bioihbjkbjnl/mcl2 huggingface dataset:
Role of Opioids in Epidural Solutions
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      It is unclear whether addition of opioids to epidural solutions for postoperative analgesia
      is beneficial. In this multicenter randomized double-blinded trial, we aim to test the
      primary hypothesis that epidural solutions containing only bupivacaine are as effective as
      solutions containing both bupivacaine and fentanyl in promoting analgesia in patients
      recovering from open abdominal surgery. We also aim to assess the incidence of
      epidural-induced hypotension, the difference in patient-reported opioid side-effects between
      the two groups. If we demonstrate no clinically important difference between the two
      interventions, clinicians will be able to substantially reduce the amount of opioids patients
      receive during their postoperative recovery, and potentially decrease the associated high
      incidence of opioid adverse effects in post-surgical patients.
    


Intervention name(s): Bupivacaine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): epidural solution containing bupivacaine 0.1% in normal saline; Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline
Other intervention name(s): Marcaine; Beatryl
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Thymoglobulin in Cadaver Donor
Condition: Prevention of Kidney Injury Associated With Brain Death
MeSH terms: Brain Death; Death; Cadaver
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To
      demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by
      decreasing expression of inflammatory markers in graft biopsies Security:To demonstrate that
      the administration of Thymoglobulin does not have side effects in renal recipients.
    

Detailed description: 
      This is randomized controlled Multicenter phase II clinical trial promoted by members from
      IdiPAZ. At least two hospital (La Paz and Santa Maria from Lisbon, will be involved. A per
      nature pilot study will recruit 10 cadaver donors from each hospital, and randomized
      half-to-half per center, for study and control groups.

      The RCT initiated in 2009 and finished in 2013.

      Cadaver donor from the study group will receive 3 mg/kg iv. Thymoglobulin 3-6 hours prior to
      organ procurement. The randomization process recruits 1:1 study/control donors.

      Kidney biopsies will be taken from each kidney before transplantation to examine the
      expression of pro-inflammatory and HLA molecules (anti-DR, VCAM, ICAM, E-selectin) at tubular
      cells by immunohistochemical techniques under blinded conditions.

      Recipients will be managed as usual and expressly followed up for one year, recording the
      incidence of delayed graft function and rejection and graft survival at the first year.

      A comparison between the results obtained in kidney biopsies and patients transplanted in
      each group will permit differentiate whether Thymoglobulin administered in cadaver modifies
      the expression of antigens by kidney tubular cells and the results obtained with
      transplantation, in terms of graft function, rejection and survival.
    

Intervention name(s): Thymoglobulin
Intervention type(s): Drug
Intervention MeSH terms: Thymoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Thymoglobulin; Cadaver donor; Kidney injury brain death related
Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      In an 8 week double blind randomized controlled split-face studies, we tried to compare the
      clinical efficacy, safety and histopathological changes between Lactobacillus fermented
      Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

      Basically, this is a split face study - one side of face randomly assigned was applied with
      LFCO and the other side with TTO in same patients.
    

Detailed description: 
      Screening of natural compounds for the development of anti-acne therapeutic agents has been
      steadily required considering various side effects of acne medications.However, previous
      studies have mainly focused on experimental tests without clinical trials and
      histopathological analysis.

      To compare the clinical efficacy, safety and histopathological changes between Lactobacillus
      fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

      Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of
      randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind
      split-face clinical trial.
    

Intervention name(s): LFCO application; TTO application
Intervention type(s): Other; Other
Intervention description(s): Application of LFCO (Lactobacillus fermented Chamaecypris obtusa ) containing creams to one randomly selected face of patients to monitor its effectiveness and safety of acne treatments.; Application of TTO (Tea tree oil) containing creams to the other side of face of patients to monitor its effectiveness and safe compared with LFCO.
Other intervention name(s): LFCO containg creams applied to acne lesions; TTO containg creams applied to acne lesions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; therapeutics; clinical trial; natural compound; Lactobacillus fermented Chamaecypris obtuse; tea tree oil
Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring
      System in the home setting is more useful than frequent self blood glucose monitoring with a
      view to modifying patient's diet and exercise habits or improvement self disease control
      efforts and at last glycemic control in patients with type 2 diabetes
    

Detailed description: 
      In diabetes management, compliance, disease awareness and empowerment of the patient play an
      important role and the immediate feedback on the effects of diet and exercise that the self
      monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use
      of SMBG has been shown to be associated with improved medication compliance and better
      metabolic control by several studies. However, because of many factors, including pain and
      inconvenience, many diabetic patients do not accept frequent fingersticks for self blood
      glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few
      seconds, without any information on glucose trends.

      So we need new glucose monitoring method that could reflect glucose trends and glycemic
      excursion continuously because glucose monitoring still remains the cornerstone of evaluating
      the efficacy of therapy and motivating self disease control in subjects with diabetes.

      Few studies have examined the effects of real time continuous glucose monitoring system
      targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous
      Glucose Monitoring System in the home setting is more useful than frequent self blood glucose
      monitoring with a view to modifying patient's diet and exercise habits or improvement self
      disease control efforts and at last glycemic control in patients with type 2 diabetes
    

Intervention name(s): Guardian RT; Education about the self monitoring blood glucose
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Glucose monitoring system; life style intervention
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule
      (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC
      relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on
      the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy
      volunteers.
    

Detailed description: 
      The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC
      relative to PIC, and lack of an effect of food on the PK of crizotinib in healthy volunteers.
    

Intervention name(s): crizotinib
Intervention type(s): Drug
Intervention description(s): Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.
Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.
Treatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.
Treatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; food effect; pharmacokinetics; crizotinib
Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
Condition: Endometrial Cancer; Sentinel Lymph Node Detection
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full
      bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent
      dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be
      visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG,
      sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will
      be identified. SLNs will be surgically removed and provided to Pathology for evaluation.
      Non-sentinel nodes will also be surgically removed, as is consistent with routine medical
      care for these patients, and given to Pathology for evaluation. A positive SLN may be the
      most accurate identifier of the extra-uterine spread of disease, and will provide information
      about the extent of surgical node removal necessary.
    


Intervention name(s): ICG Dye
Intervention type(s): Procedure
Intervention description(s): ICG Dye injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endometrial cancer; Sentinel lymph node; Indocyanine green; Near infrared imaging
GDT Vs ST for Pancreas Transplant Surgery
Condition: Pancreas Transplantation
Study type: Interventional

Summary: 
      A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes
      Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is
      done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft
      survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per
      year.

      Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the
      post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic
      benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There
      are a number of studies showing significantly improved biochemical markers of inflammation in
      animal models and in studies on septic patients (patients with an overwhelming infection)
      following GDT. Studies have also shown that GDT improves clinical outcome in post-operative
      patients and in serum inflammatory mediators. These studies have looked at "major abdominal
      surgery" but none have investigated transplant patients. Given the nature of surgery we feel
      that our patients would benefit with reduced Intensive Care Unit stay, reduced length of
      hospital stays and reduced rates of post-operative complications.

      The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It
      will last for 2 years and we hope to recruit 60 patients

      Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current
      practice. Each intervention will last for six hours post-operatively before continuing with
      normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively
      and blood samples will be taken from patients at regular intervals for 72 hours intra- and
      post- operatively. Patients will be followed up daily while an in-patient and at
      three-monthly intervals in out-patients for 1 year.
    


Intervention name(s): Goal-Directed Therapy; Standard Therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Peri-operative optimisation of fluid status, based on Oxygen Delivery; Following standard protocol during peri-operative period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreas Transplantation; Goal-directed therapy; Outcomes; Immunometric
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
Condition: Mild Cognitive Impairment; Alzheimer Disease; Alzheimer Dementia; Dementia, Vascular; Dementia With Lewy Bodies; Cognitive Impairment; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognitive Disorder
MeSH terms: Alzheimer Disease; Dementia; Neurodegenerative Diseases; Lewy Body Disease; Tauopathies; Dementia, Vascular; Cognitive Dysfunction; Neurocognitive Disorders; Cognition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive
      impairment due to Alzheimer's Disease
    

Detailed description: 
      Mild cognitive impairment ("MCI") is defined as the "symptomatic pre-dementia stage" on the
      continuum of cognitive decline. Currently, no medications have proven effective for MCI.
      Preclinical experiments indicate that NA-831 is an endogenous small molecule that exhibits
      neuroprotection, neurogenesis, and cognitive protective properties across a range of disease
      models. NA-831 has been shown to be safe and well tolerated in healthy volunteers. This study
      seeks to evaluate the efficacy and safety of NA-83 in 126 subjects with mild cognitive
      impairment due to Alzheimer's Disease
    

Intervention name(s): N-831(Traneurocin) 10 mg QD; NA-831 (Traneurocin) 20 mg QD; NA-831 (Traneurocin) 40 mg QD; Placebo oral capsule QD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 10 mg capsule of NA-831 QD for 24 weeks; Oral administration of 20 mg capsule of NA-831 QD for 24 weeks; Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks; Oral administration of oral placebo capsule QD or 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
Condition: Type 1 Diabetes; Pregnancy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This clinical trial is a safety and feasibility study to assess the performance of an
      artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health
      Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with
      type 1 diabetes (T1D).
    

Detailed description: 
      The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age
      18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic
      Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour
      closed-loop (CL) session in a supervised outpatient environment with medical staff present.
      During the session, subjects will bolus for all meals and snacks, and will perform their
      usual daily activities while being accompanied by study medical staff.

      For subjects who wish to continue use of the system, they will be offered the option of
      continuing use of the system at home in an extension phase, for the rest of their pregnancy.
    

Intervention name(s): Automated Insulin Delivery
Intervention type(s): Device
Intervention description(s): Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.
For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Other intervention name(s): Interoperable Artificial Pancreas System (iAPS)
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; pregnancy; artificial pancreas; automated insulin delivery
LTA Assessement Using Aggregometer TA-8V (Stago®)
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory
      of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago).

      The supplier of these devices does not offer reference values for these tests. There are also
      no references in the data literature. Therefore reference values must be established from
      healthy volunteer subjects.

      The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO
      (International Organization for Standardization) 15189 standard of the COFRAC ( French
      Accreditation Comity) that requires checking their proper functioning. This audit must be
      traced in a method validation folder.
    


Intervention name(s): Take blood (TA-8V (Stago®)
Intervention type(s): Device
Intervention description(s): Healthy volunteers will have 3 blood samples at M0, M3 and M6.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: light transmission aggregometry; platelets; platelet functions; von Willebrand disease; quality assessment
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of
      Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of
      SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
    

Detailed description: 
      Patients will attend up to 9 study visits over a period of up to 28 days.
    

Intervention name(s): Peginterferon Lambda-1a; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care; Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An open-label, single-blind randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Coronavirus
Depigoid Birch 5000 Longterm Study in Adults and Adolescents
Condition: Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma; Sensitization Against Betula Alba (Birch) Pollen
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to
      assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula
      alba (Birch) - versus placebo.
    

Detailed description: 
      Investigation of the long-term efficacy and safety of Depigoid Birch 5000 according to the
      perennial treatment regimen in comparison to placebo in adult and adolescent patients with
      birch pollen-induced allergic rhinitis and/or rhinoconjunctivitis to show superiority vs.
      placebo.

      As the study includes adolescent patients it is run under an approved PIP.

      Total study duration per patient will be 5 years: 3 years of perennial treatment (application
      of study medication at intervals of 4-6 weeks) followed by a treatment-free observational
      phase of 2 years (seasons).
    

Intervention name(s): s.c. injection
Intervention type(s): Biological
Intervention description(s): 3 years of therapy followed by 2 years (seasons) of treatment-free observational period
Other intervention name(s): Depigoid(R)Birch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Allergic rhinoconjunctivitis; Allergy induced asthma; Birch (Betula alba); Hayfever; Immunotherapy
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
Condition: Systemic Inflammatory Response Syndrome
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      The investigators hypothesize that the investigators can detect protein-sparing effects of
      administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an
      acute inflammatory disease. The investigators use the infusion of endotoxin, US standard
      reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate
      the effect on protein metabolism using different tracers and the investigators can measure
      the various intracellular signaling pathways of selected muscle and adipose tissue.
    


Intervention name(s): Endotoxin, US standard reference E.coli
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: sepsis; cytokine release; fever