bioihbjkbjnl/mcl2 huggingface dataset:
Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study is to compare two interventions for preparing diabetic teens and
      young adults for transition from pediatric to adult diabetes care.
    

Detailed description: 
      One will represent a short-term intensive social-behavioral intervention supported by
      peer-to-peer social networking in which subjects receive "usual care" from their current
      diabetes provider outside the parameters of the study. The second intervention will be a
      traditional transition clinic model, where subjects will receive the standard of diabetes
      care from a team of combined pediatric and adult practitioners and educators, with added
      educational modules and behavioral evaluation and support designed to facilitate the
      transition to adult care (i.e., that foster "developmentally tailored care"). The first is a
      much less intensive intervention from the standpoint of the providers and gives special
      prominence to peer support; the second is provider-intensive. The goal of both interventions
      is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes);
      i.e., to prepare the patient to move from primary support by family and providers to a
      reliance on self-ownership and self-management as a responsible, independent adult.

      Optional sub-study available for parents, spouses, and significant others.
    

Intervention name(s): Transition Social Behavioral Intervention; Diabetes Transition Clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): If you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to "taking ownership" of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study.; Patients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kinetics of Perioperative Circulating DNA in Cancer Surgery
Condition: Breast Cancer; Prostate Cancer; Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The aim of this study was to determine the kinetics of perioperative circulating DNA in three
      types of cancer. This first step will enable further studies comparing the potential impact
      of certain techniques or anesthetic products on cancer surgery.
    


Intervention name(s): Blood test
Intervention type(s): Other
Intervention description(s): plasma concentration of circulating DNA of specific genes
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.
      
Biospecimen description: 
      Blood samples
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
Condition: High Cholesterol; High Blood Pressure; Colorectal Cancer; Breast Cancer; Prostate Cancer
MeSH terms: Hypertension; Hypercholesterolemia
Study type: Observational

Summary: 
      The purpose of this study is to survey a sample of adults who have recently made a decision
      about treatment of high cholesterol or high blood pressure or a decision about screening for
      colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of
      the validity and reliability of the Shared Decision Making Process scale. Secondary goal is
      to gather evidence on the quality of decisions for these common medical situations.
    

Detailed description: 
      Study staff worked with a national sampling firm to recruit subjects for five different
      medical decisions. The five decisions are (1) treatment of high cholesterol, (2) treatment of
      high blood pressure (3) when to start breast cancer screening (4) whether or not to have
      prostate cancer screening and (5) which test to have for colorectal cancer screening.
      Respondents complete a survey about their experiences talking with health care providers
      about the specific clinical decision. The survey measured the amount of shared decision
      making, knowledge, preferences, decisional conflict and decision regret. The study will
      obtain 500 responses total, or 100 for each decision.

      Sample is an online non-probability panel of adults living in the United States. In the
      survey, participants were screened to meet specific qualifications. After 1 week, a random
      selection of 50 respondents are invited to complete the retest instrument.

      All analyses will be conducted separately for each group, and results may be pooled across
      cancer screening and medication contexts. First, study staff will examine the descriptives
      for the Shared Decision Making Process items. Study staff will also test several hypotheses
      to examine validity of the scores such as whether higher shared decision making process
      scores are associated with less decisional conflict and less regret. Staff will also examine
      retest reliability of the Shared Decision Making Process scale.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Sample was an online non-probability panel of adults living in the United States. Marketing
        Systems Group, the sample vendor, invited potential respondents from a targeted panel
        consisting of participants matching the sex, age, and group dynamics described above. In
        the survey, they were screened to meet our specific qualifications noted above.
      
Keywords: shared decision making
A Study to Evaluate BioMarkers in Blood Samples in Subjects With Rheumatoid Arthritis
Condition: Arthritis
MeSH terms: Arthritis
Study type: Observational

Summary: 
      The purpose of this study is to study the evaluation of blood samples and blood types to
      identify functional protein in the joints.
    

Detailed description: 
      Assessment of type I IFN signature in the peripheral blood and activation of type I IFN
      signaling pathway in synovial fluid (indicating expression of the functional IFN protein in
      the joints).
    

Intervention name(s): Blood samples; Synovial fluid aspiration; Synovial tissue sample
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will have visits on Days 1, 30 and 120.; Subjects will have visits on Days 1, 30, and 120.; Subjects will have visits on Days 1, 30, and 120.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or Female Adults aged 18-75 years old
Skype for Youth With Poorly Controlled Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with
      poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM.
      Examined the differential impact on the youth's adherence to the diabetes medical regimen and
      the youth's blood sugar control.
    


Intervention name(s): BFST
Intervention type(s): Behavioral
Intervention description(s): Family-based skills training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the ability of AI-700-enhanced rest-stress
      echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic
      heart disease who are indicated for single-photon emission computed tomography (SPECT)
      imaging.
    

Detailed description: 
      Assessment of myocardial perfusion has been demonstrated to provide both diagnostic and
      prognostic value to patients with ischemic heart disease by allowing the clinician to assess
      the hemodynamic significance of coronary artery disease (CAD). The primary objective of the
      clinical development program for AI-700 is to demonstrate the safety and efficacy of AI-700
      as an intravenous ultrasound contrast agent in patients with suspected myocardial perfusion
      defects.

      The patient population is comprised of patients who are being evaluated for inducible
      ischemia. The primary study objective was to determine the accuracy, sensitivity, and
      specificity of AI-700-enhanced echocardiographic imaging for detecting CAD using coronary
      angiography/left ventriculography (ANGIO/LVG) or single-photon emission computed tomography
      (SPECT) with clinical outcome as the reference standards.
    

Intervention name(s): AI-700 contrast-enhanced echocardiography
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; ischemia; echocardiography; cardiac imaging; heart disease; myocardial contrast enhancement; myocardial perfusion; wall motion; ultrasound contrast agent
BIS Monitoring of Patients With Hydrocephalus
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

Summary: 
      We tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly.
      We also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage
      patients with hydrocephaly undergoing ventricular-peritoneal shunt placement
    

Detailed description: 
      Context: Enlarged skull circumference in patients with hydrocephalus might alter bispectral
      index (BIS) values; as distorted skull contour distances sensors from a shifted cerebral mass
      as well as mental dysfunction as a result of disrupted Cerebrospinal fluid circulation.

      Objectives: Investigators tested the hypothesis that BIS values are altered in pediatric
      patients with hydrocephaly. Investigators also tested the hypothesis that BIS values are
      altered in adult post cerebral hemorrhage patients with hydrocephaly undergoing
      ventricular-peritoneal shunt placement.

      Methods: After ethics committee approval participants, or their next of kin, who gave written
      informed consent were recruited in the study. Investigators excluded potential participants
      suffering from hepatic disease. In the first study 15 pediatric patients with hydrocephaly
      and 15 pediatric control patients at approximately the same age group were included in the
      study.

      In the second study 15 post cerebral hemorrhage adult patients undergoing
      ventricular-peritoneal shunt placements and 15 adult control patients were included in the
      study.

      2 BIS sensors were placed on patients' forehead and connected to BIS-Vista monitors. In a
      quiet anesthesia induction room investigators recorded BIS-Vista for 10 min before induction.

      Remifentanil 4 ng ml-1 was started and propofol TCI was kept constant at 4 microg ml-1 with
      no adjustments for a 1 h anesthesia maintenance study-recording period when time of surgery
      allowed. Investigators also noted BIS values immediately before and after a patent
      ventricular-peritoneal shunt was successfully installed. After conclusion of surgical
      procedures, remifentanil and propofol infusions were terminated and this marked the beginning
      of the recovery phase of the study where we recorded BIS values for another 20 min emergence
      from anesthesia.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        . In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control
        patients at approximately the same age group will be included in the study.

        In the second study 15 post cerebral hemorrhage adult patients undergoing
        ventriculo-peritoneal shunt placements and 15 adult control patients will be included in
        the study.
      
Keywords: Bispectral Index Hydrocephalus
Single/Multiple Dose Bioavailability Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660
      mg relative to the established commercial Aleve 220 mg tablet following single dose
      administration and at steady-state following multiple dose administration for 4 days.
    


Intervention name(s): Naproxen Sodium 660mg; Commercial Aleve 220 mg
Intervention type(s): Drug; Drug
Intervention description(s): Extended release Naproxen Sodium (660mg) administered once a day; Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Naproxen Sodium; Bioavailability
PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are
      in general good health and selected for participation in the study according to the selection
      criteria. This study will assess the effect of food on the pharmacokinetics of PT2385
      Tablets. The study will consist of two periods and will be conducted in a crossover fashion.
    

Detailed description: 
      Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and
      non-fasting). Serial blood samples will be collected for after dose administration in each
      period. Subjects will be confined at the clinical research for a portion of each period.
    

Intervention name(s): PT2385
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female Subjects
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
Condition: Nervous System Diseases
MeSH terms: Nervous System Diseases; Status Epilepticus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety and pharmacokinetics of
      MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a
      healthcare setting.
    


Intervention name(s): SHP615
Intervention type(s): Drug
Intervention description(s): SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).
Other intervention name(s): Midazolam hydrochloride oromucosal solution; MHOS
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizure; Midazolam hydrochloride; Convulsive
Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy
Condition: Effect of Drug
Study type: Interventional

Summary: 
      This study used sequential method（Dixon's up and douwn） to determine the effective dose of
      remiazolam combined with propofol in painless upper gastrointestinal endoscopy
    

Detailed description: 
      Remimazolam tosylate is a novel benzodiazepine drug that can be used for gastrointestinal
      sedation. However, some studies have reported that the sedative effect of using remimazolam
      alone is poor, and the patient's body movements are obvious, which affects the operation of
      endoscopists. Propofol, as a commonly used sedative drug, has good sedative effects, but has
      a high incidence of adverse events, especially cardiovascular system inhibition. Therefore,
      this study will explore the effective dose of remimazolam combined with propofol, reduce the
      adverse events of propofol and increase the sedative efficacy of remimazolam. This study only
      set up one study group, fixed the dosage of propofol, adjusted the dosage of Remimazolam to
      meet the appropriate sedation requirements for patients. Patients with successful sedation
      were judged to have a negative reaction, while patients with failed sedation were judged to
      have a positive reaction. A sequential chart was drawn based on the sedation situation until
      7 positive negative reaction intersections were found, and the study ended
    

Intervention name(s): Remimazolam tosilate
Intervention type(s): Drug
Intervention description(s): The fixed dose of propofol in this study was 0.5mg/kg, with an injection time of 30 seconds. Subsequently, remimazolam was administered at an initial dose of 0.1mg/kg. After 1 minute of administration, sedation was evaluated using MOAA/S. When the MOAA/S score was ≤ 1, endoscopic examination could begin. If the patient did not show physical activity or coughing, sedation was considered successful, and the next patient's medication dose was reduced by 0.02mg/kg; On the contrary, if sedation fails, the next patient will receive an additional 0.02mg/kg of medication.Successful sedation results in a positive reaction, while failure results in a negative reaction. This study ends when 7 positive and negative reactions intersect
Intervention model: Sequential Assignment
Intervention model description: We will use the Dixon's up and down method.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: combination; effective dose; remimazolam; propofol
Endoscopic Characteristics of Duodenal and Ampullary Lesions
Condition: Duodenal Diseases
MeSH terms: Duodenal Diseases
Study type: Observational

Summary: 
      The purpose is to investigate whether polyps that look different at endoscopy, have formed
      via different mutations and have different risks of turning into cancer.
    

Detailed description: 
      Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the
      duodenal wall with minimal vertical growth. It has become evident over the last few years
      that rather than being a single entity requiring an accumulation of mutations, Duodenal and
      ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic
      pathways. It is therefore hypothesised that different polyp types have different genetic
      abnormalities, and potentially form via distinct genetic pathways, although this theory has
      not been widely examined.

      This knowledge would be important in furthering our understanding of the development of
      cancer. There is accumulating evidence that genetic abnormalities may be a better predictor
      of cancer behaviour than histological grade. Additionally, guidelines for endoscopy
      surveillance are currently a one size fits all approach that do not reflect the genetic
      heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer.
      Genetic studies may assess future cancer risk to a person in polyps once removed and plan
      surveillance endoscopy frequency.
    

Intervention name(s): Tissue Sampling
Intervention type(s): Other
Intervention description(s): A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Duodenal and/or ampullary adenomas or cancers.
      
Biospecimen description: 
      Adenoma tissue sample and control "regular" tissue sample
    
Keywords: Duodenal adenoma; Ampullary adenoma
Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block
Condition: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Thoracic Paravertebral Block; Erector Spinae Plane Block
MeSH terms: Aortic Dissection; Pain, Postoperative
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
      Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods
      such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block
      (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most
      preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the
      analgesic effect is evaluated. However, no research could be found in the literature
      combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic
      surgery operations are also different from each other. Therefore, it may be possible to
      obtain a more effective analgesic effect in patients by combining the mechanism of action of
      TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect
      of TPVB, ESPB and combined TPVB-ESPB pain after VATS.
    


Intervention name(s): Two different block and combination of these two blocks
Intervention type(s): Procedure
Intervention description(s): Thoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erector spinae block, Thoracic paravertebral block, VATS