bioihbjkbjnl/mcl2 huggingface dataset:
Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
Condition: Idiopathic Dilation of the Bronchi
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to identify the abnormalities of bronchial trans-epithelial
      transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the
      bronchi.
    

Detailed description: 
      Dilations of the bronchi happens for one child over 3000. The extended forms may progress to
      respiratory failure. More than one case over two remains of undetermined cause. If the
      prototype is the cystic fibrosis, other abnormalities of ionic transport may be the cause of
      a failure of mucociliary clearance and enhance the idiopathic dilations of the bronchi.

      The purpose of this study is to identify the abnormalities of bronchial trans-epithelial
      transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the
      bronchi, in comparison to two others groups of patients (without abnormality of ionic
      transport/with typical cystic fibrosis).
    

Intervention name(s): bronchial ddp test
Intervention type(s): Other
Intervention description(s): bronchial ddp test during endoscopy, nasal smear, bronchial smear
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dilation of the Bronchi; Bronchial potential difference; Dilation of the Bronchi (DDB)
Exploring the Effects of Sleep Patterns and Physical Activity on Asthma in Adolescents With Wrist-worn Smart Devices
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a research study to find associations between asthma symptoms and sleep patterns and
      physical activity among adolescent patients with persistent asthma. The Investigators will
      collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.
    

Detailed description: 
      Investigators from the University of Arkansas for Medical Sciences (Pediatrics), the
      University of Arkansas at Little Rock and the University of Florida will work together to
      conduct a research study to find associations between asthma symptoms, sleep patterns, and
      physical activity over an 8-week period among adolescent patients with persistent asthma.

      The goal of this research study is to find new ways for teenagers to manage their asthma.
      Full understanding of the connection and interference of sleep patterns and physical activity
      with asthma symptoms will be very helpful for teenagers with asthma to better manage their
      daily routine and asthma care. This research study will use wrist-worn devices (i.e. Fitbit®
      wristbands) to collect participants' sleep and physical activity data.
    

Intervention name(s): Fitbit® Charge Heart Rate (HR) wristband
Intervention type(s): Other
Intervention description(s): The Investigators will conduct a proof of concept and feasibility study to explore associations between asthma symptoms and sleep patterns and physical activity over an 8-week intervention period among 20 adolescent patients with persistent asthma.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep patterns; Physical activity; Fitbit
Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study plans to compare the efficacy of the nicotine patch / lorcaserin combination
      treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior
      and withdrawal symptoms.
    

Detailed description: 
      This study proposes to investigate the potential efficacy of a combination of two
      FDA-approved agents, nicotine patch and lorcaserin, for smoking cessation treatment. The
      nicotine patch which provides a sustained low dose of nicotine is a nicotine receptor
      agonist. Lorcaserin, a serotonin 5-hydroxytryptamine receptor 2C (5-HT2C) agonist, is a drug
      that is FDA-approved for weight loss, and has also recently been shown to be efficacious for
      smoking cessation. Given that these drugs act through distinct mechanisms it is hoped that
      the combination will prove more efficacious than either drug alone. It is also hypothesized
      that the combination will reduce weight gain commonly seen after smoking cessation.
    

Intervention name(s): lorcaserin; nicotine patch; placebo lorcaserin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Belviq; Nicoderm; placebo Belviq
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nicotine addiction; Cigarette smoking; Smoking cessation; lorcaserin; Belviq; Nicotine patches
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the study drug, evacetrapib, enters the
      blood stream and how long it takes the body to dispose of the study drug when given to
      participants with severe renal (kidney) impairment compared to participants with normal renal
      (kidney) function. This study will last approximately 8 weeks.
    


Intervention name(s): Evacetrapib
Intervention type(s): Drug
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Condition: COVID-19; Lung Infection
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in
      Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the
      potential of opaganib to improve and/or stabilize the clinical status of the patient.
    

Detailed description: 
      This is a phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled
      study with an adaptive design that will utilize a futility assessment. The study is planned
      be performed worldwide in up to approximately 80 clinical sites.

      After informed consent is obtained, patients will enter a screening phase for no more than 3
      days, to determine eligibility. Approximately 464 eligible patients will be randomized and
      receive either opaganib added to standard of care, or matching placebo added to standard of
      care, in a randomization ratio of 1:1. Treatment assignments will remain blinded to the
      patient, investigator and hospital staff, as well as the sponsor. As the approval and/or
      guidance for treating COVID-19 are evolving, for this protocol, standard of care will be
      defined by the recommended schemes of treatment according to the severity of the disease,
      taking into consideration regulatory approvals in one or more regions.

      Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours,
      or matching placebo, in addition to standard of care (pharmacological as defined above and/or
      supportive) at any given institution. Study drug will be administered every day for 14 days
      (Day 1 to Day 14). All participants will be followed up for 28 days after their last dose of
      study drug, which may occur at Day 14 or after premature study drug discontinuation, based
      upon patient or physician determination.
    

Intervention name(s): Opaganib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).; Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).
Other intervention name(s): Yeliva; ABC294640
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic Use
Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
Condition: Cardiovascular Diseases; Aging
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This purpose of this study is to assess the impact of consuming wolfberry on cardiovascular
      risk in Singapore's middle-aged and older adults. The investigators hypothesize that
      consuming wolfberry with a healthy eating pattern diet will contribute to improvements in
      cardiovascular health when compared to a similar diet without wolfberry.
    

Detailed description: 
      This is a 16-week parallel, single-blind (investigator), prospective randomized controlled
      trial. The study was designed based on previous research which showed that consuming 15 g/day
      of wolfberry for 4 weeks and 14 g/day of wolfberry with meal for 6 weeks increased plasma
      zeaxanthin concentrations and antioxidant status. Also, other studies reported observable
      changes in the endothelial progenitor cells and flow mediated dilation after just two weeks
      of fruit and vegetables or healthy diet interventions. Thus collectively, 16-weeks may be a
      sufficient period to detect the changes in endothelial function, whole body carotenoids, and
      anti-oxidant status, which are the outcomes of interest in this research project.
    

Intervention name(s): Wolfberry; Healthy diet
Intervention type(s): Other; Other
Intervention description(s): Consumption of cooked dehydrated wolfberry as part of a mixed meal.; Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Wolfberry (Goji berry); Healthy diet; Cardiovascular diseases; Endothelial function; Lipidomics; Middle-aged and older adults; Oxidative stress; Inflammation
A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects
Condition: Infections, Human Immunodeficiency Virus and Herpesviridae
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose escalation study to determine the safety, tolerability, and pharmacokinetic
      profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral
      (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and
      follow-up evaluations for a minimum of 12 weeks following the injection.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): GSK1265744 injectable suspension; Placebo to match injectable suspension
Intervention type(s): Drug; Other
Intervention description(s): 200 milligram per milliliter sterile solution for injection; placebo
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
The Efficacy of Electrical Version of Patient Reported Outcome
Condition: Spinal Disease
MeSH terms: Spinal Diseases
Study type: Observational [Patient Registry]

Summary: 
      Recently the importance of electrical PRO system is increased for the accuracy, convenience,
      and efficiency for both patients and physicians. For the evaluation of quality of life,
      various self-reported questionnaires is filled-out by the patient, mostly in front of
      outpatient clinic, and doctor usually take times to calculate the score. If there is
      electrical PRO which is available with mobile device, the efficacy of clinic would be
      improved. The investigators developed such a system and applied the system for patients with
      spinal disease. The investigators assessed the effectiveness of application of electrical-PRO
      in outpatients' clinic for patients who had filled-up same questionnaire in paper version.
    

Detailed description: 
      Age, sex, education levels, use of smartphone, the number of applications.
    

Intervention name(s): Electrical version patient reported outcome questionnaire
Intervention type(s): Other
Intervention description(s): Assess satisfaction of patients with "electrical version patient reported outcome questionnaire".
Other intervention name(s): Electrical patient reported outcome
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        the patients who have experienced paper questionnaire
      
Keywords: outcome assessment; self-reported; patient; clinical outcome
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A mass balance study to determine the routes and rates of elimination of radioactivity, to
      determine total radioactivity in plasma and whole blood over time and compare levels to
      JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters
      of JTZ-951 and its metabolite(s).
    


Intervention name(s): JTZ-951, 14C-JTZ-951
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: JTZ-951; Pharmacokinetics; 14C-JTZ-951; Mass balance; Time course
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      1. In order to compare the benefit, side effects, and patient preference of Ropinirole
           prolonged release when used in once-daily or twice-daily dosing

        2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged
           release
    

Detailed description: 
      1. Study subjects : Parkinson disease who are on Ropinirole immediate release or
           Pramipexole immediate release and are considering to change into Ropinirole prolonged
           release

        2. Cross over study design:

             -  Group 1: once daily dose for 2 month then into twice daily in divided dose for 2
                months

             -  Group 2: twice daily in divided dose for 2 months then into once daily dose for 2
                months

        3. Dose adjustment may be done in the first 4 weeks.

        4. Compare the benefit,side effects, and patient preference between the once daily vs twice
           daily dosing.
    

Intervention name(s): Ropinirole Prolonged release
Intervention type(s): Drug
Intervention description(s): Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Other intervention name(s): Requip PD®
Intervention MeSH terms: Ropinirole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson disease; Ropinirole
Genetic Susceptibility to Factor VIII Inhibitors
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      This international study will identify genetic factors that may influence the development of
      inhibitory antibodies in patients with hemophilia A after treatment with factor VIII.
      Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous
      research indicates that genetic factors play a role in the development of inhibitors. A
      better understanding of the influence of genes in this treatment complication may be helpful
      in predicting, treating or preventing inhibitors.

      People in families in which one or more members have severe factor VIII deficiency and one or
      more have a history of an inhibitor may be eligible for this study. Participants fill out a
      form with questions about the person's relationship to other family members taking part in
      the study. Those with hemophilia provide a brief medical history, including
      hemophilia-related information, inhibitor history and the presence of other conditions such
      as hepatitis C and HIV. All participants have a blood sample taken for laboratory and
      research tests.
    

Detailed description: 
      In collaboration with investigators of the Hemophilia Inhibitor Genetic Study (HIGS)
      multicenter study and the University of Lund, University Hospital, Malmo, Sweden, we propose
      to assess the role of genetic variants in the process of developing inhibitors to Factor VIII
      in persons with hemophilia. The discovery of genetic associations offers the potential to
      direct clinical management in order to prevent inhibitor development and improve clinical
      care in patients with inhibitors.
    

Observational model: Family-Based
Time perspective: Cross-Sectional
Keywords: Hemophilia; Antibody; Mutations; SNP; clotting
The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI
Condition: Drug-Induced Acute Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      The study adopted the superiority design of multi center, randomized, double-blind, positive
      control drug, dose finding, using two simulation skills. The qualified subjects, according to
      the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug
      control group, and received a treatment course of 4-8 weeks, all individuals were followed up
      for 4 weeks after drug withdrawal.
    

Detailed description: 
      Explore the safety and efficacy of different doses of bicyclol in treatment of acute
      drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control
      drug.

      The study adopted the design of multi center, randomized, double-blind, dose finding,
      positive control drug, superiority test, using two simulation skills. The qualified subjects,
      according to the ratio of 1:1:1, were randomized into low dose group and high dose group and
      positive drug control group, and received a treatment course of 4-8 weeks, all individuals
      were followed up for 4 weeks after drug withdrawal.
    

Intervention name(s): bicyclol tablet 25mg; bicyclol tablet 50mg; polyene phosphatidylcholine capsule 456mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.; Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.; Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
Other intervention name(s): bicyclol blank analog tablet; polyene phosphatidylcholine blank analog capsule; polyene phosphatidylcholine blank analog capsule; bicyclol blank analog tablet
Intervention MeSH terms: Polyene phosphatidylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This exploratory, randomized, open label study aims to explore the safety, tolerability,
      pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut
      microbiota of healthy subjects.
    


Intervention name(s): KB5; SG1; Lactulose
Intervention type(s): Other; Other; Other
Intervention description(s): KB5, a novel glycan, is a Kaleido laboratory code for KB174; SG1 is a novel glycan; Lactulose is a synthetic dissacharide
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microbiome; Kaleido; Kaleido Biosciences; Oligosaccharide; Glycan; Microbiome Metabolic Therapy; KB174; KB5; SG1
Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol (a supplement to 805466) is to test whether our telephone continuing care model
      can be implemented successfully by "real world" publicly funded programs. Participants will
      be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The
      investigators will train city telephone care managers to deliver our telephone continuing
      care intervention to patients in this program. The investigators will randomize 200 to
      receive this intervention or usual care and follow them for 12 months.
    


Intervention name(s): Recovery Support Counseling
Intervention type(s): Behavioral
Intervention description(s): Telephone based recovery support provided by paraprofessionals at the City of Philadelphia's Behavioral Health Department. Calls are once weekly for 8 weeks, then step down to every other week for the remainder of the year of study participation. Call frequency can be increased as a result of a rise in risk factor/protective factor ratio.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study to compare the PK of preladenant administered to participants with
      CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK
      of participants with severe CRI to healthy participants. Part 2 will compare the PK of
      participants with moderate CRI and participants with mild CRI to healthy participants. The
      primary hypotheses are that the plasma area under the concentration-time curve from time 0 to
      infinity after single dosing (AUC0-∞) of preladenant in participants with either severe,
      moderate or mild CRI is similar to that of matched healthy participants.
    


Intervention name(s): Preladenant
Intervention type(s): Drug
Intervention description(s): After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other intervention name(s): SCH 420814
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment