bioihbjkbjnl/mcl2 huggingface dataset:
Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in
      boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy
      boys.
    

Detailed description: 
      The study is designed as a randomized, double-blind placebo-controlled trial with a total
      duration of 6 months. 100-120 boys with ADHD aged 8-16 years and 30 healthy boys will will be
      randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "Eye
      q" per day divided in two daily doses (558 mg eicosapentaenoic acid (EPA), 174 mg
      docosahexaenoic acid (DHA), 60 mg gamma-linolenic acid (GLA) per day) or to placebo (olive
      oil). At 3 months a one-way treatment crossover of the placebo-group to active treatment will
      be made so that both patient groups will receive active treatment for the remaining 3 month
      period. Control group will receive active treatment for 6 month. The assessment of children
      will be made 3 times: at the point of start, after 3 months, and after 6 months. The
      assessments will be made using standardized interviews and questionnaires, neuropsychological
      tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess
      level of polyunsaturated fatty acids (PUFA) in serum and in cell membranes of erythrocytes.
    

Intervention name(s): Eye Q
Intervention type(s): Dietary Supplement
Intervention description(s): 3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Condition: UTERINE MYOMAS
MeSH terms: Leiomyoma; Myofibroma; Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      Adhesions are the most frequent complication of abdominopelvic surgery. They are internal
      scar tissues which form as a result of surgery which may abnormally join together what were
      once separate tissues and organs.

      This study will assess the safety and usability of anti-adhesion agent (gel) when used after
      laparoscopic surgery.

      The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse
      events in ADBLOCK and surgery only group) assessed at 28 days
    

Detailed description: 
      Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in
      Laparoscopic Gynaecological surgery

      Design: Randomised controlled study to assess the safety, manageability and usability of
      ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of ('virgin')
      myomas in women wishing to improve pregnancy outcomes.

      Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients (randomised
      2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.

      Clinical Site Locations:

        -  Oldenburg, Germany

        -  Neuss, Germany

        -  Berlin, Germany

      Patient Population: Women who have not completed their family planning and who are undergoing
      primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes.
    

Intervention name(s): ADBLOCK
Intervention type(s): Device
Intervention description(s): Laparoscopic surgery
Other intervention name(s): Adhesion Barrier System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: ADBLOCK; Adhesion Barrier System; laparoscopic surgery; myomectomy
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).
Condition: Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)
MeSH terms: Coronary Artery Disease; Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of dual antiplatelet therapy is considered standard of care in patients post
      percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of
      patients is considered clopidogrel resistant and this resistance is shown to be accompanied
      by future adverse events. Additionally, clopidogrel resistance has been linked with the
      CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients
      undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as
      estimated predischarge with the VerifyNow point of care system of platelet reactivity.
      Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or
      clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment
      crossover will be performed. At day 60 platelet reactivity will be determined as well. In
      addition, in all patients genetic determination of CYP polymorphisms (including the
      CYP2C19)known to affect clopidogrel metabolism will be performed.
    


Intervention name(s): prasugrel; clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): prasugrel 10 mg/day; clopidogrel per os 150mg/day
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary angioplasty; clopidogrel resistance; prasugrel
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Condition: Knee Arthroscopy; Meniscus; Inflammation; Hydrops; Cooling
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Abstract

      Background:

      Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced
      recovery after joint surgery. It is supposed to reduce pain and improve mobilization,
      enabling same day surgery.

      Hypothesis:

      Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and
      also be reflected by changes in local levels of metabolic and inflammatory variables in the
      synovial membrane.

      Study design:

      Prospective randomised study; Level of evidence 1.

      Methods:

      Forty-four otherwise healthy patients were included in the study and randomised to systematic
      cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis
      of the synovial membrane was performed postoperatively with measurements of PGE2, glucose,
      lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was
      monitored as well as postoperative pain (VAS and NRS).

      Results:

      The application of a cooling and compression device after knee arthroscopy resulted in
      significantly lower temperature in the operated knee (skin, joint capsule and
      intraarticularly).

      The cooling and compression diminished energy requirements in synovial tissue and a 3
      temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative
      pain was detected.

      Conclusion:

      Local cryotherapy and compression after knee arthroscopy significantly lowered local knee
      temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.

      Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory
      effect induced by postoperative local cooling and compression. Hypothermia is proposed to
      have a protective effect in ischemic tissue. This is probably due to a decreased metabolic
      rate and therefore decreased energy requirements as shown by stable levels of lactate despite
      lower blood flow indicated by increasing ethanol ratio.
    


Intervention name(s): Cooling and compression
Intervention type(s): Device
Intervention description(s): Cooling and compression of the knee postoperatively with an Aircast device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inflammation; arthroscopy; knee; microdialysis
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
Condition: Seroma; Breast Cancer
MeSH terms: Seroma
Study type: Interventional

Summary: 
      Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to
      provide postoperative analgesia. In addition, the successful use of TPVB is reported for some
      seroma related pain cases. Postoperative analgesia in breast surgery is a difficult and
      overworked issue due to etensive surgery and complex innervation of the breast and in
      addition to this complex mechanisms, seroma accumulation has a negative effect for patients
      postoperatively. With this study, the investigators aimed to study the effect of TPVB on
      seroma reduction for breast cancer surgery.
    


Intervention name(s): Thoracal paravertebral block
Intervention type(s): Procedure
Intervention description(s): Thoracal paravertebral block will be performed before the surgery to the TPVB group.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thoracal Paravertebral Block; Breast Surgery; Seroma Reduction
Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean
Condition: Cesarean Section; Restless Leg Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting
      approximately 10% of the population. Different literature had different views on the
      association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some
      reported that spinal anesthesia induced postoperative restless leg syndrome, but other
      studies showed that spinal and general anesthesia all two did not cause restless leg
      syndrome. A potential difference amongst these studies is that a big difference exists in
      surgical types. The investigators proposed that different types of surgery performed
      undergoing various anesthesia, and that there is a big difference in original
      pathophysiological condition. Therefore, the investigators hypothesized that pregnant women
      who have special physical states would have had an association between neuraxial anesthesia
      and restless leg syndrome in such patients who received selective cesarean section undergoing
      spinal or epidural anesthesia.
    


Intervention name(s): Spinal anesthesia; Epidural anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg; Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
Other intervention name(s): Intrathecal anesthesia; Extradural anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Restless leg syndrome; Spinal anesthesia; Epidural anesthesia; Neuraxial block
IVN-CAT-001A Performance of CAST With Different Allergens in Patients With Cat Dander Allergy
Condition: Allergy to Cats
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Primary objective of the trial:

      To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of
      cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone
    


Intervention name(s): Blood sample
Intervention type(s): Behavioral
Time perspective: Prospective
Discharge to Home and Chronic Illness Care Pilot
Condition: Solid Organ Transplant
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this study is to address a gap in knowledge needed for care of children with
      solid organ transplantation (SOT) and their parents by combining mHealth technology with an
      individualized family centered self-management intervention (referred to as myFAMI). This
      study is critical to the increased understanding of hospital to home transition and family
      management at home with the potential to transform the way clinicians approach the care of
      complex chronic illness children and families.
    


Intervention name(s): myFAMI iPad application
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: pediatric; solid organ transplant; parents; heart; kidney; liver
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled,
      adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of
      TERN-201 in patients with non-cirrhotic NASH.
    


Intervention name(s): TERN-201; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO); Nonalcoholic steatohepatitis (NASH); Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
Condition: Mental Health; Geriatrics
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study is to assess the role of cholinesterase inhibitors in affecting the
      driving ability of cognitively intact seniors using driving simulators. We hypothesize that
      the use of a cholinesterase inhibitor for two weeks will be associated with improvement in
      safe driving behavior on a simulated driving task.
    

Detailed description: 
      Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD
      poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD
      continue to drive. Memory problems themselves are poor predictors of who is actually unsafe
      on the road, and various medications that are used to treat people with AD may impact on
      their driving abilities. Donepezil is a drug used to treat the memory problems associated
      with AD. While previous studies have shown that it slows the decline of activities of daily
      living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to
      perform on computerized flight simulators, no studies have examined the impact of donepezil
      on driving abilities in older adults.

      The present investigation is a pilot study aiming to determine if donepezil helps healthy
      older drivers perform on driving simulators. Two Canadian academic centers have different
      driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten
      healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or
      identical placebo for two weeks.

      Using the driving simulator, we will assess various aspects of driving ability. These
      measures of driving performance will be compared between those who received the drug and
      those who received the placebo.
    

Intervention name(s): donepezil; Placebo (cornstarch)
Intervention type(s): Drug; Drug
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Donepezil; Driving; Cholinesterase Inhibitors; Geriatric Psychiatry; Psychopharmacology; Aricept
Trial of Weaning by Synchronized Ventilation
Condition: Neonatal Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      During assist control ventilation and pressure support ventilation (PSV), the start of
      ventilator inflation is determined by the start of the infant's inspiratory effort. During
      PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In
      a randomized trial, no significant differences were found between assist control and pressure
      support ventilation with regard to the duration of weaning, time to successful extubation,
      work of breathing, rate of asynchrony and level of respiratory muscle strength.
    

Detailed description: 
      Objectives: To test the hypothesis that the duration of weaning would be shorter using assist
      control ventilation (ACV) rather than pressure support ventilation (PSV). To determine if any
      differences in the duration of weaning reflected differences in the work of breathing, the
      rate of asynchrony or the level of respiratory muscle strength.

      Patients and methods: Thirty-six infants, median gestational age 29 (range 24 to 39) weeks,
      were randomized to weaning by either ACV or PSV. The duration of weaning was recorded. At
      baseline (study entry), 24 hours after entering the study and immediately prior to
      extubation, the work of breathing was assessed by measuring the transdiaphragmatic pressure
      time product (PTPdi), thoracoabdominal asynchrony (TAA) was assessed using respiratory
      inductance plethysmography and respiratory muscle strength measured by recording the maximal
      inspiratory pressure produced during an airway occlusion during crying (Pimax). Immediately
      prior to extubation, the level of active expiration was also assessed.
    

Intervention name(s): Treatment protocol designed to evaluate (SLE 5000 ventilator)
Intervention type(s): Device
Intervention description(s): Assist control ventilation and pressure support ventilation
Other intervention name(s): SLE 5000 ventilator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonate; Weaning; Assist control ventilation; Pressure support ventilation
Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the bioavailability, safety and tolerability of dabigatran with and without
      concomitant administration of amiodarone and the bioavailability of amiodarone and
      desethylamiodarone after administration of a single dose of amiodarone with and without
      dabigatran
    


Intervention name(s): Dabigatran etexilate; Amiodarone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amiodarone; Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
Condition: Closed Fracture of Shaft of Clavicle
MeSH terms: Fractures, Bone; Fractures, Closed
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the functional outcome in patients with a midshaft
      clavicle fracture treated with to different techniques. the first one was placing a 3.5mm
      reconstruction plate in the superior side of the clavicle and the second one placing the same
      3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the
      same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days
      after surgery. biomechanical studies have demonstrated more stable construct using an
      anteroinferior plate in clavicle fractures and we were trying to find out if it has a
      clinical relevance in patients with midshaft clavicle fractures.
    

Detailed description: 
      The purpose of this study was to evaluate the functional outcome in patients with a midshaft
      clavicle fracture treated with to different techniques.

      the first technique was placing a 3.5mm reconstruction plate in the superior side of the
      clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior
      side of the clavicle.

      the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder
      and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365
      days after surgery.

      biomechanical studies have demonstrated more stable construct using an anteroinferior plate
      in clavicle fractures and we were trying to find out if it has a clinical relevance in
      patients with midshaft clavicle fractures.
    

Intervention name(s): Open Reduction Internal Fixation superior plate; Open Reduction Internal Fixation anteroinferior plate
Intervention type(s): Procedure; Procedure
Intervention description(s): 3.5mm superior reconstruction plate; 3.5mm anteroinferior reconstruction plate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: midshaft clavicle fracture; functional outcome; anteroinferior plate; superior plate; reconstruction plate
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in
      the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than
      12 months of age compared to topical corticosteroids (TCS).
    


Intervention name(s): Pimecrolimus; Topical corticosteroids
Intervention type(s): Drug; Drug
Intervention description(s): Pimecrolimus cream 1 %; TCS
Other intervention name(s): Elidel
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis, children, infants, pimecrolimus