bioihbjkbjnl/mcl2 huggingface dataset:
Racial/Ethnic Differences in Microneedle Response
Condition: Healthy
Study type: Interventional

Summary: 
      The study to be performed will define the rate of skin barrier recovery following microneedle
      treatment of the skin in healthy subjects of differing racial/ethnic backgrounds.
    

Detailed description: 
      Transdermal drug delivery (by way of patches that adhere to the skin and deliver drug in a
      time-dependent fashion) allows for systemic drug delivery through the skin, while avoiding
      many of the side effects and challenges associated with oral or intravenous drug delivery.
      One significant challenge limiting the number of drug compounds that can be transdermally
      delivered is the hydrophobic nature of the skin, which provides a highly efficient barrier
      against the absorption of drug molecules. Microneedles are a minimally invasive means of
      allowing drug molecules to cross the skin by creating micron-sized channels (also called
      micropores) in the skin, thereby increasing its permeability. Microneedles have been safely
      used in hundreds of patients for administration of drugs and vaccines through the skin.
      Studies have demonstrated that microneedle treatment is relatively painless and
      well-tolerated by most patients.

      Following microneedle treatment, the skin must heal the micropores in order to restore
      barrier function. In young healthy individuals this process takes approximately 48 to 72
      hours when the skin is covered by an occlusive patch. The timeframe for micropore closure is
      longer in elderly individuals (>65 years of age), taking several days longer to restore the
      skin barrier. As evidenced by the differences in micropore closure rate observed with
      advancing age, biological variation can have a significant effect on the skin's healing
      properties. There are almost no data available regarding how race and ethnicity affect skin
      response to microneedle insertion. It is crucial to better understand how the rates of
      micropore closure vary in different racial/ethnic populations because the potential for
      variability in drug delivery is high if the recovery timeframes are poorly understood.

      In this study we will measure hydration and color to characterize the epidermal properties of
      individuals of different self-identified race and ethnicity. Measurements of trans-epidermal
      water loss and electrical impedance will be used to evaluate the formation of micropores in
      the skin; the electrical impedance measurements will be used to calculate the rate of
      micropore closure. All of these skin characteristics can be measured using noninvasive
      methods that are quick and painless.
    

Intervention name(s): Microneedle patch
Intervention type(s): Device
Intervention description(s): Each patch contains 50 microneedles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Peer Reviewed Research
Short Therapy for Febrile UTI in Childhood
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Febrile urinary tract infections (UTIs) are common in children, but there is no consensus
      concerning the duration of the antibiotic treatment. Current recommendations include the use
      of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation
      cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic
      overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI
      in childhood is lacking.

      The objective of this randomized controlled trial is to assess the non inferiority of a five
      days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the
      treatment of febrile UTIs in children.

      The trial results might provide evidence of the non-inferiority of a short duration of the
      antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction
      in the over-use of antibiotics and consequently limiting the emergence of antibiotic
      resistance.
    


Intervention name(s): Amoxicillin and Clavulanic Acid in Oral Dose Form
Intervention type(s): Drug
Intervention description(s): 50 mg/kg three times daily administered orally
Intervention MeSH terms: Amoxicillin; Clavulanic Acids; Clavulanic Acid
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: short antibiotic therapy; urinary tract infection; children
A Randomised Trial Comparing Supraclavicular Block vs Supraclavicular and Pecs II Block in Arteriovenous Grafting
Condition: Arteriovenous Fistula; Arteriovenous Graft; Kidney Failure, Chronic; Renal Failure, End-stage
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular
      brachial plexus block in patients undergoing arteriovenous graft creation surgery.
      Participants will be randomised into two equal groups, one receiving supraclavicular and pecs
      II blocks, the other receiving supraclavicular block and sham block (Grade 1).
    

Detailed description: 
      Regional anaesthesia (RA) for arteriovenous grafting surgery has advantages of avoiding risks
      of general anaesthesia (GA) in this group of patients with significant co-morbidities, and
      beneficial vasodilatation, which may prevent early fistula thrombosis. Hence, RA is
      preferable to GA for this surgery.

      Brachial plexus blocks (BPB) are the most commonly employed RA technique to anaesthetise the
      upper limb for this surgery. According to the results of a recent 2-year retrospective audit
      in our centre, ultrasound-guided supraclavicular BPB are the most popular RA technique for
      this surgery. Anatomically, the T1 and T2 dermatomes are often missed by the supraclavicular
      BPB. This means that the upper medial arm and axilla (sites involved in brachiobasilic and
      brachioaxillary arteriovenous grafting) may not be adequately anaesthetised, mandating
      intraoperative local anaesthetic supplementation by the surgeon. This may affect patients'
      and surgeons' acceptance of, and satisfaction with the RA technique. The ultrasound-guided
      Pecs II block, described by Blanco et al, seems to address this problem, as the intercostal
      T1-6, intercostobrachialis, long thoracic nerves and nerve to serratus anterior are targeted
      by this block.
    

Intervention name(s): Supraclavicular; Pecs II block; Sham block (Grade 1); Ropivacaine 0.5% 20ml; Ropivacaine 0.5% 10ml
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug
Intervention description(s): Ultrasound-guided supraclavicular brachial plexus block; Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior; Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection; Local anaesthetic solution administered for supraclavicular block; Local anaesthetic solution administered for pecs II block
Other intervention name(s): Naropin; Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: brachio-axillary; brachio-basilic; interfascial plane block; Pecs II block; supraclavicular brachial plexus block
Whole Body Vibration Training for Diabetic Patients With Burn Injury
Condition: Burn Injury
MeSH terms: Wounds and Injuries; Burns
Study type: Interventional

Summary: 
      Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological
      impairments. Lower limb burn involving Foot are still a challenging heath condition because
      of its important sensory role. Balance is disturbed either in patients with lower limb burn
      injury or diabetic patients. This study aime to compare between the effects whole body
      vibrational training and Yoga exercises on postural balance, and Activities-specific Balance
      Confidence in in type II diabetic Patients with foot burn
    

Detailed description: 
      Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age
      ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will
      receive low vibrational training in the form of whole body vibration for 8 weeks (n=19),
      while group (B) the control group for 8 weeks (n=19) in addition both groups will receive
      their routine medical care and physical therapy rehabilitation including balancing exercises.
      Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence
      will be measured by the Activities-specific Balance Confidence Scale (ABC) before the
      starting and after the end of treatment for all patients in both groups
    

Intervention name(s): whole body viberation; Traditional program(balance exercises and resisted exercises)
Intervention type(s): Other; Other
Intervention description(s): vibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform; balance exercises and resisted exercises
Other intervention name(s): WBV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: vibration Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks , while group B is the control, both groups will receive their routine medical care and physical therapy rehabilitation.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability of different dose combinations of MPL and grass pollen allergen and
      to identify the highest combinations of MPL and grass pollen allergen which is safe.

      Pharmacodynamics and efficacy of MPL and grass pollen allergen.
    

Detailed description: 
      Objective of this trial is to demonstrate the safety and tolerability of different dose
      combinations of MPL and grass pollen allergen and to identify the highest combination of MPL
      and grass pollen allergen which is safe.

      Other objectives are to investigate the pharmacodynamics and efficacy of MPL and grass pollen
      allergen.
    

Intervention name(s): OralvacB2MPL
Intervention type(s): Biological
Intervention description(s): Comparison of different dosages of drug
Other intervention name(s): MPL and/or grass pollen allergen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Specific Immunotherapy; Sublingual Immunotherapy
Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection
Condition: Cirrhosis; Hypertension; Status;Splenectomy; Venous Thrombosis
MeSH terms: Hypertension; Thrombosis; Venous Thrombosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Warfarin Anticoagulation are effective and
      safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic
      Splenectomy and Azygoportal Disconnection for Portal Hypertension
    

Detailed description: 
      After successful screening the cases of cirrhosis of liver irrespective of the etiology who
      have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will
      be recorded and the patient will be randomized into either interventional (warfarin) or
      control (aspirin) group. From postoperative day 3, patients in interventional (warfarin)
      group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of
      2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated
      Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous
      injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3
      months the Doppler screening for the occurrence of portal vein thrombus (PVT) or
      spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the
      therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus
      occurrence. Then one year monitoring will be done in the both groups as per the primary or
      secondary outcome.
    

Intervention name(s): Warfarin; Dipyridamole; Aspirin; Low Molecular Weight Heparin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.; From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.; From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.; From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other intervention name(s): Warfarin Sodium; Athrombine; COUMADIN; PANAWARFIN; Gardoxin; Coribon; Curantyl; Dilaplus; Acenterine; Acetard; Acetophen; Fraxiparine
Intervention MeSH terms: Aspirin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Dipyridamole; Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; Hypertension; venous thrombosis; Warfarin; Splenectomy; Azygoportal Disconnection; Laparoscopy
Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
Condition: Healthy Volunteers
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 safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian
      participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug
      in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There
      will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian
      participants in the other group.

      The duration of participation in this study is approximately 75 days from screening to the
      end of study visit. A screening visit is required within 21 days prior to the start of the
      study to determine whether the volunteer qualifies and is willing to participate in this
      research study. This study requires in-patient stay in the research clinic of 4 days (3
      nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49
      outpatient visit.
    


Intervention name(s): Cenerimod; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.; A single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
Other intervention name(s): ACT-334441
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
Condition: Infant Conditions; Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      To measure and quantify the postprandial glucose variations in response to a meal in the
      healthy 6-12 months old child and correlate this response with the composition of this meal.
    

Detailed description: 
      14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet
      including infant formula, solid foods such as mixed meat and vegetable preparation or
      marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens
      hospital and only be included in the study whenin good general health.

      FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before
      discharge from the hospital after skin preparation with anesthetic cream (Emla®) during
      hospitalization and measurements will be recorded during 2-5 days.

      It is not intended to measure capillary or venous blood glucose levels during this study.
      However, if blood is collected during hospitalization, blood glucose will be measured in
      parallel with the interstitial glucose measured with the device.

      The child will follow his usual diet without modifications. The amount of food consumed by
      the child as well as the length of the meals will be recorded by the parents. For meals made
      by the parents they will be asked to keep a sample not seen to analyze their carbohydrate
      content. The total carbohydrate content will be measured .
    

Intervention name(s): Glucose monitoring
Intervention type(s): Device
Intervention description(s): FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Glucose variation; Infant; Nutrition; interstitial glucose variation
Conectar Jugando Online: Board Games to Improve Executive Function in School-age Children (CJ-Online)
Condition: Cognitive Change; Child Development
Study type: Interventional

Summary: 
      Good development of executive functions at school has been related to a better adaptation of
      children in different areas of their daily life and, especially, with adequate academic
      performance. Taking into account the importance of play in childhood, some interventions
      aimed at training these cognitive processes have been based on the use of playful elements,
      such as modern board games. Although it is still an unexplored field of research, some
      studies with older elementary school children and with ADHD children have found significant
      improvements in executive functions after training that had the board game as a key
      intervention element. However, we still do not have studies that have explored the possible
      cognitive benefits of its use throughout the primary stage with the general population. For
      this reason, the main objective of this study is to test the effectiveness of a cognitive
      training program based on modern board games in primary education children (6 to 12 years
      old).
    

Detailed description: 
      As hypotheses, it is established that: i) the experimental group will present a significantly
      greater improvement in the neuropsychological tasks that measure executive functions and
      associated cognitive processes compared to the passive control group after the intervention;
      ii) the experimental group will present a significantly greater improvement in the tests
      evaluated by their parents after the intervention compared to the passive control group. All
      hypotheses will be controlled for age, estimate of IQ and socioeconomic status, as well as
      previous experience in board games and other cognitive activities.
    

Intervention name(s): Conectar Jugando Online Program
Intervention type(s): Behavioral
Intervention description(s): Online play sessions with modern board and card games guided by the study researchers
Other intervention name(s): Modern board and card games
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional (Clinical trial)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: executive function; modern board and card games; cognitive training; school-age children
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Condition: Alcohol Use Disorder; Post Traumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the feasibility of the revised brain
      training program with individuals diagnosed with Alcohol Use Disorder (AUD) and
      Post-Traumatic Stress Disorder (PTSD).
    


Intervention name(s): Computerized Plasticity-Based Adaptive Cognitive Training
Intervention type(s): Other
Intervention description(s): Thirty minutes of training on computerized exercises that targets executive function, memory and attention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment