bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
Condition: Schizophrenia; Cognition
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to explore the neurocognitive efficacy of Sertindole versus
      comparator in patients with schizophrenia using the MCCB.
    

Detailed description: 
      Sertindole is an atypical antipsychotic approved in the European Union (EU) for use in
      patients with schizophrenia who are intolerant to at least one other antipsychotic agent.
      During clinical development sertindole was found to be as effective in the treatment of
      schizophrenia as the first-generation antipsychotic haloperidol and as the second-generation
      antipsychotic risperidone.

      Sertindole is generally well tolerated and has a benign side-effect profile, including an
      absence of sedation, no effect on plasma prolactin levels, moderate weight gain, no
      anticholinergic-mediated cognitive impairment and a low rate of extrapyramidal symptoms
      (EPS). Sertindole has been shown to prolong the QT interval and is contraindicated in
      patients with prolonged QT interval and in patients receiving drugs known to significantly
      prolong the QT interval.

      The study is designed to provide data on the neurocognitive properties of sertindole versus
      quetiapine in patients with schizophrenia. Efficacy for cognitive impairment is assessed in
      patients who are in a stable phase of their illness, with a predefined maximum level of
      symptoms that will allow them to be included in the study. Prior antipsychotic medication
      will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study
      drugs.

      Cognitive deficiencies are an important feature of schizophrenia and correlate strongly with
      functional impairment. Improving functional outcomes in schizophrenia has a high priority and
      has resulted in the initiation of a program called Measurement and Treatment Research to
      Improve Cognition in Schizophrenia (MATRICS) leading to the development of a
      neuropsychological test battery, the MCCB which is used in this study.
    

Intervention name(s): Sertindole; Quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Once daily oral dose. Day 1-20: 4-16 mg/day (titration period). Day 21-84: 12, 16 or 20 mg/day (flexible treatment period).; Twice daily oral dose. Day 1-20: 50-500 mg/day (titration period). Day 21-84: 400, 500 or 600 mg/day (flexible treatment period).
Intervention MeSH terms: Quetiapine Fumarate; Sertindole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; MATRICS Consensus Cognitive Battery
Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced
      video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards
      the larynx around the steep blade angulation despite adequate visualization of the glottis.
      Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators
      hypothesized that using articulating stylet (AS) would enhance first attempt intubation,
      shorten the intubation time, reduce the possibility of the soft tissue trauma compared to
      conventional intubation stylet (IS) in patients with difficult airway .
    

Detailed description: 
      Patients with known airway difficulty (anticipated difficult airway (ADA) score >6) will be
      included to the study.

      All patients will receive general anesthesia for a variety of elective surgical procedure.
      Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated
      using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients
      demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores,
      Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time,
      hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.
    

Intervention name(s): articulating stylet; conventional stylet
Intervention type(s): Device; Device
Intervention description(s): patient who intubated with articulating stylet; patient who intubated with conventional stylet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: videolaryngoscope; intubation stylet; articulating stylet; difficult airway
Neuroeconomic Approach of Food Nutritionnal Assesment
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision
      making when evaluating the healthiness of food products with nutritional information
      displayed either with a Traffic Light system, a colored nutritional label, and a Guideline
      Daily Amount system, a numeric label.
    

Detailed description: 
      The investigators postulated that Traffic Light label would recruit emotion processes and
      activation of subjacent cerebral networks.

      On the contrary, the nutritional information presented in a Guideline Daily Amount label,
      would recruit, due to its numeric format and higher complexity, supplementary cognitive
      processes and activation of related brain regions.
    

Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food; Emotion; Health; Nutrition; Heuristic; Reasoning; Magnetic Resonance Imaging
Phase I Safety Study of a Recombinant MVA HIV Multiantigen Vaccine in HIV-infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV
      multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive
      immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine
      will be administered subcutaneously.
    


Intervention name(s): MVA-mBN120B
Intervention type(s): Biological
Primary purpose: Diagnostic
Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Condition: Laparoscopic Abdominal Surgery
Study type: Interventional

Summary: 
      Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to
      the internal abdominal wall at the beginning of a surgical case and remains in position until
      completion of the surgery, enabling the surgeon to clean the camera lens without removing it
      from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety
      of using the EndoClear device as a laparoscopic lens cleaning device.
    

Detailed description: 
      The ability to perform laparoscopic surgery safely and effectively depends on the
      uninterrupted progression of the operation. Any interruptions to the normal workflow of the
      procedure threatens to cause distraction which in the least can lengthen the operative time
      leading to increased hospital operating costs and exposing the patient to unnecessary excess
      anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or
      technique resulting in injury to the patient.

      Interruptions in the operating room can take many forms, from conversations to equipment
      malfunction. The goal of this study is to focus on one particular type of interruption unique
      to laparoscopic surgery - lens cleaning. It is quite common during the course of the
      procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from
      cautery devices. This necessitates having to remove the camera from the patient, cleaning it
      outside of the body, applying de-fog solution, reinserting it into the body, and having to
      reacquire the original camera position and image. This can be quite dangerous particularly in
      the middle of operative step, such as when there is ongoing bleeding, or when there are sharp
      or hot instruments within the body. Pilot data from own group demonstrates that the camera
      may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an
      operation.
    

Intervention name(s): EndoClear Lens Cleaning Device
Intervention type(s): Device
Intervention description(s): EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.
Other intervention name(s): Virtual Ports, Ltd
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Laparoscopic; EndoClear; Lens Cleaning Device
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to demonstrate that the antibacterial activity of TMC207 is
      better than placebo when added to a standardized Background Regimen (BR) for treatment of
      multi-drug resistant TB. Also safety and tolerability will be evaluated.
    

Detailed description: 
      The trial will be conducted in 2 consecutive stages, an exploratory (investigative) stage
      (Stage 1) and a proof of effectiveness stage (Stage 2). During Stage 1, a panel of 50
      participants will be randomized (participants are assigned different treatments based on
      chance) to receive either TMC207 or placebo for 8 weeks on top of a BR. In Stage 2, another
      panel of 150 participants will be randomized to receive either TMC207 or placebo for 24 weeks
      on top of a BR. TMC207 will be dosed as 400 mg every day for the first 2 weeks, and as 200 mg
      3 times/week for the following 6 or 22 weeks during Stages 1 and 2, respectively. When the
      participants in Stage 1 have completed 8 weeks double-blind (neither theparticipant nor the
      physician knows whether drug or placebo is being taken, or at what dosage) treatment with
      TMC207 or placebo (or have discontinued earlier), the primary Stage 1 analysis will be
      performed on all data of the first 8 weeks of treatment. Following this Stage 1 analysis,
      Stage 2 will be initiated and a panel of 150 new participants will be enrolled. After the
      double-blind treatment phase in both Stage 1 and Stage 2, participants will continue to
      receive MDR-TB treatment as per national treatment guidelines. They will be followed for
      safety, tolerability, pharmacokinetics, and microbiological efficacy for 96 weeks after
      receiving their last dose of TMC207 or placebo. The Data Safety Monitoring Board Committee
      will review these data on a regular basis. The DSMB/DSMC is a group of experts in
      tuberculosis and clinical trial conduct who have no commercial interests in the development
      of TMC207 and the company (Tibotec, BVBA) that is developing the new TB drug.
    

Intervention name(s): TMC207; Placebo; Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.; Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.; Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tuberculosis; MDR TB
Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors
Condition: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma
MeSH terms: Leukemia; Multiple Myeloma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will gather information about the combination the drugs plerixafor with
      sargramostim in donors of blood-forming cells (stem cells). These stem cells will be
      collected from the donor and transplanted into their sibling. The investigators believe that
      the two drugs together will provide enough stem cells for transplantation and may also reduce
      the risk of graft versus host disease.
    

Detailed description: 
      The main purpose of this study is to gather information about the combination the drugs
      plerixafor with sargramostim in donors of blood-forming cells (stem cells). Stem cells can be
      taken from the bone marrow of the pelvic bones or from the blood following treatment with
      drugs called growth factors; sargramostim is such a drug. Once stem cells leave the bone
      marrow and circulate in the blood, they are called peripheral blood stem cells (PBSCs). These
      cells can be collected through a routine procedure called apheresis, which involves placing
      two IVs into the arm which are connected to an apheresis machine; the machine then takes
      blood from the body, removes the stem cells, and returns the blood to the body.

      Normally, a growth factor called filgrastim is given to donors in order to collect the stem
      cells used for transplantation. However, when stem cells collected using filgrastim are
      transplanted in patients, a possible unpredictable complication is graft versus host disease.
      It's thought that using a different growth factor such as sargramostim might reduce the
      occurrences of graft versus host disease in patients. However, sargramostim alone does not
      provide as many stem cells for transplantation as other growth factors. Plerixafor is another
      drug that can increase the number of PBSCs in a donor, but like with sargramostim, plerixafor
      alone does not always provide enough stem cells. This is why sargramostim and plerixafor are
      being combined in this study: the investigators believe that the two drugs together will
      provide enough stem cells for transplantation and may also reduce the risk of graft versus
      host disease.
    

Intervention name(s): Sargramostim; Plerixafor
Intervention type(s): Drug; Drug
Other intervention name(s): GM-CSF, Leukine; AMD3100, Mozobil
Intervention MeSH terms: Plerixafor; Sargramostim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way
      cross over study to evaluate the potential for bronchoconstriction of the new HFA-152a
      propellant (single dose) versus the marketed HFA-134a propellant (single dose) in adult
      subjects with mild asthma.
    


Intervention name(s): Placebo 152a; Placebo 134a
Intervention type(s): Drug; Drug
Intervention description(s): Placebo pMDI formulated with the 152a propellant; Placebo pMDI formulated with the 134a propellant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the anti-inflammatory action and safety of
      Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The
      research is being conducted at up to 40 clinical research sites in the US. Study participants
      will have a number of visits to a research site over a 4-month period.
    


Intervention name(s): Dual Integrin Antagonist
Intervention type(s): Drug
Primary purpose: Treatment
4-way Crossover QT Evaluation in Healthy Subjects
Condition: Cardiac Repolarization in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate if ZTI-01 (fosfomycin for injection), an
      investigational drug being developed to treat people with complicated urinary tract and
      kidney infections, has any effect on the electrical activity of the heart.
    

Detailed description: 
      This is a single-center, randomized, placebo-controlled, four-period, cross-over study to
      assess the effect of single-doses of ZTI-01 at therapeutic (T) and supratherapeutic (ST)
      plasma concentrations on the QTc interval versus placebo (P) and an open-label moxifloxacin
      (M) control (400 mg PO).

      Assessment of safety data will include changes from baseline in vital signs and laboratory
      parameters, infusion site reactions, adverse events and clinically significant changes from
      baseline in 12-lead ECG parameters.
    

Intervention name(s): ZTI-01; Moxifloxacin 400mg; Placebo IV
Intervention type(s): Drug; Drug; Other
Intervention description(s): 6g IV fosfomycin; oral moxifloxacin (Avelox 400 mg) + IV normal saline (Placebo); IV Placebo (0.9% Normal Saline)
Other intervention name(s): IV fosfomycin; fosfomycin disodium; fosfomycin for injection; Positive control; Negative Control
Intervention MeSH terms: Moxifloxacin; Fosfomycin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way cross over (two doses of ZTI-01, placebo and oral moxifloxacin)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing the FLASHE Survey
Condition: Cognitive Testing; Interview; Survey
Study type: Observational

Summary: 
      Background:

      - The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at
      health-related topics. It is being developed for the Department of Health and Human Services.
      Researchers want to see how easy or difficult the FLASHE survey questions are to understand
      and answer. They will interview parents and teenagers to test the survey questions.

      Objectives:

      - To test the FLASHE survey questions on teenagers and their parents.

      Eligibility:

        -  Adolescents between 11 and 18 years of age.

        -  Parents of the participating adolescents.

      Design:

        -  Participants will have a one-on-one interview to test the survey questions. The
           interview will last up to an hour and a half. Participants will be allowed to skip any
           questions that they do not wish to answer.

        -  Participants will receive financial compensation for their time.
    

Detailed description: 
      The National Cancer Institute s (NCI) Division of Cancer Control and Population Sciences
      (DCCPS), Behavioral Research Program (BRP) proposes conducting formative research as an
      integral part of the development of a new data collection instrument, the Family Life,
      Activity, Sun, Health, and Eating (FLASHE) survey. Specifically, NCI proposes conducting
      cognitive testing with the objective of identifying potential sources of measurement or
      response errors within the questionnaires. Many of the questions are new questions that have
      not been previously tested, or previously-used questions that have never been used with a
      teenage population.
    

Observational model: Other
Time perspective: Cross-Sectional
Keywords: Cognitive Testing; Survey; Interview
Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart
Condition: Health Care Utilization
Study type: Interventional

Summary: 
      Our objective is to determine the effectiveness of varied outreach methods (e.g. standard
      versus tailored MyChart messaging) to children age 6-17 years old who are due for a WCC visit
      and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling
      and appointment completion.
    


Intervention name(s): No Message; Standard message; Tailored message
Intervention type(s): Other; Other; Other
Intervention description(s): No messages are sent; 2 MyChart reminders that child is overdue for well child check visit; 2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Closed Reduction With Anesthesia and no Anesthesia for Developmental Dislocation of the Hip < 6 Months
Condition: Developmental Dislocation of the Hip; Reduction Deformity of Limb
MeSH terms: Joint Dislocations; Hip Dislocation
Study type: Observational

Summary: 
      The purpose of this study is to compare the efficacy of closed reduction with anesthesia and
      no anesthesia for developmental dislocation of the hip < 6 months
    

Detailed description: 
      We treated children (<6 months) with prolonged traction before an attempted closed reduction.
      And compare the efficacy of closed reduction with anesthesia and no anesthesia for
      developmental dislocation of the hip. All the patients were followed up for a minimum of 18
      months in order to identify any avascular changes in the femoral head. The presence of
      avascular necrosis was assessed by the criteria of Salter.
    

Intervention name(s): anesthesia
Intervention type(s): Procedure
Intervention description(s): no anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        developmental dislocation of the hip（ < 6 months）