bioihbjkbjnl/mcl2 huggingface dataset:
Concentration of Ertapenem in Colorectal Tissue
Condition: Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms
MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue
      from three hours up to six hours (25% of dosing interval) after administration of ertapenem.
    

Detailed description: 
      The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal
      tissue from three hours up to six hours (25% of dosing interval) after administration of
      ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the
      colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring
      elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible
      for this study.
    

Intervention name(s): Ertapenem
Intervention type(s): Drug
Intervention description(s): powder for infusion, 1 gram I.V., single dose over 30 min.
Other intervention name(s): Invanz, EU/1/02/216/001 + /002; ATC code: J01DH03
Intervention MeSH terms: Ertapenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Condition: Burn
MeSH terms: Burns
Study type: Observational

Summary: 
      The purpose of this study is to establish an expected recovery trajectory (recovery model) in
      terms of physical and psychological function of the pediatric burn patient.
    

Detailed description: 
      The successful advancement of treatment for burns allows us now to save lives of children who
      sustain massive burn injuries. The purpose of this study is to establish an expected recovery
      trajectory (recovery model) in terms of the physical and psychological function for pediatric
      burn patients by assessing prospectively the outcomes of burn children who are treated at the
      four Shriners Hospitals for Children (SHC) burns hospitals. The study hopes to develop valid
      benchmarking of outcomes between the four hospitals and therefore, best practices will be
      utilized. This recovery trajectory will be used as a benchmark for functional and
      psychosocial outcomes following burn injury.

        -  Participants in the study complete a series of self reporting questionnaires over a
           forty-eight month period. There are a total of nine time points during the forty-eight
           month commitment when questionnaires are given to parent and/or guardian and patients if
           they are 11 years or older.

        -  Patients who undergo a reconstructive surgical procedure during their enrollment will
           fill a set of questionnaires related to the effects of the surgical procedure on their
           long-term recovery. The surgical procedure is not an intervention because of the study,
           it is part of their long-term follow-up care after their acute phase. There will be a
           pre-op and a six and twelve month post-op questionnaire.

        -  The aim of this study is to develop an expected trajectory recovery model in terms of
           physical and psychological functioning. Analysis of the data using validated burn
           specific questionnaires will allow benchmarking of outcomes between the four Shriners
           Burns Hospitals. We aim to determine predictors of positive outcomes and focus on them
           as a standard of practice.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients admitted to Shriners Hospitals-Boston,MA Cincinnati,OH, Galveston,TX and
        Sacramento, CA burn hospitals with a diagnosis of burn injury.
      
Keywords: Burns; Functional; Psychosocial; Recovery; Long-term; Pediatric; Surgical; Outcomes; Benchmarking
Foster Teens' Risk During Transition
Condition: School Adjustment; Foster Care Disruptions
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized effectiveness trial to determine whether
      adding a preventive intervention at the transition from elementary to middle school is
      effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use,
      participation in HIV- risking sexual behavior, delinquency, mental health problems, and
      school failure for young adolescents in foster care. The proposed LINKS intervention marries
      the goals of child welfare and educational systems. The aims are: a) to determine the
      effectiveness of the LINKS intervention on key behavioral health and school adjustment
      outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement
      failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to
      examine cost effectiveness and cost avoidance of LINKS.
    


Intervention name(s): LINKS
Intervention type(s): Behavioral
Intervention description(s): In the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT). In previous studies, attendance at such groups has been high, averaging about 75-80%. Missed sessions will be "made up" with an in-person visit to the foster/kin home during the week of the original session. In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: foster care; school adjustment
Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release
      Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
    


Intervention name(s): Asasantin (ER); Persantin; Acetyl salicylic acid (ASA)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates; Dipyridamole; Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there
      has been made substantial improvements in diagnosis, staging and treatment of HNC. The
      overall survival has improved, but for some subgroups it is unchanged and therefore new
      prognostic and surveillance methods are warranted.

      One of the hallmarks in cancer is the ability to invade the surrounding tissue and
      metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA)
      and its receptor (uPAR) are present at the very front of the invasive tumor and they are
      considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer
      offers a very promising target for functional PET imaging and may be a stronger prognostic
      marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to
      patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx
      and oral cavity, who are referred to curative intended radiotherapy. In this project all
      participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy
      and the prognostic efficacy is determined by assessment of the recurrence rate and mortality
      at routine clinical follow-up.
    

Detailed description: 
      In this study all included patients with head and neck cancer (HNC) have an uPAR-PET/CT scan
      performed before the initiation of the curative intended radiotherapy. After the radiotherapy
      treatment the patients attend the routine clinical follow-up programme at Rigshospitalet to
      follow the loco-regional control, signs of metastasis and the overall survival. These
      relapse- and survival parameters will be correlated to the SUVmax, SUVmean and the TNM stage
      obtained from the uPAR scan and will be compared to the findings on the routine FDG scan to
      clarify which tracer is the strongest prognostic marker in HNC.

      If any previous tissue samples have been taken from the tumour before the patient enters the
      study the uPAR immunohistopathology of the tissue sample will be compared to the uPAR-PET/CT
      findings. We will not perform any biopsies or tissue samples in this study.
    

Intervention name(s): 68Ga-NOTA-AE105
Intervention type(s): Drug
Intervention description(s): The patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up.
Other intervention name(s): uPAR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Molecular Imaging; uPAR-PET/CT; Head and neck cancer; curative intended radiotherapy
Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Gastric carcinoma is the second most common cause of cancer-related deaths and its main
      treatment modality if potentially curable is surgery but the optimal surgical resection is
      controversial. The aim of the current study was to assess the outcomes of curative D2
      compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity
      and mortality, disease recurrence and survival rates.
    

Detailed description: 
      80 consecutive patients with potentially operable gastric carcinoma were randomized via
      concealed envelopes into 2 groups (each included 40 patients), group I managed by radical
      gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2
      lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities,
      tumor recurrence and 2 years survival rates.
    

Intervention name(s): D1 lymphadenectomy; D2 lymphadenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Radical gastrectomy with D1 lymphadenectomy; Radical gastrectomy with D2 lymphadenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Operable gastric cancer; D2 vs D1 lymphadenectomy; Surgical and Oncologic outcomes
Dietary Polyphenols and Lipid Oxidation
Condition: Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      There are strong indications that (combinations of) polyphenols may be attractive candidates
      in the prevention of the metabolic syndrome and diabetes through modulation of pathways of
      fatty acid metabolism and mitochondrial function. We hypothesize that the combination of
      specific polyphenols, with partly distinct mechanisms of action, may have physiologically
      significant effects on fat oxidation through additive or synergistic effects, thereby
      improving body composition, insulin sensitivity and preventing type 2 diabetes. The following
      objective will be addressed in the current study:

      (1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG
      either in combination with resveratrol or with resveratrol and genistein) to affect systemic
      lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high
      fat meal in overweight subjects
    


Intervention name(s): Comparison of different combinations of polyphenols with respect to effects on fat oxidation
Intervention type(s): Dietary Supplement
Intervention description(s): EGCG, resveratol and genistein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of LY3053102 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study was to evaluate the safety and tolerability of the study drug
      known as LY3053102 in healthy participants. The study also investigated how much of the study
      drug entered the blood stream and how long it took the body to dispose of the study drug.
      Information about any side effects that occurred was also collected. The study was expected
      to last approximately 8 weeks for each participant (up to 4 weeks from screening to the
      administration of study drug and an additional 4 weeks of follow up).
    


Intervention name(s): LY3053102; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study Of VGX-3400, H5N1 Avian Flu Virus Plasmid DNA With Electroporation Device In Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase
      (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult
      males by IM injection followed by EP will be generally well tolerated and immunogenic.
    


Intervention name(s): VGX-3400
Intervention type(s): Biological
Intervention description(s): Plasmid DNA delivered via IM injection with electroporation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N1; Avian Influenza; DNA Vaccine; Electroporation; Intramuscular (IM) Injection
Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      BT-001 is a software program intended to help patients with type 2 diabetes, under the
      guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The
      BT-001 software delivers a type of behavioral therapy to patients via a mobile application
      that targets behaviors related to achieving glycemic control. The effectiveness of BT-001
      will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in
      the blood that measures blood sugar) compared to standard medical care in patients with type
      2 diabetes.
    

Detailed description: 
      The study will utilize an open-label, randomized, parallel-group design to confirm and
      characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC)
      when compared to SOC alone in patients with type 2 diabetes. The screening period will
      consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility.

      Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups:

      Investigational: One half of the participants will be treated with BT-001 plus SOC for 180
      days;

      Control: One half of the participants will be treated with SOC alone for 180 days.
    

Intervention name(s): BT-001; Physician-guided Standard of Care for type 2 diabetes
Intervention type(s): Device; Other
Intervention description(s): BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.; Current ADA Standard of Care Guidelines for type 2 diabetes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-Label, Randomized, Controlled
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
Condition: Hemodialysis
Study type: Interventional

Summary: 
      All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk
      of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced
      antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant
      synthesized in almost all body cells, and it is also available in many dietary sources. It
      was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10.
      Clinical benefits of Coenzyme Q10 supplementation have been documented for various
      cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10
      supplementation may have potential benefits in pediatric patients receiving hemodialysis;
      mainly due to its antioxidant activity and anti-inflammatory effects.
    


Intervention name(s): Coenzyme Q10; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oral capsules; Oral capsules
Other intervention name(s): ubiquinone, ubidecarenone, ubiquitous quinone
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study of LY900014 Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated four test formulations of a glucose lowering drug (LY900014)
      administered by injection under the skin of the abdomen. The study was conducted in healthy
      people to investigate how the human body handles LY900014 and the effect of LY900014 on blood
      sugar levels. Side effects and tolerability were documented. The study was to be conducted in
      two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last
      for about 11 to 12 weeks, including screening and follow up. Screening was required within 28
      days prior to entering into either study Part A or Part B. Part B was not executed because no
      suitable formulation was identified.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Biological; Biological
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Insomnia and Wake up and Recovery From Anesthesia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      18-55 years old 100 patients, who are planned to undergo for planned ureteroscopy will be
      participated in the study. In the preoperative room patients will be asked to participate to
      the study. If they accept 4 item Jenkins-Sleep Questionaire will be asked to them.Patients
      will be divided to two groups , with or without insomnia according to their answers to the
      questionaire. General anesthesia will be performed to all patients. At the end of operation
      anesthesia time,operation time, time of eye opening, time of transfer to the recovery room
      will be recorded in the operating room. Pain scores and recovery scores will be evaluated in
      the recovery room.
    

Detailed description: 
      18-55 years old 100 patients with American Society of Anesthesiology (ASA) physical status
      I-II,who are planned to undergo for elective ureteroscopy will be participated in this
      study.In the preoperative room patients will be asked to participate to the study and will be
      asked to answer the 4-item Jenkins-Sleep Questionaire.If they accept to participate, written
      informed consent will be taken from the patients. According to their answers to the
      questionaire , patients will be divided into two groups :those with or without
      insomnia.General anesthesia will be performed to all patients. After anesthesia induction
      with propofol 2mg/kg and rocuronium 0.6 mg/kg, patients will be ıntubated and mechanically
      ventilated. Maintenance of anesthesia will be achieved with 4-6 % desflurane in nitrous
      oxide/ oxygen (50%/50%) concentrations with the flow 5L/min. Tramadol 1 mg/kg and
      metoclopramid 1 ampul will be administered intravenously after intubation. Hemodynamic
      parameters( systolic blood pressure, diastolic blood pressure, heart rate and peripheral
      oxygen saturation), end tidal carbon dioxide values, the concentrations of inspired and
      exhaled desflurane will be recorded on the surgery start time and on the 5th,
      15th,25th,35th,45th,60 th minutes of surgery. At the end of operation ,neuromuscular blockage
      will be reversed with neostigmine (0,05 mg/kg)and atropine sulphate 0,015 mg/kg i.v.
      Anesthesia time, surgery time, time of eye opening,time of transfer to the recovery room will
      be recorded in the operating room. In the recovery room pain score will be evaluated with
      Visual Analogue Scale. Modified Aldrete Recovery Score will be used for evaluating recovery.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-55 years old 100 patients with American Society of Anesthesiology (ASA) physical status
        I-II,who are planned to undergo for elective ureteroscopy will be participated in this
        study.
      
Keywords: anesthesia; recovery; insomnia