bioihbjkbjnl/mcl2 huggingface dataset:
Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder
Condition: Social Anxiety Disorder; Sleep
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      With this study, the investigators aim to use sleep and dreaming in order to enhance exposure
      therapy for social anxiety disorder (SAD), by pairing the positive feedback phase of exposure
      (public talk) to an auditory stimulus during wake (associated sound) and subsequently
      applying this stimulus during sleep (targeted memory reactivation, TMR). Exposure therapy
      sessions will take place in a virtual reality (VR) environment, while physiological measures
      during the preparation phase of public talk such as heart rate variability (HRV), skin
      conductance response (SCR) and subjective level of anxiety (SUDS) will be used in order to
      assess treatment efficiency across the sessions. Patients with SAD according to DSM-5
      criteria will be included.

      The main hypothesis of this study is that participants who are presented with the associated
      sound during sleep (TMR group) will have reduced intensity of social anxiety compared to
      participants with no such association (control group), after both a full night's sleep with
      auditory stimulation during REM sleep in the laboratory, and after 1 week of stimulation
      during REM sleep at home. In addition, it is expected that fear-related dreams may correlate
      with anxiety levels during wakefulness after 1 week of stimulation at home.
    


Intervention name(s): Exposure Therapy and Targeted memory reactivation during REM sleep; Exposure Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories. By using targeted memory reactivation (TMR), a known method where a sound is associated with a waking experience (i.e., positive feedback in this study) and strengthening it during REM sleep, the investigators aim to accelerate the remission of social anxiety disorder.; These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Prevention of Post-Operative Shivering
Condition: Post-Operative Shivering
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase
      core body temperature (BT) in patients with core hypothermia.

      paracetamol is an antipyretic drug that has been in clinical use for a long time.

      It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that
      orally administered paracetamol can suppress in a dose-dependent manner the increase in the
      BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of
      paracetamol on postoperative shivering.
    


Intervention name(s): paracetamol; ondansetron; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): received intravenous one gram of paracetamol over a 15-minute period,; received intravenous 8 mg of ondansetron over a 15-minute period.; received intravenous 0.9% normal saline over a 15-minute period.
Intervention MeSH terms: Acetaminophen; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be
      randomized into two groups. The subjects in the Treatment Group will be administered with
      lithium carbonate, while the Control Group will receive placebo.

      Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment
      group, the dose will be adjusted according to the serum lithium level while in the control
      group there will be a sham adjustment.

      The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The
      outcomes will be compared with baseline pre-treatment data to obtain "neurological change
      scores." The efficacy and safety will be analyzed comparing the results of the treatment
      group with those of the control group.
    


Intervention name(s): Lithium Carbonate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks.; Matching placebo
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Cord Injury
Tension-free Repair of Inguinal Hernia With "Undissociate Spermatic Cord"
Condition: Inguinal Hernia, Without Mention of Obstruction or Gangrene
MeSH terms: Hernia; Hernia, Inguinal; Gangrene
Study type: Observational

Summary: 
      The theory of "undissected Spermatic cord (US)" only transected the hernia ring ends in the
      abdominal cavity, the hernia ring, hernia sac and spermatic cord will not be dissected. Its
      significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia
      sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia
      sac.
    

Detailed description: 
      In recent years, with the deepening of the anatomical cognition of the inguinal region and
      the renewal of the hernia repair concept, inguinal hernia repair has become increasingly
      mature surgical approach. However, no matter how the hernia repair modes change, the
      treatment and repair of the hernia ring has always been the focus, so that the treatment of
      the hernia sac has been neglected. From March 2014 to May 2019, there were 132 patients
      underwent inguinal hernia repair with "Undissociate Spermatic cord" theory (Undissected
      Spermatic cord and hernia sac, hernia ring and sac exclusion). All the patients were followed
      up for 18~63 months (mean of 41.5 months) without recurrence. Its significance lies in that
      inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and
      fundamentally change the treatment mode of hernia ring and hernia sac.
    

