cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

Participants will be recruited for inclusion at a routine adjustment appointment prior to planned removal of the appliances. Following removal of the appliances, consenting participants will be randomly allocated to one of two groups by computer-generated random allocation. Allocation will be concealed from the treating clinician using of an opaque sealed envelope system. Standard stone model records will be available for all participants following removal of the appliances (T0).

Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3) months following removal of the braces. All participants will be instructed to wear standard clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by night-time wear for a further 6 months. A micro-electronic timer will be integrated within the upper Essix-type retainer. All participants will be given standard advice at each recall visit.

Participants in the intervention group will receive tailored electronic reminders in the form of a mobile application. The frequency and content of the reminders will be informed by qualitative interviews involving participants from an allied trial, and from posts related to orthodontic retainers shared on social media. Instructions on the necessary duration of retention, maintenance of retainers, departmental details, allied to advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear will be included. Also, information related the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Participants in the control group will not receive additional reminders. Treating clinicians will be kept blind to the study group.

All patients failing an appointment will be sent another. Those wishing to withdraw from the trial may do so at any point without affecting continuing care with records taken at the point of withdrawal from the study with data analysis on an intention to treat basis.

Thereafter, patient experiences with electronic reminders will be evaluated on a subset of participants using one-to-one interviews.

Details related to the intervention:

Participants in the intervention group will receive access to the 'My Retainers' mobile application via a unique identification code. The researcher will demonstrate the use of the mobile application with a brief description of its features. Participants in the control group will not have access to the mobile application.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12 to 21 years
* Planned for removable retention with Essix-type vacuum-formed retainers
* In the permanent dentition

Exclusion Criteria:

* Inability to access or peruse electronic mail
* Cleft lip and palate and other craniofacial anomalies
Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.

Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume \>1.5 ml/kg) during the preoperative period in longstanding diabetic patients.

Study population :

* -Longstanding diabetic patients (group D)
* -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.

Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.

Second set of analysis will be finding correlation between US findings and suction volume in two groups.

Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.

Sample Size ; was calculated as 48 patients (24) in each group.


Eligibility Criteria:
Inclusion Criteria:

* Ages from 40 to 60 years old.
* American Society of Anesthiologist (ASA) II.
* Diabetic patients with longstanding duration(more than 6 years).

Exclusion Criteria:

* Age \<40,\>60 years .
* Pregnant female
* Obese patients (BMI ≤40)
* Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.
* Diabetic patients less than 6 years.
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys

Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.

We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.

Eligibility Criteria:
Inclusion Criteria:

* receipt of 3 doses of QHPV vaccine
* participated in primary immunogenicity study
* consent/assent with parental consent for participants age \<18 years
* willing to continue extended follow up for 36 months

Exclusion Criteria:

* decline consent
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.

Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.

Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
* Life expectancy of at least three (3) months after the start of administration of the investigational drug.
* Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.
* Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and \>=10 mm.
* Patient received at least 6 months EGFR-TKI and show tumor progress
* Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
* Patient signed consent form and adherence and geographic location are liable to follow up

Exclusion Criteria:

* CNS metastasis
* Active infection
* Bleeding tendency or blood coagulation dysfunction
* History of neurological or psychiatric disorders, including epilepsy, or dementia
* Pregnancy or breast-feeding women
* Organ transplant long-term use of immunosuppressive drugs
* Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
* Use other targeted drugs during the research
* Other conditions may not allowed to join in this study according to the researcher's judgment
The Effects of Anesthetics on Brain Network Connectivity in Patients With Supratentorial Glioma

Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. With the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. Therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as unilateral supratentorial glioma by MRI
* Selective operation
* Age over 18 years old
* ASA I-II
* Right handedness

Exclusion Criteria:

* History of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs
* History of intracranial surgery
* Drug and/or alcohol abuse
* History of dementia or mental illness
* Pregnant or lactating women
* Contraindications for MRI
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block
* Severe hepatic or renal dysfunction
Owlet Smart Sock 3 Accuracy on Infants

The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.

This prospective observational study compared the HR and SpO2 measurements of the OSS3 (Owlet, Utah, USA) with the Masimo SET® (Masimo Corporation, California, USA) in infants admitted to the University of Utah NICU. The inclusion criteria were infants who weighed 1.7-2.5 kg at the time of monitoring and were medically stable to tolerate routine care. The exclusion criteria were: infants with significant anomalies, congenital deformities, or medical instability. Infants with an intravenous catheter (IV) and skin lesions on either foot were excluded from the study. The wireless device being tested was the OSS3. The gold standard for validating the pulse oximeter's accuracy is arterial blood oxygen saturation (SaO 2 ) at the pulse oximeter sensor site. \[6\] However, obtaining SaO2 is an invasive arterial blood test for infants. To avoid this conflict, the OSS3 was tested against the reference FDA-approved wired pulse oximeter Masimo.

The study was approved by the University of Utah Institutional Review Board, and informed consent was obtained from parents. During the measurement, OSS3 and Masimo were placed on the infants with one device on each foot. Since the data obtained from the study devices can not be recorded in the hospital electronic medical record, the hospital wired pulse oximeter (Philips, Amsterdam, Netherlands) continued to be used on one of the infant's hands during the study period. OSS3 and Masimo were calibrated appropriately against the hospital wired pulse oximeter with matching HR and SpO 2 readings. Pulse oximetry data were collected simultaneously for 60 minutes on the quiet infants. The two devices (OSS3 and Masimo) continuously recorded HR (beats per minute, bpm) and SpO2 (%) every two seconds. Data from the 2 devices were uploaded and compared according to their time stamped measurements. The paired data agreement was compared using Pearson's correlation coefficient (r), Bland-Altman, Average Root Mean Square (ARMS), and Prevalence and Bias Adjusted Kappa (PABAK) analyses.

Eligibility Criteria:
Inclusion Criteria:

* Infant who weigh between 1.7kg and 2.3kg
* Infant who is admitted to U of U NICU

Exclusion Criteria:

* Infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of device
* Infant who has unstable vital signs or clinical condition
* No parental consent
* Inability to achieve adequate fit with the OSS3
FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas

Subjects with known or suspected primary soft tissue sarcoma of the extremities may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age. Most participants will be receiving care at the clinical practices of the University of Pennsylvania Health System.

Positron emission tomography (PET/CT) imaging will be used to evaluate soft tissue sarcoma hypoxia using an investigational radiotracer, 18F-FMISO Subjects will also undergo an 18F-FDG PET/CT scan close to the time of their initial hypoxia PET/CT to compare in vivo measures of hypoxia to 18F-FDG uptake. The FDG PET/CT may be performed as part of standard clinical care or as a research scan. Both PET/CT scans will occur prior to starting new therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Known or suspected soft tissue sarcoma seen on at least one type of standard imaging (e.g. CT, ultrasound, MRI, or 18F-FDG PET/CT)
2. At least 18 years of age
3. Subjects with local disease or advanced/metastatic disease will be eligible
4. Willing to consent to use of tissue from biopsy or surgery for the purposes of this study
5. Participants must be informed of the investigational nature of this study and be willing and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Females who are pregnant at the time of screening will not be eligible for this study; a urine pregnancy test will be performed at screening in women of child-bearing potential
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Periosteal Chondrosarcoma: a Single Institution Experience

Periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones.

Periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the fourth decade (2).

It has a reported incidence of local recurrences of 13-28% and a low metastatic potential, with distant recurrences occurring mostly in lungs (3).

Contrary to conventional chondrosarcomas, grading of periosteal chondrosarcomas seems not to predict prognosis. IDH1 and IDH2 mutations, characteristics of central chondromas/chondrosarcomas, have been also found in a subset of periosteal chondrosarcomas (1, 4).

These observations are based on the results from smaller series of cases (1, 5, 6), although the impact of histopathological characteristics on survival, local recurrence and metastases should be assessed in larger series of cases.

The aim of the present study is to review all the cases with a diagnosis of primary periosteal chondrosarcoma treated at the Rizzoli Institute from 1900 up to 31 December 2019, retrospectively.

The study will exam all the clinical, radiological, and histological features of this tumor with regard importance of medullary involvement, the IDH1/2 gene status, the types of treatment, the status of surgical margins, the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Dec 2019
* Diagnosis of peristeal chondrosarcoma
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

* Patients with histological diagnosis different from periosteal chondrosarcoma.
Dietary Fibre and Metabolic Benefits

The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans

The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* BMI\<30
* non smokers
* consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion Criteria:

* fasting blood glucose \>6.1 mmol/L
* known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Geriatric COVID-19 Serology

Coronaviruses are important human and animal pathogens. At the end of 2019, a new coronavirus was identified as the cause of a cluster of pneumonia cases in Wuhan, a city in China's Hubei province. It quickly spread, leading to an epidemic across China, followed by an increasing number of cases in other countries around the world. In February 2020, the World Health Organization designated the disease COVID-19, which stands for coronavirus disease 2019. The virus that causes COVID-19 is SARS-CoV-2.

The duration of protection during which a patient after infection and / or vaccination remains clinically protected and the evolution of their serology as well as their titre remains unknown


Eligibility Criteria:
Inclusion criteria:

* Age\> 75 years old
* Patient hospitalized or resident in the geriatrics center from July 1, 2020 to November 30, 2021 having presented with COVID or having benefited from a COVID vaccination.
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subject under guardianship, curatorship or safeguard of justice
Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed glioblastoma according to the 2021 World Health Organization classification
* interval of ≤4 weeks between pathological diagnosis and randomization
* aged 70 years or older
* gadolinium-enhanced MRI within 72 hours of surgery
* known o6-methylguanine-DNA-methyltransferase promoter methylation status
* Karnofsky performance score ≥60
* stable or decreasing dose of steroid (if necessary)
* no history of brain radiotherapy
* no history of any systemic chemotherapy
* adequate hematological, renal and hepatic functions for temozolomide
* able to start radiotherapy within 3 weeks from randomization

Exclusion Criteria:

* patients with spinal leptomeningeal carcinomatosis
* history of cancer other than the followings:
* carcinoma in situ of the cervix
* completely excised non-melanoma skin cancer
* cancers without any evidence of residual disease for 5 years or longer
* patients with serious active infection or other serious underlying medical conditions
* patients with psychological issues that cannot comply to the protocol
* patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
* patients who are currently participating in other clinical trials
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. They are of legal age (18) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.
  5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
  7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  8. They currently use soft contact lenses or have done so in the previous six months.
  9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

Exclusion Criteria:

* Subjects will not be eligible to take part in the study if:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breast-feeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.