bioihbjkbjnl/mcl2 huggingface dataset:
Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items
      assessing motor functional abilities in a person with neuromuscular disease.

      By exploring the potential of digital technologies applied to MFM, for each item completion
      we want to create digital animations containing different playful and informative scenarios.
      This digital evolution aims to standardize assessment on the therapist's side, but also to
      improve acceptance of scale and patient participation.

      Despite the modification of the MFM completion by digital animation, the study hypothesis is
      that the metrological qualities of the scale are retained.

      Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale
      before carrying out a validation study of the total MFM-Play.
    


Intervention name(s): MFM-Play
Intervention type(s): Other
Intervention description(s): Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will involve children with a neuromuscular disease, aged 6 to 11 years old
      
Keywords: Neuromuscular Diseases
Molar Intrusion Using High Pull Headgear
Condition: Anterior Openbite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      This prospective clinical study will evaluate the effect of high pull headgear for molar
      intrusion, compared with the control group, in adolescent patients with open bite
      malocclusion.

      The study sample will consist of 24 patients with anterior open bite divided equally in two
      groups. The sample will be collected consecutively from patients attending the Orthodontic
      Department at Damascus university.

      A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be
      applied for all patients. High pull headgears will be used in the first group, while, in the
      second (control) group, Open Bite Appliances will be used only.

      The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be
      assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post-
      treatment changes for each group will be evaluated.
    

Detailed description: 
      Open bite malocclusion is considered one of the most difficult malocclusion to correct in
      orthodontic treatment because it appears as a result of different etiological factors such as
      genetic, dental, skeletal, functional, soft tissue, and habits that play roles in its
      development. Different treatment modalities used for the treatment of an anterior open bite.
      Multiloop edgewise archwires, miniscrews, high-pull headgear, and bite blocks have been used
      for anterior open bite patients, most open bite patients characterized by increased facial
      height, class II skeletal pattern, and vertical excess in maxillary posterior teeth.

      Functional appliances, magnets, posterior bite blocks, and high pull headgear are used for
      posterior teeth intrusion. It is possible to generate intrusive force by using high pull
      headgear. Furthermore, direction of force can be changed according to the center of
      resistance of the dental units to achieve a better tooth movement control. The intrusion of
      posterior teeth will lead to decreased lower facial height by a counterclockwise rotation of
      the mandible; and improve class II skeletal relationship.

      This study was the first clinical trial, that compare the effect of high pull headgear for
      molar intrusion with the control group in adolescent patients.
    

Intervention name(s): high pull headgear + OBA; OBA (control group)
Intervention type(s): Device; Device
Intervention description(s): a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.; A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skeletal openbite; Molar intrusion; high pull headgear
SHARE Model Communication Course and Do-not-resuscitate Signing
Condition: Trauma Injury
Study type: Observational

Summary: 
      This study aimed to investigate the effect of attending a SHARE model communication course by
      emergency physicians on patient notification and signing of do-not-resuscitate (DNR) orders
      for critical patients in the emergency room.
    

Detailed description: 
      An observation form designed based on the SHARE model was completed by two observers who
      noted the communication process between physicians and patients and family members during
      patient notification and signing a DNR order. To assess the influence of physicians attending
      a SHARE model course on the signing of DNR orders, a propensity score-matched population was
      created to reduce the potential selection bias of patients and family members.
    

Intervention name(s): Patients; Physician
Intervention type(s): Other; Other
Intervention description(s): Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a do-not-resuscitate.; The current emergency medical department departments within the preparation of the attending physician
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The research subjects consisted of attending physicians, who were willing to inform consent
        forms, in the emergency department between May 2017 and April 2018.
Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and
      Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep
      infiltrating endometriosis, their levels in organ-specific involvement, their relationship
      with symptoms, and the changes of these markers in the postoperative period will be
      evaluated.
    

Detailed description: 
      Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory
      cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all
      patients before and three months after the operation.
    

Intervention name(s): endometriosis surgery; other benign condition surgeries
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopy was performed in the follicular phase of the woman's menstrual cycle and all recognizable endometriotic lesions were treated by bipolar coagulation, resection of endometriotic nodules and ovarian cystectomy.; ovarian cystectomy, bilateral tubal ligation, myomectomy etc.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic
        pelvic pain or suspected malignancy
Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, ADME study with single oral administration of [14C]-DZD9008 in
      healthy subjects.
    

Detailed description: 
      Phase 1 study to evaluate the excretion of DZD9008 radioactive dose, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of
      [14C]-DZD9008 in healthy male subjects. The purpose of this study is to investigate ADME
      properties of DZD9008 by analyzing blood, urine and feces samples collected during the study
    

Intervention name(s): [14C]-DZD9008
Intervention type(s): Drug
Intervention description(s): Each subject will receive a total of 100 mg DZD9008 oral suspension containing approximately 1 μCi of [14C] as a single administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design
Condition: Skeletal Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This study evaluates the cephalometric effects of a clear mandibular advancement appliance
      for the treatment of skeletal class II growing patients suffering from mandibular deficiency.
    

Detailed description: 
      A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of
      1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of
      acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the
      patient bites into occlusion, he/she has to advance the mandible to bring the two parts of
      the appliance together. Lateral cephalometric radiographs were obtained pre and
      post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.
    

Intervention name(s): Clear Mandibular Advancement Appliance
Intervention type(s): Device
Intervention description(s): Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional appliance; skeletal class II; mandibular deficiency; twin-block; Growing patients; Clear appliance; Aligner
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention
      of dengue fever.
    

Detailed description: 
      DENV infections can cause self-limited but incapacitating acute illness lasting four to seven
      days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain
      behind the eyes, and a rash. DENV infection can be complicated by the development of
      hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a
      bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but
      rarely in adults. People, particularly children, living in hyper-endemic areas who have
      antibodies from an earlier dengue infection with one serotype are at increased risk for DHF
      if subsequently infected by another dengue virus serotype.

      Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito
      control has failed to prevent dengue transmission; therefore, prevention of dengue through
      vaccination is an important objective of the World Health Organization (WHO) and many
      national governments, including the United States.
    

Intervention name(s): DENV-1 PIV, 2.5 µg; DENV-1 PIV, 5 µg
Intervention type(s): Biological; Biological
Intervention description(s): 2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days); 5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dengue; dengue fever; monovalent dengue vaccine
Mastery Learning Versus Time-based Education: Skill Acquisition and Retention of Basic Life Support in Laypeople
Condition: Basic Life Support; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Background:

      In cardiac arrest survival rates dramatically increase when bystanders are present and
      initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill
      retention after a traditional time-based BLS course for laypeople remains suboptimal. In
      contrast, a mastery learning-based educational approach was shown to be efficacious and might
      be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a
      mastery learning-based BLS course on skills retention of BLS in laypeople.

      Methods:

      Forty laypeople without previous BLS experiences will be randomized into the traditional
      time-based BLS course group (Control - TB group) or mastery learning-based group
      (Intervention - ML group).

      Both groups will receive BLS training consisting of 6 successive stations including diagnosis
      of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED
      use. In the ML group, subjects will deliberately practice and receive feedback at each
      station until a pre-set target level is reached. Subjects will be allowed to proceed to the
      next station only when they achieve the required target level of performance. In contrast,
      participants of the TB group will be taught the same 6 stations in two hours, according to
      standard American Heart Association BLS criteria. All subjects will have an assessment of
      knowledge and skills immediately after teaching (immediate post-test) and at four months
      (retention post-test).

      Implications:

      Previous research has shown that mastery learning-based education improves learners'
      procedural skill performance. The investigators study will determine the impact of a mastery
      learning-based BLS course on skill retention in laypeople.
    


Intervention name(s): Mastery based learning; Time based learning
Intervention type(s): Other; Other
Intervention description(s): Participants are allowed to follow the course content at their own speed; Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
Condition: Esophageal Cancer Stage III
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when
      given together with Cetuximab and radiation therapy and radiation therapy to see how they
      work in treating patients with stage III esophageal cancer.
    

Detailed description: 
      Cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and
      spread Cetuximab may also make tumor cells more sensitive to radiation therapy. Drug used in
      chemotherapy such as oxaliplatin leucovorin and Fluorouracil work in different way to stop
      the growth of tumor cells either by killing the cells or by stopping them form dividing.
      Radiation therapy uses high energy X rays to kill tumor cells. Giving cetuximab could improve
      the efficacy of chemotherapy and radiation therapy and may make the tumor smaller This phase
      II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given
      together with Cetuximab and radiation therapy and radiation therapy to see how they work in
      treating patients with stage III esophageal cancer.
    

Intervention name(s): radiochemotherapy,combination Cetuximab-FOLFOX
Intervention type(s): Drug
Intervention description(s): objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX
Other intervention name(s): objective response rate,combination Cetuximab-FOLFOX
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal neoplasms; Cetuximab; Oxaliplatin; Fluorouracil; radiotherapy
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare
      ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart
      NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded
      to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human
      insulin, will be used as an open-label comparator.
    


Intervention name(s): AT278; NovoRapid; Humulin R 500 UNT/ML Injectable Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Concentrated rapid acting insulin aspart; Rapid-acting insulin aspart; Regular human insulin
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Influence of Juggling on Selected Cognitive Functions and Postural Stability Variables.
Condition: Aging; Cognitive Change
Study type: Interventional

Summary: 
      The purpose of the study is to verify the effect of juggling exercises on selected cognitive
      functions (reaction time, attention) and postural stability variabilities (based on center of
      pressure signal) in two different protocols: [1] a randomised crossover study design, [2] a
      randomised repeated measurement design.
    

Detailed description: 
      Juggling is a form of exercise, that can engage humans, both cognitively and physically. One
      of the positive aspects of taking up this form of exercise is the growing evidence indicating
      that juggling improves the well-being of exercisers. Most importantly, the juggling
      intervention causes an increase in the volume of the gray matter and white matter in the
      human brain, and thus shows potential for neuroplasticity. In addition, unhealthy aging is
      observed nowadays, which causes both physical and cognitive decline in daily functioning,
      further interfering with the elderly's ability to perform daily activities. Therefore, the
      addition of juggling exercises may have a positive effect on the changes that occur with
      aging.

      However, currently there are hardly any data on the juggling effect on cognitive functions
      and on postural stability. Therefore, the study aims to examine the effect of juggling
      exercises on selected cognitive functions and postural stability variables in two different
      randomised trials.
    

Intervention name(s): Addition of juggling
Intervention type(s): Other
Intervention description(s): Participants will not change ther daily activities, and participate in juggling intervention lasted 4 weeks and consisted of 12 meetings (3 trainings per week), each lasting 45 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive functions; postural stability; proprioception; elderly
A Safety and PK Study of EC-18 in Healthy Subjects
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled study of the safety,
      tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no
      dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased
      to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort
      of subjects will not occur until a review of the safety and tolerability data from the
      previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor
      together confirm the safety and tolerability of EC-18 given at that dose level.
    

Intervention name(s): EC-18; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively.; Placebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively.
Other intervention name(s): EC-18 Softgel capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Healthy Volunteers; Phase I; Placebo controlled; Single Ascending Dose; PK; Oral administration; Softgel
A New Approach of Neostigmine in Unavoidable Post Operative Ileus
Condition: Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative ileus (POI) in the absence of any mechanical obstruction remains a commonly
      encountered clinical problem.So, this study aimed to show the effective way to decrease the
      rate of postoperative Ileus (POI).
    

Detailed description: 
      We honestly declare that, the use of parasympathomimetic agents such as neostigmine is not
      without risk. Patients with underlying bradyarrhythmias or those receiving β-adrenergic
      antagonists may be more susceptible to neostigmine-induced bradycardia. Similarly,
      neostigmine increases airway secretions and bronchial reactivity, which may exacerbate active
      bronchospasm. Recently, a new class of drugs-peripherally acting mu-opioid receptor
      antagonists-may help enhance multimodal management of POI. Although, the cost benefit of the
      new class of drugs is debated. It has been suggested that the individual components of
      multimodal protocols-for example, laparoscopy-may reduce certain post surgical morbidities
      (including POI) But do not by them prevent POI. Therefore, combinations of strategies with
      demonstrated effectiveness-early feeding , epidural analgesia, laparoscopic surgery, and use
      of peripherally acting mu-opioid-receptor antagonists-may help transform the reactive
      approach to POI into a proactive multimodal paradigm that effectively targets the diverse
      etiologic factors leading to this common clinical problem.
    

Intervention name(s): Neostigmine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours; Saline Placebo
Other intervention name(s): Neostigmine Group; Placebo Group
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Neostigmine, Post Operative, Ileus