bioihbjkbjnl/mcl2 huggingface dataset:
Neurofeedback Intervention for Preclinical Alzheimer's Disease
Condition: Alzheimer Disease; Subjective Cognitive Decline; Neurofeedback; Electroencephalogram
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to
      dementia. Currently, there has been no effective pharmacologic therapy for this disease.
      Electroencephalogram-based neurofeedback is considered as a potentially treatment strategy.
      In this project, the investigators aim to investigate the effectiveness of neurofeedback
      therapy on cognition for individuals with subjective cognitive decline (SCD). Participants
      will receive electroencephalogram-based neurofeedback therapy once a day for successive five
      days. Then, the investigators will evaluate the changes of memory function between baseline
      and post-therapy visits.
    

Detailed description: 
      Currently, there has been no effective therapy for Alzheimer's disease (AD).
      Electroencephalogram-based neurofeedback is now considered as a potentially intervention and
      may positively affect cognitive function for patients with AD. However, there are few
      existing studies involving the role of neurofeedback on cognition for subjective cognitive
      decline (SCD).

      Fifty participants with SCD will be recruited in this clinical trial. At baseline,
      neuropsychological tests are conducted. Participants will receive electroencephalogram-based
      neurofeedback therapy once a day for successive five days. After that, the investigators will
      evaluate the changes of memory measures, which is the primary outcome.
    

Intervention name(s): Electroencephalogram-based neurofeedback
Intervention type(s): Behavioral
Intervention description(s): In this project, SCD participants will receive electroencephalogram-based neurofeedback therapy, once a day, for 5 days. Then, the investigators will compare their memory changes between baseline and post-therapy visits.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Subjective cognitive decline; Intervention; Neurofeedback
Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain
Condition: Acute Cholecystitis; Pain; Morbidity, Multiple; Surgery; Drain Site Complication
MeSH terms: Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      The purpose of this study was to compare the frequency of pain and mean hospital stay in
      patients with and without drain insertion, following laparoscopic cholecystectomy for acutely
      inflamed gallbladder.
    

Detailed description: 
      Most hospitals in Pakistan still do not have a policy of early laparoscopic cholecystectomy
      in acutely inflamed gallbladder, partly because of feared higher conversion rates to open
      procedure and presumed increased risk of complications. There are fewer local studies to
      elaborate the role of drain after laparoscopic cholecystectomy for acutely inflamed
      gallbladder. This study was conducted to analyze the role of routine use of drains after
      laparoscopic cholecystectomy for acutely inflamed gallbladder. Does it offer any advantage in
      detecting bile leak or bleeding. Also to prove that placing drains prolongs the hospital stay
      and increases postoperative pain in comparison to patients in whom drain is not placed.

      After being informed about the study and the potential risks, all patients giving written
      informed consent, underwent laparoscopic cholecystectomy using conventional 4 port method.
      Patients were divided in two groups by lottery method. Group A - no drain group and Group B -
      drain group. Post operatively parameters of pain and total hospital stay were assessed and
      analysed.
    

Intervention name(s): Suction drain
Intervention type(s): Other
Intervention description(s): Post operatively, in both arms including drain group and no drain group, parameters of pain was assessed by visual analog scale (VAS) from 0 (no pain) to 10 (worst pain), assessed at 1st postoperative day by the duty doctor or the nurse. VAS > 3 was considered as post surgical pain. The total number of hospital stay was noted from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VAS<3, no fever and tolerating oral intake
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study objective is to compare the frequency of pain and mean hospital stay in patients with and without drain insertion, following laparoscopic cholecystectomy for acutely inflamed gallbladder.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; Hospital stay; Drain insertion; Laparoscopic cholecystectomy; Acutely inflammed gall bladder
Design of a Dressing for Gastrostomy Buttons in Pediatric Population
Condition: Gastrostomy Complications
Study type: Interventional

Summary: 
      Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube
      dislodgements, are frequent causes of emergency department visits. The investigators have
      developed two G-tube dressing designs using commercially available materials and products to
      decrease the risk of G-tube related complications. The investigators aim in this study is to
      pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental
      feedback on device designs, ease of use and G-tube stability in preparation for a final
      design and trial. Based on the feedback, further iterations will be developed and trialed in
      eligible study subjects.
    

Detailed description: 
      In order to address complications associated with gastrostomy buttons (G-buttons) or tubes
      (G-tubes) in children, the investigators developed two multi-component securement dressings.
      The purpose of this study is to try these dressings and obtain parental feedback.

