bioihbjkbjnl/mcl2 huggingface dataset:
Statistical Learning as a Predictor of Attention Bias Modification Outcome
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study examines whether the ability to extract statistical properties from the
      environment among treatment-seeking patients with social anxiety disorder can predict
      therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of
      social anxiety following ABM therapy.
    

Detailed description: 
      All participants received 6 sessions of ABM therapy away from threat. At baseline
      participants also completed a gold standard statistical learning task aimed to assess
      participants' capacity for the extraction of statistical regularity from the environment. The
      aim of the study is to determine whether the basic ability to extract rules from the
      environment at baseline could predict clinical improvement of social anxiety symptoms.
    

Intervention name(s): ABM
Intervention type(s): Behavioral
Intervention description(s): Participants are trained with a dot-probe task including angry-neutral faces. In 80% of trials the probe appears in place of the neutral face, and in 20% of trials in place of the angry face.
Other intervention name(s): attention bias modification
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: attention-bias modification; statistical learning; social anxiety disorder; treatment outcome
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing
      molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's
      disease during anti TNF-α (infliximab) therapy.
    

Detailed description: 
      The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the
      treatment have not yet been investigated.
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Crohn's disease; Infliximab; T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)
Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the
      expected recovery time.
    

Detailed description: 
      Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the
      expected recovery time.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Our study was carried out on healthy and non-specific low back pain individuals who came to
        Bahçeşehir University.
Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will determine whether supplements of the mineral zinc will improve mental health
      and school performance among schoolchildren in Guatemala.
    

Detailed description: 
      Mental health problems are an important cause of dysfunction throughout the world, accounting
      for 8.1% of the Global Burden of Disease. The need for interventions that can prevent mental
      health conditions, particularly among children, cannot be overemphasized. This study will
      determine whether zinc supplementation improves the mental health and school performance
      among children in Guatemala.

      Participants will be randomly assigned to receive daily supplements of either zinc or placebo
      for 6 months. Participants will be assessed at study entry and after the 6-month treatment.
      Participants and their parents and teachers will complete questionnaires about the
      participants' symptoms of depression and anxiety, concentration and activity levels, school
      performance, and any environmental stressors to which the participants may be exposed to.
    

Intervention name(s): 10 mg zinc oxide; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 10 mg zinc oxide; Placebo pill taken five days a week for six months.
Intervention MeSH terms: Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc; Dietary Supplements; Nutritional Supplements; Child; Mental Health; School; Guatemala
Dose-ranging Study of SKF7™ for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has been designed as a randomized, double blinded, multi-centric, placebo
      controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients
      from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™).
    

Detailed description: 
      Labisia pumila or Kacip Fatimah is a native Malaysian and Indonesian plant. It has been used
      as traditional medicine for over 400 years by both men and women for multiple treatments
      including toning and firming the abdominal area. As a water-ethanol dry extract, it has been
      reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood
      glucose and sex hormones. In Malaysia, this Kacip Fatimah extract has been used as a natural
      anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the
      trade-name of Labeesity® or SKF7™. This extract has been shown to be pesticide / herbicide
      free and has branded halal ingredient identity and security.
    

Intervention name(s): low-dose; Middle-dose; Higher-dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosage 1; Dosage 2; Dosage 3; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 parallel groups, 3 doses of study drug versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dose-ranging; Kacip Fatimah; Labisia pumila; obesity
Gold Factor on Knee Joint Health and Function
Condition: Knee Arthritis; Knee Osteoarthritis; Knee Pain Chronic; Knee Discomfort; Rheumatoid Arthritis; Knee Pain Swelling
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this clinical study was to determine whether gold nanoparticles (AuNP)
      supplement holds clinical value in improving joint health, function, and quality of life for
      arthritis patients.
    

Detailed description: 
      The purpose of this clinical study was to determine whether gold nanoparticles (AuNP)
      supplement holds clinical value in improving knee joint health, function, and quality of life
      for arthritis patients. A total of 51 participants were followed for 20 weeks through a three
      phase longitudinal study. Both subjective and objective parameters were used to measure and
      monitor changes in knee joint health and function, as well as quality of life.
    

Intervention name(s): Gold Factor (Gold Nanoparticles, AuNPs); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): AuNP used in the study is an aqueous suspension of clean-surfaced, faceted gold nanoparticles that have extraordinary catalytic capabilities. AuNP were 8 - 28 nm in diameter, with varying shapes from bipyramids to polyhedrons. To avoid contamination, AuNP was suspended in ultra-pure water, and were not coated with any proteins or molecules to avoid negative reactions within living tissues. This resulted in a rose-pink color due to the incident light inducing a specific resonance known as the localized surface plasmon resonance. The AuNP supplement used in this study contains elemental gold at 6 ppm. Study dosage is 1 oz per day, which is about 0.17 mg elemental gold per day.; For the Placebo, water and red dye were mixed to create a placebo liquid with the same rose-pink shade as the AuNP supplement, along with flavoring that matched the AuNP supplement.
Other intervention name(s): AuNP Supplement
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Fifty-one (51) subjects were determined eligible for the study after the screenings and then were divided into two groups, AuNP Supplement (n=26) and Placebo (n=25). The study was partially double-blinded, and divided into three phases as follows:
Phase 1: Supplement and Placebo groups ingested Supplement and Placebo as instructed. This phase was double-blinded.
Phase 2: Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure.
Phase 3: Both groups took the Supplement as instructed. This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee joint health; Arthritis; Gold nanoparticles (AuNPs); Knee joint function; Osteoarthritis; Rheumatoid Arthritis
Exploring Mechanisms and Morphology of QT Interval Prolongation
Condition: Long Qt Syndrome 1-2; Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Long QT Syndrome; Romano-Ward Syndrome; Death
Study type: Interventional

Summary: 
      The projects will try and optimise the risk stratification for patients with Long QT syndrome
      by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics
      and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation.
      Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics
      tested by "Brisk Standing".

      First, patients are tested with known arrhythmic triggers and they are then administered
      thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the
      patients are on Spironolactone for seven days. After seven days treatment the "Brisk
      Standing" is repeated.
    

Detailed description: 
      The aim of the projects is to try and optimise the risk stratification for patients with Long
      QT syndrome by investigating how the exposure of physical and acoustic stress will affect the
      QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic
      QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on
      the QT-dynamics tested by "Brisk Standing".

      First, patients are tested with known arrhythmic triggers and they are then administered
      thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the
      patients are on Spironolactone for seven days. After seven days treatment the "Brisk
      Standing" is repeated.
    

Intervention name(s): Beta Blockers; Spironolactone
Intervention type(s): Drug; Drug
Intervention description(s): With and without Beta Blockers; Brisk Standing before and after seven days treatment with Spironolactone
Intervention MeSH terms: Spironolactone; Adrenergic beta-Antagonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Long QT Syndrome
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery
Condition: Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Study type: Observational

Summary: 
      Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some
      cases severe complications, sometimes causing extracorporeal life support. The investigators
      have observed over several years 5 cases of instantaneous postoperative severe pulmonary
      edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery
      procedure.
    

Detailed description: 
      Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some
      cases severe complications, sometimes causing extracorporeal life support. The investigators
      have observed over several years 5 cases of instantaneous postoperative severe pulmonary
      edema. After having studied the available literature on this particular topic the
      investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive
      mitral valve surgery procedure focusing on radiological and clinical signs of unilateral
      pulmonary edema.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Collective of patients with relevant mitral valve disease scheduled for minimal-invasive
        mitral valve repair or replacement
      
Keywords: minimal-invasive surgery, mitral valve
The Effect of Body Shape on Tragus-Wall Measurement
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in
      ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis
      Metrology Index (BASMI). Being obese or slim may affect TWD. As well as the person's losing
      or taking weight may lead wrong evaluations, in comparative studies, according to the height
      or weight uneven distribution of groups may affect the results. The aim of this study is to
      investigate whether the body shape affect TWD or not.
    

Detailed description: 
      Healthy volunteers between 18-65 ages who have no disorder that may disturb posture or erect
      position (inflammatory diseases, kyphosis, scoliosis, joint deformities)will be included into
      the study. A wall corner will be used as the measurement platform; the evaluated person will
      be positioned as described in BASMI. A rigid ruler will be placed form anterior superior
      iliac spine (SIAS) to the lateral wall, parallel to the back wall; a projection point will be
      determined and its distance from back wall will be measured (SIAS-WD). In the same position,
      projection point of the middle of the humerus head and back wall distance (shoulder-WD) and
      TWD also will be measured. The relationships between these parameters will be statistically
      assessed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects between 18-65 ages who have no disorder that may disturb posture or erect
        position (inflammatory diseases, kyphosis, scoliosis, joint deformities)
      
Keywords: Tragus-to-wall distance; obesity; body shape; height; weight
5HT2CR Balance in Brain Connectivity in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This project will evaluate the role of the 5-HT2CR:5-HT2AR balance in impulsive action and
      cue reactivity in cocaine-dependent subjects as compared to non-drug using controls.
    

Detailed description: 
      The overall goal of this project is to evaluate the role of molecular interactions between
      5-HT2AR and 5-HT2CR in behavioral phenotypes that confer risk for cocaine dependence and
      relapse. Specifically, this project will evaluate the role of the 5-HT2CR:5-HT2AR balance in
      impulsive action and cue reactivity in cocaine-dependent subjects as compared to non-drug
      using controls. Brain and behavioral responses to the 5-HT2AR blocking medication mirtazapine
      will be compared between subjects who have high and low functioning of the 5-HT2CR based on
      presence of a specific, functionally-relevant single nucleotide polymorphism (SNP) of the
      5-HT2CR (Cys23Ser). The 5-HT2CR Cys23Ser SNP is thought to decrease the function of the
      protein and a preliminary observation indicates cocaine-dependent subjects carrying the CC
      genotype (Ser23 protein variant) display significantly higher cue reactivity. For Aims 1 and
      2, two fMRI analysis methods will be used: 1) a voxelwise whole brain analysis; 2) a region
      of interest analysis based on proposed integrative circuitry shown in the model below.
      Because neuroimaging studies have shown that performance of impulsive action tasks and
      exposure to cocaine-associated cues (cue reactivity paradigms) activate brain regions in
      brain circuits in humans, impulsive action and cue reactivity may be engendered in related
      pathways. To explore this hypothesis, researchers will employ functional magnetic resonance
      imaging (fMRI)-based dynamic causal modeling (DCM) to ascertain the causal influences of one
      brain region over another. Employing DCM, researchers will uncover the effective connectivity
      within nodes of the neurocircuitry involved in impulsive action and cue reactivity. This
      project will parallel preclinical work studying the relationship between 5-HT2AR and 5-HT2CR
      on impulsive action and cue reactivity.
    

Intervention name(s): Mirtazapine 15 MG Oral Tablet
Intervention type(s): Drug
Intervention description(s): The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment.
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to clarify whether neck cooling can be used to non-invasively
      lower brain temperature in healthy adults.
    

Detailed description: 
      Healthy adults were randomized to undergo an intervention in which either cold or
      body-temperature water was circulated through an adhesive wrap applied to the front of their
      necks, overlying the carotid arteries, for 120 minutes. After their first intervention,
      subjects crossed over (i.e., cold went to body-temperature, and vice-versa) on a separate
      day. Brain temperature was measured in one-minute intervals using MR thermometry.
    

Intervention name(s): Cold circulated water; Body-temperature circulated water
Intervention type(s): Device; Device
Intervention description(s): Cold water was circulated through an adhesive wrap applied to the front of the neck, overlying the carotid arteries, for 120 minutes. MR thermometry was used to measure core brain temperature in 1-minute intervals throughout the intervention. On a different day, subjects crossed over and repeated the intervention in the other study arm (i.e., cold went to body-temperature, and vice-versa).; Body-temperature water was circulated through an adhesive wrap applied to the front of the neck, overlying the carotid arteries, for 120 minutes. MR thermometry was used to measure core brain temperature in 1-minute intervals throughout the intervention. On a different day, subjects crossed over and repeated the intervention in the other study arm (i.e., cold went to body-temperature, and vice-versa).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: targeted temperature management; brain temperature; brain cooling; neck cooling
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Condition: Colonoscopy; Colon Polyps
MeSH terms: Colonic Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing
      adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients
      received fentanyl citrate for pain management followed five minutes later by AQUAVAN®
      Injection for sedation. Throughout the procedure, study personnel assessed the patient's
      vital signs and depth of sedation. After the procedure, the patient, physician, and an
      evaluator were asked to complete satisfaction surveys.
    

Detailed description: 
      Randomized, open label, multi-center, adaptive dose ranging study, in which several dose
      levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a
      desired sedation level in patients undergoing elective colonoscopy. A desired sedative
      dose/dose range and dosing paradigm will be identified based on pre-set criteria using the
      Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose
      range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides
      mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in a majority of
      patients who are pre-medicated with fentanyl citrate injection.
    

Intervention name(s): fospropofol disodium
Intervention type(s): Drug
Intervention MeSH terms: Fospropofol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Hepalatide(L47) at Phase Ib in Healthy Volunteers
Condition: Hepatitis B， Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical
      pharmacokinetics in healthy volunteers.
    

Detailed description: 
      This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be
      conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and
      8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1
      rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous
      injection once a day for seven days and will be observed for 3 days.
    

Intervention name(s): Hepalatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.; There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.
Other intervention name(s): treatment drug; control drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment