bioihbjkbjnl/mcl2 huggingface dataset:
EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This is a 10-month internet-based randomized controlled trial to evaluate whether an online
      chronic pain management program ("E-Health") can assist with reduced opioid reliance in
      chronic pain patients. About half of the eligible participants will receive access to the
      E-Health program in addition to their standard chronic pain treatment; the other half will
      just continue receiving their standard chronic pain treatment.
    

Detailed description: 
      This study will determine whether an innovative, accessible E-health intervention can assist
      with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of
      unintended opioid overdose and death. Importantly, the study will contribute to a better
      understanding of the mechanisms contributing to opioid use reduction while managing pain. The
      findings may assist in developing treatment options for a population at risk for opioid
      adverse effects.

      Potential participants will be identified through electronic health record (EHR) queries at
      participating sites. Participants will be assessed at baseline, at the end of the 4-month
      treatment period, and at 6 months following end-of-treatment through an electronic data
      capture system accessed by the participants. Other outcome data will be obtained from the
      participant's EHR data.
    

Intervention name(s): E-health program
Intervention type(s): Behavioral
Intervention description(s): The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid therapy; web-based intervention; self-management
The Study of KAP on Drink Driving in Jiangsu Province in China
Condition: Drink Driving
Study type: Observational

Summary: 
      Conduct a KAP survey before and after intervention and describe the current knowledge,
      attitudes and behaviors on drink driving in public and analyse the influential factors to
      provide rational strategies to enhance the awareness on drink driving in public.
    


Intervention name(s): health education & law enforcement
Intervention type(s): Behavioral
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        urban and rural residents in Jiangsu province aged 18-70.
      
Keywords: KAP; drink driving; public; Jiangsu province; China
A Study of Lasmiditan in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of lasmiditan in healthy Chinese participants. The purposes are:

        -  To evaluate the safety of lasmiditan

        -  To learn more about how the body processes lasmiditan

      The study will last up to 50 days for each participant.
    


Intervention name(s): Lasmiditan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease
      amyloid buildup by targeting Abeta 42 production.
    

Detailed description: 
      NGP 555 is a gamma-secretase modulator with a selective mechanism to reduce Abeta 42 while
      raising shorter Abeta forms such as Abeta 37 and 38.

      NGP 555 is being developed as a preventative disease modifying therapy for Alzheimer's
      disease.
    

Intervention name(s): NGP 555
Intervention type(s): Drug
Intervention description(s): Gamma-secretase modulator for the treatment of Alzheimer's disease
Other intervention name(s): NGP555
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Amyloid
The Effects of Cricket- and Beef-derived Protein on Plasma Amino Acid Concentrations and Appetite Responses
Condition: Aminoacidemia; Appetitive Behavior
Study type: Interventional

Summary: 
      Dietary protein plays an important role in appetite regulation. Source of ingested dietary
      protein may have different effects on appetite, satiety, and/or food intake in humans.
      Insects are a rich source of protein consumed by many people around the world; however, the
      capacity of insect-derived protein to regulate appetite and food intake is unclear. The
      purpose of this study was to compare postprandial plasma glucose, insulin, amino acid, and
      appetite regulatory hormone concentrations, subjective appetite sensations, and food intake
      following the ingestion of 25 g of cricket- and beef-derived protein in healthy young males.
    

Detailed description: 
      With the rapid increase in the global population, the production of sufficient amounts of
      conventional animal-based protein to meet global dietary demands may no longer be desired nor
      feasible. Insects may represent an environmentally sustainable additional source of dietary
      protein that has the potential to help ensure global food security in the future. However,
      the functional characteristics of insect-derived proteins when fed to humans is unclear.
      Further, how insect-derived proteins compare to other animal-derived proteins (e.g. from
      beef) have not been explored.

      The purpose of this study was to compare postprandial plasma glucose, insulin, and amino acid
      concentrations, gut-derived appetite regulatory hormones, subjective appetite sensations, and
      ad libitum energy intake following the ingestion of 25 g insect- or beef-derived protein in
      healthy young men. It was hypothesized that hyperaminoacidaemia would be more rapid following
      the ingestion of beef-derived protein compared to cricket-derived protein, although total
      amino acid availability would be similar between protein sources over a 300-minute
      postprandial period. It was further hypothesized there would be no difference between protein
      sources on postprandial subjective appetite sensations or subsequent ad libitum energy
      intake.
    

Intervention name(s): Cricket-derived Protein; Beef-derived Protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beverage containing 25 g cricket-derived protein; Beverage containing 25 g beef-derived protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dietary protein; insect protein; young men; beef collagen; amino acids; appetite
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly
      diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive
      standard TB treatment.
    

Detailed description: 
      The planned sample size of 15 participants per treatment group is in keeping with other Phase
      II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which
      based on previous studies of this type conducted at these sites, represents a conservative
      estimate of the expected drop-out rate.
    

Intervention name(s): PA-824; PA-824; PA-824; Rifafour e-275 mg; PA-824
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50mg; 100mg; 150 mg; 275 mg; 200 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Bactericidal Activity; EBA; Pulmonary Tuberculosis; PA-824; pretomanid
Television Viewing (TVV) & Puberty on Lunchtime Food Intake
Condition: Obesity Prevention
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The investigators hypothesize that television viewing will affect food intake in adolescent
      girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a
      glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the
      presence of TV. Subjective appetite will be measured as well.
    


Intervention name(s): water with noncalorie sweetener; water with glucose; TV program showed while feeding; TV program showed while feeding
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: girls; obesity; television viewing; puberty
Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Lipid Metabolism Disorder; Fatty Acid Metabolism Disorder
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut
      microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes,
      employing high-throughput sequencing technology and untargeted lipidomics.
    

Detailed description: 
      The pathogenesis of diabetes is associated with perturbations in lipid metabolism and
      intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids
      (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type
      2 diabetes remains indeterminate. The objective of this research was to investigate the
      impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants
      diagnosed with type 2 diabetes, employing high-throughput sequencing technology and
      untargeted lipidomics. The investigators randomly allocated 110 eligible participants into
      either the fish oil intervention group or the placebo control group for a 3-month
      double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of
      Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to
      investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid
      metabolites.
    

Intervention name(s): omega-3 polyunsaturated fatty acids; corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.; Participants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a randomised, double-blind trial.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Omega-3 Fatty Acids; Gut Microbiota; lipid Metabolome; glycerophospholipid; Type 2 Diabetes Mellitus
ToleroMune Ragweed Exposure Chamber Study
Condition: Ragweed Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with
      ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic,
      allergen-derived peptide desensitising vaccine, currently being developed for the treatment
      of ragweed allergy.

      This study will look at the efficacy, safety and tolerability of two doses of ToleroMune
      Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled, parallel group
      study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic
      subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The
      efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure
      Chamber)EEC.

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic,
      at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at
      least 3 days before randomisation.

      In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be
      randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14
      weeks.

      In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after
      the first administration in the treatment period and assessments will be performed identical
      to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
    

Intervention name(s): ToleroMune Ragweed; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection 1 x8 administrations 2 weeks apart; Intradermal injection, 1x8 administrations 2 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ragweed allergy; Rhinoconjunctivitis; Exposure chamber; Immunotherapy; ToleroMune Ragweed
Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Dry eye disease (DED) is a keratoconjunctive disorder that "is a multifactorial disease of
      the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and
      tear film instability with potential damage to the ocular surface. The goal of this study is
      to assess the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of
      palovarotene ophthalmic solution in healthy adult subjects.
    


Intervention name(s): Palovarotene; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): ophthalmic solution in different concentrations: Dose 1, Dose 2 and Dose 3; Placebo-to-match palovarotene ophthalmic solution vials
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
Condition: C3 Glomerulonephritis; Dense Deposit Disease; C3 Glomerulopathy; Immune Complex Mediated Membranoproliferative Glomerulonephritis; Membranoproliferative Glomerulonephritis Types I, II, and III
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranoproliferative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to determine whether ACH-0144471 (also known as
      danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants
      with low C3 levels due to either C3G or IC-MPGN.
    


Intervention name(s): Danicopan
Intervention type(s): Drug
Intervention description(s): Participants received study drug for 14 days (Treatment Period), followed by a taper over the next 7 days (Taper Period).
Other intervention name(s): ACH-4471; ACH4471; 4471; ACH-0144471; ALXN2040
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: factor D; FD; alternative pathway; complement mediated disease; idiopathic MPGN; MPGN Type I; MPGN Type II; MPGN Type III; Primary MPGN; MCGN; Mesangiocapillary Glomerulonephritis; C3 Glomerulopathy; C3G; Membranoproliferative Glomerulonephritis; C3GN; Dense Deposit Disease; DDD
Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess between the renal impaired patients and normal renal
      function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When
      prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of
      instructions.
    

Detailed description: 
      A Phase 1, Non-randomized, Open, Parallel-Group Clinical trial
    

Intervention name(s): CKD-501
Intervention type(s): Drug
Intervention description(s): From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .
Other intervention name(s): Lobeglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 1

Summary: 
      Numerous efforts have focused on the development of closed-loop systems to control anesthesia
      using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate
      measures of anesthetic depth. New systems have been recently developed to considerably
      improve anesthetic control using model-based, patient-adaptive methods. The purpose of this
      study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in
      delivering closed-loop, patient-specific hypnosis.
    


Intervention name(s): ReinLoop control software for patient-specific induction and maintenance of anesthesia; Propofol
Intervention type(s): Device; Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure
Condition: Type 2 Diabetes Mellitus; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled
      study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and
      function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).
    


Intervention name(s): Saxagliptin; Sitagliptin; Placebo to match saxagliptin; Placebo to match sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg or 2.5 mg, plain, yellow, biconvex, round, film-coated tablet; 50 mg or 100 mg, gray capsule; 2.5 mg or 5 mg, plain, yellow, biconvex, round, film-coated tablet; 50 mg or 100 mg, gray capsule
Other intervention name(s): Onglyza TM; Januvia®
Intervention MeSH terms: Sitagliptin Phosphate; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Heart Failure; Saxagliptin; Sitagliptin
Cigarette Smoke and Susceptibility to Influenza Infection
Condition: Healthy
MeSH terms: Influenza, Human; Disease Susceptibility
Study type: Observational

Summary: 
      This study will be a descriptive comparison of the effects of live attenuated influenza virus
      (FluMist) on nasal inflammation and oxidative stress in healthy young adults who are not
      exposed to smoke vs smokers. It is hypothesized that passive exposure to second-hand smoke
      (SHS) results in increased susceptibility to the effects of influenza virus in nasal
      epithelium in humans and that these effects are mediated by SHS-induced oxidative stress
    

Detailed description: 
      Epidemiologic evidence supports a significant relationship between passive cigarette smoke
      exposure and increased risk for viral respiratory illnesses. Published and preliminary data
      suggest that airborne pollutants including tobacco smoke increase susceptibility of
      respiratory epithelium to infection with influenza A and that this effect is at least
      partially mediated by oxidative stress. However, no studies have specifically looked at the
      interaction between smoking and the effects of influenza virus in human volunteers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. smokers

          2. nonsmokers who are NOT exposed to SHS
      
Biospecimen description: 
      nasal lavage fluid, urine, blood, nasal epithelial tissue from subjects who consent to have
      excess samples stored in our repository
    
Keywords: live attenuated influenza virus; inflammation; flu vaccine; FluMist; smokers