      This will involve survey using questionnaires before and after the use of two different
      G-tube dressings. Eligible patients will be identified by a nurse practitioner or attending
      surgeon. The researcher will obtain consent from the patient or their parents/legal guardian.
      The investigators will ask a series of questions regarding their current experience dressing
      and maintaining G-tube stomas. A week supply of each new prototype dressing will be provided
      to the patient or parent. Caregivers will be educated on the use of each dressing and will be
      given a number to call should they have any questions or concerns. The dressings will be
      changed daily and as needed. Once the patient is enrolled and provided with dressings, the
      investigators will perform a follow up telephone interview at one week to evaluate their
      experience and ensure they did not experience any adverse events. Caregivers will be given a
      second questionnaire to collect feedback on the dressings after two weeks either in person or
      over the telephone. They will be asked to choose their preferred dressing, provide feedback
      on advantages and disadvantages of each type and report adverse events. For inpatients, the
      investigators will obtain opinions from parents, patients, nurses and doctors. Photographs
      will be obtained at each outpatient visit or during the inpatient period for objective
      comparison.

      Once more iterations are developed, they will undergo the same clinical trial process
      (involving 10-15 subjects).
    

Intervention name(s): Gastrostomy tube dressing
Intervention type(s): Device
Intervention description(s): Two types of dressings to secure gastrostomy tube in children
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography Among Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Aneurysm; Acute Coronary Syndrome; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Syndrome
Study type: Observational

Summary: 
      The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%.
      when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in
      women.

      As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients
      with acute coronary syndrome represent a high risk population in which screening for another
      atherosclerotic site is recommended.

      Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the
      opportunity to evaluate the cardiac morphology and function and to screen for Abdominal
      Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique
      was between 91-96% for AAA screening.

      In addition, this method is cheap, available and requires only 2-3 minutes to be added to the
      standard TTE.

      we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by
      TTE in subcostal views in addition to the standard TTE examination.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients over 65 years old with ACS admitted in Intensive Cardiac Care Unit, who will be
        examined by TTE.
      
Keywords: Abdominal Aortic Aneurysm (AAA),; Echocardiography (TTE),; Acute Coronary Syndrome (ACS); Patients over 65 years old
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
Condition: Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product
      (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage
      product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled
      prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of
      BAL8728 in human plasma, urine and/or feces after a single intravenous dose of
      pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815.
      Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled
      isavuconazonium sulfate will also be evaluated.
    


Intervention name(s): Pyridinylmethyl-14C-labeled isavuconazonium sulfate
Intervention type(s): Drug
Intervention description(s): Intravenous
Other intervention name(s): BAL8557
Intervention MeSH terms: Isavuconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 14C-labeled isavuconazonium sulfate; Pyridinylmethyl-14C-labeled isavuconazonium sulfate; Healthy Subjects; BAL8728; BAL4815
Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis
Condition: Allergic Rhinitis; Allergic Conjunctivitis; Atopic Dermatitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled,
      ascending dose study to investigate the safety, tolerability, and pharmacokinetics of
      XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.
    


Intervention name(s): XmAb7195; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Retinal Vascular Changes After Ocular Blunt Trauma
Condition: Ocular Injury
MeSH terms: Eye Injuries; Wounds, Nonpenetrating
Study type: Observational

Summary: 
      This study evaluates the retinal vascular features using optical coherence tomography
      angiography in patients that received ocular blunt trauma.
    

Detailed description: 
      To investigate, using optical coherence tomography angiography, early retinal vascular
      features 48 hours after ocular trauma and to detect their changes during 6 months' follow up.

      The optical coherence tomography angiography represents a novel and noninvasive diagnostic
      technique that allows a detailed analysis of retinal vascular features.
    

Intervention name(s): Optical Coherence Tomography Angiography
Intervention type(s): Diagnostic Test
Intervention description(s): Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 40 years with diagnosis of previous ocular blunt trauma.
        They did not present other ophthalmological diseases.
The Impact of Picture Narrative Format on Print Lung Screening Communication Outcomes
Condition: Cancer Screening
Study type: Interventional

Summary: 
      The purpose of this study is to test whether a picture narrative format is more successful,
      than text with pictures or text alone, in communicating lung screening information (primarily
      defined by positive attitudes towards the design and increase in knowledge) to people likely
      to be invited to lung screening where available.
    

Detailed description: 
      Population screening is key to detecting lung cancer early at a more treatable stage. Uptake
      of screening should be equitable (i.e., screening benefits all eligible members of the
      population and does not contribute further to health disparities) and informed (i.e.,
      participants have been involved in the decision to take part and their decision aligns with
      their values and circumstances). Print decision support materials are the primary mechanism
      for encouraging engagement with cancer screening and supporting decision making. It is
      essential that we identify print communication techniques that are effective in informing
      invitees about lung screening.

      The intervention, picture narrative information about lung screening, was previously
      developed through codesign and prototype testing with people likely to be eligible for lung
      screening (50 to 75 years old, past or current heavy smokers). Participants will be
      randomised to one of three groups: Picture narrative format, Text with pictures (control 1)
      or, Text-only (control 2). This study will assess whether presenting lung screening
      information in a picture narrative format can improve lung cancer screening knowledge,
      eligibility self-assessment and attitudes. It will also assess whether perceptions of the
      information designs can explain any impact of the intervention on these outcomes and whether
      there are differences across socioeconomic groups.
    

Intervention name(s): Picture narrative information format; Text with pictures information format; Text-only information format
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Lung screening information formatted as picture narratives; Lung screening information formatted as text and non-narrative pictures; Lung screening information formatted as text with no pictures
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of three groups. They will receive the same lung screening information but the format of this information will be determined by which group they have been randomised to. All participants will complete a questionnaire immediately after viewing the lung screening information.
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Health Communication; Lung cancer screening; Messages; Comprehension; Visual; Narrative; Comics
AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients
Condition: Multiple System Atrophy, MSA
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability,
      randomized trial, in patients with Multiple System Atrophy.
    


Intervention name(s): AZD3241; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: AZD3241 administered for 12 weeks orally as a tablet.; Placebo to match AZD3241 administered for 12 weeks orally as a tablet.
Other intervention name(s): AZD3241 to match placebo administered for 12 weeks.; Placebo to match AZD3241 administered for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple System Atrophy (MSA), PET imaging, myeloperoxidase (MPO) inhibitor
Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
Condition: Conscious Sedation
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 2

Summary: 
      Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but
      it may provide insufficient anesthesia which requires the intraoperative use of additional
      topical local anesthetics and raises the need for sedation.
    

Detailed description: 
      The present study is constructed to evaluate the effect of pregabalin on sedation using
      dexmedetomidine for cataract surgery under topical anesthesia . In the
      dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the
      placebo group (control group) the patients will be premedicated by placebo capsules. All
      patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome
      measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic
      needs and side effects will be assessed as secondary outcome measurements.
    

Intervention name(s): Dexmedetomidine Injection; Placebo oral capsule; Pregabalin Oral Capsule; topical anesthesia
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion; placebo oral capsules; 150 mg pregabalin Oral Capsule; topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
Other intervention name(s): Dexmedetomidine; placebo; pregabalin; Benoxinate Hydrochloride 0.4% Eye Drops
Intervention MeSH terms: Pregabalin; Dexmedetomidine; Benoxinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-pharmaceutical Motion Sickness Mitigation
Condition: Healthy
MeSH terms: Motion Sickness
Study type: Interventional

Summary: 
      The purpose of this study is evaluate the effect of timing and magnitude on the
      administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the
      effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task
      performance.
    


Intervention name(s): Galvanic Vestibular Stimulation
Intervention type(s): Device
Intervention description(s): Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).
Masking: None (Open Label)
Primary purpose: Prevention
Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to compare between two surgical techniques for anterior
      abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical
      Transversus Abdominis Plane [TAP] block versus Rectus Sheath block as regards the efficacy
      and adverse effects
    


Intervention name(s): Surgical Transversus Abdominis Plane Block; Surgical Rectus Sheath Block
Intervention type(s): Procedure; Procedure
Intervention description(s): At the end of operation and after hemostasis, 20 ml of 0.25% bupivacaine will be injected intra-abdominally into the Transversus Abdominis plane at the midpoint of the line connecting the crista iliaca and inferior costal margin and at two locations in the lateral abdominal wall at 3-4 cm inferior to the previous midline injection. The same procedure will be repeated on the opposite side using an identical amount of local anesthetic.; At the end of operation and after hemostasis,20 ml 0.25% bupivacaine will be administered slowly under direct vision after careful aspiration to the rectus sheath space which is present inbetween rectus abdominis muscle and the posterior layer of its sheath at the upper pole of the midline incision by time of closure of the anterior abdominal wall. The procedure will be repeated on the opposite side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment