louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00796224: Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Official title: A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
Keywords: azithromycin, pharmacokinetics, pediatrics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.


Eligibility criteria: Inclusion Criteria:

* Subjects age 6 months to \< 12 years.
* Have clinical signs/symptoms of acute otitis media in at least one ear.
* Parent(s)/legal guardian(s) provide written informed consent.

Exclusion Criteria:

* Clinical significant other disease.
* Recent use of investigational drugs, prescription or nonprescription drugs.

Primary outcomes:
measure: Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
timeFrame: Predose/0 to 72 Hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)
timeFrame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Azithromycin
timeFrame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin
timeFrame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
measure: Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)
timeFrame: 1,2,3,4,8,24,48,72 hours postdose
measure: Number of Participants With a Clinical Response
timeFrame: Days 7,8,9 or 10
measure: Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Baseline up to 28 days
Other outcomes:
Locations:
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01469624: Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Official title: Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nephropathy
Keywords: Contrast Induced Nephropathy
Pentoxifylline
PCI
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general population and up to 50% in high risk population. High risk patients include those with chronic kidney disease (GFR\<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure, anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a dimethylxanthine, can also protect renal cells from CIN. It has been observed that pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective randomized trial will be conducted on patients undergoing PCI.


Eligibility criteria: Inclusion Criteria:

* All eligible consecutive patients who are admitted to the angiography center of university hospitals for PCI since April 2011 will be enrolled to enter the study.

Exclusion Criteria:

* Serum creatinine above 1.5 mg/dl
* Frank bleeding tendency
* Those previously on pentoxifylline

Primary outcomes:
measure: Serum Creatinine
timeFrame: 48 hours after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: University Hospitals
state: Fars
Study officials:
affiliation: Shiraz Unievrsity of Medical Sciences, Shiraz, Iran
name: Jamshid Roozbeh, Nephrologist
role: STUDY_CHAIR
References:
Clinical trial NCT03608124: Behavior Management Techniques Adopted by Pediatric Dentists in Egypt
Official title: Behavior Management Techniques Adopted by Pediatric Dentists in Egypt: Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric dentists either govermental university staff in Cairo or Phd students in Cairo govermental universities

Brief summary: A cross-sectional study to investigate behavior management techniques used by pediatric dentists in Egypt according to AAPD clinical guidelines.

Detailed description: Observational study to investigate behavior management techniques adopted by pediatric dentists in Egypts for different patients ages, by distributing questionnaires in Egyptian govermental universities consisting of participant's demographic information, behavior management techniques used for each age group and their opinion or comments.

Eligibility criteria: Inclusion Criteria:

* pediatric dentist and holding at least a master degree

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Behavior management
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
state: Manial
Study officials:
affiliation: Centre of evidence based dentistry
name: Hassan A. Ahmed, ahmed
role: STUDY_DIRECTOR
References:
Clinical trial NCT07003724: Patient's Knowledge About AI in Dentistry
Official title: Patients' Awareness, Attitude and Trust in the Use of Artificial Intelligence in Dentistry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patients Attitude on AI in Dentistry
Trust AI
Concerns on AI
Keywords: Artificial intelligence in dentistry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 382
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seeking dental treatment either in Public Hospitals, Universities hospitals ,or Patients in Private dental clinics

Brief summary: It's a cross sectional study , A validated questionnaire to knows patients attitude , opinion towards using AI in dentistry used before By Ayad et al on a different population.

Detailed description: The purpose of this study is to investigate public awareness, perceptions and attitudes about the application of AI in dentistry and also patients' worries as many ethical concerns may be in people's mind as algorithim unfairness, data privacy, and the possibility of employment displacement in the dental industry, by distributing a survey to a wide range of dental patients from public hospitals and private clinics , this study aims to know patient's opinions regarding the possible advantages , disadvantages , ethical concerns , and patients thoughts on using AI .

Eligibility criteria: Inclusion Criteria:

* Age range between 25 to 50
* Females and males
* Low, middle and high socioeconomic
* Egyptian patients
* acceptable educational level
* patients in dental waiting areas

Exclusion Criteria:

* Anyone above or below the age range mentioned (25-50 years )
* Special needs patients
* Non-Egyptian patients
* Non-Educated patients
* very low socio-economic class
* patients in other waiting areas rather than dental ones

Primary outcomes:
measure: Assessment of Public Awareness via Questionnaire
timeFrame: 6 Months
Secondary outcomes:
measure: Evaluation of Public Perception Via Questionnaire
timeFrame: 6 Months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00035724: Monitoring Community Trends in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Failure, Congestive
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-06
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its therapeutic management, and changes over time in the hospital and long-term survival of patients with heart failure.

Detailed description: BACKGROUND:

Heart failure is estimated to contribute to nearly 1 million hospitalizations and approximately 250,000 deaths annually in the U.S. The number of new cases of heart failure in the U.S. is estimated to exceed 400,000 annually. Though reliable estimates of the magnitude, incidence, and mortality of heart failure remain sorely lacking, heart failure is associated with a grim prognosis. However, little recent data exist, particularly from a community-wide perspective, to determine whether the incidence or survival associated with heart failure, and the management of this clinical syndrome, has changed over time.

DESIGN NARRATIVE:

The study uses residents of the Worcester (MA) metropolitan area (1990 census 437,000) and examines changes over time in these and additional outcomes for patients with validated heart failure during 1995 and 2000. Complimenting the hospital surveillance of heart failure, newly diagnosed cases of heart failure occurring in members of the largest HMO in Central Massachusetts during 1995 and 2000 will be identified and monitored over time. To accomplish the study objectives, the medical records of residents of the Worcester metropolitan area hospitalized with a discharge diagnosis of heart failure and related diagnostic rubrics will be individually reviewed and validated according to pre-established diagnostic criteria. The use of traditional criteria for heart failure as well as development of new criteria for the epidemiological study of heart failure will be an important focus of this observational study. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term survival of discharged hospital patients through the year 2005.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts, Worcester
name: Robert Goldberg
References:
citation: Goldberg RJ, Spencer FA, Farmer C, Meyer TE, Pezzella S. Incidence and hospital death rates associated with heart failure: a community-wide perspective. Am J Med. 2005 Jul;118(7):728-34. doi: 10.1016/j.amjmed.2005.04.013.
citation: Goldberg RJ, Glatfelter K, Burbank-Schmidt E, Farmer C, Spencer FA, Meyer T. Trends in mortality attributed to heart failure in Worcester, Massachusetts, 1992 to 2001. Am J Cardiol. 2005 Jun 1;95(11):1324-8. doi: 10.1016/j.amjcard.2005.01.076.
Clinical trial NCT04197024: Assessment of Exercise Capacity in Virtual Reality
Official title: Evaluation of the Impact of Immersive Virtual Reality During the Submaximal Cardiorespiratory Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: virtual reality
COPD
exercise capacity
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each individual will be evaluated by a traditional test and a virtual reality test.
Primary purpose: DIAGNOSTIC

Brief summary: The 20th century brought a dynamic development of new technologies, including virtual reality (VR). VR is an artificial image generated by IT technologies. It is most often associated with entertainment, but has a much wider application in other fields. The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer.

Detailed description: Scientists suggests that there are four types of virtual reality: immersive virtual reality, desktop virtual reality (i.e., low-cost homebrew virtual reality), projection virtual reality, and simulation virtual reality. The sense of presence or immersion is a critical feature distinguishing virtual reality from other types of computer applications. It seems interesting whether immersion in virtual reality can influence the assessment of exercise capacity. The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer. It is assumed that an exercise capacity test on a cycloergometer will be performed in a traditional form and in a virtual reality.

Eligibility criteria: Inclusion Criteria:

1. Female and male, age: 20-25 years

Exclusion Criteria:

1. diagnosed internal diseases
2. diseases and injuries of the locomotors system impairing the function of transport 3 Cognitive disorders preventing contact with the patient, Mini-Mental State Examination \< 24 points.

Primary outcomes:
measure: Exercise Testing- cycle ergometer
timeFrame: First or second day of the assessment - the traditional exercise test
measure: HRV
timeFrame: First or second day of the assessment - the exercise test in VR
Secondary outcomes:
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology
Study officials:
affiliation: The Opole University of Technology
name: Sebastian Rutkowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutkowski S, Szary P, Sacha J, Casaburi R. Immersive Virtual Reality Influences Physiologic Responses to Submaximal Exercise: A Randomized, Crossover Trial. Front Physiol. 2021 Sep 30;12:702266. doi: 10.3389/fphys.2021.702266. eCollection 2021.
Clinical trial NCT05161624: Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning
Official title: Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Tumor
Keywords: liver tumor
ablation
path planning
artificial intelligence
accuracy evaluation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver tumor patient with goal for non-evidence disease

Brief summary: CT-guided microwave ablation is one of the important treatment methods for primary or metastatic liver tumors. It has the advantages of minimally invasive, safe, and economical. For liver tumors with a diameter of less than 3 cm, it can be comparable to surgical resection. However, different doctors have different levels of experience, leading to a high risk of residues after ablation and even complications. The key is to fail to plan the needle placement reasonably. The past research on path planning was mostly conducted by the engineering team, so that the actual clinical needs were not considered comprehensively, and the sample size of verified cases was small, which limited the application of existing models in the clinical application. In previous study, we used artificial intelligence to segment the upper abdominal organs and construct the constraint function to establish the ablation path planning model, and initially verified the effectiveness of the path planning model in a small number of cases. Now it is planned to expand the number of patients enrolled to evaluate the accuracy of the ablation path planning model that we have established.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old patients with liver tumors, not limited to primary liver cancer or secondary liver metastases;
2. The number of tumors is less than 5;
3. The diameter of the tumor is less than 3 cm;
4. No local treatment of intrahepatic tumors has been done in the past.

Exclusion Criteria:

1. Diffuse liver tumor;
2. Multiple lesions in the liver\> 3cm, which cannot be completely ablated;
3. Patients with lymph node metastasis and distant metastasis outside the liver;
4. Other situations where the researcher believes that it is necessary to withdraw from the study

Primary outcomes:
measure: Receiver operating characteristic curve, ROC
timeFrame: 2 years
Secondary outcomes:
measure: Area under curve, AUC
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04598724: Addressing Barriers to Palliative Care Use in Bladder Cancer
Official title: Addressing Barriers to Palliative Care Use in Bladder Cancer Through Better Understanding of Knowledge and Belief Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle-Invasive Bladder Carcinoma
Bladder Cancer Stage II
Bladder Cancer Stage III
Bladder Cancer Stage IV
Keywords: Bladder
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bladder Cancer patient participants and care givers will be recruited from the Moffitt Cancer Genitourinary Oncology clinic and the Supportive Care clinic.

Brief summary: Investigators plan to establish an in-depth understanding of knowledge and beliefs about palliative care in advanced Bladder Cancer patients and their caregivers, and to identify factors associated with positive and negative experiences with palliative care services among those who have received them.


Eligibility criteria: Inclusion Criteria:

* Eligibility for both patient and caregiver participants will include:
* age ≥18 years
* able to speak and read English
* cognitively able to participate in study tasks
* willing to participate in surveys, semi-structured interviews, and/or focus groups
* able to participate in either a Zoom meeting or phone interview
* able to complete an emailed or paper survey
* Patient Participants: a diagnosis of muscle-invasive or locally advanced bladder cancer (stages II-IV).

Exclusion Criteria:

* Patients and caregivers will be excluded if unable to provide verbal or written consent

Primary outcomes:
measure: Development of palliative care knowledge and beliefs
timeFrame: 12 Months
measure: Proportion with accurate palliative care knowledge and beliefs
timeFrame: 12 Months
Secondary outcomes:
measure: Association between Bladder Cancer stage and palliative care knowledge
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Scott Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328324: Pattern of Upper Gastrointestinal Lesions in Upper Egypt : Clinical, Endoscopic and Pathological Evaluation
Official title: Pattern of Upper Gastrointestinal Lesions in Upper Egypt : Clinical, Endoscopic and Pathological Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pattern of Upper Gastrointestinal Lesions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic.

In elrajhi endoscopy unit

Brief summary: Upper Gastrointestinal (UGI) symptoms are among the commonest complaints for which patients seek medical attention, with the annual prevalence of dyspepsia approximating 25% . Endoscopy holds an important place in the diagnosis of UGI conditions by enabling visualization, photography, ultrasonography, and biopsying of suspicious lesions . It gives a better diagnostic yield over radiology particularly in the investigation of upper gastrointestinal bleeding, inflammatory conditions of the upper gastro-intestinal track like esophagitis, gastritis and duodenitis as well as the diagnosis of Mallory Weiss tears and vascular malformations .Dyspepsia in the absence of any other symptom was the indication for UGIE in the vast majority of patients. Close to 80% of our patients presented with dyspepsia not associated with any other symptom and in 50% of the patients the endoscopic findings were normal \[4\]. Other common reasons for UGIE were GERD symptoms, recurrent vomiting, dyspepsia associated with weight loss and patients with symptoms of UGI bleeding . Gastritis was the most frequent endoscopic finding in our patients, followed by duodenitis .Gastric ulcer was diagnosed more frequently than duodenal ulcers . Taking a biopsy is very helpful in diagnosis in our study. H. pylori colonization of the gut is the main cause of chronic gastritis and the principal etiological agent of gastric cancer and peptic ulcer disease . Gastric cancer was diagnosed, by endoscopy, about eight times more frequently in patients presenting with an alarm symptom like recurrent vomiting, dyspepsia together with weight loss or UGI bleeding .


Eligibility criteria: Inclusion Criteria:

- All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic.

Exclusion Criteria:

* Patient undergoing endoscopic intervention for previously detected endoscopic lesion

Primary outcomes:
measure: Pattern of upper gastrointestinal lesions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: