bioihbjkbjnl/mcl2 huggingface dataset:
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Danicopan
Intervention description: Danicopan was administered as multiple oral doses over a period of at least 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal; Hemoglobinuria

Summary:

      The purpose of this study was to determine the safety and efficacy of ACH-0144471 (also known
      as danicopan and ALXN2040) in currently untreated participants with PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently untreated PNH participants with PNH Type III erythrocyte and/or granulocyte
             clone size ≥10% and anemia (hemoglobin <12 grams/deciliter) with adequate
             reticulocytosis (as determined by the Investigator).

          -  LDH ≥1.5 x the upper limit of normal.

          -  Platelets ≥50,000/microliter without the need for platelet transfusions.

          -  Documentation of vaccination for Neisseria meningitidis, Haemophilus influenza, and
             Streptococcus pneumoniae, or willingness to receive vaccinations during the screening
             period.

          -  Negative pregnancy test for females prior to dosing and throughout the study.

        Exclusion Criteria:

          -  History of a major organ transplant (for example, heart, lung, kidney, liver) or
             hematopoietic stem cell/marrow transplant.

          -  Participants who had received another investigational agent within 30 days or 5
             half-lives of the investigational agent prior to study entry, whichever is greater.

          -  Participants who had received eculizumab at any dose or interval within the past 75
             days before study entry.

          -  Participants with known or suspected complement deficiency.

          -  Participants with active bacterial infection or clinically significant active viral
             infection, a body temperature >38°Celsius, or other evidence of infection on Day 1, or
             with a history of febrile illness within 14 days prior to first study drug
             administration.

          -  History of meningococcal infection, or a first-degree relative or household contact
             with a history of meningococcal infection.

          -  Females who were pregnant, nursing, or planning to become pregnant during the study or
             within 90 days of study drug administration or participants with a female partner who
             was pregnant, nursing, or planning to become pregnant during the study or within 90
             days of study drug administration.
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
Condition: Premalignant Vulvar Lesion; Benign Vulvar Lesion
MeSH terms: Precancerous Conditions
Intervention: Cefazolin
Intervention description: -If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
Intervention MeSH terms: Cefazolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized control trial will provide the most reliable data to determine the role of
      prophylactic antibiotics to decrease the wound complication rate. The investigators plan to
      perform a pilot study to evaluate actual rates of wound complications and how long it takes
      to recruit 50 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women, >=18 undergoing vulvar surgery

          -  Biopsy proven benign or premalignant lesion requiring surgical management.

          -  Women of childbearing age will be required to have a negative human chorionic
             gonadotropin (HCG) test within seven days of surgery.

          -  Scheduled to undergo surgical management for their vulvar disease supervised by a
             faculty member within the Division of OBGYN at Washington University School of
             Medicine

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Women who are pregnant

          -  Women scheduled to undergo a radical vulvectomy

          -  Women scheduled to undergo a concomitant graft, flap or plastic surgery

          -  Women <18 years of age

          -  History of prior vulvar radiation

          -  Inability to sign an informed consent form prior to registration on study

          -  Inability to understand spoken or written English

          -  Prisoner
68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
Condition: Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma; Stage IV Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma
Intervention: Computed Tomography; Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Laboratory Biomarker Analysis; Positron Emission Tomography
Intervention description: Undergo PET/CT; Given IV; Correlative studies; Undergo PET/CT
Intervention MeSH terms: Gastrin-Releasing Peptide; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor
      (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed
      tomography (CT) works in detecting regional nodal and distant metastases in patients with
      intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller
      tumors than the standard of care CT or magnetic resonance imaging scan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate adenocarcinoma

          -  Planned prostatectomy with lymph node dissection

          -  Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage
             [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)

          -  Able to provide written consent

          -  Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
             [ECOG]/World Health Organization [WHO] equivalent)

          -  Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to
             the 68Ga-RM2 PET

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time (approximately 30 minutes)

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance
Neuromuscular Blockade for Post-Cardiac Arrest Care
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Rocuronium; Normal Saline
Intervention description: Neuromuscular Blockade; Normal Saline
Intervention MeSH terms: Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Arrest, NMB, Neuromuscular Blockade, Rocuronium

Summary:

      The main purpose of this study is to evaluate if neuromuscular blockade improves lactate
      clearance (and preliminary secondary clinical outcome measures) as compared to usual care in
      post-cardiac arrest patients undergoing targeted temperature management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Cardiac arrest with sustained return of spontaneous circulation (ROSC)

          -  Comatose (i.e., not following commands) following ROSC

          -  Undergoing targeted temperature management (TTM)

          -  Time of enrollment ≤ 6 hours from initiation of targeted temperature management

          -  Serum Lactate ≥2

        Exclusion Criteria:

          -  Pre-existing dementia, severe brain injury, or dependence on others for activities of
             daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)

          -  Traumatic etiology of the cardiac arrest

          -  Protected population (pregnant, prisoner)
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Condition: Small Bowel Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Filgotinib; Placebo to match filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib, when compared
      to placebo, in establishing clinical remission defined as Crohn's disease activity index
      (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants
      will have the option to enter a separate long-term extension study if they meet eligibility
      requirements.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on
             the date of screening visit

          -  Moderately or severely active CD

          -  Minimum duration of CD of at least 6 months

          -  Presence of diseased small bowel (SB) segments in at least 1 of the following
             segments: terminal ileum, distal ileum, or jejunum

          -  Patients with additional colonic involvement of CD are permitted in study as long as
             SBCD is present

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance to at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines):

               -  Corticosteroids

               -  Immunomodulators

               -  Tumor necrosis factor-alpha (TNFα) antagonists

               -  Vedolizumab

               -  Ustekinumab

          -  Willing and able to undergo magnetic resonance enterography (MRE) per protocol
             requirements

        Key Exclusion Criteria:

          -  Presence of symptomatic or clinically significant (eg, obstructive or symptomatic)
             strictures or stenosis.

          -  Presence of fistulae

          -  Evidence of short bowel syndrome

          -  Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
             colitis, or toxic mega-colon

          -  History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or
             likely requirement for surgery during the study

          -  Use of any prohibited concomitant medications as described in the study protocol

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: CTX-4430; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Forced expiratory volume at one second (FEV1) ≥50 percent predicted at Screening

          -  At least 1 pulmonary exacerbation in the 12 months before Screening

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Medical condition that is unstable, could be adversely impacted by participation in
             the study, or could impact assessment of the study results

          -  History of organ transplantation

          -  History of alcoholism or drug abuse within 2 years before Screening

          -  Regular use of a high-dose NSAID within 60 days before Screening
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Simtuzumab; Simtuzumab placebo
Intervention description: 125 mg/mL single-dose vials administered subcutaneously once a week; Simtuzumab placebo single-dose vials administered subcutaneously once a week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 544.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Idiopathic; Pulmonary; Fibrosis; IPF

Summary:

      The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on
      progression-free survival (PFS) as determined by either a categorical decline in forced vital
      capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of
      participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified
      level in serum at baseline.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects from 45 to 85 years of age

          -  Definite IPF within 3 years prior to screening

          -  Be able to walk at least 50 meters

        Key Exclusion Criteria:

          -  Significant diseases other than IPF

          -  Obstructive lung disease

          -  Aortic aneurysm greater than or equal to 3.5 cm in diameter

          -  Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to
             randomization are not permitted.

               -  N-acetylcysteine is permitted provided the individual has been on a stable dose
                  for > 4 weeks prior to screening

               -  Concomitant use of pirfenidone or nintedanib must be in accordance with the
                  approved prescribing instructions in the country where the site is located

          -  Individuals actively listed for lung transplant are excluded. However individuals at
             transplant centers with long waiting times (greater than 1 year) may be permitted to
             enter the study after discussion with Medical Monitor.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine Treatment 1a; Placebo SABER-Bupivacaine Treatment 1b; Bupivacaine HCl Treatment 1c; SABER-Bupivacaine Treatment 2a; Placebo SABER-Bupivacaine Treatment 2b; Bupivacaine HCl Treatment 2c
Intervention description: 5.0 ml; 5.0 ml; 20.0 ml; 7.5 ml; 7.5 ml; 20.0 ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post operative pain; Local anaesthesia; Postoperative pain after arthroscopic shoulder surgery

Summary:

      The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain
      control in patients undergoing elective arthroscopic shoulder surgery on the basis of
      pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening
      period up to 14 days and a treatment period 14 days with a long term follow up visit at 6
      months. The study will provide further data on safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subacromial impingement syndrome

          -  MRI with intact rotator cuff

          -  Patients suitable for general anaesthesia

        Exclusion Criteria:

          -  Known major joint trauma, infection, avascular necrosis, chronic dislocation,
             inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen
             shoulder or previous surgery of the affected shoulder

          -  Abnormal ECG

          -  Prolonged QT syndrome

          -  Current or regular use of analgesic medication for other indication(s)
Effect of Inhaled Albuterol in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Albuterol; Placebo
Intervention description: inhalation of 270μg albuterol through a spacer; inhalation of placebo through a spacer
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the present pilot study is to test the hypothesis that in patients with group
      1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator
      therapy, inhaled albuterol causes transient pulmonary vasodilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units
             and pulmonary arterial wedge pressure <15mmHg, as documented by right heart
             catheterization within the last 3 years

          -  Regular use of oral pulmonary vasodilators

        Exclusion Criteria:

          -  Presence of chronic respiratory disease (as documented by prior lung imaging and
             pulmonary function tests), cardiovascular disease (as documented by prior
             echocardiography and/or left heart catheterization), thromboembolic PAH (as documented
             by pulmonary angiography)

          -  women of childbearing potential who do not use accepted birth- control measures

          -  pregnant and breast-feeding women

          -  respiratory infection within 4 weeks of testing

          -  A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the
             experiment day

          -  A resting O2 saturation of < 90%

          -  Current smoking

          -  BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea

          -  Use of inhaled or intravenous pulmonary vasodilators
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Condition: Bone Cancer; Chondrosarcoma; Ewing's Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Bone Necrosis; Bone Sarcoma; Osteomyelitis
MeSH terms: Osteomyelitis; Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Chondrosarcoma; Bone Neoplasms; Osteonecrosis; Necrosis
Intervention: Feraheme; Magnetic Resonance Imaging (MRI) scan
Intervention description: 5 mg/kg by intravenous (IV) administration; Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with
      ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors
      to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help
      in diagnosing patients correctly and may result in more timely treatment.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Age 10 to 21 years

          -  Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis

          -  Informed consent with assent as appropriate.

        EXCLUSION CRITERIA

          -  Contraindication to MRI

          -  Presence of metal implants

          -  Need for sedation or anesthesia

          -  Claustrophobia

          -  Hemosiderosis or hemochromatosis

          -  History of allergic reactions to similar compounds will be obtained and patients with
             positive history of allergic reactions will be excluded from the study

          -  Females who are pregnancy or nursing