bioihbjkbjnl/mcl2 huggingface dataset:
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in
      children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes
      implicated in glutamatergic signaling and neuronal activity. PART B will assess subjects who
      do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic
      signaling and neuronal connectivity.
    


Intervention name(s): AEVI-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.; Oral doses of Placebo will be administered twice daily, during the treatment period.
Other intervention name(s): MDGN-001; NFC-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modified Paramedic Sagittal vs. Transverse TMQLB
Condition: Nerve Block
Study type: Interventional

Summary: 
      The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to
      provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local
      anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan,
      posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB)
      approach has been introduced to facilitate cranial spread by injecting the local in a caudal
      to cranial direction. Currently, there are no data comparing the two techniques mentioned
      above with regards to extent of spread for PVS. Our objective is to investigate the extent of
      cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected
      with the transverse versus an modified paramedian sagittal approach for patients undergoing
      laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance
      time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.
    


Intervention name(s): transverse scan, in-plane, posterior-anterior TMQLB; paramedian sagittal scan, in-plane, caudal-cranial TMQLB
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.; The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of Honey on Nocturnal Cough and Sleep Quality
Condition: Cough; Sleep
MeSH terms: Cough
Study type: Interventional

Summary: 
      Cough is a common symptom in pediatric practice. It can be particularly troubling to children
      and their parents.It often results in discomfort to the child and loss of sleep to both the
      child and the parent. The objective of this trial was to compare the effects on nocturnal
      cough and the sleep difficulty associated with URIs of a single nocturnal dose of three
      different honey products compared to placebo
    

Detailed description: 
      Cough is a common symptom in pediatric practice.As a result, children miss daycare or school
      and parents miss a day of work. In an attempt to threat cough, caregivers frequently
      administer OTC medication to their children,with their attendant risks, kack of proven
      efficacy and the disapproval of professional organizations such as the AAP and the FDA. The
      WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has
      antioxidant properties and increases cytokine release. The objective of this trial was to
      compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a
      single nocturnal dose of three different honey products compared to placebo
    

Intervention name(s): Eucalyptus honey; Labiatae honey; Citrus honey; Silan date extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.; Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.; Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.; Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: children, cough, honey
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral
      administration.
    


Intervention name(s): Zolmitriptan intranasal.; Zolmitriptan oral.
Intervention type(s): Drug; Drug
Intervention description(s): Zolmitriptan nasal spray is supplied in a single-use, ready-to-use spray unit. It is administered in one nostril. The full protocol will explain how to use it. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.; Zolmitriptan 5 mg orally disintegrating tablet is to be taken without liquids. For oral administration, each tablet will be placed in the top of the tongue without any liquid and will disperse in a matter of seconds, then be swallowed with saliva. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analgesic Use for Pain Relief in Scorpion Sting
Condition: Scorpion Stings
MeSH terms: Bites and Stings; Scorpion Stings
Study type: Interventional

Summary: 
      In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians
      need to relieve this pain quickly.
    

Detailed description: 
      Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen
      trometamol and topical lidocaine will be compared in patients presenting with pain after
      scorpion sting.

      Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a
      tertiary emergency department. Adult patients who applied to the study with no systemic
      findings after scorpion sting and especially with pain will be randomly assigned to one of 4
      groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order
      to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the
      time of admission to the emergency department, at the 30th minute and at the 60th minute.
      Afterwards, the VAS score changes between the groups will be compared.
    

Intervention name(s): paracetamol; Dexketoprofen Trometamol; Lidocaine topical; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg intravenous paracetamol in 100 mL normal saline; 50 mg intravenous dexketoprofen Trometamol in 100 mL normal saline; Application of 5 gr of 5% topical lidocaine; 100 mL intravenous normal saline infusion+ placebo topical pomade application
Other intervention name(s): Paracerol (paracetamol); Revafen(Dexketoprofen Trometamol); Anestol pomade(lidocaine); Placebo(intravenous normal saline+placebo topical pomade)
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Ketoprofen; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
Condition: Hypertension; Stroke
MeSH terms: Stroke; Ischemic Stroke; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker)
      and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood
      pressure in hypertensive patients with a previous ischemic stroke.
    

