bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacogenetics of Alcohol: Treatment Implications
Condition: Alcohol Related Disorders; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Alcohol-Related Disorders
Study type: Interventional

Summary: 
      This study will explore the hypothesis that effects of alcohol are in part mediated by
      increased production of neuroactive steroids, which interact with GABAA-receptors. We propose
      to study non-dependent drinkers using a 4-session within-subjects design in which alcohol /
      placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid
      reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the
      5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.
    

Detailed description: 
      Alcohol has multiple pharmacological effects, though which of these effects relate to the
      risk of alcohol dependence is not clear. Animal studies indicate that the neuroactive steroid
      allopregnanolone is an alcohol-modulated endogenous agonist at GABAA receptors and that
      genetic variation in steroid 5a-reductase type I gene which generates neuroactive steroids,
      may moderate alcohol effects. To better define the role of neuroactive steroids we will
      conduct a laboratory study of non-alcohol dependent drinkers using a 4-session design in
      which alcohol/placebo beverage is paired with dutasteride/placebo pretreatment. Dutasteride,
      an inhibitor of both type I and type II 5a-reductase enzymes, blocks the production of
      5a-reduced neuroactive steroids. This study will extend our preliminary findings with
      finasteride by including a) a placebo control for alcohol, b) a more specific inhibitor of
      both 5a-reductase isoenzymes, c) a larger group of subjects (including both light and heavy
      drinkers).
    

Intervention name(s): dutasteride + ethanol; placebo medication + ethanol; dutasteride + placebo alcohol; placebo medication + placebo alcohol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes; placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes; 4 mg dutasteride administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes; placebo medication administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes
Other intervention name(s): Avodart; Avodart
Intervention MeSH terms: Ethanol; Dutasteride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: steroid 5Alpha Reductase; dutasteride; neuroactive steroid
Financial Incentives to Improve Asthma
Condition: Asthma in Children; Medication Adherence
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of this pilot randomised controlled trial is to assess the effectiveness of a
      short-term financial incentives intervention at bringing about behaviour change, namely
      short-medium term improvements in inhaled corticosteroid (ICS) adherence and asthma control
      in children and young people (CYP) with asthma.
    

Detailed description: 
      After obtaining informed consent from parents (and assent from the CYP), CYP will be enrolled
      in a 24-week programme. All participants will receive an electronic monitoring device (EMD)
      which will be programmed with twice daily audio-visual reminders and will be required to
      download the EMD-associated App onto their smartphones. All participants will be required to
      attend 3 study visits at 0 weeks (baseline), 12-weeks and 24-weeks (follow-up).

      At baseline participants will be assessed for inhaler technique and given an asthma action
      plan (if they do not have one already) and will be randomised to either the control group or
      the intervention group. Intervention period will run between study visit 1 (0-weeks) and
      study visit 2 (12-weeks). Over the intervention period, participants in the intervention
      group will use their EMD with reminders, but will also be given financial incentives
      dependent upon their daily adherence and will have access to some additional EMD-associated
      app features (including notifications, a reward totaliser and a traffic light calendar to
      monitor progress). Control group participants will receive their usual care plus the use of
      EMD with reminders over the intervention period.

      After the intervention period (at study visit 2), intervention participants will no longer
      receive rewards or be able to access the additional app features. All participants (control
      and intervention) will be able to use their EMD with reminders for the final 12-week
      follow-up period.

      After completion of the 24-week programme, all participants will be required to return their
      EMD devices and will be invited to a focus group to share experiences and feedback of the
      trial.
    

Intervention name(s): Financial incentives
Intervention type(s): Behavioral
Intervention description(s): Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Electronic monitoring device; Financial incentives; Reminders; Asthma control
Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection
Condition: Dexmedetomidine; Perioperative; Electrolyte
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Dexmedetomidine is a highly selective alpha2-adrenergic receptor agonist with sedative,
      analgesic, anti-anxiety, and inhibitory sympathetic nerve excitation properties. It is
      commonly used in clinical anesthesia and intensive care.Radical gastrectomy for
      gastrointestinal malignant tumors is a common major operation in clinical practice, with long
      operation time, great trauma and strong stress response of patients. Dexmedetomidine is often
      used in general anesthesia during such operations, but its long-term use or large dose may
      produce certain side effects.Common side effects of dexmedetomidine include bradycardia and
      hypotension, etc. Previous studies have reported that dexmedetomidine can prolong QT interval
      and is at risk of causing tip torsion type ventricular tachycardia.Abnormal Potassium may
      affect myocardial repolarization and increase the risk of tip torsion ventricular
      tachycardia.The main purpose of this study was to observe the effects of long-term use of
      dexmedetomidine on perioperative internal environment such as electrolyte and rehabilitation
      indicators during radical general anesthesia for gastrointestinal malignancy, and the
      secondary purpose was to explore the optimal dose of dexmedetomidine for general anesthesia
      for patients undergoing radical general anesthesia for gastrointestinal malignancy.
    


Intervention name(s): Dexmedetomidine; Dexmedetomidine; Dexmedetomidine; Normal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrolyte and quality of recovery of the patients; The loading dose with 1.0 μg/kg, maintenance dose with 0.25 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patient; The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patients; Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Electrolyte; Haemodynamics; Rehabilitation; Internal environment
Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention
Condition: Tobacco Smoking
Study type: Interventional

Summary: 
      The prevalence of tobacco smoking is high among persons with HIV (PWH). The investigators are
      piloting a two session computer-delivered intervention (CBI) with linkage to a community
      health worker (CHW) among hospitalized PWH with tobacco use 1a) To determine feasibility and
      acceptability of delivering this intervention and 2a) To determine intervention effect on 1)
      readiness to quit smoking and confidence in ability to quit smoking 2) uptake of smoking
      cessation therapy
    


Intervention name(s): CBI-CHW; Standard Care
Intervention type(s): Behavioral; Other
Intervention description(s): 2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks; Standard tobacco treatment care offered by the inpatient care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Condition: Infant Respiratory Distress Syndrome; Respiratory Insufficiency; Apnea of Prematurity
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test whether application of high frequency ventilation
      through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
    

Detailed description: 
      Prolonged mechanical ventilation is frequently needed to treat respiratory insufficiency and
      apnea in very low birthweight (VLBW, <1500 g) preterm infants. Endotracheal intubation and
      mechanical ventilation carry many risks including potentially fatal air leaks and
      ventilator-associated pneumonias. Less-invasive methods of respiratory support are needed to
      minimize these risks while supporting the convalescing preterm infant. We propose to test the
      effectiveness of nasal high-frequency ventilation (NHFV) in stable neonates with mild
      respiratory acidosis who are dependent on nasal continuous positive airway pressure for
      respiratory support (CPAP). Nasal high frequency ventilation may be effective in decreasing
      rates of reintubation for apnea or respiratory insufficiency in VLBW infants. We will enroll
      60 stable VLBW infants who are currently being treated with nasal CPAP and who have mild
      respiratory acidosis. Twenty patients will be assigned to each ventilator under
      investigation. Nasal high frequency ventilation will be applied at the same mean airway
      pressure as the patients' previous CPAP support. The amplitude on nasal high frequency
      ventilation will be adjusted to achieve adequate shaking of the chest wall. Blood gas
      measurements, transcutaneous continuous pCO2 monitoring, continuous pulse oximetry, and chest
      x-rays will be used to assess safety and efficacy. Study power has been calculated to detect
      a difference (drop or rise) in partial pressure of CO2 (pCO2) equal to two-thirds of the
      standard deviation of pCO2 change reported in another study (van der Hoeven et al., 1998),
      which is a clinically relevant difference.
    

Intervention name(s): Nasal high frequency ventilation
Intervention type(s): Other
Intervention description(s): use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: premature infants; very low birthweight infants; high frequency ventilation; nasal ventilation
Study for the Treatment of Crohn's Disease With Adacolumn
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn
      Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
    

Detailed description: 
      Trial Features:

        -  Medical device (Non-drug option)

        -  Most patients can remain on current treatment regimen throughout the study

      Components of the Study:

        -  Study length is 24 weeks, which includes a screening visit, ten treatment visits over
           nine weeks and 4 follow-up appointments

        -  Physical exams, laboratory tests and disease assessments conducted at no charge to the
           patient

        -  2:1 Randomization (treatment:sham)

        -  Open-Label extension offered to eligible patients
    

Intervention name(s): Adacolumn; Sham
Intervention type(s): Device; Device
Intervention description(s): Ten apheresis sessions:
One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).; Sham, ten apheresis sessions within 9 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease
Opioid Analgesia for MAB
Condition: MAB; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose
      recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared
      to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study
      will help future providers understand whether prescribing opioids are an important adjunct
      for pain control in women undergoing MAB.
    

Detailed description: 
      This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg
      oral versus placebo and stratified by gestational age (<7wks, 7-10wks). The primary outcome
      will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol
      administration.
    

Intervention name(s): Oxycodone 10mg oral; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion; Placebo given in addition to standard of care medications in women undergoing medical abortion
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution
      when compared to Placebo in subjects diagnosed with mild or moderate myopia.

      To investigate the dose response of DE-127.
    


Intervention name(s): DE-127 Ophthalmic Solution low dose; DE-127 Ophthalmic Solution medium dose; DE-127 Ophthalmic Solution high dose; Placebo Ophthalmic Solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months; Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months; High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months; Placebo Ophthalmic Solution dosed once daily for 12 months
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sprint Performance in Football Players With a Previous Hamstring Injury
Condition: Sprint Performance; Hamstring Injury
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Few studies indicate that sprint performance may be impaired in football players with a
      previous hamstring strain injury. This exploratory cross-sectional study aim to compare
      sprint performance between football players with and without a previous hamstring strain
      injury. The findings may elucidate potential indications of insufficient rehabilitation
      following a hamstring strain injury.

      Sprint performance data will be collected using the MySprint Iphone Application.

      Due to pragmatic reasons and the exploratory nature of this study the aim is to include
      players on a team level.

      Based on the prevalence of hamstring strain injuries the expected number of cases to be
      included are 10-20 football players with a previous hamstring strain injury, and a
      corresponding 80-90 number of healthy controls.

      No outcomes will be weighted (flat outcome structure).
    


Intervention name(s): Repeated-sprint test
Intervention type(s): Other
Intervention description(s): 6x30-meter sprint interspersed with 90-s rest
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Danish competitive football players
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
Condition: Post-prandial Glycemia
Study type: Interventional

Summary: 
      The aim of this study is to test the effects of Mulberry leaf extract on glucose response of
      a standardized complete meal when taken just before or when mixed with the meal.
    


Intervention name(s): Mulberry leaf extract; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smartphone-based Stress Management Intervention for Employees
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Participants were able to use the application the investigators developed for four weeks.
      With the application, the participants were able to monitor their stress level and life style
      patterns. The participants were also provided personalized stress management techniques
      including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation
      techniques-abdominal breathing, progressive muscular relaxation, and meditation-were
      incorporated. Participants' mental health status and life style patterns were evaluated at
      baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting
      for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score
      and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary
      outcome measures.
    


Intervention name(s): Stress guide
Intervention type(s): Behavioral
Intervention description(s): smartphone-based application that can evaluate stress level and teach how to manage their stress
Intervention model: Single Group Assignment
Intervention model description: Healthy individuals recruited through advertisement
Masking: None (Open Label)
Primary purpose: Supportive Care
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Condition: Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
MeSH terms: Cryptorchidism
Study type: Interventional

Summary: 
      Caudal block is one of the most effective modalities to reduce pain both during and after the
      surgery involving areas under the umbilicus. According to previous research,
      0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in
      children. Despite the fact that this high dose of dexamethasone is used to treat airway edema
      in actual practice and no adverse side effect related to dosage has been reported, it is 3 to
      15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care
      of anesthesia. Therefore, our study aims to assess the effect of the more practical,
      antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal
      block through a non-inferiority trial.
    


Intervention name(s): High dose dexamethasone; Low dose dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone; After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: caudal block; low dose dexamethasone; postoperative pain