bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Smoking Among Individuals With PTSD
Condition: Cigarette Smoking; Nicotine Dependence; Post-traumatic Stress Disorder; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effect of combining prolonged exposure, a cognitive-behavioral
      treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and
      counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month
      treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged
      exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the
      end of treatment and 6-month follow-up.

      We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease
      in cigarettes smoked will be greater among participants who receive the combined treatment
      for both PTSD and smoking.
    


Intervention name(s): Varenicline; Medication Management Counseling; Prolonged Exposure
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): 1 mg tablets, orally, twice daily x 12 weeks; 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation; 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Other intervention name(s): Chantix; Cognitive-Behavioral Therapy
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Anxiety; Behavior Therapy; Varenicline
Cholesterol-lowering Effects of Plant Stanol Ester
Condition: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Interventional

Summary: 
      Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.
      LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well
      known.
    


Intervention name(s): Plant stanol ester; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Smoothie that contains plant stanol ester; Smoothie that contains placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms
Condition: Metabolism; Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study are:

        1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and
           caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism

        2. to evaluate gender differences in the human pharmacology of MDMA

        3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects
           and pharmacokinetics of MDMA.
    


Intervention name(s): MDMA
Intervention type(s): Drug
Intervention description(s): One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
Other intervention name(s): Ecstasy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MDMA,; pharmacokinetics,; pharmacodynamics,; CYP2D6, COMT,; SERT, 5-HTTLPR, gender,; dextromethorphan,; caffeine.
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
Condition: Chronic Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is aimed at the efficacy and safety evalutation of the study treatments through a
      2-weeks study period and the subsequent follow-up-
    

Detailed description: 
      This multicenter, prospective, randomized, controlled trial will be conducted on 120
      infants-children with a diagnosis of chronic functional constipation according to the
      definition of Criteria of Rome III. The enrolled subjects will be randomized according to an
      electronically generated randomization list in 2 groups: one group will receive micro-enemas
      of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) .
      Children will receive the dedicated treatment for two weeks and then undergo a follow-up
      period of a maximun of 6 weeks.

      The hypothesis is that the protective micro-enema will help achieving regular evacuation by
      its local antinflammatory non-pharmacological action. This hypothesis is based on the finding
      that local anal inflammation can cause functional constipation due to discomfort and pain
      during evacuation or by influencing reflexes.
    

Intervention name(s): micro-enema with Promelaxin; Macrogol 4000
Intervention type(s): Device; Drug
Intervention description(s): The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.; Stool softener
Other intervention name(s): Melilax; Paxabel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized between two treatment arms
Masking: None (Open Label)
Primary purpose: Treatment
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil)
      IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics
      based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept®
      (donepezil hydrochloride) tablet by PK modeling.
    


Intervention name(s): GB-5001; Placebo; Oral cohort
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Depending on the cohort, volume will be varied to administer.; A matched volume of placebo product will be administered to each subject in each cohort.; Single dose of Aricept tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exposure, Dose, Body Burden and Health Effects of Lead
Condition: Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning
Study type: Observational

Summary: 
      This is a study of the effects that lead has on the health of the central nervous system (for
      example, memory), peripheral nervous system (for example, sensation and strength in the hands
      and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead
      workers and 135 persons without occupational lead exposure are being studied in South Korea.
      Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate
      of lead in the tissues), and lead in bone. Subjects are tested three times each over three
      years. Several genetic factors are also being assessed for the role they play in the health
      effects of lead. These genes are known to differ among individuals. We are interested to know
      whether different forms of the same genes can modify the effect lead has on health.
    


Time perspective: Prospective
Keywords: lead poisoning; central nervous system; peripheral nervous system; occupational health; genetic susceptibility
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to examine the safety, tolerability, and pharmacokinetics of single- and
      multiple-ascending doses of ACT-777991 in healthy subjects.
    


Intervention name(s): ACT-777991 (SAD); ACT-777991 (MAD); Placebo (SAD); Placebo (MAD); 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability); Microtracer matching placebo (SAD - Absolute Bioavailability); 14C-ACT-777991 microtracer (MAD - ADME); Microtracer matching placebo (MAD - ADME)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ACT-777991 administered as hard capsules for oral use.; ACT-777991 administered as hard capsules for oral use, once daily.; ACT-777991 matching placebo administered as hard capsules for oral use.; Matching placebo administered as hard capsules for oral use, once daily.; Single dose of 14C-ACT-777991 microtracer, administered intravenously.; Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.; Single dose of 14C-ACT-777991 microtracer, oral solution..; Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single-center, double-blind, randomized, placebo-controlled Phase 1 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.
    

Detailed description: 
      This study will evaluate:

        -  The safety and tolerability of a single dose of VGX-1027 as determined by: adverse event
           reporting, clinical laboratory results, vital signs, physical examinations, and
           electrocardiograms (ECGs).

        -  The pharmacokinetic (PK) profile of VGX-1027 maximum concentration (Cmax)
    

Intervention name(s): VGX-1027
Intervention type(s): Drug
Intervention description(s): Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Condition: Surgical Procedure, Unspecified
Study type: Interventional
Phase: Phase 2

Summary: 
      Two hundred children aged 1-12 years undergoing short surgery will be randomized into two
      groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol
      with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used.
      Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU)
      will be recorded.
    

Detailed description: 
      Aim of the research: In this study investigators want to examine the effectiveness of the use
      of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on
      the postoperative recovery of pediatric patients. Investigators will evaluate the safety,
      efficacy, and outcomes of the anesthesia procedure with respect to the administration of
      different anesthetics, specific pharmakocinetic profiles and compare the length of recovery
      between patients in two groups.

      Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

      Primary and secondary outcome measures: The primary outcome of this study will be extubation
      time and the secondary outcome will be time spend in PACU.

      Description of the study: Each subject included in the study will be given general anesthesia
      with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will
      be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% /
      50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio
      of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1
      ml of 2% lidocaine for the second group of patients. After extubation, patients will be
      transferred to the PACU.
    

Intervention name(s): ketamine, propofol; ketamine, propofol, lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): anesthesia with ketofol in pediatric surgery; anesthesia with ketofol plus lidocaine in pediatric surgery
Intervention MeSH terms: Lidocaine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277
      capsule
    


Intervention name(s): BIBR 277 tablet; BIBR 277 capsule
Intervention type(s): Drug; Drug
Other intervention name(s): Telmisartan; Telmisartan
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
Condition: Disorder of Upper Esophageal Sphincter
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      To see a more convincing relationship between increased body mass index and the severity of
      esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision
      or precision. From the available data, it appears that no studies in Indonesia have
      correlated the body mass index with the severity of esophageal reflux events measured by
      multical intraluminal intraluminal pH-metric in patients with GERD due to the invasive nature
      of the test. Therefore, research needs to be done to assess the effect of increased body mass
      index on the severity of esophageal reflux as measured by multical intraluminal impedance
      pH-metric in GERD patients.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) prevalence is increasing worldwide. It is known that
      GERD correlates with obesity. In order to see further association between obesity and
      severity degree of esophageal reflux, GERD must be diagnosed with greater precision and
      accuracy. Therefore, study to see the impact of obesity in esophageal reflux severity
      measured by multicanal intraluminal impedance pH-meter (MII-pH) in GERD patient is
      compulsory.

      The objective of this study is to explain the impact of obesity on severity of esophageal
      reflux in GERD patient measured by DeMeester score, hiatal hernia incidence, and the
      prolongation of acid exposure time in GERD patient.

      This cross-sectional study recruited patients from Gastroenterology Clinic, Internal Medicine
      Department Cipto Mangunkusumo Hospital during May-August 2017. Patient with normal and obese
      body mass index (BMI) suspected having GERD were surveyed using GERDQ to diagnose GERD in
      these patients. Upper gastrointestinal endoscopy were performed to see hiatal hernia. All
      patients recruited underwent MII-pH examination to measure DeMeester score and acid exposure
      time. Results were analyzed using bivariat analysis.
    

Intervention name(s): MII pH-meter
Intervention type(s): Diagnostic Test
Intervention description(s): using multichannel impedance pH-meter
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with GERD
MR- PET Guided Biologically Optimised Interstitial Brachytherapy
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The proposed two stage study will evaluate patterns of local recurrence after EBRT and
      brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in
      patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The
      first stage of the study will focus on developing MR guided interstitial brachytherapy and
      validating the concept of high risk gross tumor volume (on the basis of functional imaging
      features).

      The second stage thereafter will focus on developing biologically modulated interstitial
      brachytherapy.

      In the proposed two staged study the investigators intend to prospectively evaluate and
      validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy.
      The demonstration of technical feasibility and clinical safety of biologically modulated
      image guided radiotherapy in this pilot study for may pave the way for improving local
      control in patients with postoperative recurrences.
    

Detailed description: 
      Aims

      Stage I

      Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor
      through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

      Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to
      biological heterogeneous sub-volumes on imaging.

      Stage II:

      Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized
      interstitial brachytherapy.

      Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically
      optimized brachytherapy
    

Intervention name(s): MR PET Guided Brachytherapy
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffusion Weighted MRI; FLT PET; F-Miso PET; Image Guided Brachytherapy; Cervix; Postoperative Residual Disease/Postoperative recurrences
Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy
Condition: Cerebral Palsy; Weakness; Hypertonia
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      A newly-developed device for biofeedback of surface EMG will be used to either increase or
      decrease activity in the muscles of children with poor reaching due to cerebral palsy.
    

Detailed description: 
      Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due
      to cerebral palsy will be recruited. A muscle that is either over-active or under-active will
      be selected for each child. The child will be provided with the device to wear for 1 month in
      order to call attention to the identified muscle. At the beginning and end of the month,
      reaching will be assessed using three-dimensional kinematic motion capture. The outcome
      measure will be the speed and curvature of reaching to a target in front of the child.
    

Intervention name(s): surface EMG biofeedback
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with movement disorders, cerebral palsy.
      
Keywords: movement disorders; childhood
Deconditioning of Acquired Food Aversion
Condition: Healthy
Study type: Interventional

Summary: 
      Background. Aversive conditioning impairs the rewarding value of a comfort meal.

      Our aim is to demonstrate the potential effect of deconditioning to reverse aversive
      conditioning and restore the hedonic postprandial response.

      Methods: A sham-controlled, randomised, parallel, single-blind study will be performed on 12
      healthy women (6 per group). The rewarding value of a comfort meal will be measured at
      initial exposure, after aversive conditioning (masked administration of the same meal with a
      high-fat content) and after a deconditioning intervention (unmasking the aversive
      conditioning paradigm in the deconditioning group vs sham intervention in the control group).
      Digestive well-being (primary outcome) will be measured every 10 min before and 60 min after
      ingestion using graded scales. The effect of deconditioning (change from aversive
      conditioning to deconditioning) will be compared to sham deconditioning in the control group.

      Expected results: The comfort meal at first exposure will induce a pleasant postprandial
      experience, which will be impaired by aversive conditioning; this effect will be reverted by
      deconditioning and the hedonic value of the comfort meal will be restored.
    


Intervention name(s): Unmasking previous conditioning procedure; No unmasking of previous conditioning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will be provided.; An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will not be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; deconditioning
GO-ACTIWE Energy Metabolism
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the changes in body composition and the degree
      of compensation to exercise induced energy expenditure after 1 year of physical activity with
      either moderate or vigorous intensity in overweight and class 1 obese men and women. The
      present study is a sub study to main study "Active Commuting To Improve Well-being and Health
      in Everyday Life" (NCT 01962259)
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention