bioihbjkbjnl/mcl2 huggingface dataset:
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
Condition: Atrial Fibrillation; Arrhythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on
      exposure principles and behavioral activation, improves QoL and symptom burden in patients
      with symptomatic atrial fibrillation (AF) compared to treatment as usual. The study will
      include 120 patients with symptomatic AF despite optimal medical treatment in accordance with
      current guidelines.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat)
      affecting 3% of the population. AF is associated with poor quality of life (QoL) and large
      costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations,
      fatigue, and chest pain) are not alleviated by current medical or interventional treatments.
      Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF
      patients. Symptom preoccupation and avoidance of social and physical activities are likely to
      play important roles in the development of anxiety, depression, disability and healthcare
      utilization.

      The aim is to evaluate if CBT, based on behavioral activation and exposure principles,
      improves wellbeing and QoL in symptomatic AF patients more than a wait list offered treatment
      as usual.

      Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT
      for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will
      last for 10 weeks and include weekly therapist support, consisting of online messages and
      telephone calls. Patients on the treatment as usual wait list will be provided standardized
      written information about basic self-management in AF. The treatment as usual wait list will
      be crossed over to treatment 3 months after the treatment group has completed treatment.
    

Intervention name(s): Internet-delivered cognitive behavior therapy; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.; Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
Condition: Multiple Sclerosis; Autonomic Nervous System Dysfunction
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the
      autonomic nervous system in patients being treated for the first time with Gilenya
      (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is
      conducted to answer the question, if, and if yes, what impact the treatment with Gilenya
      (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the
      effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but
      potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya
      (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of
      interest. Maybe a better understanding of these mechanisms might even be of clinical
      relevance (e.g. risk stratification).

      The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured,
      using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with
      the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at
      rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin
      reaction is performed. The non-invasive blood pressure measurements are done by continuous,
      plethysmographic blood pressure measurement at the index finger, while the patient is
      performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate
      and blood pressure variability are calculated. The sympathetic skin reaction consists of
      measuring the change of electric conductibility of the skin (palms and soles) after an
      electric stimulus of a peripheral nerve. These parameters allow to assess the functionality
      of four important autonomic functional systems (orthostasis, sympathetic adrenergic,
      sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in
      our lab.

      Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared
      to baseline (t0) for the parameter "RMSSD" under "normal breathing".
    


Intervention name(s): Gilenya
Intervention type(s): Drug
Intervention description(s): Autonomic testing during first dose administration of Gilenya.
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: relapsing remitting; multiple sclerosis; fingolimod; Gilenya; autonomic nervous system
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Condition: Colorectal Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use
      of antibiotics for colorectal surgery is three doses.

      It has been reported that the surgical site infection rates of laparoscopic colorectal
      surgery are lower than open colorectal surgery. However, the evidence of proper application
      of antibiotic for laparoscopic colorectal surgery is still not enough.

      The investigators are researching the efficacy and safety of one dose prophylactic antibiotic
      in laparoscopic colorectal surgery.
    

Detailed description: 
      In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use
      of antibiotics for colorectal surgery is three doses.

      One randomized controlled study reported that surgical site infection rates of three doses
      prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus
      14.2%). But, surgical site infection rates between one dose and three doses were not
      different in laparoscopic subgroup of this study (11 versus 11%)

      It has been reported that the surgical site infection rates of laparoscopic colorectal
      surgery are lower than open colorectal surgery. However, the evidence of proper application
      of antibiotic for laparoscopic colorectal surgery is still not enough.

      The investigators are researching the efficacy and safety of one dose prophylactic antibiotic
      in laparoscopic colorectal surgery.
    

