bioihbjkbjnl/mcl2 huggingface dataset:
Sensory Stimulation During Simulated Driving
Condition: Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of three specific odors on simulated
      driving performance. It is hypothesized that the presence of peppermint, rosemary, and
      zest/pulp will increase memory recall for navigation and improve reaction times for braking,
      compared to performance during unscented conditions
    

Detailed description: 
      This study will examine the effect of scented odors on the attention and behavioral
      performance of healthy young adult and older adult drivers. Past research indicates that
      specific scented odors (i.e., peppermint and cinnamon) enhance motivation, performance and
      alertness, decrease fatigue and stimulate the central nervous system in a variety of
      contexts. The current study will examine the effect of three different odors on simulated
      driving as participants perform navigation and braking scenarios. This study will be the
      first of its kind to elucidate the association between specific scents and performance gains
      in simulated driving. The data will serve as proof-of-concept for eventual patient focused
      interventions relative to sensory stimulation and driving.
    

Intervention name(s): Fragrance
Intervention type(s): Other
Intervention description(s): peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine
      (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study in adult subjects with ADHD.

      Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups,
      1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening
      period of up to 2 weeks, a 6-week double-blind treatment period, and a 2-week safety
      follow-up period. The total duration of subject participation will be ~10 weeks.

      Overview of Study Visits

      Screening Period:

      Visit 1 - Screening/Baseline Visit (up to 14 days prior to dosing)

      Treatment Period:

      Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 2 days Visit 4 - Day 14 ± 2 days
      Visit 5 - Day 28 ± 2 days Visit 6 - Day 42 ± 2 days

      Follow-up period:

      Visit 7 - Day 56 ± 3 days
    

Intervention name(s): Metadoxine (MG01CI)
Intervention type(s): Drug
Intervention description(s): MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.
Other intervention name(s): Metadoxil
Intervention MeSH terms: Metadoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD,Adults,MG01CI,METADOXINE
Intravenous Lidocaine and Acute Rehabilitation
Condition: Pain, Postoperative; Opioid Consumption, Postoperative; Postoperative Fatigue
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed
      return of bowel function. The investigators therefore tested the hypothesis that including
      perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens
      the duration of hospitalization.

      Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to
      receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of
      anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1
      for 24 h postoperatively) or an equal volume of saline. All patients received similar
      intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and
      fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were
      recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes,
      C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75%
      interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests.
      P<0.05 was considered statistically significant.
    


Intervention name(s): lidocaine
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Suspension System on Impingement Syndrome
Condition: Impingement Syndrome
MeSH terms: Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      To investigate the effect of shoulder exercise using a selected suspension system exercise
      program on pain, disability, functional performance and proprioception in patients with
      subacromial impingement syndrome.
    

Detailed description: 
      Two groups were assigned to this study, the first one received four conventional exercises
      that designed for shoulder impingement syndrome, the second group received the same four
      conventional exercises plus four selected suspension system exercises.

      The sessions were conducted three times per week fir four weeks.
    

Intervention name(s): Suspension system; Dumbbells
Intervention type(s): Device; Device
Intervention description(s): Participants will be tested by four exercises designed for impingement syndrome using the suspension system; Participants will be tested by four exercises designed for impingement syndrome using Dumbbells
Other intervention name(s): Neurac system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Association Between the tDCS and FDS for Gait Rehabilitation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to verify the effectiveness of tDCS combined with foot drop
      stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate
      compromise.
    


Intervention name(s): Foot Drop Stimulatio - Neuro Orthosis; Transcranial direct brain stimulation
Intervention type(s): Device; Device
Intervention description(s): Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.; Transcranial direct brain stimulation on motor cortex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebrovascular Accident; Cerebrovascular Stroke; Cerebral Stroke
Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2
Condition: Breast Feeding; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      Methadone is a drug that offers significant therapeutic benefits to opiate dependent women
      who are pregnant. Currently, it is the treatment of choice for this group of people. The
      purpose of this study is to determine the amount of methadone in the breast milk of women who
      are breastfeeding and taking methadone for opiate addiction. In addition, this study will
      evaluate the effects of methadone on infant neurobehavior.
    

Detailed description: 
      Methadone is a drug that is commonly used to treat opiate addiction, usually as part of a
      detoxification and maintenance program. Methadone offers significant therapeutic benefits to
      pregnant women who are opiate dependent, and it is currently the treatment of choice for this
      group of people. In general, breast milk is beneficial for infants. However, there is some
      concern as to whether it is safe for women who are taking methadone to breastfeed their
      babies. The purpose of this study is to determine the amount of methadone in the breast milk
      of women who are breastfeeding and taking methadone for opiate addiction. In addition, this
      study will evaluate the effects of methadone on infant neurobehavior.

      Participants will be assigned to one of two groups: women taking methadone who will
      breastfeed their babies or women taking methadone who will bottle-feed their babies. On Days
      1, 2, 3, 4, 14, and 30, following infant delivery, plasma will be collected from both groups
      and breast milk will be collected from the breastfeeding group. These samples will be
      quantitatively analyzed for methadone. Infants will undergo neurobehavioral assessments on
      Days 3, 14, and 30, following birth. Rates and severity of neonatal abstinence syndrome will
      also be evaluated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        lactating women
      
Keywords: methadone; lactation; breastfeeding; maternal opioid dependency
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability,
      bioavailability, pharmacokinetics, and pharmacodynamics
    

Detailed description: 
      This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK,
      PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy
      Volunteers.
    

Intervention name(s): AL101; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Active dose of AL101; Saline solution administered as a single and multiple infusion as placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316
Condition: Kidney Transplantation
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter
      the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose
      adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney
      transplantation
    


Intervention name(s): LFG316; IVIG
Intervention type(s): Drug; Drug
Intervention description(s): LFG316 single dose; IVIG single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar
Condition: Scar; Hydrocortisone; Iontophoresis; Phonophoresis
Study type: Interventional

Summary: 
      The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and
      hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.
    

Detailed description: 
      Scar contractures develop and extend to the underlying connective tissue and then muscles,
      leading to reduction in joint range of motion and affecting the day-to-day activities.

      Most patients (irrespective of age, gender and ethnicity) believe that even a small
      improvement in scarring is worthwhile , any research that may help improve scar outcome is
      meaningful.

      The need of this study has developed from the rarity of information about the difference
      between the effectiveness of iontophoresis and phonophoresis in enhancing the overall
      appearance of surgical scar.
    

Intervention name(s): Iontophoresis; Phonophoresis; traditional PT program
Intervention type(s): Other; Other; Other
Intervention description(s): Hydrocortisone iontophoresis; Hydrocortisone Phonophoresis; Ultrasound and deep friction massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ketamine/Placebo Family History Positive Study
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The proposed study is the first to explore the contribution of brain glutamate systems, a
      major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study
      may lead to an enhanced understanding of the underlying neurobiological mechanism in
      high-risk individuals that may lead to the transition from moderate to excessive use of
      alcohol.
    

Detailed description: 
      Males and females with a paternal family history of alcoholism have a high risk for
      developing alcoholism. These individuals have been shown to decrease dysphoric responses to
      alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been
      shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have
      recently shown that sober alcoholics have decreased dysphoric response to the NMDA
      antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a
      vulnerability factor in those individuals susceptible to develop alcoholism. Specifically,
      the objective is to determine whether individuals with a family history positive (FHP) for
      alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to ketamine
      infusion when compared to family history negative (FHN) control subjects.

      Male and female subjects, FHP (biological father and one other first degree relative) between
      the ages of 21-30, and matched controls (FHN) will complete 2 test days in a randomized
      balanced order under double-blind conditions. Test days will involve the 60-minute
      intravenous infusion of placebo and ketamine. Outcome measures include the Biphasic Alcohol
      Scale and visual analog scales for mood states. Secondary measures include visual analog
      scales for high, similarity to ethanol, the Sensation Scale (a validated measure of
      ethanol-like sensations) and aspects of craving for alcohol.
    

Intervention name(s): Ketamine and Placebo
Intervention type(s): Drug
Intervention description(s): Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes
Other intervention name(s): intravenous
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Computerized Health Education to Promote Physical Activity
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the efficacy of providing primary care physicians and their patients
      with computer-tailored information, based on patients' responses to survey questions. The
      health education messages are designed to encourage patients to become physically active and
      to encourage physicians to counsel their patients about exercise.
    

Detailed description: 
      The main objective of this study is to determine, via a 6-month randomized controlled study,
      the efficacy of providing tailored physical activity computer reports to patients and
      physicians. The primary outcome is minutes of physical activity measured by the 7-Day
      Physical Activity Recall interview at 6 months. The intervention group completed physical
      activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants
      received four feedback reports at each time point. The reports aimed to motivate participants
      to increase physical activity, personalized to participants' needs; they also included an
      activity prescription. The control group received identical procedures, except that they
      received general reports on preventive screening based on their responses to preventive
      screening questions.
    

Intervention name(s): Tailored Physical Activity Intervention
Intervention type(s): Behavioral
Intervention description(s): Tailored physical activity computer reports will be provided to patients and physicians.
Other intervention name(s): Exercise Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Physical Activity; Wellness Programs; Health Promotion; Blood Pressure, High
The Effect of Triangular Neck Design on Crestal Bone Loss
Condition: Dental Implant Failed
Study type: Observational

Summary: 
      The objective of this retrospective study with 5-year follow-up was to compare crestal bone
      loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round
      neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography
    

Detailed description: 
      CBL is a multifactorial entity including factors related to patients, surgical technique,
      prosthetic interventions, and implant design. Thus, new developments in implant micro- and
      macro-features, such as modifications of surface characteristics and chemistry, type of
      abutment connection, thread design, and neck design have been introduced over time parallel
      to recent advances in implantology not only for reducing CBL, but also for preserving buccal
      bone dimensions around implant. Furthermore, implant neck properties have been considered as
      a determinant factor involved in maintenance of crestal bone around implant in various
      trials. Nevertheless, there is no consensus with respect to the design of implant neck for
      reducing CBL.

      The most common implant neck design is the circular one; recently, however, a newly designed
      implant with a triangular neck (TN) portion was introduced, which has reduction in the neck
      portion on three sides. This neck design provides compression-free area to alveolar crest
      during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT
      by increasing the space between the flat part of the triangle and the buccal bone cortex.
      Based our previous study with one-year follow-up, despite the implants with novel neck design
      showed a better crestal bone preservation compared to conventional neck design, long-term
      clinical trials determining the effect of TN are missing for validating the success of this
      new design. Unfortunately, the data derived from only very few short-term comparative
      clinical trials to date do not provide an answer on benefits of TN design over the CN
      implants regarding preserving crestal bone level.

      Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT
      around implants with TN and RN retaining mandibular overdentures. The null hypothesis was
      that there was a difference in CBL and BBT between two implant designs in the long-term
      follow-up.
    

Intervention name(s): Dental implant
Intervention type(s): Other
Intervention description(s): Dental implants with triangular cross-section neck design
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healty patients who was inserted dental implants with two different designs
      
Keywords: : buccal bone thickness; crestal bone loss; neck design; peri-implant soft tissue; triangular cross-section neck
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
Condition: Anorexia Nervosa; Obesity; Healthy Participants
MeSH terms: Obesity; Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Diseases characterized by abnormal low and high body weight are common in the community and
      are associated with significant morbidity, mortality and health care related costs.

      Genetic, dietary, social and psychologic factors all play an important part in these
      conditions; however the central role of gastrointestinal (GI) function and the control of
      nutrient delivery to the small bowel has not been well described in health or disease.

      We propose that the GI response to feeding varies inversely with body weight. This hypothesis
      predicts that as body weight increases, the response to a given meal decreases in terms of
      motility, neurohormonal feedback, sensation and satiety. This provides an attractive
      explanation for why thin individuals stop eating after a small amount of food (i.e. limited
      gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early
      satiety)and, conversely, why obese patients continue to eat even after nutritional
      requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak
      nutrient feedback with delayed satiety).

      This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback,
      visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and
      high (morbid obesity) body weight and in healthy, normal weight controls.

      Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9
      kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1:
      anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2
      years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years)
      and C2: obese with DM type II (n=20 over 2 years).

      Two studies will be performed

        1. Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback,
           visceral sensation and satiety in healthy controls and in patients with anorexia and
           obesity

        2. Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI
           motility, hormonal feedback, visceral sensation and satiety in patients with anorexia
           and obesity
    


Intervention name(s): Nutritional Intervention
Intervention type(s): Behavioral
Intervention description(s): Nutritional Intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Early Pain Management at Triage on Opioid Consumption
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      introduction: Pain remains one of the most common reasons of emergency department admission.
      Opioids are overprescribed in emergency departments to treat severe pain.

      objective: assessing the impact of ealy pain pain management on the use of intravenous
      morphine and on patient satisfaction.
    


Intervention name(s): Paracetamol; Tramadol/Paracetamol combination; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets of 500mg of paracetamol; 2 tablets of tramadol/paracetamol combination (32.5mg/325mg); 2 tablets of placebo
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: acute pain; emergency department; opioid consumption