bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Condition: Muscle Wasting (Atrophy) After Hip Fracture Surgery
MeSH terms: Muscular Atrophy; Wasting Syndrome; Atrophy; Cachexia; Fractures, Bone; Hip Fractures
Intervention: bimagrumab; placebo
Intervention description: Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.; Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: bimagrumab; BYM338; hip fracture; elderly; controlled clinical trial; randomized; muscle wasting; atrophy

Summary:

      The purpose of this study was to assess if bimagrumab is safe and effective in patients with
      muscle wasting (atrophy) after hip fracture surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Must have X-ray confirmed successful hip fracture repair; Must have completed surgical
        wound healing; Ability to walk a specified distance with or without a walking aid; Must
        weigh at least 35 kg.

        Exclusion Criteria:

        Must not have history of any other lower limb fractures in the past 6 months; Must not have
        certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV,
        hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at
        least 3 months in the past year;
A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Placebo; Triamcinolone (Optional)
Intervention description: Administered orally; Administered orally; Administered topically
Intervention MeSH terms: Triamcinolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic Eczema

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in
      eczema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

               1. EASI of 12 or more

               2. Greater than or equal to 10% of body surface area involvement

               3. Diagnosed with AD at least 2 years prior

          -  Have a history of inadequate clinical response to other eczema treatments

        Exclusion Criteria:

          -  Females who are pregnant or nursing

          -  Participants who do not agree to use adequate contraception

          -  Are currently experiencing or have a history of:

               -  Skin conditions such as psoriasis or lupus erythematosus

               -  Skin disease that requires frequent hospitalizations or intravenous treatment

               -  Compromised immunity

          -  Serious illness that could interfere with study participation, or a clinically
             important deviation in physical examination, vital sign measurements,
             electrocardiograms, or abnormalities on laboratory tests

          -  Currently experiencing or have a history of:

               -  Active or latent Tuberculosis or specific immunity disorders and infections

               -  Malignancy or lymphoproliferative diseases in the last 5 years (or cervical,
                  basal or squamous skin cancer re-occurrence in the last 3 years)

               -  Human Immunodeficiency Virus (HIV)

               -  Hepatitis B, Hepatitis C, or chronic liver disease

          -  Have received certain types of vaccinations
Study of Exchange of Travoprost Intraocular Implant
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle
Intervention: Travoprost
Intervention description: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Intervention MeSH terms: Travoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective is to evaluate the safety of the operative and surgical exchange
      procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to attend scheduled follow-up exams for the duration of the study

          -  Able and willing to provide written informed consent on the IRB (institutional review
             board)/IEC (institutional ethics committee)-approved Informed Consent form

          -  Best spectacle corrected visual acuity of 20/80 or better in each eye.

          -  Previously qualified for GC-009 clinical trial using the Travoprost Intraocular
             Implant with the travoprost intraocular implant (G2TR) that is present in the study
             eye.

        Exclusion Criteria:

          -  Glaucoma status as follows:

               -  Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma
                  associated with vascular disorders

          -  Corneal status as follows:

               -  Any active inflammation or edema

          -  Any pathology for which, in the investigator's judgement, the following would be
             either at risk or contraindicated:

          -  Implantation of Travoprost Intraocular Implant

          -  Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up
             visits)

          -  Fellow eye status as follows:

               -  Fellow eye actively enrolled in this trial or any other clinical trial

          -  Subject status as follows:

               -  Pregnant or planning to become pregnant during the course of the study
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left; Infarction
Intervention: Ramipril; Firibastat
Intervention description: 1 or 2 capsules administered orally, twice daily; 1 or 2 capsules administered orally, twice daily
Intervention MeSH terms: Ramipril; Firibastat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2
      study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily
      doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI.

      Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female
      subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will
      need to have a primary percutaneous coronary intervention (PCI) of the index MI related
      artery within 24 hours after MI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as
             chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive
             electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).

          -  Primary PCI of the index-MI-related artery within 24 hours after the MI.

        Exclusion Criteria:

          -  Body mass index >45 kg/m².

          -  Subject is hemodynamically unstable or has cardiogenic shock.

          -  Subjects with clinical signs of HF (Kilipp III and IV).

          -  Systolic blood pressure <100 mmHg at inclusion visit

          -  Early primary PCI of the index-MI-related artery performed within 3 hours after MI.

          -  Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin
             receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance
             imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if
             necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was
             prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB
             prescribed for another reason cannot be stopped, the subject is not eligible for study
             inclusion.

          -  Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac
             resynchronization therapy, or pacemaker within the next 3 months. If an ICD is
             indicated for ventricular arrhythmia during the course of the study, a life vest, when
             possible, should be prescribed and the ICD scheduled after study completion.
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
Condition: Squamous Cell Carcinoma of Anal Canal
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Retifanlimab
Intervention description: Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous carcinoma of the anal canal; anti-PD-1 antibody; IgG4 monoclonal antibody; INCMGA00012

Summary:

      The purpose of this study is to assess the efficacy of INCMGA00012 in participants with
      locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have
      progressed after platinum-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to comprehend and willingness to sign a written informed consent form.

          -  Confirmed diagnosis of locally advanced or metastatic SCAC.

          -  Must have received (or been intolerant to or ineligible for) at least 1 prior line of
             platinum-based chemotherapy and received no more than 2 prior systemic treatments.

          -  Must have measurable disease by RECIST v1.1.

          -  Eastern Cooperative Oncology Group performance status of 0 to 1.

          -  If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥
             300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

        Exclusion Criteria:

          -  Receipt of anticancer therapy or participation in another interventional clinical
             study within 21 days before the first administration of study drug; 6 weeks for
             mitomycin C.

          -  Radiotherapy within 14 days of first dose of study treatment with the following
             caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy
             that is > 30 Gy.

          -  Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death
             ligand protein 1 (PD-L1)-directed therapy.

          -  Active autoimmune disease requiring systemic immunosuppression.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

          -  Known active hepatitis infection.

          -  Active infections requiring systemic therapy.

          -  Is pregnant or breastfeeding or is expecting to conceive or father children within the
             projected duration of the study, from screening through 6 months after the last dose
             of study drug.
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL
Intervention description: 400/100 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C
      virus (HCV)-infected adults who are undergoing liver transplantation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver
             transplantation

        Key Exclusion Criteria:

          -  Receiving an HCV-infected liver

          -  HIV or hepatitis B virus (HBV) co-infected

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Condition: Acute Promyelocytic Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: All-Trans Retinoic Acid (ATRA); Arsenic Trioxide (ATO); Idarubicin; Gemtuzumab Ozogamicin
Intervention description: Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; Induction: 0.15 mg/kg daily IV beginning day 1; 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.; Induction: 9 mg/m2 on day 1 of induction
Intervention MeSH terms: Idarubicin; Tretinoin; Arsenic Trioxide; Gemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Healthy volunteers: No
Keywords: Acute Promyelocytic Leukemia; APL; ATRA; All-Trans Retinoic Acid; Arsenic Trioxide; Theophylline; Gemtuzumab

Summary:

      The goal of this clinical research study is to learn if the combination of arsenic trioxide
      (ATO) with ATRA and possibly idarubicin is effective in treating patients with
      newly-diagnosed APL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by
             cytogenetics, PCR, or POD test.

          2. Provision of written informed consent.

          3. Patients in whom therapy for APL was initiated on an emergent basis are eligible

        Exclusion Criteria:

          1. First trimester of pregnancy (ATRA is teratogenic)

          2. Corrected QT (QTC) interval must not be greater than 480 milliseconds.
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Condition: Paranasal Sinus Disease
MeSH terms: Paranasal Sinus Diseases
Intervention: Bacitracin
Intervention description: Bacitracin soaked nasopore sponge
Intervention MeSH terms: Bacitracin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a
      sponge soaked in Saline / and the administration of oral antibiotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must
             have middle meatus easily identified. The type of surgery will not be influenced by
             the participation in this study.

        Exclusion Criteria:

          -  Age less then 18

          -  Known sensitivity to Bacitracin

          -  Pregnancy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: RO7234292 (RG6042)
Intervention description: Intrathecal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of
      RO7234292 administered intrathecally to adult patients with Huntington's Disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have completed dosing in ISIS 443139-CS1

        Key Exclusion Criteria:

          -  Any new condition or worsening of existing condition that could make the patient
             unsuitable for participation or interfere with the patient participating in and/or
             completing the study
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Condition: Status Epilepticus; Convulsive Status EPILEPTICUS; Non Convulsive Status Epilepticus; Epilepsy
MeSH terms: Status Epilepticus
Intervention: IV Ganaxolone active; IV Placebo, non-active
Intervention description: IV; IV
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind study that will randomize subjects to ganaxolone or placebo in a 1:1 ratio as adjunctive therapy to their standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness and safety of an investigational drug, IV
      ganaxolone, as adjunctive therapy to standard of care to treat subjects with status
      epilepticus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 12 years of age and older

          -  Clinical and/or electrographic seizures

        Exclusion Criteria:

          -  Life expectancy of less than 24 hours

          -  Anoxic brain injury as primary cause of SE

          -  Recent (<24 hour) traumatic brain injury as the primary cause of SE

          -  Administered anesthesia for the treatment of SE
TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders
Condition: Allogeneic Hematopoietic Cell Transplantation
Intervention: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)
Intervention description: The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted
      allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant
      disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic
      selection device (Miltenyi Biotec).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic
             HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched
             related donors are allowed when there is a clinical desire to avoid the use of GVHD
             prophylaxis medications.

        Exclusion Criteria:

          -  Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening
             infection. Patients with a prior history of allogenic transplant without active GVHD
             or life-threatening infection can be considered.
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pegilodecakin; Nivolumab
Intervention description: Pegilodecakin plus Nivolumab; Nivolumab Alone
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone
      in participants with metastatic non-small cell lung cancer as measured by objective response
      rate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must have histologically or cytologically confirmed Wild Type NSCLC that
             is stage IV / metastatic or recurrent

          2. Participants must have received at least one prior systemic therapy that was not an
             anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the
             disease

          3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion
             Score (TPS) 0% - 49%

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          5. Participants with measurable disease by spiral computed tomography (CT) or magnetic
             resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1
             criteria

          6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
             prior to randomization

        Exclusion Criteria:

          1. Participants with active central nervous system (CNS) metastases or carcinomatous
             meningitis

          2. Participants with any serious or uncontrolled medical disorder or active infection
             with the hepatitis virus or the human immunodeficiency virus (HIV)

          3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
             anti-cancer therapy (other than alopecia and fatigue) prior to randomization

          4. Participants that have received nivolumab

          5. Participants that have received therapy with anti-tumor vaccines or other
             immuno-stimulatory antitumor agents

          6. Participants with a history of severe hypersensitivity reactions to monoclonal
             antibodies

          7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
             anti-CD-137, and/or anti CTLA-4 antibodies

          8. Participants receiving any investigational agent within 28 days of first
             administration of trial treatment

          9. Pregnant or lactating women