bioihbjkbjnl/mcl2 huggingface dataset:
Neural Account of Social Placebo Effect
Condition: Spray+ Group; Control Group
Study type: Interventional

Summary: 
      The current study aimed to reveal the neural mechanism of social placebo belief formation and
      belief representation, and also investigated how the brain pattern predict the social
      behavior performance under placebo manipulation.
    

Detailed description: 
      Participants were randomly assigned to spray+ group (sprayed with saline but told as
      "oxytocin") and control group (sprayed with saline but told as "saline"). After 10 min,
      participants were invited to the resting-state, text viewing task in fMRI scanner.

      In resting state session, participants with their eyes open and were instructed to attend to
      a black fixation cross centrally presented on a grey projection screen for 8 min (240TR).

      The Text viewing task employed a mixed block and even-related fMRI design. Participants were
      asked to judge whether they could understand the stimuli or not by a button press
      (1=understand; 2=not understand). Three kinds of stimuli were presented in separate block
      including "oxytocin-function", "oxytocin-knowledge", "robot" related stimuli, each category
      contained 20 sentences. In each block, the sentence (within one category) was presented
      pseudo-randomized from 5s to 9s (with mean duration of 7s), then followed by a jittered time
      interval (interval time = sentence duration - response time; if participants made response
      within 5s, the sentence would not disappear until its duration reached 5s). There were two
      sessions with six blocks per session, and there were 5 sentences (trials) per block. The
      order of blocks and sentences were designed to present in pseudo-random order and were
      applied to all participants.
    

Intervention name(s): spray+ manipulation; control manipulation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);; Participants in control group were told they sprayed saline (in fact, it was saline).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: social placebo effect; fMRI; neural account
Treating Clozapine-induced Sinustachycardia With Bisoprolol
Condition: Clozapine-induced Sinustachycardia
Study type: Interventional

Summary: 
      Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and
      sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This
      double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are
      efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate
      variability, QTc and T-wave morphology.
    


Intervention name(s): Bisoprolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bisoprolol "Vitabalnas" 10 mg once daily; placebo
Other intervention name(s): Bisoprolol "Vitabalans"
Intervention MeSH terms: Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clozapine; Sinustachycardia; Heartrate variability; Cardiomyopathy
Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Upper gastrointestinal (GIT) bleeding is common in high risk critically ill patients.
      Hyperacidity has been identified as one of the main reasons for bleeding.1 2 Antacids with
      different treatment modalities have been studied to establish the best regimen for
      prophylaxis against bleeding.3 4 Proton pump inhibitors (PPI) are the most common drugs used
      in the medical field as antacids. The present study was carried out to investigate the
      beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against
      upper GIT bleeding in high risk critically ill patients.
    

Detailed description: 
      A hundred and ten high risk critically ill patients were divided into two groups, fify five
      patients each. Group A received intravenous (IV) omeprazole 40mg bolus dose once daily
      followed by normal saline infusion. Group B received IV bolus of 80 mg omeprazole followed by
      8mg/h infusion. The treatment was for the whole period of ICU stay. Gastric pH, residual
      gastric volume, signs of significant upper GIT bleeding, ICU stay Hb, number of ventilator
      free days, ICU stay haemoglobin (Hb), number of red cell units transfused in ICU, ICU stay,
      and numbers of ICU survivors were recorded.
    

Intervention name(s): Omeprazole; Placebo group
Intervention type(s): Drug; Drug
Intervention description(s): Omeprazole 80 mg continues infusion; Omeprazole 40 mg single daily dose.
Other intervention name(s): Omeprazole continues infusion; Placebo for infusion
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study
Condition: Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Diabetes is key risk factor for death following acute myocardial infarction. However, the
      long-term excess risk of death associated with diabetes following acute myocardial infarction
      not known. Investigators aimed to determine the long-term excess risk of death associated
      with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI
      (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        STEMI and NSTEMI were eligible for analysis if they have been hospitalised following AMI
        between the period of 2003-2013 and were aged at least 18 years. Only records of the first
        admission were considered for analyses.
      
Keywords: Diabetes; ST-elevation myocardial infarction (STEMI); non-STEMI; Excess mortality; Relative survival
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Condition: Nephrocalcinosis; Preterm Infant
MeSH terms: Premature Birth; Nephrocalcinosis
Study type: Observational

Summary: 
      The study aims to assess the incidence and the risk factors of nephrocalcinosis in very
      preterm infants using patient data collected during hospitalisation at the Neonatology
      Centre.
    

Detailed description: 
      Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors
      promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as
      well as functional and morphological kidney immaturity. There is a correlation between the
      prevalence of nephrocalcinosis and low gestational age.

      The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis
      in very preterm infants less than 32 weeks of gestation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is a group of very preterm infants less than 32 weeks of gestation
        during hospitalisation at the Neonatology Centre.
Serum Free Light Change in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the predictive role of free Kappa/Lambda ration in
      Multiple Myeloma post-transplant.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A cohort of patients undergoing autolog transplantatio
      
Keywords: Total kappa and lambda ratio; Stem cell transplantation; Serum immunofixation
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to assess the PK and safety of a single dose of IV and oral
      formulations of lefamulin in adults with CF.
    

Detailed description: 
      Staphylococcus aureus is one of the most common causative pathogens associated with
      exacerbations of CF. Current treatment guidelines for the management of exacerbations of CF
      caused by S. aureus recommend the use of unapproved antibacterial agents. Further, many of
      the recommended treatments can only be administered via the IV route and/or have limitations
      due to safety and tolerability. Lefamulin is a novel, first-in-class, IV and oral
      pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S.
      aureus, including MRSA and strains obtained from patients with CF. Cystic fibrosis patients
      have altered drug distribution and elimination kinetics for many antimicrobials relative to
      patients without CF. While the advent of CFTR modulators has resulted in improved lung
      function and had a positive impact on the quality of life of CF patients, limited data have
      been published describing the impact of the concomitant use of CFTR modulators and commonly
      used antibacterial agents.
    

Intervention name(s): Lefamulin
Intervention type(s): Drug
Intervention description(s): Antibiotic
Other intervention name(s): BC-3781
Intervention MeSH terms: Lefamulin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, Crossover Study
Masking: None (Open Label)
Primary purpose: Other
Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Study will compare measurements made with Necklace device for stroke volume/cardiac output
      with values from a FDA-approved reference device. The gold standard that will be used is
      Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the
      Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the
      reference device and the Necklace.
    

Detailed description: 
      Study will compare measurements made with Necklace device for stroke volume/cardiac output
      with values from a FDA-approved reference device. The gold standard that will be used is
      Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the
      Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the
      reference device and the Necklace.

      The Cardiac MRI will be received ~1-4 days after the measurement is completed. The data will
      be compared with data collected from the Necklace and the reference device during the study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Men and Women between 18 and 85.
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single 125 mg oral dose of the investigational compound PD-0332991 will be administered
      alone and after steady-state dosing of tamoxifen to determine if coadministration of
      tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
    


Intervention name(s): PD-0332991 alone; Tamoxifen 60 mg; Tamoxifen 20 mg; PD-0332991 combination
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1.; On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets).; On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses.; PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose.
Other intervention name(s): PD-0332991, palbociclib; PD-0332991, palbociclib
Intervention MeSH terms: Tamoxifen; Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PD-0332991; palbociclib; tamoxifen; drug-drug interaction (DDI) study
A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, controlled clinical trial of inactivated negative ion generation or
      light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression),
      for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type,
      to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase
      and a 4 week treatment phase.
    

Detailed description: 
      This is a randomized, controlled clinical trial comparing an inactivated negative ion
      generation (placebo condition) and light-emitting photodiode therapy (active condition), for
      Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of
      Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for
      this condition. Exclusion criteria included any other current treatment for SAD, as well as
      bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full
      remission for at least one year. The trial has a 1 week baseline phase and subjects were seen
      weekly during a 4 week treatment phase. The study was double-blind. The study was conducted
      at 8 sites in the US, Canada and The Netherlands.
    

Intervention name(s): Negative Ion Generator; Light-emitting Photodiode light treatment device
Intervention type(s): Device; Device
Intervention description(s): Equivalent exposure to inactivated Negative Ion Generator; Light-emitting Photodiode light treatment device, used for 30 min before 8 am
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAD; winter depression
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Condition: Liver Cirrhosis; Liver Diseases; Hypertension, Portal
MeSH terms: Liver Diseases; Liver Cirrhosis; Hypertension, Portal
Study type: Observational

Summary: 
      The objective of the study is to collect and report technical success of direct endoscopic
      ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip®
      Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.
    


Intervention name(s): EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
Intervention type(s): Device
Intervention description(s): Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cirrhosis referred for an EGD/ EUS
      
Keywords: Fatty Liver; portal pressure measurement; portal pressure gradient
Nabilone & Marijuana Addiction
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Safety of Nabilone in reducing marijuana craving
    

Detailed description: 
      Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of
      marijuana use
    

Intervention name(s): Cesemat
Intervention type(s): Drug
Intervention description(s): 1 mg capsule per day for 21 days
Other intervention name(s): Nabilone
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Efficacy; Marijuana; Reduction; Craving
Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      Neonates undergo several painful procedures and these pain experiences can alter clinical
      outcome and behavior. The investigators aim to investigate the analgesic effect of low level
      laser for procedural pain during heel lancing of term neonates.
    

Detailed description: 
      This open-label, randomized controlled trial involves 130 term newborn infants (gestational
      ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are
      randomly assigned to low level laser group or breast milk group. Subjects in breast milk
      group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the
      participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for
      20 seconds where heel-lancing will be performed in the low level laser group. Then heel
      lancing is performed and two observers who are blinded to the intervention record the
      physiological (heart rate and oxygen saturation) and behavioral parameters (duration of
      crying and modified neonatal facial coding scores) following the procedure. Heart rate
      variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is
      used to detect the infant's salivary cortisol and amylase level as biomarker for stress
      evaluation. During the study course, digital cameras continuously record participants'
      behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical
      analysis.
    

Intervention name(s): LaserPen
Intervention type(s): Device
Intervention description(s): low level laser is used before heel-lancing for newborn screening
Other intervention name(s): power 150mW, wavelength 810nm, RJ-laser
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: low level laser group and breast milk group
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: neonates; pain; low level laser
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will use an open-label design to evaluate the safety of NP101. Adult subjects who
      meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic
      transdermal patch) for acute migraine attacks over a 12 month period.
    


Intervention name(s): NP101
Intervention type(s): Drug
Intervention description(s): NP101 study patch four hour application
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and effectiveness of topiramate (64mg,
      96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind,
      placebo-controlled, multicenter study to assess the safety and effectiveness of topiramate in
      treatment of obese patients. Patients will receive 24 weeks of treatment by topiramate or
      placebo, followed by 2 week taper and a safety follow-up. Effectiveness will be determined by
      changes from baseline to week 24 in body weight, body mass index (BMI), anthropometric
      measurements (waist circumference, hip circumference, waist/hip ration), fasting lipid
      profiles, fasting plasma glucose, HbA1c (shows average blood sugar level over months),
      fasting uric acid, fasting insulin, and blood pressures. Safety evaluations (incidence of
      adverse events, physical examinations, 12 lead ECGs, vital signs, Computerized
      Neuropsychological Test Battery) will be performed throughout the study. The study hypothesis
      is that topiramate will be effective in achieving and maintaining weight reduction in obese
      patients and is well tolerated. The patients will be randomized to receive either topiramate
      (64, 96, 192, or 384 mg daily) or placebo daily by mouth for 24 weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Hypertension; Hyperlipidemia; Body Mass Index
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is
      a prevalent and costly problem. This pilot study will compare the effectiveness of two brief
      (6 week) psychological interventions delivered to residents of rural Manitoba using
      Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants
      in the Telehealth condition will report significantly greater improvements in sleep
      parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity,
      and daytime fatigue than those in the Internet condition and that b)participants in the
      Telehealth condition will show better adherence to treatment and greater satisfaction with
      treatment than those in the Internet condition.
    


Intervention name(s): Cognitive-behavioral therapy for Insomnia (CBT)
Intervention type(s): Behavioral
Intervention description(s): 6-week course of CBT delivered either using internet or telehealth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Cognitive-Behavioral Therapy; Internet; Telehealth
A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ
      System.
    


Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction