bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
Condition: Neoplasms
Intervention: Bevacizumab
Intervention description: Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label, multicenter extension study will provide continued bevacizumab
      therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech
      sponsored study and who derived benefit from the bevacizumab therapy. Participants will
      receive the same dose and regimen of bevacizumab as used in the previous parent trial and
      continue this treatment until progression of disease or unacceptable toxicity, withdrawal of
      consent or death whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored
             parent trial and continues to have benefit as judged by the investigator

          -  Eligible for continuation of bevacizumab treatment at the end of a parent trial,
             according to parent trial protocol

          -  Able to comply with this extension study protocol (MO25757)

        Exclusion Criteria:

          -  Evidence of disease progression assessed according to parent trial protocol during the
             screening phase for this extension study

          -  Evidence of any adverse event potentially attributable to bevacizumab, for which the
             local label recommends permanent discontinuation

          -  A treatment interruption with bevacizumab of more than 42 days since the last
             administration of bevacizumab in the parent trial

          -  Evidence of any other disease that would put the participant at high risk for
             treatment-related complications
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Condition: Major Depressive Disorder; Surgery; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine; Normal saline (placebo)
Intervention description: 0.5 mg/kg over 40 minutes, intravenous.; Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking is for double blind phase only.
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: depression; ketamine; anesthesia; total joint arthroplasty

Summary:

      This study evaluates whether ketamine, given as part of an anesthetic, improves depression
      symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will
      receive a ketamine infusion during surgery, while the other half will receive a placebo
      (normal saline) during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient presenting for non-cardiac, non-intracranial surgery

          -  Major Depressive Disorder

        Exclusion Criteria:

          -  Pregnant of breastfeeding women
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: Placebo; Rifaximin
Intervention description: Placebo, oral, 0 mg BID, 6 months of treatment; Rifaximin, oral, 550 mg BID, 6 months treatment
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatic Encephalopathy; Liver Failure; Hepatic Insufficiency; Liver Diseases; Brain Diseases; Rifaximin; Cirrhosis

Summary:

      The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with
      severe hepatic impairment and Hepatic Encephalopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-breast feeding female ≥ 18 years old

          -  In remission from demonstrated overt HE

          -  Had ≥1 episode of overt HE associated with liver disease within the last 6 months

          -  MELD score of ≥ 19

          -  Has a close family member or other personal contact who is familiar with the subject's
             HE, can provide continuing oversight to the subject and is willing to be available to
             the subject during the conduct of the trial

        Exclusion Criteria:

          -  HIV

          -  History of tuberculosis infection

          -  Chronic respiratory insufficiency

          -  Current infection and receiving antibiotics

          -  Renal insufficiency requiring dialysis

          -  Active spontaneous bacterial peritonitis infection

          -  Intestinal obstruction or has inflammatory bowel disease

          -  Active malignancy within the last 5 years

          -  Current GI bleeding or has had a GI hemorrhage within past 3 months

          -  Anemia
Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Condition: Smoking Cessation
Intervention: Counseling; combination NRT
Intervention description: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking; Both groups will receive combination NRT to help with smoking cessation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: In vivo or standard of care
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and
      examine the underlying mechanisms of action associated with adherence.
    

Eligibility criteria:

        Inclusion Criteria:

        a) 18 years or older; b) qualifying as low income (as defined by making <150% above the
        poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least
        5 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than
        8 ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation
        of enrolling a large >50% African-American who average <10 CPD compared to Whites who
        average ~15 CPD.; and d) English speaking.

        Exclusion Criteria:

        a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or
        nursing (all women will be required to use an acceptable form of contraception); c)
        Currently enrolled in a smoking cessation treatment program, using NRT products, or
        prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement
        products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a
        pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or
        untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such
        as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition
        that interferes with the informed consent process (individuals stable on psychiatric
        medications will be included); or i) Daily or exclusive use of other tobacco products
        (e.g., electronic cigarettes, little cigars, etc.).
Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block
Condition: Pain; Arthroplasty, Replacement, Knee
Intervention: Levobupivacaine; Ropivacaine
Intervention description: Femoral bolus 150μM followed by femoral infusion 400μM; Bolus and infusion
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: local anesthetic; levobupivacaine; ropivacaine; femoral perineural block

Summary:

      The anaesthetic management of patients undergoing total knee replacement is still not
      standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor
      block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good
      pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting.
      Combined single injection femoral / sciatic blocks give good pain relief, but for a variable
      length of time (between 12 and 24 hours).

      In contrast, continuous femoral perineural infusion of local anaesthetic provides very good
      pain relief for several days. Pain relief is maintained by a constant infusion of local
      anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local
      anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full
      mobilisation within 24 hours Given that ropivacaine may offer a more advantageous
      pharmacological profile (less lipid solubility) compared to levobupivacaine, the
      investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain
      relief after surgery. Thus, the investigators aim in this study is to compare the median
      effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after
      total knee replacement. Further, calculation of the equipotent median effective dose's of
      each local anaesthetic allied to objective measurement of quadriceps motor block using an
      electromyogram will allow us to determine the sensory - motor split of each local
      anaesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients >18 years of age and non pregnant presenting for elective knee
             replacement

        Exclusion Criteria:

          -  Signs of cardiac failure (3rd heart sound, lung crepitations)

          -  Type I and type II diabetes

          -  Abnormal cardiac arrhythmias

          -  Hypovolaemia

          -  Presence of seizures,

          -  Dementia,

          -  Depression

          -  Encephalopathy,

          -  Terminal illness with a life expectancy < 3 months

          -  Age < 18 years

          -  Pregnant

          -  Coagulopathy
Contrast Nephropathy and Nitrates
Condition: Contrast Induced Nephropathy
MeSH terms: Kidney Diseases
Intervention: Intravenous Nitroglycerin; IV Fluids
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography
      that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is
      used during coronary angiography to see the coronary arteries. It has been shown that
      exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some
      high risk patients it progresses into renal failure.

      This research study offers a new possible option to prevent CIN. We propose that if
      intravenous nitroglycerin is given before the procedure it may lower the chances of
      developing contrast-induced nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be scheduled for percutaneous coronary angiography.

          2. Patients must have a Mehran score more or equal to 6 before the procedure.

          3. Patients must have baseline creatinine and hemoblogin drawn before the procedure.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Patients on renal replacement therapy before randomization, will be excluded.

          2. Being exposed to any types of nitrates 48 hours prior to randomization,

          3. History of allergic reaction to any of the components of intravenous nitroglycerin.

          4. Exposure to contrast media 4 days prior randomization.

          5. Planned revascularization in the next 24 to 48 hours of the first PCI procedure.

          6. The patient is hypotensive (<90/60mmHg) at the time of randomization.
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Condition: Autism Spectrum Disorder; Asperger Syndrome; Aspergers Syndrome
MeSH terms: Syndrome; Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome
Intervention: Milnacipran; Placebo
Intervention description: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.; Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ASD; Autism; Autism Spectrum Disorder; Asperger Syndrome; Asperger; PDD; PDD-NOS

Summary:

      Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders
      beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates
      suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very
      substantial costs associated with caring for patients with ASD, and ASD has the highest
      Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,
      including social deficits, repetitive behaviors and language deficits. Patients can also have
      associated symptoms of attentional deficits, disruptive behaviors and intellectual
      disability. There is currently no Food and Drug administration (FDA) approved treatment for
      the core symptoms of autism, but risperidone and aripiprazole have FDA approval for
      disruptive behaviors associated with autism.

      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults
      with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and
      normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a
      role in behavior adaptations and performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female patients

          -  Aged 18-50 years

          -  Diagnosis of Autism Spectrum Disorder

          -  intelligence quotient greater than 70

        Exclusion Criteria:

          -  Pregnant subjects

          -  Patients deemed by comprehensive psychiatric interview to have a significant risk of
             suicide
Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Condition: Bronchiolitis; Wheezing
MeSH terms: Bronchiolitis; Respiratory Sounds
Intervention: 0.9% Sodium Chloride; 3% Sodium Chloride
Intervention description: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.; Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Phase: Phase 4
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: 2 Months
Maximum age: 24 Months
Healthy volunteers: No
Keywords: bronchiolitis; hypertonic; saline; salbutamol

Summary:

      - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to
      severe bronchiolitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All pediatric patients aged 2 months to 24 months of age, both genders attending the
             pediatric emergency service.

          -  With first episode of wheezing associated with respiratory distress and a history of
             upper respiratory tract infection.

          -  You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu
             (HSJD) from 6 to 16 at entry points (moderate and severe degree).

        Exclusion Criteria:

          -  Subjects with a history of previous wheezing, asthma, or who have received
             bronchodilator treatment before the present illness.

          -  Subjects with chronic lung disease, with heart disease, with congenital or acquired
             anatomic abnormalities of the airway.
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Intervention: Moderate Procedural Sedation with a sedative medication.; Deep Procedural Sedation with a sedative medication.; propofol
Intervention description: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.; procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
Intervention MeSH terms: Propofol; Hypnotics and Sedatives
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: propofol; moderate procedural sedation; deep procedural sedation; memory; emergency department

Summary:

      This study is a clinical trial of moderate sedation versus deep sedation with propofol for
      procedural sedation in the Emergency Department. The purpose of this study is to compare the
      rate of amnesia and respiratory depression rate in patients who receive moderate sedation to
      those that receive deep sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults undergoing procedural sedation with propofol in the emergency department

        Exclusion Criteria:

          -  < 18 years old

          -  Pregnant

          -  Previous allergic reaction to propofol

          -  Prisoner

          -  Unable to provide informed consent
Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3054.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      A study to investigate the incidence of influenza and influenza-related complications, in
      adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female age 50 years or older at the time of the first vaccination.

          -  non-childbearing female

          -  Availability to follow up by phone

          -  Subjects with residence status allowing free mixing with general community

        Exclusion Criteria:

          -  Use of non-registered products

          -  Pregnancy

          -  Hypersensitivity to a previous dose of influenza vaccine

          -  Acute disease at the time of enrolment/vaccination.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine

          -  Any contra-indication to intramuscular administration of Fluarix™

          -  For subjects enrolled in the immunogenicity subset only: administration of
             immune-modifying drugs within 7 days prior to the vaccination