bioihbjkbjnl/mcl2 huggingface dataset:
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Condition: Esophageal Carcinoma
MeSH terms: Esophageal Neoplasms
Intervention: Botulinum Toxin Type A; Esophagectomy; Quality-of-Life Assessment
Intervention description: Given IM; Undergo esophagectomy; Ancillary studies
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well botulinum toxin type A works in preventing
      complication after surgery in patients with esophageal cancer. Botulinum toxin type A may
      cause less complications of nausea and vomiting after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic
             anastomosis

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Participant must understand the investigational nature of this study and sign an
             Independent Ethics Committee/Institutional Review Board approved written informed
             consent form prior to receiving any study related procedure

        Exclusion Criteria:

          -  Patients who have a history of gastrointestinal dysmotility or functional
             gastroparesis, including diabetic gastroparesis, central and peripheral nervous system
             disorders, renal failure, medication side effects, including chronic dependence of
             promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use over
             2 years due to non-cancer causes

          -  Patients who have a history of previous gastric or duodenal surgery

          -  Patients who have a history of duodenal ulcer or duodenal fibrosis

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Allergy to botulinum toxin and/or egg

          -  Pregnant or nursing female participants

          -  Unwilling or unable to follow protocol requirements

          -  Any condition which in the investigator's opinion deems the participant an unsuitable
             candidate for study participation
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Macitentan; Placebo
Intervention description: Macitentan 10 mg, oral tablet, to be taken once daily.; Matching placebo oral tablet, to be taken once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)

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

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the
             obstruction being surgically inaccessible (i.e., distal disease).

          -  Female 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:

          -  Previous pulmonary endarterectomy.

          -  Recurrent thromboembolism despite sufficient oral anticoagulants.

          -  Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.

          -  Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value)
             or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or
             known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial
             lung disease, emphysema).

          -  Acute or chronic conditions (other than dyspnea) that limit the ability to comply with
             study requirements in the 3-month period prior to Screening visit or during the
             Screening period.
Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
Condition: Cardiac Arrest; Metabolic Acidosis
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Acidosis
Intervention: Sodium bicarbonate; Normal saline
Intervention description: Administer Sodium bicarbonate 50 mEq IV over 2 minutes; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sodium Bicarbonate

Summary:

      A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary
      resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at
             10 minutes of cardiopulmonary resuscitation

        Exclusion Criteria:

          -  age <18 trauma patient Do Not Resuscitate state
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: XmAb5871; Placebo to match XmAb5871
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus
      Erythematosus (SLE) disease activity improvement achieved by a brief course of
      disease-suppressing steroid therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of SLE as defined by the ACR criteria

          -  Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented
             within one year prior to randomization

          -  Investigator has assessed the patient and in their judgment, the SLE disease activity
             is not organ threatening

          -  Both investigator and patient agree that it is acceptable to discontinue their current
             immunosuppressant SLE medications and receive a brief course of IM steroid therapy

          -  If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of
             prednisone to enter screening, and must be able to taper to ≤10 mg/day by
             randomization

        Exclusion Criteria:

          -  History or evidence of a clinically unstable/uncontrolled disorder, condition or
             disease, other than SLE that, in the opinion of the investigator would pose a risk to
             patient safety or interfere with the study evaluation, procedures or completion

          -  Patients who have organ threatening manifestations of SLE including active Class 3 or
             4 lupus nephritis requiring induction or maintenance therapy or any other disorder for
             which stopping SLE therapy is contraindicated

          -  Active CNS lupus such as seizures or psychosis that in the opinion of the investigator
             would preclude participation

          -  Unstable hemolytic anemia or thrombocytopenia

          -  Patient is pregnant or breast feeding, or planning to become pregnant while
             participating in the study

          -  Use of any biologic therapy (including belimumab) within 6 months of randomization, or
             prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12
             months of randomization
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Condition: Neovascular (Wet) Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: aflibercept; High-dose aflibercept
Intervention description: Intravitreally (IVT) administered as a liquid formulation in a vial; Intravitreally (IVT) administered as a liquid formulation in a vial
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
Enrollment: 106.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objectives of the study are to determine the safety of high-dose aflibercept
      (hereafter referred to as HD) and to determine if HD provides greater intraocular
      pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal
      aflibercept injection (hereafter referred to as IAI).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV)
             secondary to nAMD

          -  Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS)
             letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

        Key Exclusion Criteria:

          -  Evidence of CNV due to any cause other than nAMD in either eye

          -  Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than
             1 microaneurysm) in either eye in diabetic patients

          -  Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab,
             brolucizumab, pegaptanib sodium) in the study eye

          -  Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific
             monoclonal antibodies, gene therapy)

          -  Previous use of intraocular or periocular corticosteroids within 120 days of screening
             or treatment with an IVT steroid implant at any time in the study eye

          -  History of vitreoretinal surgery (including scleral buckling) in the study eye

          -  Any other intraocular surgery within 12 weeks (84 days) before the screening visit

          -  History of corneal transplant or corneal dystrophy in study eye

        NOTE: Other protocol defined inclusion/exclusion criteria apply.
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Condition: Accidental Falls; Fall Due to Loss of Equilibrium; High Risk of Falls Due to Mobility Limitation; Diabetes; Arthritis; Cancer; Peripheral Arterial Disease; Parkinson's Disease; End Stage Renal Failure on Dialysis
MeSH terms: Parkinson Disease; Kidney Failure, Chronic; Peripheral Arterial Disease; Peripheral Vascular Diseases; Mobility Limitation
Intervention: MBB AFO; Control
Intervention description: Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO; Subjects will be provided with a pair of New Balance 813 shoes
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Ankle Foot Orthoses; falls; Fall Prevention; Frailty; Concern for falls; Footwear; Mobility

Summary:

      The investigators propose a randomized control trial to evaluate long term effects and
      effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of
      falling in older adults.

      Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling,
      frailty status, and adverse events

      Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical
      activities • Characterize the feasibility of the MBB AFO device on patient adherence,
      acceptability, user-friendliness, and perception of benefit for daily usage
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 or older

          -  High concerns or high risk of fall

          -  Ambulatory

        Exclusion Criteria:

          -  Presence of an active wound infection on either of the foot and ankle

          -  Use of medication or a medical condition that may have unstable (fluctuate over time)
             or temporary (less than one month) impact on gait and balance

          -  Acute fractures on the foot

          -  Participant of an interventional study within the last 30 days

          -  Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m
             (~six feet) without assistance

          -  Major foot amputation

          -  Unable or unwilling to participate in all procedures
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Intervention: Esomeprazole; Placebo
Intervention description: Sugar pill
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: CF

Summary:

      Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may
      lead to worsening lung function and more respiratory infections for a person with CF. This
      study will look at treating GERD with a medication, esomeprazole. The medication stops
      stomach acid from being made. The study will see if there are fewer respiratory infections
      and improved lung function in patients with CF when taking esomeprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis

          2. Age > 18 years

          3. Stable maintenance medical regimen during the previous 6 weeks.

          4. Negative pregnancy test (women of childbearing potential) at both screening and
             baseline visits.

          5. Women of childbearing potential must be using medically acceptable contraception.

          6. At least two respiratory exacerbations per year requiring oral and/or intravenous
             antibiotics for each of the two years prior to study entry, but no more than 4
             exacerbations requiring intravenous antibiotics during either of those years.

        Exclusion Criteria:

          1. Previous anti-reflux or peptic ulcer surgery,

          2. Use of proton pump inhibitor (PPI) within the past two weeks

          3. Pulmonary exacerbation requiring antibiotics within the previous 2 weeks

          4. Parenteral hyperalimentation

          5. Cigarette smoking

          6. Treatment with azoles, iron, anti-coagulants, digitalis

          7. Use of any investigative drugs within the previous month.

          8. Use of over the counter acid suppressor agents (not including acid neutralizers)
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ingenol mebutate; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2
      trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily
      treatment for 2, 3 or 4 consecutive days compared to vehicle gel
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area
        of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

        Exclusion Criteria:

          -  Location of the treatment area (trunk (except chest) or extremities)

               -  within 5 cm of an incompletely healed wound,

               -  within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
                  (SCC)

          -  Prior treatment with ingenol mebutate within the selected treatment area

          -  Lesions in the treatment area that have:

               -  atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous
                  horns) and/or,

               -  recalcitrant disease (e.g., did not respond to cryotherapy on two previous
                  occasions)
Atovaquone for Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Experimental Group; Placebo Group
Intervention description: Continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days; Continued standard of care therapy together with matching placebo
Intervention MeSH terms: Atovaquone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the current study is to accelerate the use of a clinically available
      therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19
      addressing a serious and emergent unmet medical need.

      This is a randomized, double-blind study of atovaquone therapy in adult participants
      hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria
      may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment
      groups:

      Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg
      atovaquone twice daily (administered with a meal or snack) for up to 10 days

      Treatment Group 2: continued standard of care therapy together with matching placebo
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours

          2. Age ≥18 years old

          3. Able to provide informed consent, or (as allowed by IRB), immediate availability of
             designated legally authorized representative to provide consent by proxy

          4. Anticipated hospitalization for >48 hours

        Exclusion Criteria:

          1. Participation in any other clinical trial with antiviral activity against COVID-19

          2. Breastfeeding women

          3. Known hypersensitivity to atovaquone or formulation excipient

          4. Active treatment with rifampin

          5. HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma
             gondii

          6. Not expected to survive for 72 hours. 7) >14 days from symptom onset
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Condition: Metastatic Seminoma
MeSH terms: Seminoma
Intervention: Carboplatin AUC-10
Intervention description: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve
      (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron
      emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of
      patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A
      PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a
      complete response patients received 3 cycles of treatment. If the PET - CT scan did not show
      a complete response patients received 4 cycles of treatment. After treatment, patients were
      followed up for 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG)
             good prognosis.

          2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance
             over 25 ml/min.

          3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.

          4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate
             dehydrogenase are acceptable).

          5. Males aged ≥18 and ≤75 years.

          6. Able to give written informed consent prior to study entry.

          7. Patients must be sterile or agree to use adequate contraception during the period of
             therapy.

        Exclusion Criteria:

          1. Metastatic seminoma with any non-pulmonary visceral metastases.

          2. Raised Alpha-fetoprotein.

          3. Any previous chemotherapy or radiotherapy.

          4. Currently enrolled in any other investigational drug study.

          5. Other malignancy except basal cell.