bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Matching Placebo; IW-1973
Intervention MeSH terms: Praliciguat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT
      to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ambulatory male or female

          -  Patient's body mass index score is >20 and <40 kg/m2 at the Screening Visit

          -  Women of childbearing potential must have a negative pregnancy test at the time of
             check-in and must agree to use double-barrier contraception throughout the duration of
             the study

          -  Patient's health is stable with no clinically significant findings on a physical
             examination

          -  Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or
             nurse practitioner > 6 months before the Screening Visit, and an entry HbA1c that does
             not mandate prompt intervention for improved control

          -  Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months
             before the Screening Visit and BP within the protocol's acceptable range

          -  Patients must be on a stable regimen for glycemic control, and a stable regimen for
             hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi)
             or angiotensin receptor blocker (ARB)

          -  Patient has abnormal endothelial function measured by the EndoPAT

          -  Other inclusion criteria per protocol

        Exclusion Criteria:

          -  Patient has a clinically significant active or unstable medical condition that, in the
             opinion of the Investigator, would preclude trial participation

          -  Patient is on medication(s) that when co-administered with a soluble guanylate cyclase
             (sGC) stimulator, could increase the risk of hypotension

          -  Patient has evidence of severe or active end-organ damage attributable to diabetes

          -  Patient has severe renal insufficiency, has undergone renal transplantation, or has
             planned renal transplantation

          -  Other exclusion criteria per protocol
Capnometry-Assisted Breathing Training for COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH); Pulmonary Rehabilitation (PR)
Intervention description: Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.; Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that
      aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used
      in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon
      Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will
      emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing
      (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is
      approximately 60 minutes long. The principal investigator will implement the CATCH
      intervention. The principal investigator will implement the CATCH intervention. Patients will
      use the Address Stress app on a smart phone or computer tablet as part of their home
      breathing exercises.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over 40 years of age

          -  has COPD documented in their electronic medical record, as defined by FEV1/FVC of <
             0.70 on pulmonary function testing (spirometry), or as shown on a chest CT

          -  Can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest

          -  Is medically cleared to participate in NYULMC's outpatient pulmonary rehabilitation
             program

          -  English speaking. Pregnant patients will not be enrolled in the study

        Exclusion Criteria:

          -  Requires 24-hour supplemental oxygen

          -  Has cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination
             (MMSE)

          -  Is actively being treated for lung cancer (E.g. with chemotherapy or upcoming surgery)

          -  Has morbid obesity (BMI > 40)

          -  Is currently smoking

          -  Has unstable cardiac disease defined by a history of a myocardial infarction in the
             past 3 months
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
Condition: Caries,Dental; Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis; Dental Caries
Intervention: Kovanaze Nasal Spray; Articaine Injection
Intervention description: Intra-nasal local anesthetic; Local anesthetic
Intervention MeSH terms: Oxymetazoline; Tetracaine; Carticaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cavities

Summary:

      The primary goal of the study is to compare the success rates of pulpal anesthesia (defined
      as ability to complete the intended dental procedure without the need for rescue anesthesia)
      between Kovanaze nasal mist and Articaine needle anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists Class I or II

          -  Preoperative heart rate of 55 to 100 beats per minute

          -  Maximum blood pressure reading of 166/100 mmHg

          -  Treatment for a pathology in the maxillary anterior tooth or premolar that requires
             administering local anesthesia

        Additional Pediatric Inclusion Criteria:

          -  Children >20 kg who require pulpotomy, restorative procedures, or stainless steel
             crowns in one maxillary tooth

        Additional Endodontic Inclusion Criteria:

          -  Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior
             teeth

        Additional General Practice Inclusion Criteria:

          -  Adults who require restorations in the maxillary teeth that would need local
             anesthesia

        Exclusion Criteria:

          -  Inadequately controlled thyroid disease

          -  Five or more nosebleeds in the past month

          -  Known allergy to any study drug or para-aminobenzoic acid

          -  History of methemoglobinemia

          -  Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline),
             or non-selective beta adrenergic antagonists (i.e. propranolol);

          -  Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: 0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in
      patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients
      in the study: the first group will include patients who have never received eculizumab for
      treatment of PNH. The second group will include patients who have received treatment with
      eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495
      for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH by flow cytometry

          -  For treatment naive patients: subjects must not have received treatment with
             eculizumab prior to or during the Screening Period and must have a lactate
             dehydrogenase (LDH) level ≥2 times the upper limit of normal (xULN) during Screening

          -  For patients who previously received eculizumab: subjects must have received treatment
             with eculizumab for at least 6 months prior to Screening

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
Condition: Metastatic Colorectal Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: MORAb-004; Placebo; Best supportive care
Intervention description: MORAb-004 8mg per kg IV once a week; Placebo - normal saline IV once a week; Best supportive care to improve quality of life
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mCRC; chemorefractory metastatic colorectal cancer

Summary:

      The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe
      in the treatment of metastatic, colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females >18 years old

          -  Diagnosis of metastatic, colorectal cancer

          -  Significant medical conditions must be well-controlled and stable for at least 30 days
             prior to the first treatment infusion

          -  Be willing and able to provide written informed consent

        Exclusion Criteria:

          -  No prior treatment for metastatic colorectal cancer

          -  Other serious systemic diseases (bacterial or fungal)

          -  Clinically significant heart disease or an arrhythmia on an ECG within the past 6
             months

          -  Known allergic reaction to monoclonal antibody therapy
Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Intervention: Capecitabine; Oxaliplatin
Intervention MeSH terms: Capecitabine; Oxaliplatin
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: 18 Years
Healthy volunteers: No
Keywords: capecitabine; oxaliplatin

Summary:

      There are limited treatment options available for patients with advanced pancreatic ductal
      adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety
      of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced
      and metastatic PDAC treated in the first and second lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  At most one prior chemotherapy regimen for unresectable or metastatic disease. Any
             adjuvant chemotherapy must have been completed more than 12 months prior to beginning
             protocol therapy

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  At least one measurable lesion according to RECIST criteria that has not been
             irradiated

          -  Adequate laboratory parameters as outlined in protocol

          -  Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely,
             given the drug-drug interaction between coumadin and capecitabine

          -  Negative serum pregnancy test within 14 days prior to registration

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Life expectancy < 3 months

          -  Serious, uncontrolled, concurrent infection(s)

          -  Any prior oxaliplatin or fluoropyrimidine therapy

          -  More than one prior chemotherapy regimen for unresectable or metastatic disease

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
             to 5-fluorouracil or platinum compounds

          -  Any active second malignancy

          -  Clinically significant cardiac disease or myocardial infarction within the last 12
             months

          -  Evidence of CNS metastases or history of uncontrolled seizures, central nervous system
             disorders or psychiatric disability

          -  Other serious uncontrolled medical conditions

          -  Major surgery within 4 weeks of the start of study treatment, without complete
             recovery

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  Known, existing uncontrolled coagulopathy
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab; Matching placebo of ofatumumab
Intervention description: Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content); Matching placebo in pre-filled syringes
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: double-blind; placebo controlled; ofatumumab; relapsing multiple sclerosis; Japanese patients; MS; RMS; adult; OMB157

Summary:

      The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with
      relapsing multiple sclerosis (RMS) in Japan and the other countries
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS (RMS)

          -  At least 1 appearance of a new neurological abnormality or worsening of pre-existing
             neurological abnormality during the previous 2 years prior to Screening AND an MRI
             activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the
             previous 1 year prior to randomization

          -  EDSS score of 0 to 5.5

        Exclusion Criteria:

          -  Primary progressive MS or SPMS without disease activity

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
Condition: Glomerulosclerosis, Focal Segmental
MeSH terms: Glomerulosclerosis, Focal Segmental
Intervention: VX-147
Intervention description: Tablets for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in
      participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis
      (FSGS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  APOL1 genotype of G1/G1, G2/G2, or G1/G2

          -  FSGS diagnosed by kidney biopsy

        Key Exclusion Criteria:

          -  Evidence of non-APOL1-mediated FSGS

          -  Participants with known sickle cell disease

          -  Solid organ or Bone marrow transplant

        Other protocol defined Inclusion/Exclusion criteria may apply.
Optimizing Anesthesia for Post Partum Tubal Ligations
Condition: Pregnancy Related
Intervention: Chloroprocaine; Bupivacaine
Intervention description: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural; 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
Intervention MeSH terms: Bupivacaine; Chloroprocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to
      low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients
      undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded
      study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible
      for enrollment in this study. Outcomes measured will include: ability to achieve an adequate
      level required for surgery (T6), rate of epidural activation, and duration of the block. The
      investigators hope to determine the usefulness of each drug using the EVE technique in the
      setting of PPBTL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center
             will be eligible for the study

        Exclusion Criteria:

          -  age less than 18 years old

          -  allergy to either local anesthetic class (amide or ester)

          -  contraindication to spinal anesthesia
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab; Trastuzumab
Intervention description: Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.; Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Intervention MeSH terms: Trastuzumab; Pertuzumab
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: 18 Years
Healthy volunteers: No

Summary:

      This study will examine the safety and efficacy of pertuzumab in combination with high-dose
      trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease
      progression in the brain following radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed HER2-positive MBC

          -  Progression of or new brain metastases after completion of whole-brain radiotherapy or
             stereotactic radiosurgery

          -  Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days
             prior to enrollment

          -  Stable systemic disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  LVEF at least 50%

          -  Adequate hematologic, renal, and hepatic function

          -  Life expectancy more than 12 weeks

        Exclusion Criteria:

          -  Progression of systemic disease at Screening

          -  Leptomeningeal disease

          -  History of intolerance or hypersensitivity to study drug

          -  Use of certain investigational therapies within 21 days prior to enrollment

          -  Current anthracycline use

          -  Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use

          -  Active infection

          -  Pregnant or lactating women

          -  Significant history or risk of cardiac disease

          -  Symptomatic intrinsic lung disease or lung involvement

          -  History of other malignancy within the last 5 years