bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Progressively causes the breakdown of cognitive functions and impairs quality of life for
      patients and their caregivers. In addition to memory impairment, visual attention is also
      compromised, even at the stage of mild cognitive impairment due to AD (MCI-AD). No treatment
      has been found for MCI-AD; therefore, attention has been drawn to non-invasive brain
      stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to
      enhance cognitive functions by modifying brain plasticity. In the current research,
      investigator aim to examine the long-term effects of the optimal multiple-session tDCS
      protocol in MCI-AD on visual attention including the transfer to an ecologically valid
      virtual environment and identify the neural underpinnings of tDCS-induced behavioral
      aftereffects using a combined tDCS/ MRI network-based approach.
    

Detailed description: 
      Investigator will investigate the long-term effects of 10 active tDCS consecutive sessions
      using an optimized stimulation protocol as compared to a placebo stimulation on visual
      attention in the MCI-AD. A two-parallel-group, randomized, placebo-controlled design will be
      used. In addition, the cognitive transfer of tDCS will be evaluated. Repeated tDCS sessions
      will be performed in 10 consecutive sessions (2 weeks: Monday to Friday) over one preselected
      ROI together with ongoing visual attention training. During the stimulation, investigator
      will use the visual matching task. Before the repeated stimulation sessions, participants
      will undergo the neurocognitive examination. Behavioral examinations of the trained and
      untrained tasks (i.e. the transfer tasks) will be performed to assess the baseline
      performance. MRI protocol consisting of T1, T2, FLAIR, and fMRI during the task performance
      (visual matching task), resting state fMRI, and DTI sequences will be acquired before and
      after the whole 10-day stimulation protocol in order to search for active vs. placebo
      tDCS-induced changes in brain activation and resting state functional and structural
      connectivity and to identify neural correlates of behavioral changes. Behavioral assessment
      of the trained task and the transfer task will be repeated immediately after and again at a
      one-month follow-up visit after the end of the last stimulation session
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): 2mA stimulation for 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mild Cognitive Impairment; Transcranial direct current stimulation
A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer
      in DMD participants by measuring biological and clinical endpoints in three parts: two
      48-week randomized, double-blinded, placebo-controlled periods (Part 1 and Part 2), and an
      open-label follow-up period (Part 3). Participants who are randomized to placebo in Part 1
      will have the opportunity for treatment with delandistrogene moxeparvovec in Part 2.

      In order to provide a uniform approach to monitoring long-term safety and efficacy in
      participants who received SRP-9001 in a clinical trial, the Sponsor has amended Study
      Completion for this study to occur at Week 130. Therefore, participants have transitioned and
      will complete the remainder of the Part 3 follow up visits in a long-term extension study,
      SRP-9001-305 (NCT05967351).
    


Intervention name(s): delandistrogene moxeparvovec; placebo
Intervention type(s): Genetic; Genetic
Intervention description(s): Single IV infusion of delandistrogene moxeparvovec; Single IV infusion of matching placebo
Other intervention name(s): SRP-9001; delandistrogene moxeparvovec-rokl; ELEVIDYS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel up to the measurement of the primary outcome at Week 48. At the beginning of Part 2, participants who were originally assigned to placebo will have the opportunity to receive delandistrogene moxeparvovec. All participants will be followed for 5 years following treatment with delandistrogene moxeparvovec.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; Gene-Delivery; DMD; Ambulatory; Pediatric; North Star Ambulatory Assessment (NSAA); Percent Dystrophin Positive Fibers (PDPF)
Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
Condition: Migraine; Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Migraine Disorders; Dizziness
Study type: Observational

Summary: 
      The aim of this study is to analyze the clinical aspects of patients with BPPV associated
      with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the
      clinical aspect and the therapeutic outcome is different.
    

Detailed description: 
      Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All
      patients' charts were reviewed by independent observer. The type of BPPV and associated
      problems were noted. Patients with migraine were investigated in terms of age, gender,
      symptoms, affected side and the cure rate. Their data were compared with those having no
      migraine. Mean values and standard deviations (± SD) were calculated. One way ANOVA test was
      used for the analysis. Significance was set at p < 0.005.
    

Intervention name(s): Particle re-positioning maneuver
Intervention type(s): Procedure
Intervention description(s): Patients with posterior canal BPPV (PC-BPPV) were treated with Epley maneuver. Patients with superior canal (SC-BPPV) were treated with Li or reverse Epley maneuver. Patients with lateral canal (LC) apogeotropic or geotropic nystagmus were treated with Barbeque, Semont's or Gufoni maneuvers. If geotropic or ageotropic type nystagmus is equal intensity on both sides. The involved side was determined according to the patient sense of disturbance or lying down positioning test. If the patient has involvement of both sides according to Dix-Hallpike maneuver. Therapeutic maneuver was applied to the more severe side. All patients were re-evaluated at maximum 7 days.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        BPPV patients only confirmed by VNG
      
Keywords: migraine; benign paroxysmal positional vertigo
Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      this study conducted to evaluate the effectiveness of preoperative tour to simulation
      operating theater on reducing children's and parents' preoperative anxiety. half of the
      participant were taken in a tour to a simulation operating theater before the day of
      operation and the other half were given the standard of care.
    

Detailed description: 
      the investigators examined the effectiveness of a preoperative tour to a simulation operating
      theater guided by an expert anesthesia technologist on reducing the Preoperative anxiety
      levels for children who were scheduled for elective day case procedures under general
      anesthesia, and their parents' anxiety levels through a 10-months randomized controlled trial
      at tertiary medical center in Riyadh-Saudi Arabia, and confirmed that children and parents
      who received the intervention had significantly lower preoperative anxiety levels than
      controlled children and parents.

      Given that, the results showed critical levels of preoperative anxiety among school age
      children, and that preoperative tour to simulation operating theater as a child-friendly
      maneuver is directly applicable and could be considered for children scheduled for day-case
      procedures under general anesthesia.
    

Intervention name(s): simulation
Intervention type(s): Behavioral
Intervention description(s): Dyads allocated to the IG were taken into a tour to a simulation operating room accompanied by an expert anesthesia technologist two weeks before the day of surgery. This simulation operating theater is a real operating room equipped with a surgical trolley, sealing surgical lights, anesthesia machine, vital signs monitor, stethoscope, surgical trays, surgical sink, and gas supply pendent. It was prepared with popular cartoon characters, child manikin, and face masks connected to the anesthesia circuit and re-breathing bag. After being assessed by anesthesia clinic doctors, children and their parents in the IG were given a chance to visit the simulation operating room, to receive orientation, education, and demonstration orientation about what they are going to experience in the operating room. Children were encouraged to apply vital signs monitoring, and to simulate providing mask anesthesia induction to a child manikin.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of Woodsmoke on Vascular Function
Condition: Vascular Function
Study type: Interventional

Summary: 
      Exposure to air pollution is a well established risk factor for the development of heart
      disease. Firefighters are exposed to excess air pollution in the form of wood smoke during
      the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have
      been linked to specific duties and in particular fire suppression, but the reasons for this
      increase in risk are not well understood. Exposure to wood smoke may alter blood vessel
      function and increase blood clot formation to explain the link between fire suppression and
      heart attacks.

      The investigators wish to determine the effect of exposure to wood smoke at concentrations
      found at the perimeter of a woodland fire on blood vessel function and clotting in healthy
      non-smoking male professional firefighters or volunteers. Volunteers will be studied before
      and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body
      exposure chamber. The investigators will perform comprehensive vascular assessments
      thereafter.

      Understanding the effects of wood smoke on the blood vessels and clotting will be an
      important first step in helping to protect firefighters from heart disease. Through research,
      the investigators hope to identify methods to minimise the risk of heart attacks in
      firefighters and understand the health effects of a major source of air pollution that is
      relevant to the general population.
    


Intervention name(s): Forearm Vascular Study; Badimon Chamber
Intervention type(s): Procedure; Procedure
Intervention description(s): Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).; Ex-vivo assessment of thrombus formation using the Badimon Chamber
Other intervention name(s): Other Names:; BK; SNP; ACh
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Firefighter; Woodsmoke; Vascular function; Air Pollution; Endothelial function; Thrombosis
Berry Components and Blood Sugar & Fat Metabolism
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective of this study is to determine which components of berries improve
      glucose metabolism and increase fat oxidation in humans.
    

Detailed description: 
      The aim of this study is to improve understanding of how diet can regulate glucose metabolism
      and fuel use. Previous human and animal studies have demonstrated that berries can improve
      gluco-regulation and increase fat oxidation. The aim of this study is to determine which
      component of berries is conveying this health benefit.
    

Intervention name(s): Mixed Berry Diet; Carbohydrate Control Jello; Fiber Enriched Jello; Low Fiber Mixed Berry Juice
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Mixed Berry Treatment; Carbohydrate Control; Fiber Control; Anthocyanin Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered
      by Oral Inhalation) with Moxifloxacin and Placebo.
    


Intervention name(s): MAP0004; Inhaler Placebo; Moxifloxacin; Placebo Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol; Placebo for Inhaler administered in Treatments A and C; 400mg encapsulated tablet administered in Treatment A as per protocol; Placebo for Moxifloxacin administered in Treatment B and Treatment C
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing.
      Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the
      ability of tumor cells to grow and spread. Others find tumor cells and help kill them or
      carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody
      3F8 may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when
      given together with monoclonal antibody 3F8 in treating patients with metastatic
      neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the clinical toxicity of beta-glucan in combination with monoclonal antibody
           3F8 in patients with metastatic neuroblastoma.

        -  Evaluate the biologic effects of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of beta-glucan.

      Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV
      over 30-90 minutes on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 4 courses
      in the absence of disease progression or unacceptable toxicity and with a human antimouse
      antibody (HAMA) titer < 1,000 U/mL.

      Cohorts of 3-6 patients receive escalating doses of beta-glucan until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Patients undergo urine, bone marrow, and blood sample collection periodically for biological
      studies. Samples are analyzed for antibody-dependent cellular cytotoxicity,
      complement-mediated cytotoxicity, and serum HAMA response via immunohistochemistry.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): beta-glucan; monoclonal antibody 3F8; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Biological; Biological; Other; Other
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma; disseminated neuroblastoma
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Condition: Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and
      Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.
    

Detailed description: 
      This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and
      Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the
      maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion
      cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize
      the safety and tumor response by CT.
    

Intervention name(s): CM082 Tablet
Intervention type(s): Drug
Intervention description(s): CM082 tablets taken orally once a day on 28-day cycles
Other intervention name(s): X-82
Intervention MeSH terms: Vorolanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced cancer
Assessment of Fears of Patients Standing at the Operating Block
Condition: Anxiety and Fear
Study type: Observational

Summary: 
      The term "outpatient" refers to all the medical, organizational and administrative care that
      allows the patient to leave the same day the structure where the ambulatory procedure was
      performed. The usual rule for patients undergoing endoscopic surgery or surgery under general
      anesthesia is to transport them to the endoscopy or operating room lying on a stretcher, even
      if they can walk independently.

      In recent years, the procedure of bringing the patient standing in the operating room seems
      to have many advantages. It is readily accepted by patients and may even lessen their
      anxiety.

      Nevertheless, reluctance and fears are sometimes expressed by patients who do not know this
      new procedure. Our team has introduced this procedure for patients admitted to the ambulatory
      hospitalization sector and to join the endoscopy sector.

      The aim of our work is therefore to objectify the fears expressed by patients who have to go
      to the endoscopy room before general anesthesia and to evaluate their progress after
      endoscopy
    

Detailed description: 
      Nowadays, the procedure of the patient standing in the operating room or in endoscopy has
      become frequent in the outpatient management of patients. Indeed the advantages are numerous:
      better fluidity of the patient circuits to the block, reduction of the stress of the operated
      one etc. Yet some patients might experience fears.

      Thus, in order to improve our practice, we want to take into account your experience with
      this innovative procedure.

      To determine patients' fears concerning their endoscopic standing before general anesthesia
      and to evaluate their evolution after this first experience

      After your installation in the preoperative area, we submit a questionnaire that corresponds
      to the first part of the document and then accompanied by a hospital agent you will walk
      towards the entrance to the endoscopy room. These questions are about your possible fears and
      your degree of anxiety.

      After an endoscopy under general anesthesia, you will be taken back to your stretcher room
      where you will complete the second part of the questionnaire which deals with the same topics
      as the questions asked before the endoscopy.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        any patient presenting at the block and corresponding to the criteria over a period of 3
        months
Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
Condition: Neuropathic Pain
MeSH terms: Neuralgia; Chronic Pain
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity
      after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical
      potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary
      goal, the project will analyse possible correlations between the magnitude of cortical
      plasticity and that of the pain-relieving effect.

      In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory
      cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a
      cross-over randomized study.

      Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4
      weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over
      randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI
      (motor activation) performed before the first rTMS session and the last day of each session
      of rTMS.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): 20Hz and Theta Burst stimulation, both at 80% of motor threshold in contralateral intrinsic hand muscles. Five consecutive days of each mode of stimulation, separated by a minimum of 4 weeks. Daily self-monitoring of pain, sleep quality and fatigue by mans of a 10-item questionnaire
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Stimulation of the Motor Cortex (SCM); Pharmacoresistant; rTMS
A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects
Condition: Pediculus Capitis
Study type: Interventional

Summary: 
      A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically
      superior to a sham control with one hour of combing.
    

Detailed description: 
      Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice
      infestations in children and adult subjects under simulated real world conditions.
    

Intervention name(s): Apply Liquid Then Comb Out
Intervention type(s): Device
Intervention description(s): Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour
Other intervention name(s): Resultz Application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: lice comb; human head lice infestations; combing solution