bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
Condition: Postoperative Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain
      after surgery remains a significant clinical problem as it impairs recovery adversely and may
      lead to the transition to chronic pain. The open approach represents a major physical trauma
      including postoperative pain and discomfort in the convalescence period. Adequate control of
      postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled
      analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic
      analgesia and may also elicit side effects that may delay hospital discharge. Preventing
      early and late postsurgical pain is an important challenge for anesthesiologists and
      surgeons.

      Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker)
      are popular analgesic adjuvants for improving perioperative pain management. The
      investigators designed this double-blind, placebo controlled study to test and compare the
      preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic
      pain after elective open nephrectomy.

      The investigators propose a double-blind placebo-controlled study of patients undergoing
      elective open nephrectomy. All patients will receive normal "patient-controlled analgesia
      morphine" in addition to study drugs or placebo. Research will be conducted at Charles
      Nicolle teaching hospital.
    

Detailed description: 
      Participants will be randomized into one of three study groups: Group L: intravenous
      lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h
      intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg
      followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control
      Group C: an equal volume of saline. The anesthetic technique will be standardized, and the
      postoperative assessments included pain scores, opioid consumption, recovery of bowel
      function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months,
      patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4
      questionnaire.
    

Intervention name(s): Ketamine; Lidocaine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketamine infused at 0.1 mg/kg/hour; Lidocaine infused at 1 mg/kg/hour; An equal volume of saline
Other intervention name(s): Saline
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ketamine; Lidocaine; Nephrectomy; Chronic pain
Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study is being conducted as a prelude to a randomized trial to compare
      levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to
      demonstrate recruitment potential, to provide prospective data on the tolerability of
      levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide
      limited data on it's efficiency, and to provide data to assist in selecting a dose to use in
      a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity
      for investigators to gain experience in using levodopa prior to a randomized trial.
    

Detailed description: 
      Amblyopia is the most common cause of monocular visual impairment in both children and young
      and middle-aged adults. Both patching and atropine are accepted treatment modalities for the
      management of moderate amblyopia in children. Despite best efforts with conventional
      amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal
      visual acuity in the amblyopic eye. In a previous PEDIG study (ATS3) where children 7 to 13
      years old were treated with atropine and patching, only 36% of the children with moderate
      amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.
    

Intervention name(s): levodopa/carbidopa; patching; levodopa/carbidopa
Intervention type(s): Drug; Device; Drug
Intervention description(s): Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation); 2 hours daily patching; Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)
Other intervention name(s): Coverlet, 3M Opticlude, Ortopad®
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amblyopia; Patching; Levodopa
The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have
      been randomized to receive an electronic alert in their electronic medical chart to remind
      primary care physicians to screen them for chronic hepatitis B.
    


Intervention name(s): Electronic HBV Alert
Intervention type(s): Other
Intervention description(s): Electronic HBV Alert deployed in electronic medical charts of at risk patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Mass Screening
Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at
      change in pulmonary vascular resistance (PVR) as the primary endpoint.

      In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be
      given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline
      and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints,
      quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will
      also be evaluated.

      Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower
      pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label
      clinical trial.
    


Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potential Health Effects of Aronia Intake
Condition: Health Effects of Aronia
Study type: Interventional

Summary: 
      Intervention cross-over study during which participants receive standardized amounts of
      aronia berry tablets or placebo for three months, then wash out for three months, then aronia
      tablets or placebo for three months. The potential health effects are investigated. Following
      parameters are measured before and after each period of tablet intake: 1) Blood pressure, 2)
      Lipid fractions, 3) Testosterone, 4) Phase II markers, 5) HbA1c, 6) HSCRP, 7)
      F2-isoprostanes, and 8) semen quality.
    


Intervention name(s): Aronia, washout and then placebo; Placebo, washout and then aronia
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Three tablets three times à day for three months then washout for three months, then three placebo tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.; Three tablets three times à day for three months, then washout for three months, then three aronia tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent
      of improvement in PASI score at week 12.
    

Detailed description: 
      The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent
      of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio.
      Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and
      8.
    

Intervention name(s): 70 mg SC; 210 mg SC; 140 mg SC; 280 mg SC; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 70 mg SC; 210 mg SC; 140 mg SC; 280 mg SC; Placebo SC
Other intervention name(s): AMG 827; AMG 827; AMG 827; AMG 827
Intervention MeSH terms: Brodalumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella
Condition: Rubella; Measles
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences
      demonstrate the benefit for providing the universal access to vaccines containing measles and
      rubella antigens, mainly due to, respectively, mortality in children and malformations in
      fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation
      double viral vaccine anti-measles and rubella (MR), which is developed and produced at
      Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in
      human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and
      monitored for local and systemic adverse events and titration of antibodies. The study will
      last 11 months in total.
    

Detailed description: 
      This is a Phase II-III, controlled, randomized and double blind for the evaluation of a
      double viral vaccine anti measles and rubella (MR), which is under the development at
      Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in
      human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and
      monitored for local and systemic adverse events and immunogenicity. The study will last 11
      months in total.
    

Intervention name(s): Measles and Rubella vaccine; Measles, Mumps and Rubella vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Administration of the experimental vaccine (MR).; Administration of the comparator vaccine (MMR).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Double Viral Vaccine Measles and Rubella; Safety Efficacy Imunogenicity
Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Condition: Temporary Auditory Threshold Shift
Study type: Interventional
Phase: Phase 2

Summary: 
      Exposure to loud sounds can cause hearing loss. The purpose of this research study is to
      evaluate potential prevention of temporary changes in hearing that may occur after listening
      to music through an iPod or personal music player. We will measure temporary changes in
      hearing in subjects who listen to music and take either the study drug, SPI-1005, or a
      placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be
      taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione
      Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
    


Intervention name(s): SPI-1005 Low dose; SPI-1005 Middle dose; SPI-1005 High dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral capsules, 200 mg ebselen, twice daily, 4 days; Oral capsules, 400 mg ebselen, twice daily, 4 days; Oral capsules, 600 mg ebselen, twice daily, 4 days; Oral capsules, 0 mg ebselen, twice daily, 4 days
Other intervention name(s): 200 mg Ebselen; 400 mg Ebselen; 600mgEbselen; 0 mg Ebselen
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Temporary Auditory Threshold Shift; Hearing Loss; Deafness; SPI-1005; Ebselen
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Condition: Fever; Sweating; Hot Flashes; Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neutropenia; Fever; Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in
      patients with cancer.

      PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia
      and fever in patients with cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the response rate to therapy within 72 hours of starting daptomycin in cancer
           patients with neutropenic fever.

      Secondary

        -  Assess the percentage of bacterial cures in patients with documented gram-positive
           bacterial infections.

        -  Assess time to afebrile state.

        -  Assess the pharmacokinetic data of daptomycin in neutropenic patients.

        -  Document the incidence of breakthrough infections that require a change of therapy or
           additional agents to clear.

        -  Assess the tolerability of daptomycin in neutropenic patients.

        -  Assess and document adverse events and toxicity due to daptomycin.

      OUTLINE: This is an open-label, pilot study.

      Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the
      patient is still febrile at 72 hours, daptomycin is administered.

      Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not
      neutropenic (absolute neutrophil count [ANC] > 500/mm³), and have no signs of infection after
      72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic
      (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute
      neutrophil count (ANC) > 500/mm³ for 2 consecutive days. Patients who are febrile with or
      without continued neutropenia (ANC < 500/mm³) after 72 hours of therapy continue to receive
      daptomycin for up to 10-14 days in the absence of unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention description(s): daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neutropenia; infection; unspecified adult solid tumor, protocol specific; fever, sweats, and hot flashes
External Trigeminal Nerve Stimulation for Epilepsy
Condition: Epilepsy; Seizure Disorders
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS).
      TNS involves external electrical stimulation of sensory nerve located above the eyes and over
      the forehead. The purpose of this study is to determine if TNS is safe and effective using a
      rigorous randomized active-control clinical trial design in 50 people with epilepsy.
    

Detailed description: 
      Poorly controlled epilepsy is a disabling condition, affecting over one million Americans.
      Neurostimulation is a promising alternative for patients who have failed medical therapy, and
      who are not resective surgical candidates.

      Trigeminal Nerve Stimulation (TNS) is a novel form of neurostimulation, and has a strong
      antiepileptic effect in an animal model of seizures. Preliminary data in humans indicates TNS
      is well tolerated and may be effective in people with intractable epilepsy.

      TNS is an alternative mode of neurostimulation, because the Trigeminal Nerve can be
      stimulated in minimally-invasive fashion.

      This is a randomized double blind study of Trigeminal Nerve Stimulation, which compares high
      stimulation to an active control. Subjects with poorly controlled partial onset seizures who
      meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are
      randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50
      subjects are to be enrolled at two sites.

      Study outcomes are the following:

        1. Percent change in seizure frequency during the treatment period compared with the
           baseline (pre-treatment) period.

        2. Time to the 4th seizure

      The primary comparisons will be between and within groups.
    

Intervention name(s): Trigeminal Nerve Stimulation
Intervention type(s): Device
Intervention description(s): External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: partial seizures; poorly controlled epilepsy; intractable epilepsy; treatment resistant epilepsy; Trigeminal Nerve; Trigeminal Nerve Stimulation
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
Condition: Multiple Sclerosis; Neuromyelitis Optica
MeSH terms: Multiple Sclerosis; Neuromyelitis Optica; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      First in human study to assess the tolerability and safety profile of treatment with
      dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
    


Intervention name(s): Tolerogenic Dendritic cells loaded with myelin peptides
Intervention type(s): Biological
Intervention description(s): Somatic-cell therapy medicines application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Fluid Milk in Attenuating Hyperglycemia and Hypertriglyceridemia After Meal
Condition: Oral Glucose Tolerance Test; High Fat Tolerance Test
MeSH terms: Hyperglycemia; Hypertriglyceridemia
Study type: Interventional

Summary: 
      Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed
      in the regular diet. Milk products are unique in that they produce high insulin response
      despite their low glycemic index. The general aim of the proposed study is to determine the
      effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride
      after meals and its associated physiological mechanisms. The investigators hypothesize that
      the consumption of one or two servings of non-fat milk added to a standard oral glucose
      tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate
      postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the
      postulated improvement in postprandial metabolic response due to the consumption of fluid
      milk will be associated with increased postprandial insulin secretion as well as
      insulin-mediated endothelial vasodilation and whole-limb perfusion.
    

Detailed description: 
      A double blind randomized placebo-controlled crossover experimental design with six
      treatments will be used. A total of 30 young (20-40 year old) healthy men and women will
      serve as subjects. Following 2 days of physical activity and dietary control, subjects will
      consume a standard OGTT load or high fat tolerance load on the morning of Day 3. The solution
      used in the meals will be mixed with one or two servings of non-fat milk or placebo (either
      carbohydrate matched or total calorie matched). Before and after the test meals are consumed,
      blood samples will be obtained for later analysis of glucose, triglycerides, insulin, and
      inflammatory cytokines and brachial artery flow-mediated dilation and femoral artery vascular
      conductance will be measured. The present research project should provide new and clinically
      useful insight into the role of conventional dairy products on metabolic homeostasis. If the
      working hypotheses are supported, the information could be used as an initial/preliminary
      basis for recommendations for the consumption of fluid milk in the prevention of metabolic
      diseases.
    

Intervention name(s): non-fat milk; carbohydrate control beverage; caloric control beverage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 serving of non-fat fluid milk; 1 serving of carbohydrate control beverage (Carbohydrate powder + water); 1 serving of caloric control beverage (carbohydrate powder + protein powder + water)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endothelial dependent vasodilation; blood flow; blood glucose; triglycerides; non-fat milk; dairy