bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed as a long-term extension to the Phase 3 parent-study SM04690-OA-11. It
      aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects
      with knee osteoarthritis (OA). The first 48 weeks will be single-blind and placebo-controlled
      while the remainder of the study will be open-label and uncontrolled. Subjects must enroll no
      later than 6 weeks following completion of the parent-study.
    

Detailed description: 
      At the first visit (Day 1), all subjects will complete Patient Acceptable Symptom State
      (PASS) and pain Numeric Rating Scale (NRS) assessments and then receive a blinded study
      injection into their target knee (the same target knee injected in the parent study), with
      subjects receiving the same treatment (either 0.07 mg LOR or placebo) as they received in the
      parent study. Subjects will have clinic visits for pain and function assessments, collection
      of adverse events, and knee radiographs. At Week 48, all subjects, regardless of previous
      treatment, will receive an injection of 0.07 mg LOR into their target knee. Subjects will
      receive injections of 0.07 mg LOR into their target knee every 52 weeks thereafter until end
      of study.
    

Intervention name(s): Placebo; Lorecivivint
Intervention type(s): Drug; Drug
Intervention description(s): Healthcare professional-administered intra-articular injection of vehicle.; Healthcare professional-administered intra-articular injections of lorecivivint.
Other intervention name(s): Vehicle; SM04690
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SM04690; Wnt pathway inhibitor; osteoarthritis; Biosplice Therapeutics, Inc.; Samumed; lorecivivint
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
Condition: Spasms, Infantile; Epilepsy
MeSH terms: Epilepsy; Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of
      cortical abnormality versus multiple drug therapy in children with infantile spasms
      refractory to standard therapy.

      II. Assess how infantile spasms interfere with development and whether this is partially
      reversible.

      III. Determine the predictors of good surgical outcome and whether surgery permanently
      controls seizures and improves development.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to 1 of 2
      treatment groups. The first group undergoes sequential antiepileptic therapy with pyridoxine,
      corticotropin, valproic acid, carbamazepine, and nitrazepam. The sequence of administration
      may be altered based on drugs taken prior to entry. Any drug may be omitted due to medical
      contraindications or prior use at study doses or higher.

      The second group undergoes surgical resection of the zone of cortical abnormality. A
      functional hemispherectomy is performed for hemiparesis or diffuse unihemispheric
      dysfunction.

      If seizures are controlled in the first group at 3 months, the current medication is
      maintained; if seizures are not controlled, sequential therapy continues to completion.
      Patients experiencing uncontrolled seizures at 6 months cross to surgery.

      Surgical patients experiencing uncontrolled seizures at 3 months or persistent seizures after
      taper of pre-study antiepileptics cross to drug therapy.

      All patients are followed at 6 months and 1, 2, 3, 5, 7, and 10 years.
    

Intervention name(s): carbamazepine; corticotropin; nitrazepam; pyridoxine; valproic acid; Surgery
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Pyridoxine; Carbamazepine; Valproic Acid; Nitrazepam; Adrenocorticotropic Hormone
Allocation: Randomized
Primary purpose: Treatment
Keywords: infantile spasms; epilepsy; neurologic and psychiatric disorders; rare disease; seizures
Iron Absorption From Iron-enriched Aspergillus Oryzae
Condition: Iron-deficiency; Absorption; Iron; Anemia, Iron Deficiency; Bioavailability; Serum Iron
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly
      possibly leading to higher concentrations of non-transferrin bound iron which induces
      oxidative stress. The objective of this study was to determine how quickly iron enters into
      blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to
      ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind,
      cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as
      20 mg iron as ASP.
    

Detailed description: 
      In a double-blinded cross-over design, 17 research participants were randomly given one of
      three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each
      iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy
      sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a
      meal with one of the three iron supplements in a random order and all participants consumed
      the three supplements 2 weeks in between each treatment. Prior to consuming the test meal
      with iron supplement for each treatment, blood was collected for baseline serum iron
      measuremt. Following consumption of the meal with iron, subsequent blood draws were taken
      every 30 minutes over the time period of 4 hours to assess the incease in serum iron.
      Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum
      at baselime. After two weeks other treatments were administered to each participant. The
      serum iron response curves for each treatment were constructed and the area under the curve
      (AUC) was calculated with the change of serum iron from baseline.
    

Intervention name(s): Ferrous sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.
Other intervention name(s): ASP (10 mg); ASP (20 mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blinded, cross-over experimental design, whereby subjects were randomly given three different iron supplements with a meal in three different visits. All three visits (iron treatments) were each separated by two weeks time.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anemia; Iron deficiency anemia; Iron fortification; ferrous sulfate; aspergillus oryzae; iron supplementation; AUC
A Positron Emission Tomography Occupancy Study Using Ligand [11C]AS2471907 and Following Oral Dosing of ASP3662
Condition: Pharmacokinetics of ASP3662; Displacement of Radiotracer; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use
      [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain
      prior to and following single oral dose administration of ASP3662.
    

Detailed description: 
      This is a two-part study where Part 1 will assess the test/retest variability of the ligand
      ([11C]AS2471907). Part 2 will assess the level and time-course of enzyme occupancy following
      ASP3662 dosing. Subjects will be confined to the clinic for up to 2 days.
    

Intervention name(s): [11C]AS2471907; Positron Emission Tomography (PET); ASP3662
Intervention type(s): Other; Radiation; Drug
Intervention description(s): intravenous radiotracer; Imaging scanning procedure; oral
Other intervention name(s): Up to 4 single dose IV administrations (≤ 10 mL infused over approximately 1 minute) are planned; totaling less than 100 μg.
Intervention MeSH terms: AS2471907
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: [11C]AS2471907; ASP3662; Positron Emission Tomography (PET); Brain enzyme occupancy
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Condition: Analgesia; Sternotomy
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare
      postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed
      with local anesthetic solution with or without perineural adjuvants in patients following
      cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving
      PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic
      pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and
      epinephrine.
    

Detailed description: 
      This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed
      consent will be obtained from all study participants prior to randomization. Patients
      scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest
      Baptist will be screened for eligibility. These patients will be approached for enrollment by
      research staff either during their preoperative assessment clinic visit prior to their
      surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to
      participate will be randomized into one or other arm and PIFB will be performed after skin
      closure and before transport from the operating room to the ICU. For patients who are
      randomized at enrollment but later excluded due to exclusion criteria prior to block
      placement, their randomization assignment will be replaced at the end of the initial
      recruitment.
    

Intervention name(s): Pecto-intercostal Fascial Block (PIFB); PIFB with adjuvants
Intervention type(s): Drug; Drug
Intervention description(s): PIFB done with bupivacaine and epinephrine; PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pecto-intercostal Fascial Block; Postoperative; Pain; Cardiac Surgery
Ivabradine in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the efficacy of Ivabradine therapy in patients with
      congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.
    

Detailed description: 
      -  Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,
           Damanhour University

        -  All participants have agreed to take part in this clinical study and provide informed
           consent

        -  A 3 months, prospective interventional study.

        -  Sixty ambulatory, clinically stable symptomatic patients with systolic chronic HF (≥ 4
           weeks), on optimized standard medical therapy were consecutively included and randomly
           allocated to the ivabradine group (n=30) and non-ivabradine group (n=30).

        -  The baseline evaluation comprised physical examination, NYHA class, 12-lead
           electrocardi¬ography (ECG), Echocardiography, blood sampling for laboratory
           measurements, including NT-Pro BNP and Neopterin.

        -  Patients in the Ivabradine group were administered Ivabradine 5 mg twice daily and doses
           (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR
           at rest and tolerability.

        -  Patients were followed up after 1 week of initiation of ivabradine therapy then monthly
           till the end of the study.

        -  Peripheral venous blood samples were drawn between 8 and 9 am after a 30-min rest in the
           supine position. Serum samples were frozen at -80°C until assay.

        -  Levels of NT-Pro BNP and Neopterin were detected using ELISA kits as prescribed by
           manufacturer.

        -  Statistical tests appropriate to the study will be conducted to evaluate significance of
           results

        -  Results, conclusion, discussion and recommendations will be given
    

Intervention name(s): Ivabradine Oral Tablet; Blacebo plus standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability plus their standard treatment.; Blacebo plus standard treatment
Other intervention name(s): Procoralan 5 mg film-coated tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Uterosacral Ligament Suspension Clip
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This study seeks to gain a more thorough understanding of the postoperative location of the
      sutures placed during uterosacral ligament suspension. Characterization of the surrounding
      anatomy in a living model will enhance surgical technique by delineating safer suture
      locations and decrease the incidence of morbid complications for patients.
    

Detailed description: 
      Uterosacral ligament suspension Is a commonly performed procedure to support the vaginal apex
      at the time of pelvic reconstructive surgery for pelvic organ prolapse (POP). Despite being a
      well established durable option for patients, there is little research detailing ligament
      suspension suture location in the living model. The available literature is limited to
      cadaveric studies, which suggest suture placement is in close proximity to vital structures
      such as the ureter, blood vessels, rectum and nerves.

      This study seeks to describe suture location in relation to the surrounding anatomy in
      postoperative patients following high uterosacral ligament suspension. The secondary aim is
      to determine safe zones for suture placement.

      Seventeen women (aged 18-85) under the care of Cincinnati Urogynecology Associates, a
      physician group of TriHealth, who have chosen vaginal hysterectomy with uterosacral ligament
      suspension (USLS) as the treatment choice for pelvic organ prolapse (POP) will be enrolled.

      At the time of surgery, a titanium vascular clip (size small) will be applied to the base of
      each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to
      help in identification by imaging.

      On postoperative day (POD) 1, patients will undergo CT pelvis scans. The CT scan will involve
      administration of IV contrast for imaging of the ureters and vascular structures. The clip
      will fall off when the sutures dissolve at 12 weeks postoperatively. All patients will be
      asked to complete a lower extremity neurological questionnaire preoperatively and
      postoperatively.
    

Intervention name(s): Vascular Clip
Intervention type(s): Device
Intervention description(s): Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
Other intervention name(s): Clip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Condition: Cochlear Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      After cochlear implantation, cochlear nerve is stimulated by giving a current over the
      electrodes placed in the cochlea and the current is measured by electrically evoked Compound
      Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch
      on), after 3months and 6 months following cochlear implantation.
    

Detailed description: 
      After cochlear implantation, cochlear nerve is stimulated by giving a current over the
      electrodes placed in the cochlea and the current is measured by electrically evoked Compound
      Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and
      after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT)
      is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ.
      It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) -
      levels of the recipient's speech processor map. Intraoperative NRT in conjunction with
      electrode impedance data can help indicate the integrity of the implanted electrodes and the
      electrode/auditory nerve interface, confirming that the implant is functioning correctly
      intraoperatively.
    

Intervention name(s): Cochlear implant
Intervention type(s): Device
Intervention description(s): After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cochlear implant; threshold of electrically evoked compound action potential; neural response telemetry
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Condition: Overweight/Obese Women
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Individuals have a significant capacity to adapt to different environments by changing their
      core metabolic pathways. This adaptation is especially important in regards to diet.
      Epidemiological research over the last several decades have shown that diets high in
      saturated fats have a greater ability to cause insulin resistance and the 'metabolic
      syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the
      risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as
      compared to high carbohydrate or high saturated fat diets, result in increased insulin
      sensitivity and improved lipid profiles.

      In this application, the investigators propose to systematically assess the effects of two
      diets enriched in either saturated or unsaturated fatty acids and determine the cellular and
      molecular mechanisms of the apparent increase in insulin sensitivity. The investigators
      hypothesize that individuals will 'adapt' to the different diets and the investigators will
      be able to generate predictive alterations in gene expression and metabolites that underlie
      the alterations in metabolism. In parallel, the investigators will test the ability of these
      different diets to affect the release of gastrointestinal hormones that may be critical to
      modulation of appetite.
    


Intervention name(s): High Fat Diet
Intervention type(s): Other
Intervention description(s): Subjects will adhere to their specific diet for four weeks. For both diet treatments, the diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated. For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high fat diet treatment; insulin sensitivity
Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine whether Super-Bolus is more effective in postprandial
      glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with
      type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion,
      CSII).
    


Intervention name(s): Insulin Glulisine; Insulin Aspart; Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.; A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.; A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Other intervention name(s): Apidra; NovoRapid; Humalog, Liprolog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: super bolus; diabetes type 1; insulin bolus; high glycemic index meal; prandial insulin requirement; postprandial glycemia; insulin pump therapy
The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
Condition: Emergence Delirium
MeSH terms: Emergence Delirium
Study type: Interventional

Summary: 
      Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children
    

Detailed description: 
      Children < 8 years old who scheduled for elective opthalmic surgery are randomly assigned to
      Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale
      Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed,
      and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled
      ventilation is started.

      In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused
      (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of
      saline is infused.

      Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's
      Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30
      minutes after surgery.
    

Intervention name(s): Magnesium; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Mg is administered during anesthesia until 5 minutes before surgery ends; Same volume of saline is infused until 5 minutes before surgery ends
Other intervention name(s): Magnesium sulfate; Normal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention