bioihbjkbjnl/mcl2 huggingface dataset:
Simulation Training and Teamwork Concerning Intubation on the Icu
Condition: Airway Management
Study type: Interventional

Summary: 
      To assess effects of the simulation education on the group intubating patients in the iCU, in
      this prospective study investigators will video-record real-life intubations and simulations.
      From videos will be assessed correlation of technical and non-technical skills before and
      after the education and performance in real-life vs simulation intubation.
    

Detailed description: 
      The aim of this trial is to study the effects of simulation education on the action of the
      group managing patient's airway in the intensive care unit (ICU). Before simulations
      investigators will video-record 20 real-world intubations. Consequently will be run
      simulations to whole staff of the ICU. After the education further 20 real-world intubations
      will be recorded. Also simulations are recorded. From the videos investigators assess
      technical and non-technical skills of the group before and after simulation education,
      correlations between groups and influence of the education on action of the group. On the
      first part of the study, hypothesis is that group's good non-technical skills improve also
      technical skills. On the second part of the study hypothesis is that performing well in
      simulation correlates with performing well in real-world situation and teams with less
      experience the correlation is stronger.
    

Intervention name(s): simulation education
Intervention type(s): Behavioral
Intervention description(s): Intubation protocol will be trained by simulation exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: intubation; simulation; airway management; education; video-record; checklist
VitalFlow Healthy Volunteer Study
Condition: Normal Subject / Healthy Volunteers
Study type: Interventional

Summary: 
      Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with
      tolerability and safety in subjects Healthy humans.
    

Detailed description: 
      Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes
      in cerebral blood flow safely, without generating adverse effects unknown to the technique.

      Our specific objectives:

        1. Perform tolerability and safety tests of magnetic stimulation on the facial nerve.

        2. Establish the optimal stimulation threshold associated with tolerability in order to
           apply it to the final design of the Magnetic Stimulation (MS) system.

        3. Measure whether the threshold found shows any increase in cerebral perfusion in the
           subject with respect to their baseline.
    

Intervention name(s): magnetic facial nerve stimulation
Intervention type(s): Device
Intervention description(s): Magnetic stimulation of facial nerve.
Intervention model: Single Group Assignment
Intervention model description: Prospective
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: facial nerve; magnetic stimulation; cerebral blood flow
Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement
Condition: Anterior Maxillary Narrow Ridge
Study type: Interventional

Summary: 
      A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow
      ridges after ridge splitting flapless technique using an interchangeable guide.
    

Detailed description: 
      A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria.
      Then the selected participants underwent ridge splitting with the aid of interchangeable
      guide. After ridge splitting, all patients had simultaneous implant placement followed by
      clinical and radiographical evaluation over a period of 6 months.
    

Intervention name(s): ridge splitting flapless technique using interchangeable guide followed by implant placement
Intervention type(s): Procedure
Intervention description(s): An informed consent is taken from all the patients
I. Presurgical phase:
Proper dental and medical history.
Scaling and oral hygiene measurements.
Clinical examination.
Radiographic examination. Clinical bucco-lingual measurements was done using calipers to ensure the patients would meet our initial inclusion criteria prior to further investigations.
III. Fabrication of interchangeable surgical guide stent from primary impression:
Optical scanning of the dental casts was done using Ceramill map 400
surgical stent was designed using Mimics Innovation Suite 19 ™ software.
Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique.
All patients will be operated under local anesthesia, stent was placed on ridge and adapted well after disinfection osteotomy was done using piezotome splitting tips Implant-insertion was started immediately
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Study of Children and Adolescents With Craniopharyngioma
Condition: Craniopharyngioma; Obesity
MeSH terms: Craniopharyngioma; Adamantinoma
Study type: Interventional

Summary: 
      The present investigation is a prospective, multicenter study evaluating craniopharyngioma
      patients' prognoses following the various currently-practiced therapeutic strategies.Primary
      goals of the study are to establish quality standards and compare the various therapy
      strategies with respect to their effectiveness and impact on the quality of life of treated
      patients. A stratified randomization of two treatment arms will be conducted with respect to
      timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors
      are incompletely resected. The researchers will investigate whether an immediate,
      postoperative irradiation is superior to progression-contingent irradiation based on
      alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month
      post op) to 3 years after randomization. Progression-free survival and overall survival will
      be examined as closely-related subgoals.Postoperative data will be evaluated via a
      surveillance study for all complete resection patients as well as for those patients under 5
      years of age regardless of their resection grade.
    


Intervention name(s): Radiation; wait and watch
Intervention type(s): Radiation; Other
Intervention description(s): Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy); wait ans watch, MRI controls, irradiation at the time of progression of residual tumor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of life; Endocrinology; Oncology; Hypothalamus; Irradiation; Neurosurgery; Pediatric Brain tumors; Randomized trial
A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges
Condition: Healthy Volunteer Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated
      with a single dose or four study treatments in a randomized sequence.
    


Intervention name(s): 4 mg nicotine lozenge; 2 mg nicotine lozenge; 2 mg nicotine prototype; 4 mg nicotine prototype
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): marketed formulation; marketed formulation; 2 mg; 4 mg
Other intervention name(s): Nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NRT; Bioequivalence; Nicotine
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Condition: Female Pattern Hair Loss, Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the effect of Minoxidil 2% Solution and
      Botanical Hair Solution Regimen in women with thinning hair and female pattern hair
      loss/androgenic alopecia (Ludwig I and II).
    


Intervention name(s): Treatment: Minoxidil 2% / Botanical Hair Solution for Women
Intervention type(s): Drug
Intervention MeSH terms: Minoxidil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TRENDY Follow-up: Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular
      hemodynamics, and in animal experiments its alteration has been associated with morphological
      changes characteristic of diabetic nephropathy. The investigators aimed to assess in a
      prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to
      examine whether impairment of basal NO activity of the renal vasculature is related to
      development and progression of diabetic nephropathy and other cardiovascular endpoints.
    


Intervention name(s): Telmisartan 80 mg/d; Ramipril 10 mg/d
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Ramipril
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with type 2 diabetes mellitus and normo or microalbuminuria
      
Keywords: type 2 diabetes mellitus; endothelial function; renal hemodynamics
Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison
      with collagen membrane for management of periodontal intrabony defects.
    

Detailed description: 
      Twenty patients suffering from advanced chronic periodontitis were included in this
      randomized controlled clinical trial. Each subject contributed matched pairs of two- or
      three-walled intrabony defects. Each pair of periodontal defects were randomly assigned into
      the experimental group; periosteal pedicle graft guided tissue membrane or the positive
      control group; bioresorbable collagen guided tissue regeneration membrane. Clinical and
      radiographic parameters were recorded at baseline and at 6 months postoperatively.
    

Intervention name(s): Periosteal pedicle graft; Bioresorbable collagen membrane
Intervention type(s): Procedure; Biological
Intervention description(s): Autogenous pedicle graft harvested from the periosteum; Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a
      safe and effective vaccination strategy against malaria. The vaccines have been found to be
      well tolerated when tested in Gambian adults, young children and infants, who are at risk of
      severe malaria. Both vaccines will be given to participating infants at the same time as some
      EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still
      helpful in making the body's defense system respond.
    


Intervention name(s): ChAd63 ME-TRAP / MVA ME-TRAP
Intervention type(s): Biological
Intervention description(s): Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immune response; Vaccine; Malaria
A Study of Ad26.COV2.S in Healthy Adults (COVID-19)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3
      milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL
      versus 0.5 mL), 28 days after vaccination.
    


Intervention name(s): Ad26.COV2.S
Intervention type(s): Biological
Intervention description(s): Ad26.COV2.S will be administered as IM injection.
Other intervention name(s): JNJ-78436735, VAC31518
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the efficacy and safety of early combination therapy with
      Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM
      inadequately controlled by prior monotherapy with metformin.
    

Detailed description: 
      Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic
      treatment option. Disease progression renders monotherapy less effective in controlling blood
      glucose over time, with approximately half of the patients requiring additional therapy by 3
      years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood
      glucose is well accepted.

      In combination therapy, selection of suitable drug may be individualized depending on their
      health conditions. However, it is advisable to select drugs having different mechanism
      considering their complimentary action with each other. Therefore, sulfonylureas and
      metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance",
      the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety
      of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical
      studies as combination is more effective than monotherapy using each drug in blood glucose
      control.

      Also, new approaches are required in order to attain and maintain good glycaemic control over
      time and aggressive earlier introduction of combination therapy is being increasingly
      recommended over conventional stepwise strategies.
    

Intervention name(s): Glimepiride/metformin fixed combination; Metformin HCl
Intervention type(s): Drug; Drug
Intervention description(s): Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks
Maintenance dose for 10 weeks after 2~14 weeks of dose titration
Dose titration according to titration algorithm based on daily mean SMBG; Metformin HCl 500mg~1250mg bid for 12~26 weeks
Maintenance dose for 10 weeks after 2~14 weeks of dose titration
Dose titration according to titration algorithm based on daily mean SMBG
Other intervention name(s): Amaryl M; Diabex
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 DM
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
Condition: Hemorrhage; Soft Tissue Bleeding; Hepatic Parenchyma Bleeding
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant
      Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft
      tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and
      thoracic (non-cardiac) surgery in paediatric patients.
    

Detailed description: 
      This is an open label, prospective, randomised, multicentre, controlled, clinical study
      comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct
      to haemostasis when conventional methods of controlling mild or moderate bleeding are
      ineffective or impractical during surgery in paediatric patients.

      At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding
      Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or
      SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4
      and 10 minutes from randomisation.

      Enrolment will be staggered by age (as required by the European Medicines Agency (EMA)
      Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to <18 years of
      age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from
      birth) to <1 year of age will follow. Ongoing safety assessment will ensure adequate safety
      monitoring occur during the staged enrolment.

      Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14
      days) post-surgery.
    

Intervention name(s): EVARREST™ Sealant Matrix; SURGICEL®
Intervention type(s): Biological; Device
Intervention description(s): EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.; SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Other intervention name(s): EVARREST™ Fibrin Sealant Patch; oxidized regenerated cellulose
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibrin Sealant; Hemostatics; Coagulants
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
Condition: Prevention of Pregnancy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low
      Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the
      TCu380.
    

Detailed description: 
      This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety,
      Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as
      compared to a concurrently controlled, commercially available standard copper "T" IUD
      (TCu380).
    

Intervention name(s): VeraCept Intrauterine Copper Contraceptive; TCu380 IUD
Intervention type(s): Device; Device
Intervention MeSH terms: Copper; Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: contraception; IUD; copper
Evaluation of PillCam® Express Capsule Endoscopy Delivery System
Condition: Small Bowel Disease; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic
      capsule placement Capsule Endoscopy Delivery System.
    

Detailed description: 
      Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in
      subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected
      anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be
      challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery
      System is intended to provide physicians with the capability to place capsules in the
      proximal duodenum using the accessory channel of a standard endoscope.

      The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for
      small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide
      and is well accepted by subjects and physicians as well as the professional societies.

      Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the
      device description section.

      This study is designed to evaluate the performance and safety of the Capsule Endoscopy
      Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD)
      endoscopy
    

Intervention name(s): PillCam® Express Capsule Endoscopy Delivery System
Intervention type(s): Device
Intervention description(s): The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter.
Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.
The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free.
Intervention model: Single Group Assignment
Intervention model description: To evaluate the safety and efficacy of an endoscopic capsule placement device.
Masking: Single (Investigator)
Primary purpose: Device Feasibility
Keywords: capsule endoscopy; small bowel disease; inflammatory bowel disease; Subjects indicated for EGD endoscopy