bioihbjkbjnl/mcl2 huggingface dataset:
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
Condition: HIV
Intervention: Raltegravir; Raltegravir
Intervention description: Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.; Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HIV raltegravir intensification replication activation

Summary:

      This study will examine whether intensification with raltegravir of a suppressive
      antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial
      effect on cryptic viral replication and the immune system. Specifically, the investigators
      will examine the effect that raltegravir intensification of ART has on episomal cDNA
      frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial
      translocation.
    

Eligibility criteria:

        Inclusion Criteria:

        To qualify for this study, participants will need to have:

          1. At least 18 years of age

          2. Documented HIV-1 infection

          3. CD4+ count <350 cells/mm3 at the time of enrollment or CD4+ count increase of <100
             cells/mm3 within the past 2 years

          4. Plasma viral load <400 copies/ml at all testing time points within the preceding 2
             years AND <50 copies/ml by RT-PCR or <75 copies/ml by bDNA at the 2 testing time
             points immediately preceding enrollment into the study

        Exclusion Criteria:

        To qualify for this study, patients must not meet any of the following exclusion criteria:

          1. Pregnancy or breast-feeding

          2. Prior use of raltegravir at any time in the past

          3. Use of any investigational, immunomodulatory, immunosuppressive agents within 90 days
             prior or during this study

          4. Alcohol or substance abuse that in the opinion of the investigator might interfere
             with patient compliance or safety

          5. Any condition or pre-study laboratory abnormality that in the opinion of the
             investigator might interfere with patient compliance or safety
Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
Condition: Non-transfusion Dependent Thalassemia
MeSH terms: Thalassemia
Intervention: deferasirox
Intervention description: Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing.
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Non-transfusion dependent thalassemia; NTDT; deferasirox; ICL670; LIC; Liver Iron Concentration

Summary:

      Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia
      based on change in liver iron concentration from baseline after 52 weeks of treatment.
      Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT
      patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia
        intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron
        concentration >/= 5 mg Fe/g dw Serum Ferritin >/= 300 ng/mL

        Exclusion Criteria:

        HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood
        transfusion 6 months prior to study start, significant proteinuria, creatinine clearance
        </= 40 ml/min, serum creatinine > ULN, ALT >5 x ULN, active hepatitis B or C, cirrhosis

        Pediatrics Only:

        A patient's weight of at least 20 kg is required to allow dosing of 5 mg/kg with one tablet
        of 125 mg
Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy; Diabetic Traction Retinal Detachment; Vitreous Hemorrhage
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Vitreous Hemorrhage; Hemorrhage
Intervention: Bevacizumab; Vitrectomy; Sham injection
Intervention description: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation); vitrectomy of 25 gauge system.; Sham injection one day before vitrectomy
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 69.0
Sex: All
Healthy volunteers: No

Summary:

      We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular
      tissue and whole body, intravitreal injection of a low concentration of bevacizumab and
      conducting vitrectomy shortly after the injection is useful. In the present prospective,
      double-masked, randomized, controlled study, we aimed to verify the usefulness of
      intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy
      for PDR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)

          -  Indicated for vitrectomy

        Exclusion Criteria:

          -  History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection
             of steroids or retinal photocoagulation within 6 months
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: d-cycloserine
Intervention description: 50mg dose d-cycloserine v placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; cognition; d-cycloserine; memory

Summary:

      The study aims to assess the effects of single dose and repeated weekly dosing of 50mg
      d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients.
      The study will also examine the effects of 50mg d-cycloserine on positive symptoms and
      negative symptoms, as well as assess tolerability and side-effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female

          2. Age 18-65 years

          3. Diagnosis of schizophrenia or schizoaffective disorder, depressed type

          4. Stable dose of antipsychotic for at least 4 weeks.

          5. Able to provide informed consent

          6. Able to complete a cognitive battery

        Exclusion Criteria:

          1. Current treatment with clozapine

          2. Dementia

          3. Seizure disorder

          4. Unstable medical illness

          5. Active substance abuse

          6. Pregnancy, nursing, or unwilling to use appropriate birth control measures during
             participation if female and fertile.
A Randomized Clinical Trial of Alcohol Care Management
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Alcohol Care Management; Usual Care
Intervention description: Care management for alcohol dependence with a focus on pharmacotherapy; Usual care included a referral to a specialty addiction treatment program.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alcoholism; primary care; treatment

Summary:

      A randomized study of Alcohol Care Management for the treatment of alcohol dependence in
      primary care settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be men and women = 18 years of age;

          -  meet criteria for alcohol dependence;

          -  drink more than an average of 2 drinks per day prior to study entry (over the last 60
             days);

          -  have adequate hearing to participate in assessment

        Exclusion Criteria:

          -  show no evidence of current abuse or dependence of illicit substances other than
             marijuana;

          -  no current hallucinations;

          -  no current symptoms of mania;

          -  be relatively cognitively intact

          -  not actively participate in specialized addition or behavioral health treatment within
             the prior 12 months
The Feasibility of Florbetapir Quantitation in Europe
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Florbetapir (18F)
Intervention description: No Florbetapir (18F) will be administered in this study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 96.0
Sex: All
Healthy volunteers: No

Summary:

      This study will evaluate whether the addition of quantitation as an adjunct to visual
      interpretations significantly improves the accuracy of Amyvid scan interpretation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Readers have undergone Amyvid reader training

          -  Readers have not more than minimal experience with quantitation of amyloid PET scans

        Exclusion Criteria:

          -  Readers have previously been trained to quantitate amyloid PET scans
Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Condition: Incomplete Reversal of Neuromuscular Block
Intervention: Sugammadex; Neostigmine
Intervention description: Sugammadex will be given for reversal of neuromuscular blockade.; Neostigmine will be given for reversal of neuromuscular blockade.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study will compare patient recovery measures after reversal of neuromuscular blockade
      with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle
      strength, time to extubation and quality of recovery in the post anesthesia care unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be willing and able to provide written informed consent for the study

          -  Participant must be greater than or equal to 18 years of age

          -  Participant must be ASA (American Society of Anesthesiologists) class I, II or III

          -  Planned use of neuromuscular blocking drugs

          -  Planned use of endotracheal intubation

          -  Planned for extubation to occur in the OR

        Exclusion Criteria:

          -  ASA (American Society of Anesthesiologists) Class IV

          -  Age < 18 years old

          -  Inability to give oral or written consent

          -  Known or suspected neuromuscular disorder impairing neuromuscular function

          -  True allergy to muscle relaxants

          -  A (family) history of malignant hyperthermia

          -  A contraindication for neostigmine or sugammadex administration

          -  Serum creatinine level of greater than 2.0 mg/dL

          -  Surgery where the patient's arm is not available for neuromuscular monitoring

          -  A plan to extubate under deep anesthesia

          -  Pregnant
Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
Condition: Surgery
Intervention: Propofol 2mg/kg; Etomidate 0.3 mg/kg; Propofol 1 mg/kg; Etomidate 0.15 mg/kg
Intervention description: 2 mg/kg; 0.3 mg/kg; 1 mg/kg Propofol; 0.15 mg/kg Etomidate
Intervention MeSH terms: Propofol; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients in 3 cohorts will be administered 30 second bolus by manual hand push
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Etomidate; Propofol

Summary:

      Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of
      anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective non-cardiac surgery

          -  ASA physical status of 2 or 3

          -  Age equal to or greater than 18 years old

        Exclusion Criteria:

          -  Adults unable to provide consent

          -  Age less than 18 years old

          -  Pregnant women

          -  Prisoners

          -  Difficult airway

          -  Morbid Obesity

          -  Preoperative sedation use

          -  Severe Cardiac, pulmonary and liver disease

          -  Hypotension and shock

          -  Emergency surgeries

          -  Allergy to propofol or etomidate
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
Condition: Renal Transplantation
Intervention: Enteric-coated Mycophenolate Acid (EC-MPA); Mycophenolate Mofetil (MMF); Placebo MMF; Placebo EC-MPA
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Renal Transplantation; Immunosuppression; Renal transplant recipients; Gastrointestinal symptoms associated with MMF therapy

Summary:

      To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic
      acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
    

Eligibility criteria:

        Inclusion criteria:

          -  Recipients of first or second cadaveric, living unrelated or living related kidney
             transplant.

          -  Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable
             and controlled gastrointestinal symptoms.

          -  Recipients who are at least 4 weeks post renal transplantation with stable renal
             function.

        Exclusion criteria:

          -  Multi organ transplant or previous transplant with organ other than kidney

          -  History of GI disorder prior to transplant

          -  Evidence of GI disorder induced by infection, underlying medical condition, or con med
             other than MMF

          -  Modification of GI med or MMF dose within one week

          -  Evidence of graft rejection, treatment of acute rejection, unstable renal function
             within 1 week of (baseline) visit

        Other protocol-defined inclusion/exclusion criteria may apply
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
Condition: Long-term Safety of TIP
Intervention: TBM100
Intervention description: Tobramycin inhalation powder (TIP) 112mg/b.i.d
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: CF, Open-label, TIP, phase IV, extension study

Summary:

      The purpose of this extension study is to collect additional 48 weeks of safety data from
      patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting
      second year safety data through this study is to obtain long-term (2 years) safety data of
      TIP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the core study CTBM100C2401 and able to comply with all protocol
             requirements of the extension study

        Exclusion Criteria:

          -  Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry
             into the extension

          -  Use of loop diuretics within 7 days prior to entry into the extension study

          -  Pregnant or nursing women

          -  Women of child bearing potential unless using highly effective method of contraception
             as indicated in the protoco
Ziprasidone And Olanzapine's Outcomes In Mania
Condition: Acute Mania; Bipolar Disorder, Manic
MeSH terms: Mania; Bipolar Disorder
Intervention: ziprasidone hydrochloride; olanzapine
Intervention description: Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.; Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
Intervention MeSH terms: Olanzapine; Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus
      olanzapine in the treatment of acute mania. An open label extension will further evaluate the
      efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment
      was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007.
      Subjects that were enrolled at the time completed the study as per protocol. There were no
      safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was
      January 10, 2008.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x)
             or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini
             International Neuropsychiatric Interview (MINI)) at screening.

          -  A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).

        Exclusion Criteria:

          -  Have a diagnosis of learning disability or organic brain syndrome.

          -  Have a substance-induced psychotic disorder or behavioral disturbance thought to be
             due to substance abuse.
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
Condition: Airway Complication of Anaesthesia
Intervention: Laryngoscopy order: 1) MAC, 2) Levitan; Laryngoscopy order: 1) Levitan, 2) MAC
Intervention description: Laryngoscopy with MAC, then Levitan; Laryngoscopy with Levitan, then MAC
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 105.0
Sex: Female
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A laryngoscope is a medical instrument that is used to get a view of the voice box and the
      space in between the vocal cords. A laryngoscope is used to place a breathing tube into the
      trachea (windpipe or airway) to protect the patient's airway and provide a way to help a
      person breathe during surgery; this is called intubation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild
             systemic disease, ex. asthma, high blood pressure)

          2. Elective surgery requiring endotracheal intubation

          3. English speaking

          4. Age 16 - 75 years

        Exclusion Criteria:

          1. Significant gastroesophageal reflux disease (GERD) that may require alternate
             induction/intubation techniques

          2. Prior history of a difficult intubation requiring an awake tracheal intubation

          3. Clinical predictors of a potentially difficult intubation requiring an awake
             intubation

          4. BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult
             intubation)