bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of nitro-glycerine on the
      microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.

      Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In
      this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no
      common therapy in the rest of the world. The investigators now compare nitro-glycerine and
      placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).
    

Detailed description: 
      This study starts at admission of the patient on the ICU. In the next 24 hours the patient
      receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we
      evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters.

      Informed consent is obtained of the relatives.
    

Intervention name(s): nitroglycerin iv; placebo = nacl 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes; 4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
Other intervention name(s): nitropohl; isotonic saline
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: microcirculation; sepsis; nitroglycerine; SDF imaging
The Study of Metastatic Pancreatic Adenocarcinoma
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen
      Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary
      objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease
      control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor
      progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study
    

Detailed description: 
      Phase I: 2~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which
      error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's
      design of 25 patients in the first stage and 27 patients in the second stage.
    

Intervention name(s): S-1,Leucovorin,Oxaliplatin,Gemcitabine
Intervention type(s): Drug
Intervention description(s): Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Other intervention name(s): G-CSF
Intervention MeSH terms: Leucovorin; Gemcitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enroll the 80 patients in this trial
To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This was a prospective, multicenter, open-label, self-controlled study to evaluate the
      efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose
      measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.

      Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous
      blood glucose or fingertip blood glucose to evaluate System accuracy capability.
    

Detailed description: 
      At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek
      Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were
      collected from each subject during fasting, after breakfast and after lunch.After the end of
      blood glucose measurement, the data were recorded, including adverse events and device
      defects during the test. The subjects were required to stay in the examination room for 5-10
      minutes, during which they completed the product use evaluation questionnaire.
    

Intervention name(s): Non-invasive glucose meter; EKF analyzer; Accu-Chek Guide
Intervention type(s): Device; Device; Device
Intervention description(s): Blood glucose levels were measured while fasting, after breakfast, and after lunch，Place your index finger into the non-invasive blood glucose meter and wait for the instrument to display the reading.; Blood glucose levels were measured while fasting, after breakfast, and after lunch，After collecting venous blood and separating plasma, blood glucose detection is performed using the EKF analyzer with the hexokinase method.; Blood glucose levels were measured while fasting, after breakfast, and after lunch，Use Accu-Chek Guide blood glucose meter to prick the finger and obtain blood for glucose measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Glucose Self-Monitoring; Non-invasive glucose meter
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well LY3316531 is tolerated and what side
      effects may occur in healthy participants and participants with psoriasis. The study drug
      will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into
      a vein in the arm).

      This is a three-part study. Participants will enroll in only one part. Parts A and B are for
      healthy participants and Part C is for participants with psoriasis. Participation could last
      between 16 and 57 weeks.
    


Intervention name(s): LY3316531 - IV; LY3316531 - SC; Placebo - IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV.; Administered SC.; Administered IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Digitally Assisted Recovery Coach
Condition: Alcohol Use Disorder; Alcohol Withdrawal
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The aims of this proof-of-concept study are to determine the feasibility of 1) using a
      smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2)
      monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to
      care post-detox.
    


Intervention name(s): Digitally assisted peer recovery coach
Intervention type(s): Behavioral
Intervention description(s): The certified peer recovery coach utilized an existing care coordination smartphone app to provide support to the patient during and after an inpatient detoxification treatment for alcohol use disorder. The coach utilized the telephone or text messages to send daily motivational messages, remind about upcoming appointments, and checked-in if responses were concerning. Follow-up by the coach continued for 30 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol use disorder; peer recovery coach; smartphone app
Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure
Condition: Renal Failure; Critical Care; Gram Positive Bacteria
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Treatment of infections in critically ill patients remains a significant challenge to
      intensivists world-wide with persisting high mortality and morbidity. Compelling evidence
      suggests that source control of the pathogen and appropriate antibiotic therapy remain the
      most important interventions to improve patients' outcome, the latter including the
      administration of a suitable molecule at an optimized dosage regimen.

      Daptomycin is the first representative of a new family of antibiotics, the cyclic
      lipopeptides. Its bactericidal effect against Gram-positive bacteria, including
      meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in
      critically ill patients having infections due to resistant Gram positive strains.

      Unfortunately, no PK study has been performed in infected critically ill patients without
      renal replacement therapy. A vast array of pathophysiological changes can occur in infected
      critically ill patients, leading to changes in volume of distribution and clearance of
      antibiotics in these patients, which may affect the antibiotic concentration at the target
      site.

      It is therefore important to better characterize daptomycin PK in infected patients with
      various degrees of renal failure in order to define optimal dosing regimens.

      This project aims to identify optimal daptomycin administration schemes in critical care
      patients with various degrees of renal impairment
    


Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention MeSH terms: Daptomycin
Keywords: Pharmacokinetics
Fentanyl Use for Sedation in Esophagogastroduodenoscopy
Condition: Endoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether conscious sedation with a narcotic and
      sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy
      to achieve optimal patient comfort and ease of procedure.
    

Detailed description: 
      Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into
      the intestines. It is a routine test and considered very safe. However, patients can
      experience discomfort from air insufflation in the stomach and unpleasantness due to gagging
      during the procedure. Conscious sedation with medications like sedatives and narcotics are
      used to improve patient satisfaction and enhance physician ability to perform an optimal
      examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist
      and the goal is always to use the lowest dose possible to achieve the best examination.
      Combination therapy (with a sedative & narcotic) may increase the adverse effect profile
      compared to a sedative alone and not improve the overall experience of the physician or
      patient. The goal of our study is to assess in randomized, double-blind, placebo controlled
      study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation
      compared to a sedative (midazolam) alone.
    

Intervention name(s): Midazolam; Fentanyl; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.; 100mcg intravenously given in 2mL syringe at start of procedure; One dose of saline (2ml)
Intervention MeSH terms: Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endoscopy; sedation; opioid; narcotic
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
Condition: Aspiration
Study type: Interventional

Summary: 
      During surgery, there is a risk that food or liquid in the stomach might be forced back up
      the throat where it could enter the lungs (aspirate) and result in serious complications or
      even death. This is why people going for surgery are required not to eat before their
      surgery. However, in emergency situations it is often not possible to know whether a patient
      has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to
      determine if there is content in a patient's stomach and how much. This test involves an
      ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.

      The purpose of this study is to determine how accurate these measurements are. In other
      words, how good are we at detecting an empty stomach from one that has liquids, or solids in
      it. You are being asked to participate in this study because we require non-pregnant
      volunteers in order to answer the aforementioned study question.
    


Intervention name(s): Food intake
Intervention type(s): Other
Intervention description(s): Either drinking a cup of clear liquid, or having a cup of coffee and a muffin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Ultrasound; Gastric area; Accuracy; Aspirate
Patient Satisfaction With Virtual Postoperative Visit
Condition: Post-Op Complication
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      This is a prospective, randomized study designed to evaluate the effects of different initial
      postoperative follow-up modalities. Given the nature of the study, it is not possible for
      either the surgeons or the subjects to be blinded. To reduce bias that may occur due to each
      surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than
      individual subjects) will be randomized to one of two postoperative follow-up modality groups
      (traditional or virtual).
    


Intervention name(s): Traditional; Virtual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Surgeons (rather than individual subjects) will be randomized to traditional Postoperative follow-up modality groups. They will adhere to this form of postoperative follow-up for all of their surgical patients (subjects) for one month.; Surgeons (rather than individual subjects) will be randomized to virtual postoperative follow-up modality group. They will adhere to that form of postoperative follow-up for all of their surgical patients (subjects) for one month.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study includes two periods. In Period 1, Participants who meet eligibility criteria will
      be randomized in a 1:1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose
      B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be
      re-randomized at Week 13 in a 1:1 ratio to receive a twice-daily oral LNK01001 Dose A or
      LNK01001 Dose B for 12 weeks (period 2). Participants who receive LNK01001 ( Dose A and Dose
      B) in Period 1 will maintain the treatment dose in Period 2.
    

Detailed description: 
      This study includes a 35-day screening period; a 12-week randomized, double-blind,
      parallel-group, placebo-controlled treatment period (Period 1); a 12-week double-blind period
      (Period 2); and a 28 to 35-day follow-up period (FU).

      Participants who meet eligibility criteria will be randomized in a ratio of 1：1：1 to 3
      treatment groups in period 1， the placebo group will be rerandomized in a 1:1 ratio to
      LNK01001 Dose A or LNK01001 Dose B at week 13.

        1. Group 1: LNK01001 Dose A BID (Day 1 to Week 12)， LNK01001 Dose A BID (Week 13 and
           thereafter)

        2. Group 2：LNK01001 Dose B BID (Day 1 to Week 12)， LNK01001 Dose B BID (Week 13 and
           thereafter)

        3. Group 3: Placebo (Day 1 to Week12) ， LNK01001 Dose A BID (Week 13 and thereafter)

        4. Group 4: Placebo (Day 1 to Week12) ， LNK01001 Dose B BID (Week 13 and thereafter)

      Participants who complete the Week 12 visit (end of Period 1) will enter Period 2, and
      continue to receive LNK01001 Dose A or Dose B treatment. Starting at Week 12, rescue therapy
      is allowed.
    

Intervention name(s): LNK01001 Dose A; LNK01001 Dose B; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules taken orally; Capsules taken orally; Capsules taken orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Testing Strategies to Encourage Weight Loss in an Employer Setting
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel
      ways of structuring financial incentives to motivate and sustain long-term weight loss. The
      study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to
      participate in a 6-month weight loss program and an additional 3-month follow-up period. The
      primary outcome measure in this randomized control trial will be pounds of weight lost
      between baseline and 6 months. The goal of this study is to evaluate whether a novel
      financial incentive program delivered through a workplace can effectively encourage sustained
      weight loss among obese employees.

      The study hypotheses are 1) mean weight loss will be greater in all the intervention groups
      compared to the control group by the end of the 24-week intervention period; and 2)
      individuals in the intervention groups will have a lower mean weight at the end of the
      12-week follow-up period than individuals in the control group.
    


Intervention name(s): No intervention; Group-based payout; Individual payout
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months; Monthly weigh-ins for 6 months where five sequential participants, randomized to this condition, will be joined into virtual groups where individual rewards for weight loss are dependent on the weight loss of others in the group, with follow-up weigh in at 9 months; Monthly weigh-ins for 6 months and if monthly goals are met, participants receive payout at the end of the month, with follow-up weigh-in at 9 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Motivation; Workplace; Web platform
Microplastica Pollution Awareness Level of Students
Condition: Environmental-Pollution-Related Condition
Study type: Interventional

Summary: 
      This study aims to raise awareness among individuals about plastic and microplastica
      pollution, reduce plastic consumption, reduce the amount of plastic waste that grows
      cumulatively every year, and contribute to the development of a livable environment.
    

Detailed description: 
      The aim of this research is to investigate the effect of environmental health education given
      at the 9th-grade level on the microplastica pollution awareness level of students.

      This pretest-posttest experimental study with a randomized control group was conducted
      between 2022 and 2023 in three high schools in a province in eastern Turkey. The sample of
      the study consisted of 90 ninth-grade students (experimental group: 45, control group: 45),
      and the sample magnitude was determined by power analysis. Tools such as the "Personal
      Information Form" and "Microplastica Pollution Awareness Scale (MPAS)" were used to collect
      data. Training was given to the experimental group as a nursing intervention in a total of 4
      sessions at 15-day intervals. No intervention was applied to the individuals in the control
      group. In the data evaluation process, percentage distribution, arithmetic mean, standard
      deviation, chi-square test, correlation and regression analyses were used.

      While no significant difference was observed in the MPAS total score in the control group
      according to the pre-test and post-test mean scores, a significant difference was observed in
      the MPAS total score in the experimental group (p≤0.05). When the posttest mean scores of the
      experimental and control groups were examined, it was observed that the posttest mean scores
      of the experimental group were higher than the posttest mean scores of the control group and
      there was a statistically significant difference (p≤0.05).

      It was observed that the microplastica pollution awareness level of the experimental group
      students who received environmental health training increased significantly.
    

Intervention name(s): Education group; No training was given
Intervention type(s): Other; Other
Intervention description(s): Students in the experimental group were educated about environmental health and microplastica, and nursing interventions were made. The training was organized for twenty minutes in each session, with a total of four sessions at two-week intervals.; No training was given
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is a randomised control study with pretest-posttest design.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Enviromental health; Microplastics; Student
A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A of the study will test the safety, the amount of drug in the body, and effects of the
      drug in the body after multiple doses. This will be conducted in healthy overweight adults.
      Part B of the study will test the effects of multiple doses of the investigational drug on
      the amount of midazolam, an approved drug, in healthy adults.
    


Intervention name(s): PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo; midazolam; PF-06282999; midazolam; PF-06282999
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, 10 mg, every 8 hours, 14 days; Tablet, 0 mg, every 8 hours, 14 days; Tablet, 30 mg, every 8 hours, 14 days; Tablet, 0 mg, every 8 hours, 14 days; Tablet, 100 mg, every 8 hours, 14 days; Tablet, 0 mg, every 8 hours, 14 days; Tablet, 250 mg, every 8 hours, 14 days; Tablet, 0 mg, every 8 hours, 14 days; Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days; Tablet, 0 mg, every 8 or 12 hours, 14 days; Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14; Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days; Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14; Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science