bioihbjkbjnl/mcl2 huggingface dataset:
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Condition: Traumatic Hemorrhage
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Saline control
Intervention description: 1 gram of prehospital Tranexamic Acid; Saline Control
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 903.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Tranexamic acid; randomized; hemorrhage; blinded

Summary:

      The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given
      during emergency medical transport to a level 1 trauma center in patients at risk of
      hemorrhage is associated with lower 30 day mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Blunt or penetrating injured patients at risk of bleeding being transported via air or
             ground medical services from the scene of injury or from referring hospital to a
             definitive trauma center that is participating in the trial AND

          2. Within 2 hours of time of injury AND

          3. Hypotension (Systolic Blood Pressure (SBP) < 90mmHg)

               -  At scene of injury or during air or ground medical transport

               -  Documented at referring hospital prior to air or ground medical transport arrival

             OR

          4. Tachycardia (heart rate >110 beats per minute)

               -  At scene of injury or during air or ground medical transport

               -  Documented at referring hospital prior to air or ground medical transport arrival

        Exclusion Criteria:

          1. Age > 90 or < 18 years of age

          2. Inability to obtain intravenous access or intraosseous

          3. Documented (radiographic evidence) cervical cord injury with motor deficit

          4. Known prisoner

          5. Known pregnancy

          6. Traumatic arrest with > 5 minutes CPR without return of vital signs

          7. Penetrating cranial injury

          8. Traumatic brain injury with brain matter exposed

          9. Isolated drowning or hanging victims

         10. Wearing an opt out bracelet.

         11. Isolated fall from standing

         12. Patient or Family Objection at scene
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine
Intervention description: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single intervention group, bilateral erector spinae blocks with 0.2% ropivacaine, to assess the feasibility of this technique for postoperative pain control following surgeries involving sternotomies in children.
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: erector spinae block; regional anesthesia; sternotomy; ropivacaine

Summary:

      Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral
      continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort
      of children undergoing surgical sternotomy prior to planning an appropriately powered,
      randomized, controlled trial of the same.

      Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae
      blocks for post-sternotomy pain is a feasible intervention for consideration in a larger
      trial by demonstrating a 75% or greater successful intervention completion rate without any
      major adverse outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled as part of the cardiac surgical ERAS program.

          2. Scheduled for a primary sternotomy.

          3. Ages 3-21 years.

        Exclusion Criteria:

          1. Patients undergoing reoperative procedures.

          2. Significant scoliosis or other anatomic contraindications to ESB.

          3. History of bleeding or current therapeutic dose anticoagulant use.

          4. Significant intraoperative hemodynamic instability or bleeding, as ascertained by
             clinicians taking care of the patient.

          5. Patients with severe neurodevelopmental delays.

          6. Patients with previous chronic pain syndromes.

          7. Patients with a history of opioid treatment at any point in the 2 months prior to
             surgery.

          8. Lack of parental consent and/or child assent.
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Cadazolid; Vancomycin; Cadazolid-matching placebo; Vancomycin-matching placebo
Intervention description: Cadazolid 250 mg as oral suspension twice daily.; Vancomycin 125 mg as oral capsules 4 times daily; Placebo matching cadazolid and administered orally twice daily; Placebo capsules matching vancomycin and administered orally 4 times per day
Intervention MeSH terms: Vancomycin; Oxazolidinones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile infection; Post-antibiotic diarrhea

Summary:

      This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
      in subjects with Clostridium difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent.

          -  Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
             an adequate and reliable method of contraception.

          -  Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
             recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
             or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
             C. difficile toxin test on a stool sample produced within 72 hours prior to
             randomization.

        Exclusion Criteria:

          -  More than one previous episode of CDAD in the 3-month period prior to randomization.

          -  Evidence of life-threatening or fulminant CDAD.

          -  Likelihood of death within 72 hours from any cause.

          -  History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

          -  Antimicrobial treatment active against CDAD administered for > 24 hours except for
             metronidazole treatment failures (MTF)

          -  Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
             quinolones.

          -  Unable or unwilling to comply with all protocol requirements.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
Condition: Skin Structures and Soft Tissue Infections
MeSH terms: Soft Tissue Infections
Intervention: iclaprim; vancomycin
Intervention description: Experimental treatment; Active comparator
Intervention MeSH terms: Vancomycin; Iclaprim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim
      compared to vancomycin for the treatment of skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. written informed consent;

          2. ≥18 years of age;

          3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

          4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

          5. the presence of purulent or seropurulent drainage or at least three signs and symptoms
             of infection (discharge, erythema, swelling, warmth, or pain).

        Exclusion Criteria:

          1. severely impaired arterial blood supply such that amputation of the infected
             anatomical site is likely;

          2. infected diabetic foot ulcers;

          3. infected decubitus ulcers;

          4. necrotizing fasciitis or gangrene;

          5. uncomplicated skin or skin structure infection;

          6. infections associated with a prosthetic device;

          7. suspected or confirmed osteomyelitis;

          8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression
             therapy.
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: CT-P10; Rituxan
Intervention description: 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.; 375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by
      overall response rate at 7 months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma

          -  Ann Arbor Stage II, III or IV

        Exclusion Criteria:

          -  Has receive rituximab

          -  Allergies or hypersensitivity to murine, chimeric, human or humanised proteins

          -  Previous treatment for NHL

          -  Any malignancy

          -  Current or recent treatment with any other investigational medicinal product or device

          -  pregnant or lactating
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis; Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to investigate the safety and efficacy when administering PA21
      with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving stable maintenance hemodialysis 3 times a week

          -  Dialysis patients with hyperphosphatemia

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder

          -  Patients having severe gastrointestinal disorders

          -  Patients having severe hepatic disorders
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Nutrition Disorders
Intervention: Liraglutide; Placebo
Intervention description: Administered once daily subcutaneously (s.c., under the skin); Administered once daily subcutaneously (s.c., under the skin)
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 251.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate the effect of
      liraglutide for weight management in pubertal adolescent subjects with obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male or female, age 12 to less than 18 years at the time of signing informed consent
             and less than 18 years at date of randomisation

          -  BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off
             points and equal or above the 95th percentile for age and sex (for diagnosis of
             obesity)

          -  Stable body weight during the previous 90 days before screening V2 (below 5 kg
             self-reported weight change)

          -  History of failing to lose sufficient weight with lifestyle modification as judged by
             the investigator and documented in subject's medical record

        Exclusion Criteria:

          -  Pre-pubertal subjects (Tanner stage 1) at screening V2

          -  Type 1 diabetes mellitus (T1DM)

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2)

          -  Medullary thyroid carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine
             causes)

          -  Treatment with medications within 90 days before screening V2 that, based on the
             investigator's judgement, may cause significant weight change. This should also
             include treatment with any of the following medications: pramlintide, orlistat,
             zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like
             peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)

          -  Anti-diabetic treatment other than metformin

          -  History of major depressive disorder within 2 years before screening V2
Low Dose Aspirin for Venous Leg Ulcers
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: Aspirin; Placebo
Intervention description: 150 mg aspirin in capsule form once daily for up to 24 weeks; Matching placebo capsule containing inert bulking agent
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Identical placebo with only difference being unique code on bottle containing product.
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous ulcer, varicose ulcer, gravitational ulcer, aspirin

Summary:

      Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,
      lifestyles and activity, especially in older patients. There are few effective treatments -
      compression therapy (tight bandaging or stockings) helps healing, but about half the people
      with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin
      as well as using compression may speed up healing for VLU, but the current evidence is not
      enough to change clinical practice. We will conduct a randomised controlled trial to test
      whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Determined to have a venous leg ulcer (clinical indications of venous ulceration,
             Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)

          -  Able to tolerate compression therapy

          -  Able to provide written informed consent

          -  Confirmation with participant's general practitioner that the participant can take low
             dose aspirin or placebo.

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  History of myocardial infarction, stroke, transient ischaemic attack, angina or
             significant peripheral arterial disease

          -  History of adverse effects related to aspirin use

          -  Currently using aspirin, or other anti-platelet or anticoagulant therapy

          -  Opinion of screening medical practitioner at National Institute of Health Innovation
             that participant has an existing condition or treatment that is a contraindication to
             use of aspirin or to participation in the trial.
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Intervention: 2.5 mg Chlorhexidine gluconate chip
Intervention description: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peri-Implantitis; Periodontal Diseases; Chlorhexidine gluconate; PerioChip; Anti-Infective Agents; Mouth Diseases; Antiseptics

Summary:

      The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine
      gluconate chip) in the treatment of patients with Peri-implantitis.

      The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival
      debridement is more effective in the treatment of peri-implantitis when compared to the
      common method of mechanical subgingival debridement alone. The primary efficacy measure will
      be the reduction in probing pocket depth at 6 months as measured at sites of qualifying
      target implant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general health

          -  At least one implant in the oral cavity with clinical and radiographical signs of
             peri-implantitis. Including bone loss in combination with bleeding and/or suppuration
             on probing and a peri-implant Probing Depth (PD) of 5-8 mm.

          -  The implants have been in function for more than 2 years.

          -  Fixed prosthetic restoration of the implant.

        Exclusion Criteria:

          -  Pregnancy.

          -  Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.

          -  Allergic reaction to Chlorhexidine.

          -  Active Periodontitis which required definitive treatment.

          -  Presence of orthodontic appliances, or any removable appliances, that impinges on the
             tissues being assessed.

          -  Use of systemic antibiotic therapy and/or chronically use of non-steroidal
             anti-inflammatory drugs (NSAIDs).

          -  Uncontrolled diabetes, of any type.
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer Metastatic
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: 18F-DCFPyL; PET/CT Imaging
Intervention description: A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL; PET/CT imaging will be acquired 1-2 hours post-PyL injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron emission tomography; biochemical recurrence; rising PSA; PET/CT; Diagnostic; Imaging; PSMA; radical prostatectomy; BCR

Summary:

      This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging
      in patients with suspected recurrence of prostate cancer who have negative or equivocal
      findings on conventional imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male >/= 18 years of age

          -  Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with
             subsequent definitive therapy

          -  Suspected recurrence of prostate cancer based on rising PSA after definitive therapy
             on the basis of:

               1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a
                  confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or

               2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that
                  is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic
                  Radiology and Oncology [ASTRO]-Phoenix)

          -  Negative or equivocal findings for prostate cancer on conventional imaging performed
             as part of standard of care workup within 60 days prior to Day 1

          -  Life expectancy ≥6 months as determined by the investigator

          -  Able and willing to provide informed consent and comply with protocol requirements

        Exclusion Criteria:

          -  Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
             five (5) physical half-lives prior to Day 1

          -  Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH
             agonist or antagonist) for prostate cancer

          -  Treatment with ADT in the past 3 months of Day 1

          -  Receipt of investigational therapy for prostate cancer within 60 days of Day 1

          -  Subjects with any medical condition or other circumstances that, in the opinion of the
             investigator, compromise the safety or compliance of the subject to produce reliable
             data or completing the study