bioihbjkbjnl/mcl2 huggingface dataset:
Mastiha Treatment for Obese With NAFLD Diagnosis
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in
      Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due
      to the lack of specialized treatment, many new efforts focus on exploring alternative,
      non-pharmacologic means for managing the disease, including bioactive substances in fruits,
      vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a
      great variety of bioactive phytochemical compounds and demonstrates antioxidant,
      antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the
      contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis
      that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4
      centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical
      trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been
      conducted. The effectiveness of the proposed intervention will be evaluated via clinical and
      laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at
      correlating genetic and epigenetic markers with metabolomic and intestinal microbiota
      profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be
      allocated to either verum or placebo group. Duration of the intervention will be 6 months and
      the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning
      and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body
      composition, dietary habits, physical activity, family history and smoking status will be
      assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation,
      as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the
      metagenome profile will be examined in stools. Both groups will receive counselling to allow
      for body weight regulation up to 5%. Compliance will be assessed monthly and side effects
      will be reported.
    


Intervention name(s): Mastiha; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Mastiha is a natural product of Greece and has a license of manufactures Foods for Particular Nutritional Uses and of National Organization of Medicines (EOF).; Placebo is designed to have identical characteristics with verum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Boostrix™10 Years After Previous Booster Vaccination
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a
      dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa
      in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to
      participate in this study.This protocol posting deals with objectives & outcome measures of
      the booster phase. The objectives & outcome measures of the primary phase are presented in a
      separate study (see reference).
    

Detailed description: 
      All subjects will receive a booster dose of the vaccine that they received in their primary
      study. Subjects who received the investigational vaccine formulation, will receive Boostrix™
      in the present study.
    

Intervention name(s): Boostrix™; Boostrix™-US formulation
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular, single dose; Intramuscular, single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immune persistence; Boostrix; dTpa booster study
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
Condition: Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      This study is designed to assess the effect of oligofructose administration for 12 weeks on
      Body Mass Index (BMI) of overweight and obese children.
    

Detailed description: 
      The prevalence of childhood overweight and obesity is reaching epidemic proportions. There
      have been no effective methods for preventing or treating obesity in childhood so far
      prompting interest in new interventions. One potential option for obesity prevention is the
      use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet
      enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower
      level of triglycerides . A similar effect has been observed in healthy adults. Available
      evidence suggests that the addition of oligofructose to the diets of overweight or obese
      adults may increase satiety and thus reduce energy intake. Currently, there are no data on
      the effect of oligofructose in overweight and obese children.
    

Intervention name(s): Oligofructose; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks; Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
Other intervention name(s): Orafti P95, Beneo-Orafti, Belgium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Satiety; Oligofructose; Prebiotic
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial
      evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses
      (Part B) of CVL-354.
    


Intervention name(s): Drug: CVL-354; Drug: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution/suspension; Oral solution/suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A of the trial is a double-blind, randomized, placebo-controlled 4-period, 4-sequence, crossover design to evaluate the PK, safety, and tolerability of single doses of CVL-354 in healthy participants. Except for a potential food effect period, all treatments will be administered under fasted conditions.
Part B of the trial is a double-blind, randomized, placebo-controlled trial to evaluate PK, safety, and tolerability of CVL-354 in multiple ascending doses.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Healthy Volunteer; Mental Disorders
REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks
Condition: Postoperative Pain; Craniotomy; Dexamethasone; Scalp Nerve Blocks
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to
      an increased risk of postoperative complications. Most pain following craniotomy arises from
      the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local
      anesthesia seem to provide effective, safe, however transient postoperative analgesia which
      does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has
      been observed to significantly prolong the duration of analgesia of nerve blocks (e.g.,
      saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus
      nerve block). On the contrary, a study reported that perineural dexamethasone did not appear
      to prolong the analgesic time after supratentorial craniotomy. However, all patients in this
      study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during
      the perioperative period, which possibly masked the role of single local low doses of
      perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp
      nerve blocks without the backdrop of perioperative glucocorticoid deserves further
      clarification.
    


Intervention name(s): Bupivacaine; Dexamethasone combined with bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): The control group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus normal saline 1 ml. The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.; The DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus 4 mg dexamethasone (1 ml). The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
Condition: Physical Fatigue; Return to Sport; Injury Prevention; Functional Performance
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The main objective of this project is:

      1. To assess the influence of physical fatigue on a return-to-play test battery in a healthy
      population. In a later stage, these experiments could be carried out in a clinical context
      (e.g. in an ankle sprain population).

      The researchers will use a randomized, placebo controlled, counter-balanced, cross-over
      design. Twenty healthy subjects will visit the lab 3 times. On the first visit
      (familiarisation trial), the investigators will collect the participants' characteristics.
      The participants will also be familiarized to the procedures and materials of the experiment
      during this first visit. The second and third visit contain the experimental setup and will
      proceed as follows: first, the participants will fill in a pre-test checklist, a mental
      fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected
      from the ear lobe to determine lactate and glucose levels; also, blood pressure will be
      checked. Next, the subjects will carry out a functional test battery (hop test, vertical jump
      test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion
      (SRPE) is measured to indicate how fatigued the participants feel due to the test battery;
      also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These
      measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate
      protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards,
      researchers will collect blood lactate, glucose and blood pressure two times more;
      participants have to fill in M-VAS (2x), perform the same test battery, and fill in the SRPE
      scale one more time.

      Heart frequency will be measured continuously during the trials.
    


Intervention name(s): Physical Fatigue; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Maximal cycling effort for 30s (Wingate modified); time-matched task (sitting on the bike without pedalling)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Randomized Study of Hormonal Regulation of Infantile Hemangioma
Condition: Hemangioma
MeSH terms: Hemangioma
Study type: Interventional

Summary: 
      OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone
      agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring
      hemangiomas.

      II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the
      safety of GnHRa in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified
      according to gender and by position of the lesion (periorbital vs nonperiorbital).

      All patients receive oral prednisone daily for 3 weeks. Patients are then randomized to
      receive either placebo or leuprolide IM every 3 weeks, while continuing oral prednisone.
      Tumors are assessed at 1, 3, and 6 weeks. If the tumor is not responding, the leuprolide will
      be administered every 2 weeks. Tumors are reassessed at 3 and 6 months, at which point the
      treatment is stopped. Responding patients are observed every 3 weeks for 3 months. If the
      tumor begins to grow again, leuprolide may be administered for another 3 months. Patients
      whose tumors grow rapidly during treatment may crossover to the alternate therapy, repeat the
      leuprolide or prednisone therapy, or undergo surgical excision.
    

Intervention name(s): leuprolide; prednisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prednisone; Leuprolide
Allocation: Randomized
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; hemangioma; rare disease
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to
      HGP1705 in Healthy Volunteers
    

Detailed description: 
      A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety,
      Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
    

Intervention name(s): HIP1802; HGP1705
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, double-blind, placebo and positive-controlled, randomized, partial
      6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401
      (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.
    


Intervention name(s): CEP-26401; donepezil hydrochloride; modafinil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.; Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated; modafinil 200 mg tablet, over-encapsulated; Placebos formulated to match each active drug
Other intervention name(s): Irdabisant; Aricept; Provigil
Intervention MeSH terms: Modafinil; Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Irdabisant; cognitive impairment
Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)
Condition: Seasonal Affective Disorder (SAD)
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective
      disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under
      debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate
      the neural networks of the human brain and improve cognitive performance in healthy subjects.
      Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the
      investigators will study the effect of transcranial bright light treatment via ear canals on
      depressive and anxiety symptoms in patients suffering from SAD in randomized controlled
      double-blind study design.
    


Intervention name(s): Transcranial bright light therapy; Transcranial placebo treatment
Intervention type(s): Device; Device
Intervention description(s): The bright light treatment was given transcranially via ear canals by using bright light device. The bright light was produced using two light-emitting diodes (LEDs). The bright light was transmitted into both ear canals by an optical fibre. Daily 12 minutes TBL was taken at home during forenoon.; The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Social Media Alcohol Intervention
Condition: Drinking Behavior; Risky Drinking
MeSH terms: Drinking Behavior
Study type: Interventional

Summary: 
      Social media provides frequent interaction with online social networks, increasing exposure
      to peer influences, which could affect alcohol use in negative or positive ways. The proposed
      study will recruit adolescents and emerging adults using social media ads, and conduct online
      screening, enrolling 975 risky drinkers in a randomized controlled trial comparing three
      conditions: 8-week Social Media Intervention + Incentives, 8-week Social Media Intervention
      Only, and an e-news attention control condition. These innovative design features will
      provide the critical next step in harnessing social media to reduce alcohol misuse, which
      could have enormous public health impact by altering the alcohol use trajectories of youth.
    

Detailed description: 
      The proposed study will recruit adolescents and emerging adults (ages 16-24) using social
      media ads and conduct online screening, enrolling 975 risky drinkers (i.e., using AUDIT-C
      screener) in a randomized controlled trial (RCT) comparing three conditions: 1) Social Media
      Intervention + Incentives (n=325), 2) Social Media Intervention Only (n=325), and 3)
      Attention Control E-News condition (n=325), with post baseline follow-up assessments at 3, 6,
      and 12 months. Interventions will include access for 8 weeks to unique, secret group pages
      facilitated by e-coaches (supervised by therapists), with dynamic content emphasizing
      reducing alcohol use/misuse as well as concomitant risk behaviors (other drug use based on
      co-ingestion and common motives for use).
    

Intervention name(s): SMI + I; SMI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This 8-week social media based intervention consists of e-coaches delivering positive content to facilitate peer interaction. Participants will earn incentives for interaction during the intervention (8 weeks).; This 8-week social media based intervention consists of e-coaches delivering positive content to facilitate peer interaction. This group will NOT receive incentives for their participation in the secret group.
Other intervention name(s): Social Media Intervention + Incentives; Social Media Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Alcohol; Teens; Young Adults; Social Media
Infections Associated With the Use of Alemtuzumab
Condition: Patients Treated With Alemtuzumab
Study type: Observational

Summary: 
      The aim of this study is to propose infection prophylaxis from Asian multinational
      retrospective analysis of infectious complications in patients who were treated with
      alemtuzumab
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients received alemtuzumab as a treatment for hematologic malignancy
      
Keywords: alemtuzumab, infection, prophylaxis, treatment
Sex Differences in Risk for Alcohol Abuse
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This study will determine the neural and hormonal mechanisms underlying sex differences in
      sensitivity to the disinhibiting effects of alcohol in heavy drinkers.
    

Detailed description: 
      Alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual
      and society at large. Knowing who is at risk for alcohol abuse, and why, is crucial for the
      development of effective prevention and treatment strategies. Alcohol abuse has been
      traditionally considered a male-oriented problem and as a consequence research on risk
      factors specific to women has been minimal. However, the sex gap in substance abuse is
      closing rapidly, and findings from both animal and human studies suggest that females are
      actually more vulnerable to drug use than males. As such, there is an urgent need to identify
      sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention
      and treatment efforts. One clear candidate risk factor is poor inhibitory control, both in
      terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of
      alcohol. Recent studies suggest that sex hormones affect inhibitory control in drug-free
      individuals, potentially contributing to sex differences in baseline levels of inhibition.
      However, the degree to which fluctuations in sex hormones influence sex differences in
      inhibition-related brain function in sober and intoxicated individuals is not known. The
      proposed project will determine the neural and hormonal mechanisms underlying sex differences
      in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

      The overall objective of the research is to identify hormonal determinants of alcohol effects
      on brain activation during response inhibition (BARI) in young adult female and male
      drinkers. BARI will be assessed using functional magnetic resonance imaging (fMRI) during
      performance of the stop signal task. This task reliably activates right-lateralized
      prefrontal regions implicated in inhibitory control. This study will assess BARI during IV
      alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal
      phases and in men at matched intervals.
    

Intervention name(s): Alcohol
Intervention type(s): Drug
Intervention description(s): Alcohol will be administered by IV infusion (60mg%). Brain activation during response inhibition (BARI) will be assessed using fMRI during performance of the stop signal task.
Other intervention name(s): ethyl alcohol
Intervention MeSH terms: Ethanol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: brain activation during response inhibition; BARI; fMRI; stop signal task; sex difference; menstrual; inhibitory control