bioihbjkbjnl/mcl2 huggingface dataset:
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-02545920; PF-02545920; Placebo; Risperidone
Intervention description: 5 mg tablet every 12 hours for 28 days; 15 mg tablet every 12 hours for 28 days; One tablet/capsule every 12 hours for 28 days; 3 mg capsule every 12 hours for 28 days
Intervention MeSH terms: Risperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; acute exacerbation; inpatient

Summary:

      This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of
      acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study
      will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for
      PF-02545920 compared to risperidone and placebo treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia with acute exacerbation of illness

          -  The current acute exacerbation of schizophrenia must be less than 4 weeks duration
             prior to the initial evaluation.

        Exclusion Criteria:

          -  Subjects with evidence or history of clinically significant uncontrolled medical
             illness

          -  Subjects with a current diagnosis of schizoaffective disorder, major depression,
             bipolar disorder, or obsessive compulsive disorder.

          -  Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic
             criteria for psychoactive substance dependence (excluding nicotine dependence) within
             12 months of screening or DSM-IV defined substance abuse within 3 months prior to
             screening.
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Condition: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Intervention: Afamelanotide; Placebo
Intervention MeSH terms: Afamelanotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety and efficacy of afamelanotide
      (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic
      therapy using porfimer sodium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Caucasian subjects undergoing photodynamic therapy with porfimer
             sodium;

          -  Aged greater than 18 years;

          -  Written informed consent prior to the performance of any study-specific procedure.

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to afamelanotide or the polymer contained in the
             implant;

          -  Non-Caucasian patients;

          -  Personal history of melanoma or dysplastic nevus syndrome;

          -  Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other
             malignant or premalignant skin lesions;

          -  Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to
             baseline) or lactating;

          -  Females of child-bearing potential (pre-menopausal, not surgically sterile) not using
             adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide,
             intrauterine device);

          -  Participation in a simultaneous clinical trial for another investigational agent or
             within 30 days prior to the screening visit;

          -  Patients unable to give informed consent;

          -  Patient needs for concomitant medication with potential photosensitizing effects e.g.
             antibiotics like tetracyclines.
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
Condition: Neuromuscular Blockade
Intervention: Placebo; Sugammadex; Esmeron®
Intervention description: 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).; Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.; Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 99.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969;
      MK-8616) when administered for the reversal of neuromuscular blockade in male participants
      receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1
      (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease).
      The primary objective of this study is to explore the dose-response relation of sugammadex
      given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg
      Esmeron®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of ASA class 1 to 2.

          -  Participants scheduled for surgical procedures with an anticipated duration of
             anesthesia of at least 75 minutes, without further need for muscle relaxation other
             than for intubation.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations is
             expected.

          -  Participants known or suspected to have neuromuscular disorders and/or significant
             hepatic or renal dysfunction.

          -  Participants known or suspected to have a (family) history of malignant hyperthermia.

          -  Participants known or suspected to have an allergy to narcotics, muscle relaxants or
             other medication used during general anesthesia.

          -  Participants receiving medication known to interfere with neuromuscular blocking
             agents such as anticonvulsants, aminoglycosides, and Mg^2+.

          -  Participants who have already participated in this trial.

          -  Participants who have participated in another clinical trial, not pre-approved by NV
             Organon, within 30 days of entering into this trial.
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Condition: Infant, Preterm
MeSH terms: Premature Birth
Intervention: neurally adjusted ventilatory assist (NAVA) ventilator mode
Intervention description: Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Maximum age: 12 Weeks
Healthy volunteers: No
Keywords: mechanical ventilation; diaphragm electrical activity; pressure support

Summary:

      The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist
      (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory
      oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison
      with currently used standard ventilation (synchronized intermittent mandatory ventilation
      with pressure-support ventilation, SIMV+PSV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  preterm infants mechanically ventilated

          -  ventilatory set frequency is under 25

          -  with informed consent of their parents

        Exclusion Criteria:

          -  major congenital anomalies

          -  patients without self respiratory effort

          -  use of sedative or anesthetic drugs

          -  grade III or IV intraventricular hemorrhage

          -  phrenic nerve palsy or insufficiency
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Condition: Hypertriglyceridemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypertriglyceridemia
Intervention: ISIS 678354; Placebo
Intervention description: ISIS 678354 solution for SC injection.; Sterile Normal Saline (0.9% NaCl).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: AKCEA-APOCIII-LRx; IONIS-APOCIII-LRx; Dyslipidemia; Metabolic Disease; Hyperlipidemia; Cardiac Disease; Lipid Metabolism Disorders; Triglycerides High; Vascular Diseases

Summary:

      This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of
      different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG)
      levels in participants with hypertriglyceridemia and established CVD or at a high risk for
      CVD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or
             peripheral artery disease).

          -  Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per
             deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤)
             500 mg/dL (≥ 5.7 mmol/L) at Screening.

          -  Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.

          -  Must be on standard-of-care preventative therapy for known CVD risk factors.

        Key Exclusion Criteria:

          -  Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
             stroke/transient ischemic attack (TIA).

          -  Within 3 months of Screening: coronary, carotid, or peripheral arterial
             revascularization, major non-cardiac surgery, or lipoprotein apheresis.

          -  Heart failure New York Heart Association (NYHA) class IV.

          -  Type 1 diabetes mellitus.

          -  Type 2 diabetes mellitus with any of the following:

               -  Newly diagnosed within 12 weeks of Screening.

               -  Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.

               -  Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of
                  new medication within 12 weeks of Screening [with the exception of ± 10 units of
                  insulin].

          -  Body Mass Index (BMI) greater than (>) 40 kilograms per square meter (kg/m^2).
Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Povidone-Iodine; Essential oils; Tap water
Intervention description: Gargle; Gargle; Gargle
Intervention MeSH terms: Povidone-Iodine; Listerine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 arms
Gargle with povidone-iodine
Gargle with essential oils
Gargle with tap water
Control
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gargle; povidone-iodine; essential oils; tap water

Summary:

      The purpose of this study is to assess the ability of regular gargling to eliminate severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4
      arms interventional study compares the effect of gargling using povidone-iodine, essential
      oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019
      (COVID-19) patients.

      Findings from this study will provide new insight into the importance of gargling in the
      treatment and prevention of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. adult aged 18 years and above

          2. able to understand instructions

          3. Stage 1 COVID-19

          4. < 5 days of illness or diagnosis

        Exclusion Criteria:

          1. Less than 18 years old

          2. Unable to understand instructions

          3. Stage 2 & 3 COVID-19

          4. Respiratory symptoms or fever on admission

          5. Abnormal chest radiograph or computed tomography (CT) findings on admission
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: Bevacizumab; Rituximab
Intervention MeSH terms: Bevacizumab; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Bevacizumab; Rituximab

Summary:

      The purpose of this study is to assess the feasibility, efficacy and safety of adding
      bevacizumab to rituximab compared to rituximab alone in patients with previously treated
      follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one
      previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in the study, you must meet the following criteria:

          -  Follicular NHL, grades 1 or 2 confirmed by a biopsy sample

          -  18 years of age or older

          -  Evidence of disease progression at time of study entry

          -  Must have had at least one previous chemotherapy regimen and not more than two
             previous chemotherapy regimens.

          -  Patients who have received previous rituximab are eligible as long as progression
             occurred more than six months following completion of previous rituximab therapy.

          -  Measurable or evaluable disease

          -  Able to perform activities of daily living without considerable assistance

          -  Adequate bone marrow, kidney, and liver function

          -  Signed informed consent obtained prior to initiation of any study-specific procedures
             or treatment.

        Exclusion Criteria:

        You cannot participate in the study if any of the following apply to you:

          -  Treatment with more than two previous chemotherapy regimens

          -  Prior treatment with bevacizumab or other similar agents

          -  Progressive NHL less than 6 months after receiving previous rituximab

          -  More than 1 prior treatment with investigational agents within 4 weeks prior to
             entering this study

          -  Spread of NHL to brain or nervous system

          -  History of any other uncontrolled or significant disease or medical condition that may
             put them at high risk for treatment complications with these agents

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Condition: Blunt Chest Wall Trauma; Rib Fracture; Sternal Fracture
MeSH terms: Fractures, Bone; Wounds and Injuries; Rib Fractures
Intervention: Liposomal bupivacaine; 0.9% sodium chloride
Intervention description: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position; 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall
      trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anticipated length of stay of at least 72 hours

          -  Blunt chest wall trauma with two or more rib or sternal fractures

          -  Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal
             body weight using IS within the first 24 hours of admission

        Exclusion Criteria:

          -  Known allergy to bupivacaine

          -  Respiratory failure requiring intubation within 24 hours prior to enrollment

          -  Known or suspected atrioventricular nodal blockade process requiring cardiology
             evaluation or pacemaker placement

          -  Hemodynamic instability (defined as new intravenous vasopressor or inotrope
             requirement or mean arterial pressure < 55 mmHg)

          -  Signs of active myocardial ischemia or non-ST elevation MI

          -  > 20 rib fractures

          -  Weight < 50 kg or > 150 kg

          -  Pregnancy

          -  Incarceration
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Parsaclisib
Intervention description: Parsaclisib at the protocol-defined dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Marginal zone lymphoma; phosphatidylinositol 3-kinase (PI3K)δ inhibitor; indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

Summary:

      The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment
      regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL)
      who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 18 or older (except in South Korea, aged 19 or older).

          -  Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and
             splenic subtypes.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse
             diameter and ≥ 1.0 cm in the longest perpendicular diameter.

          -  Participants with splenic MZL who do not meet the radiographically measurable disease
             criteria described herein are eligible for participation provided that bone marrow
             infiltration of MZL is histologically confirmed.

          -  Participants must be willing to undergo an incisional or excisional lymph node or
             tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
             archival tissue.

          -  Eastern Cooperative Oncology Group performance status 0 to 2.

        Exclusion Criteria:

          -  Evidence of diffuse large B-cell transformation.

          -  History of central nervous system lymphoma (either primary or metastatic) or
             leptomeningeal disease.

          -  Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
             inhibitor.

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of the first dose of study
             treatment.

          -  Active graft versus host disease.

          -  Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
             eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
             will be eligible if they are negative for HCV-RNA.
Autologous Fecal Therapy
Condition: Infectious Disease of Digestive Tract
MeSH terms: Communicable Diseases; Infections
Intervention: Autologous fecal microbiota therapy; Placebo
Intervention description: Saline enema
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fecal microbiota therapy

Summary:

      Ten healthy volunteers will be recruited to receive either an autologous stool transplant or
      a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,
      and safely, restore a patient's fecal microbiome after antimicrobial exposure.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Adults 18-70 years of age-

        Exclusion Criteria:

        history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial
        exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or
        risk of becoming pregnant during the study period; gastroenteritis in the last 3 months;
        incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon;
        unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change
        in diet or medications, or elective surgery, during the study period; or a history of an
        intestinal disorder -