Intervention name(s): Cefotetan
Intervention type(s): Drug
Intervention description(s): preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Other intervention name(s): Yamatetan
Intervention MeSH terms: Cefotetan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Surgery; Surgical Wound Infection; Laparoscopy; Anti-Bacterial Agents
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
Condition: Cognitive Behavioral Therapy and Problem Solving; Autism Disorders and Maternal Stress
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Cognitive behavioral therapy sessions can effectively reduce distress in mothers of children
      with autism. here we emphasize on the role of problem solving appraisal in CBT sessions to
      improve problem solving skills ability and minimize psychological distress . pre-
      intervention assessment (T1) for all participants , then designed 8 sessions for study group
      will apply .

      post intervention assessment (T2) will conduct immediately after CBT sessions
    

Detailed description: 
      mothers of children with autistic spectrum disorders have a lots of burdens due to child
      symptoms its, lack of availability of services and limited resources , thus in turn lead them
      to become unable to face problems/stressors and to be psychological distress. CBT is an
      effective therapy to minimize stress, anxiety and depression. Mothers who participated in the
      study recruited from three governmental hospitals that has an out patients clinics
      specialized in autism and other developmental disorders for children at ElBehairah governate
      , Egypt . Based on inclusion and exclusion criteria for mothers and their children, mothers
      informed about the nature of the study and their benefits for participations. assessment
      tools will use ; depression ,anxiety and stress scale (DAS) and problem solving inventory
      (PSI). First assessment will occur , then randomly the participants divide into either study
      ( intervention) group or control group .CBT sessions will provide for study group to enhance
      their problem solving ability and psychological state. Second assessment (T2) will occur
      after finishing program sessions for all participants
    

Intervention name(s): CBT techniques
Intervention type(s): Behavioral
Intervention description(s): through CBT sessions , the participants apply problem solving process in managing their stressors . examining the role of cognitions, emotions, and behaviors to form cause and effect relationship of participants psychological distress
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Autism disorders, maternal stress
Testing the Feasibility and Preliminary Effect of Summer Camp
Condition: Childhood Obesity Prevention
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This pilot randomized controlled trial was designed to assess the feasibility and preliminary
      efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode
      Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children
      randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017
      or 2018. As part of the consent process, children randomized to SAU agreed to experience an
      unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or
      other structured summer programming). Primary feasibility outcomes included retention,
      engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy
      for excess summer weight gain), physical activity engagement, sedentary behavior, and diet
      (energy intake and diet quality), were collected by blinded research staff at the end of the
      school year, midsummer and the end of the summer.
    


Intervention name(s): Boys and Girls Club summer day camp
Intervention type(s): Behavioral
Intervention description(s): Daily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Summer Camp; Child overweight / obesity; Diet; Physical Activity
Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, multi-center study to describe the immune persistence of the priming
      dose and describe the immunogenicity and safety of a booster dose of Meningococcal
      Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in
      children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW
      conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358).

      The objectives were:

        -  To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a
           booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3
           years earlier as toddlers.

        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days
           after a booster dose of MenACYW conjugate vaccine in children who received either
           MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.

        -  To describe the antibody responses against tetanus toxoid 30 days after a booster dose
           of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine
           or Nimenrix® 3 years earlier as toddlers.

        -  To describe the safety profile of a booster dose of MenACYW conjugate vaccine in
           children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as
           toddlers.
    

Detailed description: 
      Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54
      (NCT03205358) were eligible for enrollment. All participants received a single booster dose
      of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30
      days after vaccination. Safety was assessed throughout the study period, and included
      solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination);
      unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring
      throughout the trial.
    

Intervention name(s): MenACYW conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal Meningitis; MenACYW conjugate vaccine; Quadrivalent meningococcal vaccine
Rouxbe Pilot for MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS)
      patients who are participating in a pilot cooking course. This online cooking training
      program is currently available to general public through the company "Rouxbe" for a fee. Data
      gathered from this cooking course will be used to develop novel ways of promoting healthy
      eating habits in people with MS. The investigators will use the data from blood tests,
      questionnaires, and demographics to assess the feasibility and effectiveness of this program.
      This is an outpatient program designed for people with MS that would occur regardless of
      whether participant data is collected.

      This pilot cooking course will run for approximately four weeks. The investigators intend
      start to the training course in mid-March 2015. Subjects will be followed prior to course
      initiation for baseline data gathering, at four weeks from baseline, twelve weeks from
      baseline, and twenty-four weeks from baseline.
    


Intervention name(s): Cooking Course
Intervention type(s): Behavioral
Intervention description(s): This is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet; cooking; multiple sclerosis; fatigue
Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      With this study researchers want to collect information on how long the pain relief lasts
      after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no
      medication) over 12 hours in subjects experiencing moderate to severe pain after having their
      wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary
      relief of minor aches and pains.

      Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It
      contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever
      (acetaminophen).
    


Intervention name(s): Naproxen Sodium (Aleve, BAY117031); Hydrocodone/Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 220 mg per tablet, two tablets (440 mg), intake a single dose orally.; 5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.; two tablets, intake a single dose orally.
Intervention MeSH terms: Acetaminophen; Naproxen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postsurgical Dental Pain
Safety Study of GCS-100 to Treat Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic
      kidney disease.
    


Intervention name(s): GCS-100
Intervention type(s): Drug
Intervention description(s): GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
Condition: Ovarian Cyst Benign
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare hemostasis, ovarian function preservation effect, and
      safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic
      unilateral ovarian cystectomy
    

Detailed description: 
      In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@
      was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed
      by comparative evaluation of hemostasis, ovarian function preservation, safety using
      postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical
      examination
    

Intervention name(s): Surgiguard
Intervention type(s): Drug
Intervention description(s): Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
Other intervention name(s): laparoscopic unilateral ovarian cystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic unilateral ovarian cystectomy; SurgiGuard; Hemostasis; Ovarian function preservation; Bipolar electrocauterization
VR Training on Hand-Eye Coordination and Reaction Time in Students
Condition: Virtual Reality
Study type: Interventional

Summary: 
      Virtual reality (VR) is a three-dimensional image, which is created by means of computer
      programs. In most educational communities VR has been used as an opportunity to support many
      students. VR allows the user to observe the world generated for their own needs as the real
      world and experience impressions that are not available in real life. It was decided to
      examine how immersive VR-game will affect the eye-hand coordination on reaction time on
      students. The experimental group received a five-day training sessions using immersive VR
      game "Beat Saber", while control group was inactive comparator.
    

Detailed description: 
      Eye-hand coordination can be defined as the ability to perform activities that require the
      simultaneous use of eyes and hands. Eye-hand coordination supports our daily activities,
      interactions with objects and people, and is critical to understanding how the brain creates
      internal models of the space and generates movement within it. Along with the development of
      technology, opportunities for stimulation of eye-hand coordination with the use of technical
      novelties have appeared. Virtual reality (VR) is a three-dimensional image, which is created
      by means of computer programs. It has become one of the technologies that offer many
      possibilities of application and use of its various aspects that can bring great benefits in
      the real world. In most educational communities VR has been used as an opportunity to support
      many students. It can be assumed that VR can help trainers or teachers, especially music
      teachers, by interacting through movement, realization and graphic images, to develop and
      shape skills such as eye-hand coordination. The use of virtual reality gives a wide range of
      possibilities for training, so it was decided to examine how it will affect the coordination
      of the eye-hand and reaction time in students.
    

Intervention name(s): VR training
Intervention type(s): Device
Intervention description(s): A musical game called Beat Saber was used to conduct training sessions. The participant's task was to cut through the blocks of various colors in his direction to the rhythm of music, using two virtual swords. The swords were controlled by the player with controllers of different colors. Blocks had to be cut with a sword whose color matches the block and in the right direction which is indicated by an arrow on the block. The training session consisted of 4 music tracks with different paces and intensities of objects. In addition, during the song, the participant had to avoid objects-objects that randomly appeared in the game scenario - forcing the whole body to move.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: VR; eye-hand coordination; reaction time; exergame