bioihbjkbjnl/mcl2 huggingface dataset:
Brain Imaging and Mental Disorders of Aging Intervention
Condition: Cognition Disorders
MeSH terms: Mental Disorders; Psychotic Disorders; Cognition Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this project is to determine if a cholinesterase inhibitor is more effective than
      placebo in delaying cognitive and brain functional decline in people at risk for Alzheimer's
      disease.
    

Detailed description: 
      Studies to date show that pictures of the brain using PET (positron emission tomography) scan
      measures predict memory decline in people with genetic risks for developing AD. They have
      also been shown to predict memory decline in people with mild memory complaints. These
      findings are consistent with other evidence that the changes of Alzheimer's Disease (AD)
      begin years before the doctor can confirm a diagnosis.

      In this study, PET and genetic risk studies will be performed in people with mild memory
      complaints. A total of 138 participants (age 40 to 90 years) who are at risk for further
      memory decline will be enrolled. They will be randomized (like the flip of a coin) to one of
      two treatment groups, donepezil (a medication to treat mild AD) or placebo, and followed 18
      months for evidence of future decline. Participants will receive magnetic resonance imaging
      (MRI) scans, PET scans, genetic risk assessment for Alzheimer's Disease, and
      neuropsychological assessments. Repeat brain imaging studies will be performed at the end of
      the 18-month treatment trial.

      These procedures will allow researchers to explore how baseline brain function and genetic
      risk for AD onset influences brain metabolic rate and memory decline, and treatment outcome.
      Participants receiving donepezil are expected to show less evidence of decline than those
      receiving placebo. This project will expand a growing research program in early detection and
      prevention of AD, designed (1) to identify persons without memory complaints who are most
      likely to benefit from early intervention and (2) to provide an objective way to monitor the
      activity in the brain.
    

Intervention name(s): donepezil; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Alzheimer's disease; Mild Cognitive Impairment
Iron Bioavailability From Fortified Food
Condition: Iron Bioavailability
Study type: Interventional

Summary: 
      Determination of fractional iron absorption from bouillon fortified with 3 labeled iron
      compounds.
    

Detailed description: 
      This single center trial will be single-blind to the subject, controlled, fully randomized
      with crossover design in 22 healthy females aged 18-40 years old.

      Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days
      after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after
      last stable isotope intake blood sampling (V7).
    

Intervention name(s): Labeled iron salt Fe54; Labeled iron salt Fe57; Labeled iron salt Fe58
Intervention type(s): Other; Other; Other
Intervention description(s): Fe salt enriched with Fe 54 isotopes; Fe salt enriched with Fe 57 isotopes; Fe salt enriched with Fe 58 isotopes
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study of Cephalexin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different preparations of an antibiotic called
      cephalexin to determine if they are essentially the same. The study has two periods.
      Participants will receive one preparation of cephalexin in each period. At least 7 hours will
      pass between the study periods. The study is expected to last about 2 days for each
      participant, not including screening or follow-up.
    


Intervention name(s): Cephalexin
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): Keflex®
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery
Condition: Orthognathic Surgery
Study type: Interventional

Summary: 
      patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of
      maxilla , are divided into two groups: one group receives custom titanium plates which is
      patient specific and the other group receives prebent titanium plates done on printed postop
      plan model before surgery.
    


Intervention name(s): Orthognathic surgery (lefort1)
Intervention type(s): Procedure
Intervention description(s): Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate
Other intervention name(s): Dentofacial surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: orthognathic; virtual planning; custom plates
Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether the investigational drug GM602, is
      effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot
      blocking the flow of blood through one, or more of the blood vessels supplying the brain)
      when administered up to 18 hours after symptoms begin.
    

Detailed description: 
      Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic,
      caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic
      drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke
      approved by the FDA. Treatment with tPA must be administered within three hours of the stroke
      onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602
      is an investigational drug that may act as a neuroprotectant in patients who have had a
      stroke. It is thought to stop cell death and reduce inflammation in the injured area of the
      brain. This study is designed to evaluate the safety and efficacy of GM602 administered
      intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the
      initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle
      Cerebral artery region.
    

Intervention name(s): GM602; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 12 moderate and 12 severe patients will receive GM602.; First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or Matching Placebo (Bacteriostatic Saline) for GM602 in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 6 moderate and 6 severe patients will receive placebo.
Other intervention name(s): GM6; GM604; GM608; MNTF; Bacteriostatic saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Middle Cerebral Artery Ischemic Stroke within 18 hours
Anatomical Resection in Colorectal Liver Metastases Patients
Condition: The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      The type of liver resection (anatomical resection, AR or nonanatomical resection, NAR) for
      colorectal liver metastases (CRLM) is subject to debate. The debate may persist because some
      certain prognostic factors, associated with aggressive biological behavior of tumor, have
      been overlooked. The aim of our study was to investigate the characteristics of patients who
      would benefit more from anatomical resection for colorectal liver metastases.
    

Detailed description: 
      729 patients who underwent hepatic resection of CRLM were retrospectively collected from June
      2012and May 2019. Treatment effects between AR and NAR were compared in full subgroup
      analyses. Tumor relapse-free survival (RFS) was evaluated by a stratified log-rank test and
      summarized with the use of Kaplan-Meier and Cox proportional hazards methods.
    

Intervention name(s): Anatomical Resection
Intervention type(s): Procedure
Intervention description(s): Based upon the segmental anatomy of the liver according to Couinaud system, AR was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these. NAR, known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study was a retrospective cohort study based on our prospectively collected colorectal
        cancer database. All adult patients who underwent curative-intent liver resection for CRLM
        between June 2012 and May 2019 at Zhongshan Hospital in Shanghai and had available data on
        KRAS/NRAS/BRAF status, were eligible for inclusion.
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
Condition: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to
      see what the best dose should be for children in the future. Pharmacokinetics is to see how
      the body absorbs, distributes, breaks down and gets rid of the study drug. The
      pharmacokinetics of certain drugs may be altered in children due to developmental differences
      in various organ functions responsible for drug elimination, as well as in general
      distribution characteristics. The safety of moxifloxacin in children with infections will
      also be looked at. Results from this study will be used to guide dosing strategies of the
      larger clinical trial planned for children
    


Intervention name(s): Moxifloxacin (Avelox, BAY12-8039); Moxifloxacin (Avelox, BAY12-8039); Moxifloxacin (Avelox, BAY12-8039)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous (IV) infusion of moxifloxacin administered over 60 minutes, at an initial dosage of 5 milligram per kilogram per body weight (mg/kg/BW) with dose escalation to 6 mg/kg in subjects of age 6 years (yrs) to less than or equal to (<=) 14 years.; Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 7 mg/kg/BW with dose escalation to 8 mg/kg in subjects of age 2 years to less than (<) 6 years; dose escalation was based on evaluations of the pharmacokinetic (PK) and safety data from the subjects in a preceding cohort.; Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 9 mg/kg/BW with dose escalation to 10 mg/kg in subjects of age 3 months to < 2 years; dose escalation was based on evaluations of the PK and safety data from the subjects in a preceding cohort.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled
      with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be
      used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence
      peptide. The images will be recorded and analyzed for relative fluorescence pattern and
      intensity and correlated to patient diagnosis and clinical outcomes.
    

Detailed description: 
      A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide
      labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct
      is proposed. The study will test the safety and efficacy of administering this agent
      (QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the
      evaluation of biliary disorders.

      This is a pilot study of a single study group at a single center. The investigators intend to
      enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study
      should take 12 to 24 months to complete. The expected duration of each subject's
      participation is 2 to 7 days.

      Subjects will be recruited around their standard of care procedure. The endoscopists
      performing study procedures are all credentialed to do these procedures at the UWMC Digestive
      Health Center.

      ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will
      evaluate the potential risk (if any) for the subject to continue with the study procedure.
      Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the
      site of interest through a catheter in the standard endoscope. Five minutes after QRH-882260
      Heptapeptide application, the unbound peptide will be washed off using the endogator
      irrigator and the residual liquid will be suctioned. Pictures with reflection-light and
      fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC)
      inserted via the instrument channel of the standard endoscope before the QRH-882260
      Heptapeptide application, immediately after application and then again after the QRH-882260
      Heptapeptide is rinsed.

      The area of interest identified will be biopsied at the discretion of the endoscopist per
      clinical care. Any specimens taken will be for clinical care only and will be sent for
      routine histology per UWMC standard of care.
    

Intervention name(s): QRH-882260 Heptapeptide
Intervention type(s): Drug
Intervention description(s): Imaging agent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
Condition: Degenerative Disc Disease; Intervertebral Disc Disease; Low Back Pain
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),
      obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease
      (DDD). The trial is based in previous results with autologous MSC (Orozco et al.,
      Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective,
      randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing
      Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists
      of two arms with 12 patients each one. Patients in the experimental arm will be given a
      single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be
      infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We
      shall follow the evolution of pain, disability and quality of life as well as disc fluid
      content by Magnetic Resonance Imaging (T2-calibrated).
    


Intervention name(s): Allogenic Mesenchymal Stromal Cells; Mepivacaine
Intervention type(s): Biological; Drug
Other intervention name(s): Mesenchymal stem cells (MSC); MSC injection; MSV (MSV=MSC prepared following Valladolid IBGM procedure); Sham-treated comparator; Mepivacaine is also known as Carbocaine; Mepivacaine is also known as Polocaine
Intervention MeSH terms: Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Degenerative Disc Disease,; Intervertebral Disc Disease; Low Back Pain; Nucleus pulposus; Stem cell; Cellular therapy; Regenerative therapy; Mesenchymal stem cells; Bone marrow; Musculoskeletal Diseases; Mesenchymal Stromal Cells (allogenic)
Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
Condition: Intravenous Anesthetic Interaction "Unrecognized Condition"
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine
      infusion initiated and maintained during surgery, on propofol requirements during general
      anesthesia.
    

Detailed description: 
      Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased.
      Lidocaine infusion during and after abdominal surgery decreases postoperative pain and
      reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous
      lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present
      studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS
      (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided
      to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine
      infusion, initiated and maintained during surgery, on propofol requirements and anesthetic
      depth as measured by BIS.
    

Intervention name(s): Intravenous lidocaine infusion; Placebo (0.9% saline infusion); Propofol 1% (intravenous infusion); Placement of arterial line
Intervention type(s): Drug; Other; Drug; Procedure
Intervention description(s): Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, lidocaine 1% infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).; Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, 0.9% saline infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).; Propofol is administered according to a widely-accepted pharmacokinetic model, initially dosed to a target controlled infusion (TCI) of 4.5 micrograms/ml, and titrated by step increases of 0.5 every minute until loss of conscience is obtained and BIS values are less than 50. During the maintenance phase of anesthesia propofol TCI is actively titrated to maintain BIS values between 40 and 50. If BIS is out of this range for more than 10 seconds, propofol is adjusted in 0.5 ug/mc to maintain BIS values in the predetermined limits.; An arterial line was placed in the anesthetised patient´s right arm by the investigator and arterial samples were obtained every 10 minutes since initiation of the study infusion to determine plasmatic lidocaine and propofol levels (if the infusion was saline the samples were not analyzed). The arterial line was removed before the end of surgery.
Intervention MeSH terms: Lidocaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox
      GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when
      using the pREset to treat acute occlusions of cerebral vessels will be analyzed.

      *German: "Gesellschaft mit beschränkter Haftung", limited liability company
    

Detailed description: 
      ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox
      GmbH Germany) will be examined. The effectiveness, safety and the long-term success when
      using the pREset to treat acute occlusions of cerebral vessels will be analyzed.

      In this study the market-approved, self-expandable stent retriever (pREset, phenox GmbH,
      Germany) will be used to achieve a direct flow recovery.

      The thrombectomy system will be unfolded directly in the vessel occlusion. In a second step,
      the system and the thrombus will be pulled back into the guide catheter.

      It is planned to enroll 100 patients at the age of 18 until 85 years, with a NIHSS (National
      Institutes of Health Stroke Scale) ≥ 8 and ≤ 30. The preconditions for study enrollment are
      the written consent of the patient or of the legal representative and the fulfillment of all
      mentioned inclusion and exclusion criteria. Pregnant women are excluded from study
      participation.The clinical interventions are in accordance with the clinical standard of care
      for the treatment of this patient population.

      The mRS (Modified Rankin Scale) on day 30, the NIHSS on day 90 and an imaging procedure on
      day 90 may be performed by the study site provided that it corresponds to the clinical
      standards of the study site.
    

Intervention name(s): pREset thrombectomy retriever
Intervention type(s): Device
Intervention description(s): Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 patients harboring an acute ischemic stroke in at least one of the major intracranial
        arteries
      
Keywords: Ischemic, Acute