louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03456739: The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis
Official title: The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suppurative Otitis Media
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-07
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with suppurative otitis media with effusion

Brief summary: ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion, serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each subject will be generated. Using correlation analysis, we will compare between microbial compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be collected from patients and cultured to test antibiotic resistance.


Eligibility criteria: Inclusion otitis media with effusion,parental informed consent, age between 1 - 9 years, no known immune deficient disorder -

Exclusion Criteria:no parental consent, known immune disorder, current acute otitis media.

-

Primary outcomes:
measure: microbiome variability
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical Center
name: saqer massuod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02455739: Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
Official title: Effect of Gum Chewing on Intestinal Functions After Gynecologic Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disorder Postoperative
Keywords: intestinal function
chewing gum
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to assess whether postoperative gum chewing improve intestinal functions.

Detailed description: We will randomize patients into two groups after gynecologic operations. One group will chew gum, the other group not and we will assess the gastrointestinal function functions.

Eligibility criteria: Inclusion Criteria:

* Women underwent gynecologic operation
* Women who are eligible for gum chewing

Exclusion Criteria:

* Women with previous gastrointestinal intervantion
* Women with previous abdominal surgery

Primary outcomes:
measure: Gastrointesitinal function
timeFrame: postoperative first 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil
Study officials:
affiliation: Zeynep Kamil
name: Ateş Karateke, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT02830139: Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer
Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Neoplasm of Colorectum
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.

Detailed description: To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility criteria: Inclusion Criteria:

* Histological proved diagnosis of locally advanced colorectal cancer.
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
* Eligible for radical colorectal resection with lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis or peritoneal metastasis during surgery (M1).
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: progression-free survival
timeFrame: 5 years
measure: distant metastasis rate
timeFrame: 5 years
measure: peritoneal metastasis rate
timeFrame: 5 years
measure: local recurrence rate
timeFrame: 5 years
measure: complication rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT04011839: Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery
Official title: Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing scheduled orthopedic surgery for which perinervous catheter analgesia is usually indicated (complex shoulder, elbow, femur, knee, foot surgery) will be included.

Brief summary: Continuous peripheral nerve blocks are considered as the gold standard for postoperative analgesia in orthopaedic surgery (shoulder, knee, foot). These techniques are also used in chronic pain.

The main disadvantage of these techniques is that they can drive a more or less deep motor block that slows down the rehabilitation process. This disadvantage could be prevented (or minimized) by adapting the protocol for administering local anesthetics or by changing molecules (levobupivacaine 0.625 mg/ml instead of ropivacaine 2 mg/ml). There is no literature comparing the effectiveness of the sensory block and its impact on the motor block according to the administration protocol and/or the type of local anesthetics.

The main judgement criterion of such a study could be a composite criterion crossing the quality of the sensory block and the depth of the motor blockades, the ideal being to have a perfect sensory block without any motor block.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* ASA score 1 to 4
* Scheduled orthopaedic surgery
* consent to participate

Exclusion Criteria:

* Pregnant, parturient, or breastfeeding woman
* Emergency situation
* Contraindications to local anaesthesia
* Patient refusal

Primary outcomes:
measure: Comparison between sensory Block Quality and motor Block deep
timeFrame: Day1 to Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
References:
Clinical trial NCT06199739: Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip
Official title: Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bony Weight Bearing Disorder
Keywords: fracture reduction
proximal femur fracture
geriatrics
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.

Patients and methods:

For this prospective single center clinical trial study, we recruited 14 proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.


Eligibility criteria: Inclusion Criteria:

* Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.

Exclusion Criteria:

* Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.

Primary outcomes:
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 1 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 3 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 6 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 12 postoperatively
Secondary outcomes:
measure: visual analog pain score
timeFrame: Record at months 1 postoperatively
measure: visual analog pain score
timeFrame: Record at months 3 postoperatively
measure: visual analog pain score
timeFrame: Record at months 6 postoperatively
measure: visual analog pain score
timeFrame: Record at months 12 postoperatively
measure: Complication
timeFrame: Functional and radiographic evaluations were performed at months 1, 3, 6, and 12 postoperatively
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far-Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT03149939: Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
Official title: Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperuricemia
Hemodialysis Complication
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2017-05-11
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is no clear data about use of febuxostat among hemodialysis patients, apart from very small case series. The aim of this study is to investigate the efficacy of using febuxostat for the treatment of Hyperuricemia among hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Hemodialysis patient
* Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males)

Exclusion Criteria:

* Patient currently and/or recently received drugs for hyperuricemia within the last three months
* Patient had recent (within 3 months) change of erythropoiesis stimulating drugs or other drug known to increase uric acid e.g furosemide

Primary outcomes:
measure: Change in serum uric acid
timeFrame: at three months of Febuxostat 40 milligrams Tablet therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00689039: Study of an Extended Release (ER) Tablet, Single and Repeated Dosing
Official title: A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1305
safety
pharmacokinetics
multiple ascending doses
Safety and pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
* Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

Exclusion Criteria:

* ECG findings outside normal range
* Potassium outside normal reference values

Primary outcomes:
measure: Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: During all dosing visits
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
name: Marianne Hartford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301439: Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions
Official title: Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Caries
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Universidade Metropolitana de Santos
First posted: 2022-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity of the restorations.


Eligibility criteria: Inclusion Criteria:

1. Healthy child, without systemic changes;
2. Good behavior;
3. Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.

Exclusion Criteria:

1. Children with any serious systemic disorder;
2. Lack of cooperation.
3. Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.

Primary outcomes:
measure: Changes in the Longevity Of Restorations
timeFrame: Three, 6 and 12 months after treatment.
Secondary outcomes:
measure: Changes in the biofilm index
timeFrame: Baseline, 3, 6, and 12 months after treatment.
measure: Changes in Salivary PH
timeFrame: Baseline, 6, and 12 months after treatment.
measure: Changes in The Presence of Caries Lesions
timeFrame: Baseline, 6, and 12 months after treatment.
measure: Technique Perfomance Time Duration
timeFrame: During the procedure.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06932939: Comparison of CAMBRA123 and AAPD (CAT) for Caries Risk in Egyptian Children
Official title: Comparison of Two Caries Risk Assessment Tools CAMBRA123 Versus (CAT) AAPD Among a Group of Egyptian Children: A Cross- Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Caries Experience
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 376
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted at the outpatient clinics of the Pediatric and Dental Public Health Department among group of (3-6) years old- Faculty of Dentistry, Cairo University - Egypt.

Brief summary: This study goal is to compare two indices in Egyptian children aged 3-6 years in caries detection and time needed for assessment which will contribute to variable data for pediatric oral health assessment locally and globally.

Detailed description: This study will ensure that patients receive precise evaluations and guide early, appropriate preventive measures or treatments. Over time, this will contribute to reducing caries progression and related complications. Also, Parents become more aware of their children's dental health status, emphasizing the importance of early detection and intervention. Furthermore, Comparing the indices will provide insights into which tool is most efficient and reliable for detecting caries in children 3-6 years old.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 6 years.
* Both genders.
* No underlying medical conditions affecting oral health.

Exclusion Criteria:

* Uncooperative patient.
* Children with cognitive impairments that prevent understanding the study procedures.
* Parents refused.

Primary outcomes:
measure: Caries risk assessment using AAPD
timeFrame: baseline (single visit)
measure: Caries risk assessment using CAMBRA123
timeFrame: baseline (single visit)
Secondary outcomes:
measure: Time For index Application
timeFrame: baseline (single visit)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
state: Giza
Study officials:
References:
citation: Featherstone JDB, Crystal YO, Alston P, Chaffee BW, Domejean S, Rechmann P, Zhan L, Ramos-Gomez F. A Comparison of Four Caries Risk Assessment Methods. Front Oral Health. 2021 Apr 28;2:656558. doi: 10.3389/froh.2021.656558. eCollection 2021.
citation: Devraj IM, Shankaraguru GM, Jairam LS, Dhull KS, Bhojraj N. Comparison of two different caries risk assessment tools for infants and toddlers - A cross-sectional study. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):9-14. doi: 10.4103/jisppd.jisppd_546_23. Epub 2024 Apr 15.