV) seropositive
                  or, active hepatitis related to B or C viral infection

          -  Prior treatment with L-asparaginase (irrespective of the form)

          -  History of grade 3 transfusional incident (life threatening)

          -  Patient presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to
             the unavailability of phenotype compatible Red Blood Cells Concentrate

          -  Patient included in another clinical trial during the last 4 weeks
Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Condition: Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Extranodal Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Radiation Therapy
Intervention description: Undergo radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Healthy volunteers: No

Summary:

      This trial studies the side effects of radiation therapy used alone, and if it can achieve a
      high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high
      energy sources to kill cancer cells and shrink tumors. This treatment may improve the
      patient's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study

          -  Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended
             to have treatments with antibiotics prior to enrollment to this protocol

          -  Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy
             etc) are also eligible as far as they never had stage 3 or 4 disease during the course
             of the disease or disease progression to the opposite side of the diaphragm (as the
             time course of the response to antibiotic therapy can be very variable among patients,
             sometimes requiring more than one year for complete response, failure to antibiotic
             therapy can be very variable among patients, sometimes requiring more than one year
             for complete response, failure to antibiotic treatment will be defined as no response
             or progression of the disease documented by endoscopy and biopsy)

          -  Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular
             adnexal involvement or due to multiple sites within Waldeyer's ring will still be
             eligible

        Exclusion Criteria:

          -  Patients who had previous radiation dose to the site of the current primary disease
             which would lead to violation of known radiation tolerance limit of that particular
             site if treated again

          -  Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm
             will be ineligible

          -  Previous or concurrent malignancy in any form would not be an exclusion criterion.
             However, patients who receive chemotherapy for concurrent malignancy will be excluded
             from statistical analysis

          -  Low blood cell counts would not be exclusion criteria as far as the patient is willing
             to accept supportive measures such as transfusions, filgrastim and epoetin
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Condition: Hernia; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: 5x5cm bupivacaine collagen sponges
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess pain intensity for the first 72 hrs after aggravated movement (cough)
      following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man ≥18 years

          2. Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal
             preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or
             laparoscopic umbilical herniorrhaphy to be performed according to standard surgical
             technique under general anesthesia.

          3. Willing to use opioid rescue analgesia.

        Exclusion Criteria:

          1. Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.

          2. Scheduled for bilateral inguinal herniorrhaphy.

          3. Undergone a prior herniorrhaphy at the location scheduled for repair.

          4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: HTS-519 Insert
Intervention description: Maximum feasible dose of HTS-519 Insert per diseased nail
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519
      Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 18 - 74 years of age inclusive

          -  Fungal toenail infection of one or both of the large (great) toenails

          -  The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and
             non-dermatophyte] are not allowed)

          -  Willingness not to have professional pedicures or application of any nail polish
             product or nail cosmetics to the toenails after the screening visit

        Exclusion Criteria:

          -  History of any significant chronic fungal disease other than onychomycosis or
             immunocompromised condition

          -  Any abnormalities of the nail or previous surgery of the toenail that could prevent a
             normal appearing nail if clearing of infection is achieved

          -  Significant confounding conditions as assessed by the study doctor

          -  Participation in any other trial of an investigational drug or device within 30 days
             or participation in a research study concurrent with this study

          -  No administration of systemic antifungal medications within 6 months prior to
             screening visit

          -  No application of prescription topical antifungal medications for toenail fungus
             within 3 months or other commercially available topical medications for toenail fungus
             applied directly to the toenails within 1 month prior to screening visit

          -  Tinea pedis (athlete's foot) that would require systemic treatment

        Other protocol-defined inclusion/exclusion criteria may apply
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
Condition: Cardiac Failure; Myocardial Failure; Congestive Heart Failure; Heart Decompensation
MeSH terms: Heart Failure
Intervention: BMS-986231; Furosemide; Placebo
Intervention description: Intravenous administration; Intravenous administration; Intravenous administration
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in
      participants with heart failure and weakened heart function given a standard dose of
      diuretic.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Left ventricular ejection fraction <45%, as assessed by echocardiography, a multigated
             acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months

          -  On stable chronic guideline-directed therapy for HF including chronic loop diuretics,
             ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these
             medications in the past 2 weeks

          -  At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg
             bumetamide)

        Exclusion Criteria:

          -  SBP < 115 mm Hg or > 180 mm Hg at screening or pre-randomization

          -  Heart rate < 50 beats per minute (bpm) or > 120 bpm at screening or pre-randomization

          -  Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy,
             idiopathic hypertrophic or uncorrected severe valvular disease

        Other protocol defined inclusion/exclusion criteria could apply
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Guselkumab Dose 1; Guselkumab Dose 2; Golimumab Dose 1; Golimumab Dose 2; Placebo
Intervention description: Guselkumab Dose 1 will be administered as IV infusion.; Guselkumab Dose 2 will be administered as SC injection.; Golimumab Dose 1 will be administered as SC injection.; Golimumab Dose 2 will be administered as SC injection.; Placebo will be administered.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical efficacy and safety of combination
      therapy with guselkumab and golimumab in participants with moderately to severely active
      ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before
             screening

          -  Moderately to severely active UC as defined by Mayo score

          -  History of inadequate response to or failure to tolerate conventional therapy

          -  Has screening laboratory test results within the study protocol defined parameters

          -  A woman of childbearing potential must have a negative highly sensitive serum (beta
             human chorionic gonadotropin) pregnancy test result at screening and a negative urine
             pregnancy test result at Week 0

        Exclusion Criteria:

          -  Has severe extensive colitis as defined in the study protocol

          -  Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

          -  Has a history of latent or active granulomatous infection, including histoplasmosis or
             coccidioidomycosis, before screening

          -  Has any known malignancy or has a history of malignancy (with the exception of basal
             cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in
             situ that has been treated with no evidence of recurrence; or squamous cell carcinoma
             of the skin that has been treated with no evidence of recurrence within 5 years before
             screening)

          -  Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or
             their excipients
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: Pridopidine
Intervention description: 45 mg BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 248.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Huntington's disease, pridopidine

Summary:

      The purpose of the study is to collect and assess long term data on the safety, tolerability,
      and efficacy of pridopidine in patients with Huntington's disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pride HD completion within the last 6 months, including 2 week follow up period or
             patients who transitioned from the Open HART study or patients who complete future
             safety and efficacy clinical trials of pridopidine. In addition, patients who have
             already completed their defined study period under Open PRIDE HD global or local
             amendments and have discontinued treatment with pridopidine will be allowed to re
             enter the Open PRIDE HD study.

          -  Women of child bearing potential or male participants: Adequate contraception and
             birth control

          -  Good general health

               -  other criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal
             function to PRIDE HD;

          -  Similar concomitant medication restrictions to PRIDE HD.

               -  other criteria apply, please contact the investigator for more information
Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo on signs and symptoms of dry eye disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery within
             twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Macitentan
Intervention description: Macitentan 10mg, oral tablet, once daily
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)

Summary:

      Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
      for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as
             scheduled (i.e., who remained in the DB study up to Week 24).

          -  Females of childbearing potential must have a negative pre-treatment serum pregnancy
             test, be advised on appropriate methods of contraception, and agree to use 2 reliable
             methods of contraception.

        Exclusion Criteria:

          -  Permanent discontinuation of DB study treatment due to an hepatic adverse event or
             liver aminotransferase abnormalities.

          -  Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable
             psychiatric illness) that, in the opinion of the investigator, may interfere with
             treatment compliance or interpretation of the results, or that may influence the
             ability to comply with any of the study requirements.