Intervention name(s): Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
Intervention type(s): Procedure
Intervention description(s): patient undergoing Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        inguinal hernia patients
      
Keywords: Undissociate Spermatic cord; Inguinal hernia; Hernia exclusion; Hernial sac
The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.
Condition: Muscle Relaxation
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in
      morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted
      body weight, and actual body weight.
    

Detailed description: 
      The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in
      morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted
      body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to
      train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

      Time need for extubation (time from administration of sugammadex to extubation), and duration
      of stay in post anesthesia care unit (PACU), will be used as secondary outcome.
    

Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): sugammadex given based on 3 measurements of body weights
Other intervention name(s): bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Sugammadex; morbidly obese patients; bariatric surgery; neuromuscular blockade
Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training
Condition: Obesity; Insulin Resistance; Type2 Diabetes; Exercise Training
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Obesity and insulin resistance are worldwide epidemic and taking a major public health toll.
      Obesity also increases the risk for cognitive impairment which is also an increasing medical,
      societal, and economic challenge. The ultimate goal of this proposal is to develop a
      statistical model to assess systemic cross-talk between brain, peripheral tissues, gut
      microbiota and glucose metabolism. Integrated with exercise training intervention the results
      will be utilized to provide disease risk profiling and personalized predictions of exercise
      training as a drug free treatment for insulin resistance and type 2 diabetes.
    


Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): Subjects are required to exercise four times a week during six months. Exercise training consists of endurance training, resistance training and high-intensity interval training adjusted to subject's fitness level.
Intervention model: Single Group Assignment
Intervention model description: Exercise Training for six months
Masking: None (Open Label)
Primary purpose: Prevention
Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when
      co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company)
      and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine
      alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age,
      and there is great potential for the vaccines to be given concurrently. The aim of this trial
      is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity
      or reactogenicity of Kinrix.
    

Detailed description: 
      Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix,
      Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month
      1(Group 2).

      All subjects in both groups to provide blood samples prior to vaccination on day 0 and at
      month 1 (for Group 2, blood sampling is prior to vaccination with Varivax).

      Duration of the study will be approximately 6 months for each subject with a safety telephone
      contact 6 months after vaccinations.
    

Intervention name(s): GSK Biologicals'Kinrix®; Merck and Company's MMRII; Merck and Company's Varivax
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose as intramuscular injection at visit 1; One dose as subcutaneous injection at visit 1; One dose as subcutaneous injection at visit 1 or at visit 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Co-administration; Immunization; Preschool; Booster
Effect of TPN171H on Spermatogenesis
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in
      healthy male subjects.
    

Detailed description: 
      Safety Study in male subjects
    

Intervention name(s): TPN171H 10mg; TPN171H Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.; Subjects were given Placebo with 240 mL warm water under fasting condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility Study on the Model School Pediatric Health Initiative Pilot Project
Condition: School Board Health Centers
Study type: Observational

Summary: 
      This is a prospective cross sectional study to assess the feasibility of a school based
      health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in
      Toronto. The SBHC allows inner-city children who face barriers to accessing health care the
      opportunity to receive health care in their school.The primary aim of this study is to
      determine utilization of the SBHC. Establishing feasibility of the SBHC would support further
      development and expansion of this program into other inner city schools.
    

Detailed description: 
      A chart review of the first year of the SBHC was conducted. Feasibility metrics included the
      number of children who enrolled at the SBHC. Efficacy metrics included the proportion of
      enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled
      children who attended and received new diagnoses and treatment plans
    

Intervention name(s): Students attending SBHC
Intervention type(s): Other
Intervention description(s): School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All students of Sprucecourt Public School as well as the fourteen surrounding inner city
        public schools and their siblings. All children attending the on-site Parenting and Family
        Literacy Centre.
      
Keywords: School Board Health Center; Pediatrics
Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young
      people. The disease is characterized by a heterogenic phenotype and the disease course by
      flares and remissions. As in most chronic diseases the economic burden of IBD is important
      due to direct health care costs and disability. Health care reorganization for IBD patients
      in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal
      inflammation results in irreversible bowel damage and complications and none of the presently
      available drugs is effective for all patients and many drugs have possible severe side
      effects. To prevent complications of the disease and side effects IBD should be monitored
      carefully. In the Netherlands however there is a shortage of gastroenterologists where the
      incidence of IBD is rising. Secondly evidence exists that direct involvement of health care
      workers, patient empowerment and integrated care can improve the outcome of chronic diseases.
      Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not
      systematically followed in routine care. Finally the government demands registration of
      efficacy endpoints for expensive drugs in the near future. Therefore the investigators
      developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD
      patient's organization (CCUVN). "myIBcoach" contains E-learning modules, monitors disease
      activity, disability, quality of life, adherence, infections, smoking status, side effects,
      stress and malnutrition on fixed time points with validated questionnaires, allows the
      patient to communicate with health care workers and gives feedback to the back office and the
      patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and
      compliance of IBD-patients and health care workers with this telemedicine tool.

      The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care
      via the telemedicine tool myIBDcoach.
    


Intervention name(s): myIBDcoach; Standard care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemedicine; Patient empowerment; Integrated care
Diaphragmatic Function in Ventilated Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of
      the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic
      force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intubated patients in intensive care unit
      
Keywords: Mechanical ventilation; Ventilator induced diaphragmatic dysfunction; Weaning; Neuromuscular diseases- Respiratory function tests; Intubated patients in intensive care unit
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Participants will be smokers who want to quit, and have visible nicotine stains on their
      teeth. They will be given toothpaste and a toothbrush to use during the study, and will have
      an equal chance of being assigned to use either a nicotine gum or microtab. They will visit
      the study site five times during the 12 week trial to have their teeth examined.
    

Detailed description: 
      This evaluator-blinded, randomized, 12-week parallel-group controlled trial compares
      Nicorette® Freshmint gum versus Nicorette® Microtab in healthy smokers who are motivated to
      quit smoking and who have visible staining of teeth.

      The trial is comprised of five visits (baseline, Weeks 1, 2, 6, and 12). At baseline,
      subjects will be provided with a standardized toothpaste and toothbrush; use of any other
      oral hygiene or tooth-whitening product is prohibited. At all visits after baseline, smoking
      status and use of study treatment will be checked. Teeth staining and teeth shade will be
      rated at baseline and at 2, 6 and 12 Weeks using the Modified Lobene Stain Index and the
      Vita® Shade Guide, respectively.
    

Intervention name(s): Nicotine; Nicotine; Nicotine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nicotine Gum 2 mg, Lot number GD922A; Nicotine gum 4 mg, Lot number GC962A; Nicotine Microtab 2 mg, Lot number GB196G
Other intervention name(s): Nicorette® Freshmint Gum; Nicorette® Freshmint Gum; Nicorette® Microtab
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Tooth Staining
Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation
Condition: Stroke; Apraxia
MeSH terms: Apraxias
Study type: Interventional

Summary: 
      The objective of the clinical trial is to investigate whether weak transcranial direct
      current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke
      rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham
      stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient
      stay in a rehabilitation center. Additionally, motor tasks are performed before and after the
      stimulation. The effect of the weak current stimulation on motor function is assessed 3-4
      days after the last stimulation and 3 months after enrollment.
    

Detailed description: 
      Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric
      stroke, evidence-based therapies do not exist. This randomized controlled clinical trial
      (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on
      therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left
      hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left,
      lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days
      in combination with motor tasks before and after the stimulation. The effect of the
      stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed
      study mode ensures a double-blind study design (patient and investigator). The performance in
      the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation,
      compared to baseline, serves as primary endpoint of the study. Secondary endpoints are
      evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days
      after the last stimulation and 3 months after enrollment.
    

Intervention name(s): anodal tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): 2 mA, 10 min, 5 sessions; sham stimulation, 10 min, 5 sessions
Other intervention name(s): neuroConn DCS, model no. 008; neuroConn DCS, model no. 008
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS
SEPA III: The Effectiveness Trial
Condition: HIV Prevention
Study type: Interventional

Summary: 
      The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado;
      Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to
      reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by
      community agency personnel. The study recruits Hispanic women between the ages of 18 and 50
      who are sexually active and are randomized to either SEPA or a Wait-List Control condition.
    


Intervention name(s): SEPA III
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention