bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Observational

Summary: 
      The primary objective of this study is to measure how LDL apheresis affects levels of
      inflammatory and cholesterol markers in human beings. The investigators will address this
      question by drawing pre- and post-LDL apheresis blood from patients who are undergoing this
      procedure. A secondary objective of this study is to learn how specific inflammatory markers
      behave in our blood in terms of time to rebound back to normal levels. The investigators will
      address this question by drawing post-LDL apheresis blood at predetermined time intervals.
    

Detailed description: 
      Numerous epidemiological investigations have demonstrated the importance of cholesterol -
      specifically low density lipoprotein (LDL) - in the development and progression of
      atherosclerosis. A continuing relationship between cholesterol level and coronary morbidity
      has been established. The initial approach for managing elevated cholesterol includes
      lifestyle interventions, namely eating a low fat diet, weight loss in overweight patients,
      and regular aerobic exercise. Once lifestyle interventions have been applied, pharmacologic
      therapy becomes a mainstay of therapy, conventionally with a statin followed by adjunctive
      medicines as indicated. Certain populations that are refractory to aggressive
      pharmacotherapy, however - such as patients who have familial hypercholesterolemia (FH) -
      necessitate alternative means of lipid management. Therapeutic considerations in these
      patients include LDL apheresis and a number of rare procedures such as partial ileal bypass,
      liver transplantation, portocaval shunting, and possibly gene therapy in the future.

      The anti-inflammatory effects of LDL apheresis and its effects on endothelial function are
      not well known. Considering several pathways of atherogenesis, and inflammation as a central
      mechanism thereof, LDL apheresis may theoretically provide synergistic benefit of lipid
      lowering as well as proinflammatory agent lowering that can lead to significantly decreased
      atherogenesis. This study looks to address these questions by assessing the effects of LDL
      apheresis on inflammatory and lipid markers.
    

Intervention name(s): LDL Apheresis
Intervention type(s): Procedure
Intervention description(s): LDL Apheresis
Other intervention name(s): Apheresis; LDL filtration
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study focuses on people who are currently on stable LDL apheresis treatment for high
        cholesterol.
      
Biospecimen description: 
      Blood samples only
    
Keywords: LDL apheresis; Familial hypercholesterolemia; Inflammatory markers; Hyperlipidemia; Cardiovascular disease
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients
      with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): Ensifentrine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks; Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a pilot study with a single active treatment arm. The study is designed to assess the
      efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2
      Diabetes. In particular, the primary outcome measure is a reduction in A1c.
    


Intervention name(s): TNM (thermoneuromodulation device)
Intervention type(s): Device
Intervention description(s): The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromodulation; caloric vestibular stimulation; Type 2 Diabetes
A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Condition: Urinary Stone
MeSH terms: Urinary Calculi; Urolithiasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if CBD oil has any effect on decreasing
      postoperative pain control following ureteroscopy for urinary stone disease, and to determine
      if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used
      drug) used by patients after undergoing ureteroscopy for urinary stone disease.
    


Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.; The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
Other intervention name(s): Epidiolex
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A Positron Emission Tomography (PET) Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the
      brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of
      JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor
      interaction of JNJ-55308942.
    


Intervention name(s): JNJ-55308942; [18F]-JNJ-64413739
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-55308942 will be administered as oral solution.; [18F]-JNJ-64413739 fluid for injection administered intravenously.
Intervention MeSH terms: JNJ-55308942
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes
Condition: Depressive Symptoms; Hypomania Nos Single Episode or Unspecified
MeSH terms: Mania; Depression
Study type: Interventional

Summary: 
      This study will investigate the effects of aerobic exercise on mental states, cognition, and
      long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and
      in non-clinical school children
    

Detailed description: 
      Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk
      of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic
      exercise might have positive effects in enhancing cognition and improving clinical symptoms
      in non-clinical and preclinical population and patients with mood disorders. This randomized
      controlled trial will investigate short-term (3 months) effects of aerobic exercise on
      cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical
      outcomes of high-risk states.
    

Intervention name(s): aerobic exercise; Placebo controlled group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months; 6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurocognition; high-risk; prognosis
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally
      active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown
      effectiveness in the treatment of asthma.

      The aim of the study is to investigate the effect of roflumilast taken orally together with
      low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one
      dose level once daily together with inhaled corticosteroids at one dose level twice daily.
      The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24
      weeks). The study will provide further data on safety, tolerability, and effectiveness of
      roflumilast.
    


Intervention name(s): Roflumilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Roflumilast; Corticosteroids
Confirmatory Study of BK1310 in Healthy Infants
Condition: Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial Meningitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP,
      diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection,
      when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as
      efficacy and safety, in healthy infants.
    


Intervention name(s): DPT-IPV-Hib; Hib vaccine; DPT-IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.; 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.; 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other intervention name(s): BK1310; ActHIB®; Tetrabik
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenza type b; Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine; Hib; DPT-IPV
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
Condition: Intubation; Videolaryngoscopy; Infant
Study type: Interventional

Summary: 
      The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the
      equipment best suited to assist the intubation, with the best overview, shortest time to
      intubation and use these numbers to make a sample size calculation for the full protocol. The
      investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than
      infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade
      for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with
      an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the
      later, which the patient was randomized to.
    


Intervention name(s): Storz videolaryngoscope; Airtraq
Intervention type(s): Device; Device
Intervention description(s): Storz videolaryngoscope being used for the actual intubation; Airtraq being used for the actual intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
State-wide Health Approach to Increase Reach and Effectiveness: Study 2
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      Behavioral weight loss programs can successfully reduce body weight, but these programs are
      available to limited numbers of overweight and obese individuals. This project evaluates a
      unique weight loss approach that combines a self-sustaining weight loss campaign (for
      outreach) with training in behavioral weight loss strategies and tests the efficacy of adding
      components designed to enhance accountability and increase motivation for weight loss.
    

Detailed description: 
      This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms:
      (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based
      behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions
      (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring
      information and achieving clinically significant weight loss. The primary outcome is weight
      loss at 12 weeks.
    

Intervention name(s): Shape Up Rhode Island + Online weight loss program; Shape Up Rhode Island + Online weight loss program + Groups; Shape Up Rhode Island + Online weight loss + Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.; Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions.; Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with
      stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4
      weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.
    


Intervention name(s): elamipretide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days; Subcutaneous injection of placebo administered once daily for 28 consecutive days
Other intervention name(s): MTP-131; Bendavia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; HFpEF; elamipretide; MTP-131; Bendavia™
The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose
      in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide
      important information on the potential health benefits of isomaltulose consumption in Asian
      population. It will also reveal how the three main ethnicities in Singapore respond to
      isomaltulose and whether the response differs from the Caucasians.
    

Detailed description: 
      The objective of the present study is to investigate the glycaemic effect of isomaltulose in
      Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty
      participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians
      completed data sets, aged between 21 and 40 years will be recruited from the general public
      in Singapore. Participants will be asked to attend two test sessions for this study.
      Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50
      g of available carbohydrate).
    

Intervention name(s): Isomaltulose; Sucrose
Intervention type(s): Other; Other
Intervention description(s): Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.; Sucrose is normal table sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Satiety Response of White and Brown Rice Compared to Glucose Control
Condition: Food Selection
Study type: Interventional

Summary: 
      The investigators hypothesize that consumption of either white or brown rice will be more
      satiating than glucose control.
    

Detailed description: 
      This study is an acute, randomized, repeated measures design with 20 subjects. Subjects will
      consume 3 test breakfasts, white rice, brown rice, or glucose control, each containing 400
      calories. Treatments will be one week apart. After consumption of the controlled breakfast,
      subjects will complete visual analogue scales (VAS) for satiety response. Additionally, they
      will consume a pizza lunch and record food intake for the next 24 hours. Breath gas samples
      will be collected to estimate fermentation of fiber in the large intestine. Also, subjective
      data on gastrointestinal tolerance will be collected.
    

Intervention name(s): White Rice, Brown Rice, Glucose
Intervention type(s): Other
Intervention description(s): white rice, brown rice, glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: satiety; obesity; food intake
Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms
Condition: Adult ALL; Post-traumatic Stress Disorder; Obsessive-Compulsive Disorder; Disgust; Guilt; Shame
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by
      Francine Shapiro in 1987 and can be adapted for online and in presence administration. The
      aim of this study is to assess if a EMDR program (administered both online and in presence,
      depending on different conditions of patients) may help people recruited from general
      population suffering from COVID19 second (November 2021 to February 2022) and third (March
      2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and
      obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their
      subjective unit of distress (SUD) and validity of cognition (VoC) levels.
    


Intervention name(s): EMDR
Intervention type(s): Behavioral
Intervention description(s): Eye movement Desensitization and Reprocessing (as decribed in the 8-phases protocol), administered both online or in presence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; OCD; Disgust; Guilt; Shame; Body; EMDR
Examining Choice Architecture for Genetic Testing Decisions
Condition: Decision Making
Study type: Interventional

Summary: 
      The goal of this application is to gain a deeper understanding of decision-making for genetic
      testing and identify effective choice-architecture-based strategies to improve decisions in
      genetic testing. The investigators hypothesize that choice architecture (i.e. framing)
      affects decision-making for hypothetical genetic testing scenarios.
    

Detailed description: 
      After providing opt-in electronic consent, eligible consented participants will be randomized
      to one of two hypothetical genetic testing scenarios (rare, life-altering genetic condition
      or common, life-threatening genetic condition). The genetic testing scenarios include brief
      detailed information about genetic testing (i.e. how results may influence treatment
      decisions) as well as information about standard approaches to treatment. Subjects will be
      randomized to receive a framing conditions (e.g. choice, opt-in, opt-out, enhanced choice).
      Participants will select a preferred testing option to the hypothetical scenario and will
      complete several validated instruments.
    

Intervention name(s): choice decision frame; opt-in decision frame; opt-out decision frame; enhanced choice (context) decision frame; enhanced choice (norms) decision frame; enhanced choice (affect) decision frame
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): active choice for genetic testing; "gain" frame for genetic testing; "loss" frame for genetic testing; consequences of genetic testing; social norms for genetic testing; commitments for genetic testing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)
Masking: Single (Participant)
Primary purpose: Health Services Research