bioihbjkbjnl/mcl2 huggingface dataset:
Low Dose Naltrexone (LDN) Immune Monitoring
Condition: Fibromyalgia
MeSH terms: Fibromyalgia
Study type: Interventional

Summary: 
      We have found that low dose naltrexone (LDN) can substantially reduce pain associated with
      fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The
      purpose of this study is to determine if LDN lowers inflammatory markers in individuals with
      fibromyalgia.
    

Detailed description: 
      Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the
      first two weeks, a baseline phase will be used to collect data on immune function and
      symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in,
      participants will be advised that they may receive a placebo during the trial. Participants
      will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo
      survey software. Participants will also provide a blood sample twice every week for the
      duration of the study. Plasma inflammatory markers will be tested using a luminex based
      63-plex inflammatory assay panel.

      The primary aim of the study is to test if 8 weeks of LDN administration is associated with a
      reduction in pro-inflammatory markers in plasma in women with FM.
    

Intervention name(s): Low Dose Naltrexone
Intervention type(s): Drug
Intervention description(s): Naltrexone 4.5 mg p.o. nocte
Other intervention name(s): LDN; Naltrexone
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
Condition: Acute Respiratory Distress Syndrome; Shock; Ventilatory Failure; Cardiogenic Pulmonary Edema
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Pulmonary Edema; Hypoventilation
Study type: Interventional

Summary: 
      The objective of our study is to evaluate the efficacy of helmet ventilation as compared with
      Face mask in patients with respiratory failure.
    

Detailed description: 
      Respiratory failure is often treated with endotracheal intubation and mechanical ventilation.
      Although, the institution of mechanical ventilation is considered life saving, the associated
      complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and
      neuromuscular weakness are not without considerable morbidity and mortality.

      Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic
      respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory
      failure in immunocompromised patients.

      Despite the advantages of non-invasive ventilation via facemask, some patients fail because
      of mask intolerance and severity of disease. Further limitation to facemask non-invasive
      ventilation is that the seal integrity is lost when higher pressures are required.
      Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock
      may require such higher pressures.

      In an attempt to improve patient tolerability and deliver higher pressures, a transparent
      helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the
      entire head and neck of the patient. The design of the helmet confers some important
      advantages: 1) the transparency allows the patient to interact with the environment; 2) the
      lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems
      of leaking with higher airway pressures that are seen with the face mask; 4) it can be
      applied to any patient regardless of facial contour.
    

Intervention name(s): Non invasive ventilation using a helmet hyperbaric device; Noninvasive ventilation via facemask
Intervention type(s): Device; Other
Intervention description(s): Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.; Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
Other intervention name(s): Sea-Long medical treatment hood; mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: noninvasive ventilation; acute hypoxemic respiratory failure; Acute respiratory distress syndrome; shock
Liking Adaptation to Beverages of Varying Sweetness Levels Following Prolonged Exposure
Condition: Sweetness Liking Adaptation
Study type: Interventional

Summary: 
      This is a double-blind, controlled, parallel, randomized sensory study. The study will
      consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers
      and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3
      interventions for six months (24 weeks):

        -  Intervention 1: Control (full sweetness) beverage

        -  Intervention 2: Step-wise sweetness reduction series of beverages

        -  Intervention 3: Moderate sweetness (reduced sweetness) beverage

      The primary outcome is to assess the perception changes in sweetness (magnitude scale) and
      sweetness liking (Likert scale) of a test product and a control product over a period of six
      months. The study endeavors to explore whether consumers of sweetened carbonated beverages
      can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption
      of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate)
      sweetness.

      Additional analysis will be to assess dietary compensation for sweetness in the step-wise and
      moderate reduction arms compared to the control arms (the full calorie and low calorie
      control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and
      servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record
      pre-intervention and monthly for 6 months.
    


Intervention name(s): Flavored carbonated soft drink (CSD) at different sweetness levels
Intervention type(s): Other
Intervention description(s): Beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sweetness; liking; adaptation; intensity; low calorie sweetener; full sugar; carbonated soft drink; sensory; taste; dietary compensation; beverage; perception
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
Condition: Diabetes; Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The hypertriglyceridemia at fasting status has been known to be an important risk factor for
      cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an
      attention as a superior predictor of CVD because of non-fasting state for more than 12 hours
      and importance of triglyceride-rich lipoprotein.

      We aim to investigate the relationship of postprandial triglyceride after fat tolerance test
      and intima-medial thickness and to suggest normal reference of postprandial triglyceride
      after fat tolerance test. In addition, we evaluate the correlation of postprandial
      triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate
      clinical importance of postprandial triglyceride in assessment of cardiovascular risk.
    


Intervention name(s): Oral fat tolerance test
Intervention type(s): Dietary Supplement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Postprandial period; triglyceride; Diabetes mellitus, type 2; Prediabetic state
Shape Up Somerville: Eat Smart Play Hard
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Community-based environmental approach to obesity prevention targeting first, second, and
      third grade students in Somerville, MA.
    

Detailed description: 
      This study will demonstrate using measures of effectiveness, the feasibility of partnering
      with the community to create, disseminate, implement and evaluate Shape Up Somerville: Eat
      Smart. Play Hard., a community-based environmental change intervention to prevent obesity in
      culturally diverse, high-risk, early elementary school children. Based on formative work with
      parents, children, teachers, school food service, school officials, and community members, a
      community-wide campaign will be developed with targeted environmental change strategies for
      early elementary school children within the before-, during-, and after-school environments
      reinforced by changes within the home and community to support behavioral action and
      maintenance. The intervention targeting children will bring the energy equation into balance
      by offering numerous physical activity options that total up to 125 kcals per day and by
      improving the composition of the food served and the dietary options, particularly snack
      foods, available throughout the day. This study will measure awareness and participation of
      the partners and residents within the community. In addition the temporal change in BMI
      z-score will be monitored internally in 700 Somerville children and externally in 1000
      control children from 2 demographically-matched communities for one year and will be compared
      to the change in BMI z-score in children participating in Shape Up Somerville with children
      from control communities over the one-year intervention and for one year of follow up. If
      successful, Somerville will serve as the model community that paves the way for
      cost-effective nationwide environmental action to prevent obesity at the community level.
    

Intervention name(s): Nurtition and Physical Activity Education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood Obesity; Community-based Participatory Research; School intervention; Parental Involvement
Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT)
Condition: Obesity
Study type: Interventional

Summary: 
      The study is a single-blind, randomised crossover study, investigating how a high glycaemic
      potato affects satiety in humans compared to a low glycaemic potato. This is done to shed
      further light on the discussion about whether potatoes with a high glycaemic index increases
      the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular
      disease.
    

Detailed description: 
      The POSAT study follows a single-blinded randomized crossover design. Each subject will have
      two separate intervention days with at least a six-day washout period in between. On the two
      intervention days the subjects will be randomized into receiving a breakfast containing
      isocaloric amounts of either low or high GI potatoes. VAS will be measured 5 minutes before
      the meal, immediately after the meal is consumed and in intervals of 30 minutes thereafter
      until 2,5 hours after the initial meal. After this the subjects will be served a standardized
      homogenous ad libitum meal. The amount of food consumed will be registered. The subjects will
      be asked to fast for 8-10 hours prior to the trial days and abstain from vigorous physical
      activity and alcohol consumption for 2 days prior to each trial day. The trial will be
      conducted over a total of 8 days with 5-6 study subjects pr. trial day. The trial days will
      be spread out over a total of 2 weeks to allow for a 1-week washout period between trial days
      for each subject.
    

Intervention name(s): Low glycaemic potato; High glycaemic potato
Intervention type(s): Other; Other
Intervention description(s): The Carisma potato variety is used as the low glycaemic index potato.; The Arizona potato variety is used as the high glycaemic index potato.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-blind randomized crossover
Masking: Single (Participant)
Primary purpose: Prevention
Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This clinical trial will test a combined group therapy plus mobile cognitive behavioral
      therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order
      to change motivational negative symptoms linked to defeatist attitudes.
    

Detailed description: 
      The primary purpose of this project is to test whether a psychosocial intervention, Cognitive
      Behavioral Social Skills Training (CBSST) combined with a smartphone-based
      cognitive-behavioral therapy for negative symptoms called, Mobile-assisted Cognitive
      Behavioral Therapy for Negative Symptoms (mCBTn) can reduce defeatist performance attitudes
      in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe
      experiential negative symptoms.The project will also identify the optimal dose to engage the
      defeatist attitude target. Pupillary responses, an objective psychophysiological biomarker of
      effort, will be recorded during a cognitive task as a secondary outcome to determine its
      potential as an end point in clinical trials of motivation and effort.
    

Intervention name(s): Mobile-assisted CBT
Intervention type(s): Behavioral
Intervention description(s): mCBTn combines the CBT components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group therapy and mobile smartphone interventions from our prior clinical trials research.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; CBSST; mobile CBT; negative symptoms
PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers
Condition: Infections, Respiratory
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics
      of PA after oral ascending dose administration to healthy male volunteers.
    

Detailed description: 
      The first-in-human dose (FHD) trial is a randomized, double-blind, placebo-controlled,
      dose-escalation trial assessing safety, tolerability and pharmacokinetics (PK) of single and
      multiple oral doses of PA in healthy male subjects.

      The study consists of two stages: single dose administration and multiple dose
      administration.

      The single dose administration stage includes 5 cohorts, multiple dose administration stage
      includes at least 4 cohorts (groups). Each cohort includes 8 subjects (6 active drugs and 2
      placebos). Cohorts intake ascending doses of study drug. The dose of 1st cohort is 1,0 mg/ml,
      the doses for the following cohorts will be estimated by the Data Monitoring Committee based
      on pharmacokinetics and safety results of previous group.

      For each subject study includes screening period, one baseline period on Day -1, a treatment
      period (1 day - at single dose stage; 14 days - at multiple dose stage), followed by safety,
      PK, assessments up to 72-96 hours post dose. Follow-up visits will take place on Day 7 ; 30;
      60 (single dose stage) and 30; 60; 90 (multiple dose stage).
    

Intervention name(s): Potentiator of antibiotics (PA); Placebo PA
Intervention type(s): Drug; Other
Intervention description(s): Intervention is administered to patients in this Arm; Intervention is administered to patients in this Arm
Other intervention name(s): Albumin complex of tetraiodide
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Safety; Iodine complex; Pharmacokinetics; Antibiotic potentiator
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assess feasibility and clarify the design of future
      study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or
      prevention of migraine symptoms.
    


Intervention name(s): n-VNS
Intervention type(s): Device
Other intervention name(s): gammaCore
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; migraine; non invasive; gammacore
Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
Condition: Botulism
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to
      evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
      NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin
      BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6,
      placebo:therapeutic, with a total study population of 24. The study duration is projected to
      be approximately 8 months, with subject participation in cohort A being approximately 13
      weeks, and subject participation in cohort B and C being approximately 17 weeks. The primary
      objectives of this study are to assess the safety and tolerability of escalating doses of
      NTM-1632 administered intravenously in healthy adults.
    

Detailed description: 
      This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to
      evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
      NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin
      BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6,
      placebo:therapeutic, with a total study population of 24. The study duration is projected to
      be approximately 8 months, with subject participation in cohort A being approximately 13
      weeks, and subject participation in cohort B and C being approximately 17weeks. The primary
      objectives of this study are to assess the safety and tolerability of escalating doses of
      NTM-1632 administered intravenously in healthy adults. The secondary objectives are to 1)
      assess the pharmacokinetic characteristics of NTM-1632 following a single intravenous
      administration and 2) assess the immunogenicity of NTM-1632 following a single intravenous
      administration.
    

Intervention name(s): NTM-1632; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Monoclonal antibody mixture of XB10, XB18, and XB23; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BoNT; botulinum; Botulism; Clostridium; Neurotoxin; NTM-1632
A Study of Baricitinib in Healthy Japanese Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand the relationship of 3 different dosage forms of
      baricitinib. This study will also explore the effect of food on how the body absorbs
      baricitinib. This study will last about 5 weeks, not including screening. Screening is
      required within 28 days prior to the date of first dosing.
    


Intervention name(s): Baricitinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY3009104
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University
Condition: Pain, Back; Neck Pain; Postural; Strain; Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Neck Pain; Back Pain; Internet Addiction Disorder
Study type: Interventional

Summary: 
      This study will be conducted in the Department of physical therapy, College of Applied
      Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in
      smart phone addiction among students of jazan university
    

Detailed description: 
      Four hundreds students with age 19 to 26 years old, and right dominant hand, will be
      recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be
      randomly assigned to into a heavy user group (n=300; female and male students) and a control
      or regular use group (n=300; female and male students) according to their smartphone
      addiction proneness scale.

      Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New
      York, USA) is used to measure the hand grip strength and pinch strength.

      Algometer Commander (JTech Medical Company) is used on the location of the trigger point to
      assess the amount of pressure the patient could sustain before the patient registered the
      pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle
    

Intervention name(s): Pain Pressure Threshold; Hand Grip Force
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.; For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected.
Other intervention name(s): PPTs
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more.
we have two variables to be assessed:
Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle)
Hand grip force
Masking: None (Open Label)
Primary purpose: Diagnostic