bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      This study is a prospective randomized controlled clinical trial. It was performed on sixteen
      patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws
      in fracture fixation from clinical and radiographic perspectives.
    

Detailed description: 
      This study is a prospective randomized controlled clinical trial. It was performed on sixteen
      patients with anterior mandibular fractures, selected from those admitted to the Emergency
      Department of Alexandria University Hospital. Ethical approval for the study was obtained
      from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A
      written informed consent was signed by patients before the operation.

      Patients were divided equally into two groups, each consisting of eight patients. Assignment
      of each patient into one of either group was done using computer random numbers.

      Group 1: underwent open reduction and internal fixation using two lag screws. Group 2:
      underwent open reduction and internal fixation using double Y-shaped plates.
    

Intervention name(s): Lag Screws; double Y-shaped plates
Intervention type(s): Device; Device
Intervention description(s): Method of internal fixation; Method of internal fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
McGrath vs. C-MAC Video Laryngoscopy Comparison in Endotracheal Tube Insertion
Condition: Intubation; Difficult or Failed
Study type: Interventional

Summary: 
      Tracheal intubation is commonly performed using a standard Macintosh blade, but recently
      there has been advanced technology using video laryngoscopy (VL).In this modern era, there
      are various types of available VL to make it easier for anesthesiologists to perform
      intubation, especially in patients with difficult airway anatomy.

      Various studies showed different results regarding the effectiveness of both C-MAC® and
      McGrath®, by assessing the comparison of the effectiveness, valuable information will be
      obtained for further consideration by experts in choosing the best tools in the future.
    


Intervention name(s): Endotracheal intubation
Intervention type(s): Device
Intervention description(s): Endotracheal intubation using either McGrath or C-MAC video laryngoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      COVID-19 pandemic has an important impact on the health care provided by the
      anesthesiologists. Different societies of anesthesiology have provided guidelines and
      recommendations on how to manage patients who have been tested positive for COVID-19 or
      suspected to be infected. It is therefore important to know whether these guidelines have
      been implemented or were possible to be implemented. Otherwise patients who are presenting
      COVID-19 often show pulmonary complications. The airway management and the ventilation
      management of these patients can be therefore challenging and can possibly influence their
      outcome. It is thus important to obtain a large database with information about the
      characteristics of these patients, how these patients have been managed and their in-hospital
      outcome. Information regarding the correct implementation of guidelines is as well necessary
      for future guidance of health care providers.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pediatric and adult patients who are tested positive for COVID-19 or who are suspected
        to be infected and who require anesthesia care for their intervention
Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
Condition: Metatarsalgia
MeSH terms: Metatarsalgia
Study type: Interventional

Summary: 
      22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.

      Testing involves pedobar pressures and a validated comfort questionnaire.
    

Detailed description: 
      22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer
      testing involved pedobar pressures and a validated comfort questionnaire.

      x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal
      (IM) angles will be recorded.

      Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus,
      hammertoes will be recorded.

      Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel)
      and possible Emed system (Novel).

      3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS
      according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a
      reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.

      Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be
      regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus
      etc has an effect.

      16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the
      investigators have enough power.
    

Intervention name(s): orthopaedic stilettoe; standard stiletto; comfy trainer
Intervention type(s): Other; Other; Other
Intervention description(s): stilettos with orthopaedic in-sole buildt into the shoe; standard stiletto without insole; comfy trainer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: metatarsalgia; pedobar; foot; stiletto; insoles
68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG
Condition: Tumor, Solid; Positron-Emission Tomography
Study type: Interventional

Summary: 
      As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is
      promising as an excellent imaging agent applicable to various cancers. In this research, we
      investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy
      volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions
      in various types of cancer, and compared with 18F-FDG PET/CT.
    

Detailed description: 
      As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is
      promising as an excellent imaging agent applicable to various cancers. In this research, we
      investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy
      volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous
      68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence
      detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The
      numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual
      interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to
      18F-FDG PET/CT.
    

Intervention name(s): 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
Intervention type(s): Diagnostic Test
Intervention description(s): Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tumor; Solid; Positron-Emission Tomography; diagnosis
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
Condition: Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide
      nasal spray administered along with a fixed combination of inhaled fluticasone
      dipropionate/salmeterol.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergy; Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever
Phase 1 Study of Levocetirizine
Condition: Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single blind, single dose, randomized, partial cross-over study to
      confirm bioequivalence between levocetirizine and cetirizine.
    


Intervention name(s): levocetirizine; cetirizine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): levocetirizine; cetiridine; placebo
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Addressing Gender Based Violence in HIV Testing and Counseling
Condition: Intimate Partner Violence
Study type: Interventional

Summary: 
      The overarching goal of this study is to pilot an approach to HIV testing and counseling
      (HTC) that addresses intimate partner violence. The results of the study will fill an
      important gap in the literature and contribute to efforts by Kenyatta National Hospital in
      Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better
      address intimate partner violence in our work.
    


Intervention name(s): IPV/GBV HTC
Intervention type(s): Behavioral
Intervention description(s): Participants will be interviewed after receiving their services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Condition: Metastatic Breast Cancer; Bone Metastases
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1
      mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth
      factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be
      randomized into two groups.
    

Detailed description: 
      The administration of Zometa in short intervals has been implied to be more potent in
      maximizing its antitumor and antiangiogenesis effects, while dosing every four weeks is an
      appropriate strategy for the prevention and management of bone metastases. This study was
      designed to explore the relationship between dosing of Zometa and level of circulating VEGF.
    

Intervention name(s): Zoledronic acid; Zoledronic acid
Intervention type(s): Biological; Drug
Intervention description(s): Zometa 1 mg weekly (intravenous); Zometa 4 mg every four weeks (intravenous)
Other intervention name(s): Zometa
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Bone metastasis; Circulating VEGF; Zoledronic acid; Angiogenesis
Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      The primary study objective is to determine if subjects experiencing an acute ischemic stroke
      due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization
      Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS)
      than those subjects treated with IV t-PA alone
    


Intervention name(s): Intravenous (IV) recombinant human tissue plasminogen activator (rtPA); Solitaire revascularization device
Intervention type(s): Drug; Device
Intervention description(s): Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA); Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels and Smoking Behavior Among Early Adolescents in Jordan
Condition: Asthma; Tobacco; Waterpipe; Cigarettes
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Hypotheses:

        1. adolescents in intervention schools who are given Triple A program plus ASP will show
           more awareness in regards to cigarettee smoking health effects and less nicotine
           dependencethan those in the control schools who are given Triple A alone.

        2. adolescents with asthma in intervention schools who are given Triple A program plus ASP
           will show less asthma symptoms and better control than those in the control schools who
           are given Triple A alone.

        3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide
           (CO) in their breath than those who are not active or passive smokers.

        4. there is a positive correlation between self-report questions regarding student smoking
           status and levels of CO in their breath
    


Intervention name(s): TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge
Intervention type(s): Behavioral
Intervention description(s): Its is a school-based peer-led asthma and smoking prevention program that aims at improving asthma control and lowering nicotine dependence among smokers.
Other intervention name(s): Triple A in Jordan (TAJ)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Asthma; Tobacco; Waterpipe; Cigarettes; Adolescents; Peer education; Jordan
Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects
Condition: Heathly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Part 1 Randimization, Double blinded, Placebo controlled, Dose escalation(10mg, 20mg,
           40mg) of MIT-001 SC or IV single administration to evaluate safety, tolerability and PK
           in healthy adult.

        2. Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple
           administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in
           healthy adult.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple dose,
      dose escalation clinical trial in 40 healthy subjects. This study consists of part 1(single
      dose for group 1, 2, 3) and part 2(multiple dose for 7 days to group 1 and 2). Subjects will
      be assigned in 6:2 allocation to receive active or placebo treatments. The purpose of this
      clinical trial is to evaluate the safety, tolerability and pharmacokinetic properties of
      MIT-001 after single and multiple subcutaneous administration in healthy adults and to
      compare IV administration.
    

Intervention name(s): Single subcutaneous administration and Blood collection; Single subcutaneous administration and then IV injection.; MIT-001 20mg and 40mg_Multiple administration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single subcutaneous administration and Blood collection; Single subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled.; Multiple subcutaneous administration for 7 days and then blood collection
Other intervention name(s): MIT-001 10mg and 20mg; MIT-001 40mg; MIT-001 20mg and 40mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a
      single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in
      RSV-seronegative infants and children 6 to 24 months of age.

      This study was a companion study to CIR 313.
    

Detailed description: 
      Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
      respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study
      evaluated the safety, infectivity, and immunogenicity of a single dose of RSV
      D46/NS2/N/ΔM2-2-HindIII, a recombinant live-attenuated RSV vaccine, in RSV-seronegative
      infants and children 6 to 24 months of age.

      Participants were randomly assigned to receive a single dose of the D46/NS2/N/ΔM2-2-HindIII
      vaccine or placebo (administered as nose drops) at study entry (Day 0).

      Participants could be enrolled in the study outside of RSV season (between April 1 and
      October 14 for most sites or-for sites with local RSV seasons that start earlier-as specified
      on a site-by-site basis in the Manual Of Procedures). All participants remained on study
      until they completed the post-RSV season visit between April 1 and April 30 in the calendar
      year following enrollment. Participants' total study duration was between 6 and 13 months,
      depending on when they enrolled in the study. Participants attended several study visits
      throughout the study, which included physical examinations, blood collection, and nasal
      washes. Participants' parents or guardians were contacted by study staff at various times
      during the study to monitor participants' health.
    

Intervention name(s): D46/NS2/N/ΔM2-2-HindIII; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops; Isotonic diluent; administered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
Condition: Roux en Y Gastric Bypass Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to evaluate how the body absorbs and processes the medication
      sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric
      bypass surgery. Participants will be asked to take part in this study at three time points:
      1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve
      months following surgery. This study will enroll approximately 30 participants.
    


Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Single dose sertraline 100 mg, tablet and solution
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Gastric Bypass; Bariatric Surgery; Sertraline; Zoloft; Pharmacokinetic
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
Condition: Alcoholic Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Observational

Summary: 
      This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram
      in subject who participated in and completed the Livercellgram Phase 2 trials (refer to
      ClinicalTrials.gov.Identifier: NCT01875081).
    

Detailed description: 
      This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram
      in subject who participated in and completed the Livercellgram Phase 2 trials (refer to
      ClinicalTrials.gov.Identifier: NCT01875081).

      This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic
      liver cirrhosis. Subjects who signed this follow-up observation informed consent form will
      participate in a safety assessment (tumor marker test, occurrence of adverse events and
      serious adverse events, clinical laboratory tests, vital sign, physical examinations.).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have completed the Livercellgram phase 2 study and can agree to participate in
        the long term observation study by oneself.
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment
      of major depressive disorder compared to placebo & to evaluate quality of sleep, overall
      quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and
      Seroquel XR refer to the same formulation. The SR designation was changed to XR after
      consultation with FDA.
    


Intervention name(s): Quetiapine Fumarate Sustained Release
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Seroquel SR™; Major Depressive Disorder