Detailed description: 
      Design: Multi-center, randomized, double-blind, active control, titrated dose,
      non-inferiority trial

      Population Studied: We will prospectively recruit 250 hypertensive patients who had ischemic
      stroke 2 or more weeks previously and were admitted at 7 centers in the Seoul metropolitan
      area in South Korea.

      Interventions: After a 2-week washout period, all patients will undergo baseline 99mTc-HMPAO
      single photon emission computed tomography (SPECT), blood pressure evaluation, NIHSS
      examination, and laboratory test prior to treatment. The patients will be randomized to
      receive either cilnidipine 10-20mg or losartan 50-100mg once daily for 4 weeks with a target
      systolic blood pressure of < 140mmHg and diastolic blood pressure of < 90mmHg. After 4-week
      treatment, all patients will receive follow-up SPECT and blood pressure evaluation. For the
      quantitative CBF analysis, SPECT will be performed with a single machine in one center.

      Outcome Measures: Primary outcome measure is the percentile change of global CBF on SPECT
      between pre- and post-treatments. Secondary outcome measures include the percentile change of
      regional CBF, the proportion of patients less than 8.6% decrease of global CBF, and the
      change of NIHSS score.
    

Intervention name(s): cilnidipine
Intervention type(s): Drug
Intervention description(s): Cilnidipine 10~20mg, qd, po for 4 weeks.
Other intervention name(s): Arms: Losartan, Cilnidipine; Cinalong
Intervention MeSH terms: Losartan; Cilnidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHERISH; Ischemic Stroke
Effect of Acetazolamide on Exercise Performance in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)
      vs. placebo on exercise performance at altitude in patients with COPD.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on exercise performance in lowlanders with
      chronic obstructive pulmonary disease travelling to altitude. Participants living in the
      Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high
      altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo),
      will be administered 24 hours before departure at 760 m and during the stay at altitude.
      Outcomes will be assessed during the stay at 3200 m.

      Exercise performance will be evaluated by maximal cycling spiroergometry and constant load
      ergometry.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise performance; maximal spiroergometry; airway disease; emphysema; prevention; acetazolamide; altitude
A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
Condition: Healthy Volunteer; Atopic Dermatitis; Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Dermatitis, Atopic; Dermatitis; Eczema; Hidradenitis
Study type: Interventional
Phase: Phase 1

Summary: 
      KT-474 is an oral heterobifunctional small molecule IRAK4 degrader being developed for the
      treatment of interleukin-1 receptor (IL-1R)/toll-like receptor (TLR)-driven
      immune-inflammatory diseases. This first-in-human (FIH) study will characterize the safety,
      tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and
      multiple ascending doses of KT-474 in healthy volunteers and patients with atopic dermatitis
      (AD) or hidradenitis suppurativa (HS). The effects of food on the absorption of KT-474 will
      also be evaluated in healthy volunteers.
    

Detailed description: 
      This is a first-in-human (FIH), Phase 1 randomized, placebo-controlled, single and multiple
      ascending dose trial of KT-474 that will characterize the safety, PK and PD of orally
      administered KT-474 after a single dose (Part A) and after repeated dosing first in healthy
      adult volunteers (Part B) and then in patients with AD or HS (Part C). Initially, a dose
      range of KT-474 in single ascending dose (SAD) escalation cohorts will be explored in healthy
      subjects. Up to five single dose cohorts of healthy subjects is also planned to understand
      food effects (FE) on the PK of KT-474. Enrollment of healthy subjects into 2-week multiple
      ascending dose (MAD) escalation cohorts will be initiated once sufficient safety and PK data
      from multiple SAD cohorts are available to inform the safe starting dose for the 2-week MAD
      portion of the study. After the MAD portion in healthy subjects is completed, the safety, PK,
      and PD of a dose of KT-474 that was found to be safe in healthy subjects when administered
      for 2 weeks will then be evaluated in AD or HS subjects for 28 days of dosing. Separately,
      additional multiple dose cohorts evaluating once every other day and/or twice weekly dosing
      schedules at or below previously evaluated dose levels in healthy volunteers may be
      initiated.
    

Intervention name(s): KT-474/Placebo; KT-474
Intervention type(s): Drug; Drug
Intervention description(s): KT-474 or matching placebo oral tablet(s); KT-474 oral tablet(s)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Hidradenitis Suppurativa; Immune-inflammatory diseases
Protein Supplementation and Muscle Recovery in Football
Condition: Skeletal Muscle Damage; Muscle Inflammation; Muscle Recovery; Soccer Performance
MeSH terms: Myositis; Inflammation
Study type: Interventional

Summary: 
      Soccer is an intermittent sport including a high number of powerful actions such as
      accelerations, decelerations, changes of direction, jumps and impacts that incorporate a
      strong eccentric component and may therefore lead to skeletal muscle damage. Indeed, match
      activity is associated with the onset of muscle damage and an acute inflammatory response
      that result in attenuated performance for as long as 1 to 3 days. In competitive soccer
      though, multiple matches are performed within a small-time frame resulting in inadequate
      muscle recovery and reduced field performance. Supplementation with milk proteins following
      intense exercise protocols has been shown to stimulate protein synthesis and facilitate
      muscle recovery. Thus, the aim of the present investigation is to examine the effects of milk
      protein supplementation on muscle recovery and soccer-specific performance during an
      in-season microcycle with two matches performed three days apart.
    

Detailed description: 
      In a double-blind, cross over, repeated measures design 20 men soccer players will receive
      either placebo (PLA) or milk protein isolate (PRO, 80% casein-20% whey) throughout recovery
      following two matches performed three days apart. On match days, players will receive a dose
      immediately after the match (PLA vs PRO: 25g of protein) and then at 3h (PLA vs PRO: 30g of
      protein) and 6h (PLA vs PRO: 25g of protein) post-match. On each day of the remaining days,
      players will consume a single dose of PLA or PRO (20g of protein) with breakfast. All players
      will participate in regular in-season training following matches. Field activity during both
      matches and daily practices will be monitored using GPS devices. Heart rate will be
      continuously recorded during each match and training session. Blood samples will be collected
      at baseline as well as 2 hours after the first match, daily for three days after the first
      match, 2 hours after the second match and daily for 3 days after the second match.
      Performance (isokinetic strength, 20-m speed, repeated sprint ability) and muscle soreness
      will be assessed at baseline daily for 3 days after both matches. Muscle biopsies from vastus
      lateralis will be collected at baseline and one day after each match.
    

Intervention name(s): Milk protein isolate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water; 500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a laboratory-based hypnosis session
      compared to an attention control condition on peripheral blood flow, autonomic stress
      responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and
      examine how perceived disease-related stigma may affect these responses.
    


Intervention name(s): Hypnosis; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.; A 30-minute historical story read by a research clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescence; Autonomic Nervous System; Hypnosis; Pain; Sickle Cell Disease
Respiratory Physiotherapy After Cardiac Surgery
Condition: Functional Disturbance Following Cardiac Surgery
Study type: Interventional

Summary: 
      Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac
      surgery patients, the breath-stacking technique has been proposed as an alternative to
      increase pulmonary volumes in the post-operative period.

      Objective: To compare inspiratory volume and electromyographic activity of respiratory
      muscles during breath stacking technique and incentive spirometry in patients undergoing
      cardiac surgery.
    

Detailed description: 
      The purpose of the present study are:

        1. to evaluate and compare the inspiratory volume during the course of Breath Stacking and
           Incentive Spirometry techniques in patients submitted to myocardial revascularization
           surgery.

        2. to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and
           diaphragm muscles during both techniques.
    

Intervention name(s): Breath Stacking
Intervention type(s): Behavioral
Intervention description(s): To perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds.
Other intervention name(s): respiratory exercises
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physiotherapy; cardiac surgery; breath Stacking