bioihbjkbjnl/mcl2 huggingface dataset:
Clinical & Radiographical Evaluation of the Effect of Dycal & Biodentine in DPC in Primary Teeth
Condition: Dental Pulp Exposure
MeSH terms: Dental Pulp Exposure
Study type: Interventional

Summary: 
      The purpose of this study was clinical and radiographical evaluation of the effect of calcium
      hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp capping in
      primary teeth.
    

Detailed description: 
      The aim of the present study is to compare Calcium Hydroxide cement (Dycal) ® and Calcium
      Silicate cement (Biodentine)TM as pulp capping agents in primary molars. The objective of
      this study include the evaluation of clinical and radiographic efficacy of Calcium Hydroxide
      cement (Dycal) ® and Calcium Silicate cement (Biodentine)TM, and their response in direct
      pulp capping treatment on primary molars during a 6 months follow up. After following the
      proper standardized procedure for direct pulp cap. In the current study direct pulp capping
      was performed using calcium hydroxide cement (Dycal)® and Calcium Silicate cement
      (Biodentine)TM on 60 primary teeth of children equally divided between 2 study groups
      randomly of both the sexes aged 4-9 years old. Complete case history was recorded in detail
      and intraoral periapical radiograph was also taken for teeth indicated for direct pulp
      capping. Written consent was obtained from the parents of participants before starting the
      procedure. Strict standardized procedure had been followed and the pulp capping agent
      (Dycal®/BiodentineTM) were applied according to the manufacturer's instructions.Each patient
      was evaluated clinically and radiographically for any abnormal clinical signs and symptoms at
      1,3 and 6 months postoperatively.Better results for the success of the study could be
      relatively enhanced by close attention to rigid criteria for case selection, standardization
      of direct pulp capping procedure and meticulous performance of the procedure appear to be
      prerequisites for successful treatment.
    

Intervention name(s): Direct Pulp Capping using Dycal and Biodentine
Intervention type(s): Procedure
Intervention description(s): The operative procedure performed as follows: i)Administration of L.A and rubber dam isolation. ii)High-speed carious enamel removal. iii)Dentine mechanical curettage. iv)Manual final dentine curettage using a spoon excavator. v)Hemorrhage control by cotton pellet moistened with 2.5% sodium hypochlorite placed over the exposure for 1-2min. vi)The exposure site would then be dried with sterile cotton pellet.The operator shall apply the pulp capping agent(dycal/Biodentine)according to the manufacturer's instructions.And then another cover of glass ionomer is applied.This would be followed by permanent restoration.
Other intervention name(s): DPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup
      after single oral dosing in healthy Chinese male subjects.
    


Intervention name(s): Lacosamide (LCM) tablet; Lacosamide (LCM) syrup
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg; Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lacosamide; Syrup; Bioequivalence; Tablet
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
Condition: To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy
      in our institution.
    

Detailed description: 
      A double blinded randomized controlled trial in which cases were given 1000mg intravenous
      tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo
      water for injection into same amount of intravenous fluid. outcome of both groups in terms of
      intraoperative blood loss, duration of surgery, postoperative packed cell volume and total
      blood loss with risk of blood transfusion were then determined.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups comprising of cases and control
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tranexamic acid, Myomectomy, Blood loss, Gravimetric
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the
      treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
    


Intervention name(s): SHP465; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHP465 capsule 6.25 mg orally once daily for 4 weeks; Placebo matching to SHP465 capsule orally once daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Hyperactivity; SHP465
Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women
Condition: Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable
      bioavailability to a single IM injection of Makena®.
    


Intervention name(s): Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL); Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention type(s): Drug; Drug
Other intervention name(s): Makena SQ; Makena
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CERTAS Programmable Valve Registry
Condition: Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension
MeSH terms: Hydrocephalus; Intracranial Hypertension; Hydrocephalus, Normal Pressure; Pseudotumor Cerebri
Study type: Observational [Patient Registry]

Summary: 
      Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable
      Valves.
    

Detailed description: 
      The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for
      shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

      The clinical investigation specifically aims to collect data on the performance measures
      outlined below. Data will be collected per standard of care, given the nature of the clinical
      investigation to capture real world data (registry); timing, frequency, and methodology of
      assessing the performance outcomes may therefore differ per center, subject, and/or visit.

      1) Improvement of the following symptoms related to hydrocephalus:

        -  Gait disturbances;

        -  Spatial impairment;

        -  Cognitive abilities;

        -  Urinary incontinence;

        -  Pain caused by headaches;

        -  Visual acuity.
    

Intervention name(s): CODMAN CERTAS Programmable Valves
Intervention type(s): Device
Intervention description(s): Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for
        their condition, as determined by their clinician.
Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII
Condition: Injury of Extensor Tendon of Hand (Disorder)
Study type: Interventional

Summary: 
      Functional recovery measurement : Comparing early active mobilization versus immobilization
      after extensor tendon repair in zones IV to VIII.

      Immobilization for six weeks has been the postoperative protocol for the patients with hand's
      extensor tendon repair in our institute. In this study early mobilization of the hand i.e.
      also an internationally followed way, is compared with the aforementioned immobilization
      protocol to see which turns out to be a better option in the interest of the patient.
    

Detailed description: 
      patients selection in both groups will be random by using close envolupe technique.

      In group A ( immobilisation) physiotherapy will start by the end of 4th week and the upper
      limit of flexion would be 45 degrees.

      In group B ( EAM) physiotherapy will start by the end of 1st week and the upper limit of
      flexion would be 30 degrees.
    

Intervention name(s): physiotherapy
Intervention type(s): Procedure
Intervention description(s): Two protocols have been described for physiotherapy of post extensor tendon injuries. one is immobilization till 3 weeks and than gradual increase in active motion of hand. The second protocol is early active motion. this would be done under senior physiotherapist.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Healthy patients with only extensor tendon injuries will be recruited in this study and will randomly divided in two groups. An intervention in the form of rehabilitation will be given to patients in two different protocols than outcomes will be assessed.
Masking: Single (Participant)
Primary purpose: Treatment
Study of CXA-10 in Healthy Volunteers
Condition: Acute Kidney Injury (Nontraumatic)
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to
      demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various
      incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion
      vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects
      of CXA-10 will be investigated.
    


Intervention name(s): CXA-10 emulsion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
Intervention MeSH terms: CXA-10
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nitro-fatty acids; anti-inflammatory; Nrf2 activation; contrast induced AKI
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
Condition: Genital Warts
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and activity of GS-9191
      ointment in the treatment of genital warts. GS-9191 ointment is intended for topical
      application directly to genital warts on the skin.
    


Intervention name(s): GS-9191 ointment; GS-9191; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.; GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.; Placebo matching GS-9191 ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: genital warts; venereal warts; human papilloma virus
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
Condition: HIV-1-infection
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment
      of HIV-positive patients with immune reconstitution disorders. Researchers previously used
      Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found
      that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In
      addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine has
      better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and
      more stable high CD4+ T cell counts. In addition, extensive studies on the administration of
      Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The
      researchers hypothesized that Zadaxin® has a better therapeutic effect on HIV-positive
      patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the
      viral load, and has better safety.
    

Detailed description: 
      All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2
      weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive
      22 weeks. It is still recommended to continue treatment until the end of the study. All
      subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th
      week, perform 4 follow-up and record the changes in CD4+ T cell count and proportion, CD8+ T
      cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of
      exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety
      assessment is performed, including adverse events, electrocardiogram and a series of
      laboratory tests (blood routine, liver and kidney function, etc.).
    

Intervention name(s): Zadaxin
Intervention type(s): Drug
Intervention description(s): 1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the successive 22 weeks.
Other intervention name(s): Thymosin α1
Intervention MeSH terms: Thymalfasin
Intervention model: Single Group Assignment
Intervention model description: All participants eligible for study received the same open label drug
Masking: None (Open Label)
Primary purpose: Treatment
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
Condition: Vascular Access Complication
Study type: Interventional

Summary: 
      The study will test a hypothesis that the AccuCath™ System will have a higher rate of
      successful first attempt peripheral intravenous (IV) placement, higher completion of therapy,
      fewer complications, longer dwell times, and higher user satisfaction compared to
      conventional IV catheters.
    

Detailed description: 
      This study is designed to evaluate user/physician preference as it relates to use of a 510(k)
      cleared vascular access and catheter device compared with conventional needle/catheter
      vascular access devices, in terms of first stick success rates, dwell time, device-related
      vascular complications and adverse events and overall user and patient satisfaction. As noted
      above, the study is designed to formally test the hypothesis that the AccuCath™ System will
      exhibit superiority in terms of the rate of successful first attempt peripheral IV placement,
      higher completion of therapy, fewer complications, longer dwell times and higher user
      satisfaction compared to conventional intravenous catheters.
    

Intervention name(s): AccuCath IV Catheter Device; Conventional IV Catheter Device
Intervention type(s): Device; Device
Intervention description(s): Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.; Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Other intervention name(s): Rapid Intravascular Start System (RIVS); AccuCath System; AccuCath IV device; AccuCath; AccuCath PIV; AccuCath Short IV; AccuCath IV Catheter; Insyte Autoguard; Insyte Autoguard PIV; Insyte Autoguard IV Catheter; Insyte Autoguard IV device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IV Catheter comparison; AccuCath versus Conventional IV Catheters; IV Catheter Study; IV Catheter User Preference Comparison; First Attempt Success Rate for IV Catheters; AccuCath Device Performance; Complication Rates for IV Catheters; Average Dwell Time for IV Catheters; Patient Satisfaction with IV Catheters; Clinician Satisfaction with AccuCath Device Performance
Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
Condition: Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray
Study type: Interventional
Phase: Phase 2

Summary: 
      Trial with medicinal products

      Recent studies revealed that radiation-based procedures in patients may lead to DNA
      double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human
      blood lymphocytes have shown a protective effect of antioxidant agents which have been
      described to decrease the number of DNA double-strand breaks.

      This study represents a prospective, double-blinded, randomized, single center, and
      placebo-controlled phase II clinical trial which analyzes the capability of antioxidant
      agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in
      patients undergoing radiation-based cardiac examinations (30 patients with high-dose
      radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without
      radiation exposure).

      A protective effect of antioxidant drugs in patients undergoing radiation-based examinations
      could therefore change patient management and would provide an important clinical impact.
    


Intervention name(s): Low-dose radiation exposure; High-dose radiation exposure; No radiation exposure
Intervention type(s): Radiation; Radiation; Other
Intervention description(s): what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once; what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once; Subjects not undergoing any radiation exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer
Condition: Colorectal Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to compare postoperative immune function (e.g. NK cell activity)
      of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based
      anlagesic regimen after laparoscopic colorectal surgery
    


Intervention name(s): fentanyl-based analgesia; local anesthetic wound infiltration-based anlagesia
Intervention type(s): Drug; Drug
Intervention description(s): fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour; continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour
Intervention MeSH terms: Fentanyl; Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: analgesia; colorectal surgery; immunity; local anesthetics; opioids
Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
Condition: Biliary Anastomotic Stenosis; Biliary Stricture
MeSH terms: Constriction, Pathologic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Biliary complications are one of the most common problems after orthotopic liver
      transplantation (OLT),occurring in up to 24% of patients.

      Anastomotic strictures have been endoscopically managed with plastic stents placement.
      Recently, partially and fully covered metal stents have been alternatively used to treat
      refractory benign biliary stenosis. The investigators purpose is to compare efficacy and
      safety of metallic stents versus multiple plastic stents in the endoscopic management of post
      transplant biliary complications.
    

Detailed description: 
      Patients with biliary stricture after OLT will be randomly assigned following simple
      randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or
      multiple plastic stents placement were randomized according to a computer generated
      randomization sequence and allocated in a 1:1 ratio to one of two treatment groups.

      Final success will be defined as clinical resolution of the stricture without the need to
      repeat endoscopic, percutaneous or surgical treatment.
    

Intervention name(s): Self-expandable metalic stent; Multiple plastic stents
Intervention type(s): Device; Device
Intervention description(s): Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.; Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Other intervention name(s): Wallflex, Boston Scientific; Boston Scientific; Wilson Cook; Olympus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biliary anastomotic stricture; orthotopic liver transplantation; ERCP