cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Periodontitis in Sample of Egyptian Population

Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional study

The aim of this study is to assess the prevalence, severity, and extent of periodontitis through full-mouth examination of CAL, and its association withsociodemographic, behavioral and environmental risk factors, in anEgyptian sample will be recruited from diagnostic center at Faculty of Dentistry, Cairo University, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* - All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.

Exclusion criteria:

1. patients undergone periodontal therapy in the last 6 months.
2. patients with psychomotor dysfunction.
3. Patients less than 18 years old.
4. Edentulous patients
Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 18 years
* Diagnosis of ADHD
* A score of at least 3 (mildly ill) on the clinician administered Clinical Global Impressions-Severity (CGI-S)

Exclusion Criteria:

* Currently taking stimulant medications (within one week of first study visit). Patients will not be asked to discontinue any treatments for the purpose of this research study. Subjects will include treatment naïve patients and patients who were previously treated with stimulant medications, but are not currently treated, and meet study criteria.
* Having an adverse reaction to methylphenidate, or other stimulant medication
* Current psychiatric disorder, including bipolar I or II disorder, major depressive, disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome, or history of psychosis
* Patient is at risk for clinically significant deterioration due to study protocol, as assessed by primary medical investigator (Dr. Grant)
* Confirmed genetic disorder with cognitive and/or behavioral disturbances
* Active, unstable medical illness that may interfere with cognition or compromises safety of the patient
* History of head trauma with loss of consciousness or any evidence of functional impairment due to, and persisting after, head trauma
* Neurological disorder, mental retardation, intellectual or disability, or other non-ADHD cause of cognitive impairment
* Pregnant or breast-feeding women
* Having a contraindication to MRI, including a pacemaker, defibrillator or other medical implant, other metal objects, or claustrophobia, or for having braces or other metal in the head region (likely to create an artifact on the MRI scans).
* Currently smoking or using controlled or illicit substances, including alcohol.
Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM

This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.

Data about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.

Patients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.

At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.

Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.

Expectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18years
* Good systemic health, with ASA classification \<= 2
* Columbus Bridge ProtocolTM reinstation from at least six months

Exclusion Criteria:

* Heavy smokers (\>= 10 cigarettes per day)
* Pregnancy or breastfeeding
* Autoimmune diseases with or without oral involvement
* Biological complications on at least one of the dental implants
* Perimplantits diagnosis, defined according to Lindhe et al's criteria \[5\]
* Radicular bone \<4mm, evaluated by means of RX
* Use of gingival overgrowth inducing drugs
* Cognitive or motor impairments
* Full-arch reinstations performed in other structures
* Respiratory issues
* Infective diseases
Total Intravenous Anesthesia and Inhalation Anesthesia

The aim of us is to define the incidence of postoperative complications and recovery time in view of two anesthesia procedures.

During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative complications and recovery period were determined as tachycardia, bradycardia, hypertension, hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures were compared in terms of these postoperative complications and recovery time.

Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages, 583 patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA methods between 1st Jan, 2016 and 1st Jan, 2017. The ones who had insufficient data in their files and who were conscious / superficial sedation patients were excluded from the study. The patients were allocated to two groups as TIVA and IA. The total intravenous anesthesia group was named "Group TIVA" , and the volatile anesthesia group was named "Group IA".

All the patients were opened vascular access after being taken into the operation room and were given anesthesia induction with 1 µg/kg fentanyl, 2 mg/kg propofol and 0,8 mg/kg rocuronium. The patients in Group IA were given 1-2% volume sevoflurane in 50% oxygen and 50% nitrous oxide during maintenance of anesthesia, while the patients in group TIVA were applied 4-10 mg/kg/h propofol and 0.05-0.1 µg/kg fentanyl IV infusion with 50% oxygen and 50% air. While being woken up, each patient was given 0.3 mg/kg tenoxicam for analgesia and 0.2 mg/kg metoclopramide for nausea-vomiting prophylaxis in a routine way. Each patient was taken into recovery room after extubation and pulse rate, non-invasive blood pressure (NIBP) and oxygen saturation monitorization were done. Postoperative complication and vital finding tracks of each patient were done as usual and were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA procedures between 1st Jan, 2016 and 1st Jan, 2017.

Exclusion Criteria:

* The ones who had insufficient data in their files and who were conscious/superficial sedation patients were excluded from the study.
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: Two hundred and forty women with elective laparoscopic hysterectomy were randomly divided into four groups: the control group (group C, n=60) received an equal volume of saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D, n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60) received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion). Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
* Aged 40-60 years
* Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

* History of allergy to local anesthetics
* BMI\>30
* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative opioids medication and psychiatric
* preoperative bradycardia
* preoperative atrioventricular block
* Subjects who experienced severe hypotension (mean arterial pressure \[MAP\] \<60 mmHg) or bradycardia (heart rate \[HR\] \<40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a body mass index (BMI: weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 32.0 kilogram per square meter (kg/m\^2), extremes included, and a body weight not less than 50.0 kg
* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
* Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Female participant, except if postmenopausal, must have a negative highly sensitive serum beta human chorionic gonadotropin at screening
* Participant must be non-smoker for at least 6 months prior to the first study drug administration

Exclusion Criteria:

* Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 90 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula or below 90 mL/min/1.73 square meter (m\^2) for estimated glomerular filtration rate \[eGFR\] according to the Chronic Kidney Disease Epidemiology Collaboration equation \[CKD-EPI\]), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the particiapant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV), simeprevir (SMV) or dabigatran etexilate mesylate or their excipients
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation

The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* The patient is an ambulatory cardiology patient.
* The patient is at least 18 years old.
* The patient is sinus or in atrial fibrillation.
* The patient is able to perform the study procedures together with the study assistant.

Exclusion Criteria:

* Patients with a pacemaker
* Inclusion in another clinical trial that may influence the results of this trial
* The patient is unable to comprehend the informed consent.
A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals

Protocol directed weaning has been shown to reduce the duration of mechanical ventilation for patients admitted to the intensive care unit (ICU) of tertiary centres. However, this benefit has not previously been studied in a community hospital setting. We therefore sought to evaluate the impact of an evidence-based weaning guideline on the outcomes for patients receiving mechanical ventilation in the ICUs of community hospitals in a cluster randomized controlled trial involving 11 community hospitals.


Eligibility Criteria:
Inclusion Criteria:

* patients ventilated for more than 24 hours

Exclusion Criteria:

* patients less than 16 years of age patients who receive only non-invasive ventilation patients chronically ventilated at time of ICU admission patients who will not be candidates for weaning from ventilation at time of admission If withdrawl of life support is imminent at the point the patient has been ventilated for 24 hours
Evaluation of Product Effectiveness of the Intervention for Patients With Knee Osteoarthritis

Osteoarthritis of the knee is a common, chronic joint pathology that causes participants to suffer from pain, dysfunction, and reduced quality of life. The goal is to improve the quality of life and rehabilitation of patients by making rehabilitation exercises electronic and the system can be personalized to their specific conditions.

The focus of this study was on exercise interventions, and an interactive software was designed that combines repetitive motion and real-time feedback mechanisms. The software provides a series of rehabilitation movements that are specific to the characteristics of osteoarthritis of the knee in older adults, aiming to help participants gradually improve joint range of motion and muscle strength through exercise. The real-time feedback mechanism, on the other hand, monitors the participants' exercise status in real time through wearable devices, providing intuitive feedback to the participants to ensure that they perform the rehabilitation movements correctly, thus ensuring the scientificity and safety of the exercise.

In this study, investigators designed an exercise assessment and exercise intervention system for patients with knee osteoarthritis. In the exercise assessment part, the study combines several tools. First, the WOMAC scale was used to systematically assess patients' joint pain, stiffness, and dyskinesia. Second, physical function tests are used to assess the patient's overall exercise capacity, including indicators such as the number of sit-ups and rises. In addition, a wearable device was designed in this paper for real-time collection of knee angle information.


Eligibility Criteria:
Inclusion Criteria:

1. Those who meet the diagnostic criteria for osteoarthritis and are diagnosed with osteoarthritis of the knee;
2. Age greater than grade 18 years old;
3. Good communication and comprehension skills, able to understand the questionnaire clearly;
4. Informed consent and willingness to participate in the study.

Exclusion Criteria:

1. Patients with knee pain caused by other diseases;
2. Patients with severe knee pain and discomfort;
3. Patients with severe organic lesions of vital organs such as heart, brain and kidney;
4. Patients who have been treated with knee replacement.
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis from Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer

Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined.

The aim of this Study is to compare the effects of intra-pemetrexed Plus third-generation small molecule TKI drugs (e.g. 'osimertinib') versus third-generation small molecule TKI drugs alone in leptomeningeal metastasis from EGFR mutation positive NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 75 years.
2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del).
3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO/EANO guidelines.
4. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
5. No history of severe nervous system disease.
6. No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. Patients with poor compliance or other reasons that were unsuitable for this study.
Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Severe sepsis or septic shock for at least 24 hours
* Documented or suspected infection
* Sepsis-induced immunosuppression
* Men and women ≥ 18 years old

Exclusion Criteria:

* Autoimmune disease
* Organ transplant or bone marrow transplant
* Cancer treated in the past 6 months
* Hepatitis B virus (HBV) Infection
* Human Immunodeficiency Virus (HIV) infection and not on therapy prior to this episode of sepsis
* Hepatitis C virus (HCV) infection and still has virus (not cured)
HIV-HBV Co-Infection and Liver Disease

Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of HIV-infected individuals in developed countries are chronically infected with HBV. HIV infection impacts on the natural progression of HBV infection, increasing levels of HBV replication and the risk of liver-associated mortality. Liver diseases associated with HBV are affected by the antiviral drugs used for HIV infection (toxic side effects), the current immune function in the patient, by improvements in the immune system brought about by control of the HIV infection, and by the development of resistance to the antiviral agents used for both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART) for their HIV infection.

This study will recruit patients who are co-infected with HIV and HBV, and are currently taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP clinics who are referred to the Alfred Hospital.

The aim of the study is to investigate chronic hepatitis B and its impact on the progression of liver disease in HIV-infected persons receiving HAART.

This will be achieved by 6 monthly assessment with medical history, physical examination, bloods for markers of liver disease and hepatitis B activity and completion of questionnaires to measure adherence and alcohol use.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* HIV positive
* 2 positive Hepatitis B surface antigen results 6 months apart
* provision of informed consent

Exclusion Criteria:

* unable to provide informed consent