bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
Condition: Procedural Anxiety; Laceration of Skin
MeSH terms: Emergencies; Lacerations; Anxiety Disorders
Study type: Interventional

Summary: 
      The investigators propose a pilot study to examine the feasibility of utilizing immersive
      virtual reality to reduce procedural anxiety in children undergoing non-facial laceration
      repair in the Pediatric Emergency Department.

      The investigators hypothesize that virtual reality will be well-received by patients and
      their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the
      immersive virtual reality experience.
    


Intervention name(s): Virtual Reality App
Intervention type(s): Other
Intervention description(s): Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: procedural anxiety; virtual reality; anxiolysis; laceration repair; pediatric
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized, open label, parallel group, multicenter study. There will be two
      phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of
      regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients
      with type 2 diabetes who have either been on a prior regimen of insulin for less than 6
      months and were taking less than 50 U total of insulin per day OR are candidates for the
      initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore
      further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at
      Week 24.
    


Intervention name(s): pramlintide acetate (Symlin); rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]); basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals; subcutaneous injection, dosing based on titration guidelines; subcutaneous injection, dosing based on titration guidelines
Other intervention name(s): Symlin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro; Insulin Detemir; Insulin glulisine; Pramlintide; Insulin, Short-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Symlin; Amylin; insulin; Humalog; Novolog; Apidra
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
Condition: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      A research study that will evaluate if giving surfactant medication to premature babies
      weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.
      We are enrolling those premature babies who continue to require the breathing tube and the
      mechanical ventilator at days 7-10 of life.
    

Detailed description: 
      Pulmonary surfactant is required for normal lung function. Data from a previous study suggest
      that as many as 75% of chronically ventilated extremely low birthweight premature infants
      have at least one episode of surfactant dysfunction beyond the first week of life, as
      measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes
      of surfactant dysfunction are significantly associated with clinically significant
      respiratory decompensations. We hypothesize that booster doses of surfactant given during the
      second and third week of life to extremely low birth weight premature infants requiring
      persistent intubation and mechanical ventilation will improve their respiratory status during
      the first 28 days of life. We propose to enroll premature infants < 1250 gm birthweight,
      between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants
      requiring persistent intubation and mechanical ventilation for respiratory support at 7-10
      days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the
      standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory
      severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study
      duration is 36 months, and recruitment of study patients will occur at The Hospital of the
      University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St.
      Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland
      Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical
      Center, NY.
    

Intervention name(s): Infasurf
Intervention type(s): Drug
Intervention description(s): Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria
Other intervention name(s): Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)
Intervention MeSH terms: Calfactant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prematurity; Lung Disease; Hyaline Membrane; Surfactant
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
Condition: Hypertension; Elevated Cholesterol; Overweight and Obesity
MeSH terms: Overweight; Hypercholesterolemia
Study type: Interventional

Summary: 
      This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention
      in the treatment of excess body weight, hypercholesterolemia, and hypertension in the
      clinical setting.
    

Detailed description: 
      Plant-based diets have emerged in the literature as effective therapeutic strategies in the
      reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and
      vegetable consumption has also been associated with the reduction of these clinical
      indicators.

      Participants were instructed to follow a prescribed, raw, plant-based dietary intervention
      for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods,
      free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were
      provided to the participants for the full duration of the intervention. Emphasized were raw
      fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods
      were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued
      unless otherwise clinically indicated. Participants were not advised to alter their exercise
      habits.

      Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at
      baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks.
      Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
Intervention model: Single Group Assignment
Intervention model description: Repeated measures, single group design.
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is for research purposes only and is not intended to treat any medical condition.
      The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of
      ACT-709478 in healthy male participants. The participants will be treated in a crossover
      design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the
      absorption and breakdown of the study drug in the body.

      The duration of participation in this study is approximately 8 weeks from screening to the
      end of study visit. A screening visit is required within 21 to 3 days prior to the start of
      the study to determine whether the participant qualifies and is willing to enter in this
      research study. This study requires the participant to have two in-patient stays in the
      research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after
      each dose the participant will have an examination. There will be an in-between period (i.e.,
      time between the end of period 1 and study treatment administration in Period 2) of 7 to 14
      days. A safety follow-up telephone call for all participants who have received at least one
      study treatment will take place 30 to 40 days after the end of study examination or study
      discontinuation.
    


Intervention name(s): ACT-709478; ACT-709478
Intervention type(s): Drug; Drug
Intervention description(s): 1 film-coated minitablet contains 2 mg of ACT-709478; 1 hard capsule contains 10 mg of ACT-709478.
Intervention MeSH terms: ACT-709478
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic
      profile of KVD824 following single and multiple doses of novel KVD824 modified-release
      formulations compared with a reference KVD824 immediate release formulation.
    

Detailed description: 
      Part 1 of the study was a single-centre, open-label, non-randomised, 6-period crossover study
      designed to investigate the PK and safety of KVD824 MR prototype formulations (with or
      without an additional KVD824 IR capsule) compared to a reference KVD824 IR capsule
      formulation in healthy male and female subjects. Part 2 was an optional part designed to
      investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or
      without an additional KVD824 IR capsule) in healthy male and female subjects in both the fed
      and fasted state. Note: this Part was not conducted as sufficient information on food effect
      was collected in the other Parts of the study.

      Part 3 was a single-centre, randomised, double-blind, placebo-controlled, multiple dose group
      study to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation
      (with or without an additional KVD824 IR capsule) in healthy male and female subjects. Part 3
      started following completion of Part 1.
    

Intervention name(s): KVD824 Prototype 1 modified-release tablet; KVD824 Prototype 2 modified-release tablet; KVD824 Immediate-Release Capsule; Placebo to KVD824 Prototype 1; KVD824 Prototype 3 modified-release tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg modified-release tablet; 300 mg modified-release tablet; 300 mg immediate-release capsule; Placebo to 300 mg KVD824 Prototype 1 modified-release tablet; 300 mg modified-release tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
XP1000 RF Therapy on Waist Circumference Reduction
Condition: Circumferential Reduction; Waist Circumferential Reduction
Study type: Interventional

Summary: 
      This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive
      temporary reduction of waist circumference by disruption of adipocyte cells.
    

Detailed description: 
      This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of
      circumferential waist reduction following 4 treatment sessions delivered once a week over a
      4-week period. The objective of the study is to demonstrate the effectiveness of the
      treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3
      cm across the waist line relative to the base line assessment and their mean waist
      circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.
    

Intervention name(s): XP1000 RF; sham XP1000 RF
Intervention type(s): Device; Device
Intervention description(s): Treatment of adipose tissue within the fat layer with XP1000 RF.; Treatment of adipose tissue within the fat layer with XP1000 RF.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hyperspectral Imaging to Assess and Predict Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Observational

Summary: 
      This study is designed to test a prototype imaging instrument that relies on Medical
      HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot
      ulceration and wound healing. The imaging system utilizes the biomarkers of oxyhemoglobin
      (oxyHb) and deoxyhemoglobin (deoxyHb), in the upper layers of skin on the foot as: a metric
      for assessing wound healing, a reflection of microvascular disease, and determining tissue at
      risk for forming new ulcers. MHSI results will also be compare with ABI and TcPO2
      measurements.
    

Detailed description: 
      ULCER HEALING STUDY: This is a study comparing measurements from a cohort of 66 diabetic
      subjects (30 Type 1 and 36 Type 2) with at least one foot ulcer. The study will take place at
      three medical centers. Each center will enroll 22 subjects (10 Type 1 and 12 Type 2).
      Subjects will be required to participate in eleven (11) clinic visits over a 6 month period.
      The first visit will last approximately three hours and each of the other visits will last
      about two hours. The eleven visits will be scheduled as follows in the Table to the right.

      At the initial visit the subject will give informed consent and a full medical history, and
      will schedule the dates of the remaining visits for the study. The subject recruiter will
      contact each subject one week prior to each subsequent visit to either confirm the subject's
      attendance or to re-schedule the visit.

      NEW ULCER PREDICTION STUDY: This is a study comparing measurements of 210 "high risk"
      diabetic subjects (90 Type 1 and 120 Type 2) over an 18-24 month period. The study will take
      place at three medical centers. Each center will enroll 70 subjects (30 Type 1 and 40 Type
      2). Subjects will all be required to participate in nine (9) clinic visits. The nine visits
      will be scheduled as follows in the Table to the right.

      The first visit will last approximately three hours and each of the other visits will last
      about 2 hours. At the initial visit the subject will give informed consent and a full medical
      history, and will schedule the dates of the visits for the rest of the study. The subject
      recruiter will contact each subject one week prior to each subsequent visit to either confirm
      the subject's attendance or to re-schedule the visit.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Clinic population - diabetic patients at high risk for ulceration
      
Keywords: hyperspectral imaging; tissue oxygenation; diabetic foot ulcers; wound healing; prevention
Catheter System Feasibility Clinical Trial
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Feasibility clinical study to evaluate the safety and effectiveness of the catheter system
      for the percutaneous creation of an arteriovenous fistula for patients with end stage renal
      disease requiring dialysis access.
    


Intervention name(s): Percutaneous creation of an arteriovenous fistula
Intervention type(s): Device
Intervention description(s): Use of catheter system for percutaneous creation of an arteriovenous fistula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of
      the central nervous system. It is thought that MS, which is one of the main causes of
      non-traumatic neurological dysfunction in young adults, affects approximately two and a half
      million people worldwide. The annual cost caused by MS is reported to be between $ 8,528 and
      $ 54,244 per patient. Due to the destruction of the central nervous system, MS has a wide
      range of sensory, motor, cerebellar and cognitive dysfunctions. These dysfunctions may lead
      to a limitation of physical activity in people with MS. In addition, people with MS may limit
      their physical activity because they fear the worsening of their symptoms. Physical
      inactivity and sedentary life style are thought to be among the reasons that increase the
      risk of developing chronic diseases such as cancer, hypercholesterolemia, hypertension,
      arthritis, osteoporosis, obesity, type 2 diabetes, depression and cardiovascular diseases in
      people with MS. It is reported that these chronic diseases secondary to MS increase mortality
      by 1.7 times. In addition, these diseases have been associated with increased disability,
      decreased quality of life, and hospitalization. Physical inactivity can increase disability
      and mortality by aggravating health problems caused by the disease. For this reason, it is
      emphasized that there should be studies to increase physical activity in people with MS.
      Studies have shown that physical activity improves muscle strength, aerobic capacity, gait
      and balance and reduces fatigue in people with MS. In addition, it is stated that physical
      activity increases self-efficacy and improves positive perspective in patients with MS. When
      the literature is examined, it is seen that there are studies about physical activity in MS
      but they have methodological limitations. There are a limited number of studies on the
      effectiveness of the programs planned to increase the level of physical activity. The aim of
      our study was to investigate the effects of physical activity program and online training
      program on physical activity in patients with MS.
    


Intervention name(s): Supervised Exercise Program; Online Education Program
Intervention type(s): Other; Other
Intervention description(s): The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.; The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Rehabilitation; Physical Activity; Exercise
Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine whether inflammatory bowel disease in children
      involve the respiratory tract as expressed by increased levels of the Fraction of exhaled
      Nitric Oxide (FeNO) and spirometry.
    

Detailed description: 
      Inflammatory bowel disease, Crohn's disease (CD) and Ulcerative colitis (UC) are chronic
      inflammatory diseases with remissions and exacerbations. CD and UC are associated with a
      variety of systemic (extra-intestinal) manifestations. In some studies, clinical and
      subclinical pulmonary abnormalities are described in active IBD as well as in the stable
      situation.

      Nitric oxide (NO) is an important mediator of inflammation in several pathological
      conditions.Patients with lung diseases, like asthma, have higher levels of the Fraction of
      exhaled Nitric Oxide (FeNO) in active disease in comparison with healthy volunteers. One
      study in adult IBD patients showed increase in FeNO levels in those patients, with positive
      correlation with the disease activity and negative correlation between the disease activity
      and pulmonary functions.

      We hypothesised that respiratory tract inflammation as expressed by FeNO and spirometry in
      pediatric IBD patients will correlate to the activity of the primary disease.

      Methods: FeNO levels and spirometry will be assess for 40 patients with CD or UC (age 4-18
      years) during remissions and exacerbations, calculated by the Pediatrics Crohn's Disease
      Activity Index (PCDAI) and the Pediatrics Ulcerative Colitis Activity Index (PUCAI),
      respectively.

      Two aged matched groups, the first of healthy children and the second of chronic abdominal
      pain will serve a controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients with IBD addmited to the pediatric ward due to exacerbations and
        children with IBD who come for routine visit to the pediatric gastroenterology clinic at
        the "DANA" Hospital for Childrens, at the Sourasky Medical Center, Tel-Aviv