louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00463333: Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: postoperative delirium
psychometric testing
EEG
serum markers
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2007-04-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Summary:

Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.


Eligibility criteria: Inclusion Criteria:

* All patients at Intensive Care Unit over a defined time period
* Over 18 years old

Exclusion Criteria:

* Elective heart and vascular patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Intensive Care Unit, Clinic of Anesthesiology
Study officials:
affiliation: Medical Faculty, Clinic of Anesthesiology, University of Heidelberg
name: Markus A Weigand, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of Anesthesiology
name: Konstanze Plaschke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plaschke K, Kopitz J, Mattern J, Martin E, Teschendorf P. Increased cortisol levels and anticholinergic activity in cognitively unimpaired patients. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):433-41. doi: 10.1176/jnp.2010.22.4.433.
Clinical trial NCT04570033: The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Official title: The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperparathyroidism
Parathyroid Adenoma
Keywords: PET/CT
fluorocholine
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
First posted: 2020-09-30
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).

Detailed description: We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Eligibility criteria: Inclusion Criteria:

* primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan

Exclusion Criteria:

* pregnancy
* patient's lack of consent to the examination

Primary outcomes:
measure: The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Military Institute of Medicine
name: Andrzej Mazurek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordellat IM. Hyperparathyroidism: primary or secondary disease? Reumatol Clin. 2012 Sep-Oct;8(5):287-91. doi: 10.1016/j.reuma.2011.06.001. Epub 2011 Oct 20.
citation: Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.
citation: Lopez-Mora DA, Sizova M, Estorch M, Flotats A, Camacho V, Fernandez A, Abouzian S, Fuentes-Ocampo F, Garcia JIP, Ballesteros AIC, Duch J, Domenech A, Duarte AM, Carrio I. Superior performance of 18F-fluorocholine digital PET/CT in the detection of parathyroid adenomas. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):572-578. doi: 10.1007/s00259-020-04680-7. Epub 2020 Jan 9.
Clinical trial NCT06819033: Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
Official title: Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aphthous Ulcer
Keywords: magic mouthwash
laser treatment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of laser photobiomodulation and "Magic Mouthwash" for treatment of pain in pediatric patients with aphthous ulcers , to assess how photobiomodulation influences the rate of healing of aphthous ulcers in pediatric patients and to measure changes in pain levels reported by pediatric patients undergoing photobiomodulation treatment for aphthous ulcers.


Eligibility criteria: Inclusion Criteria:

* Patient/guardian speaks either English or Spanish
* Patient presenting with one or more aphthous ulcers in their mouth, identified during a scheduled dental appointment
* No previous PBM treatment to the presenting aphthous ulcer(s)
* Guardian able to partake in a follow-up phone call in either the English or Spanish language

Exclusion Criteria:

* Patient presents with aphthous ulcers recently treated with PBM
* Patient presents with herpes labialis (cold sores)
* Patients presents with systemic disease that affects soft tissue/mucous healing

Primary outcomes:
measure: Change in Quality of life as assessed by questionnaire (Likert scale)
timeFrame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment
measure: Pain as assessed by how frequently patient complains of pain (Likert scale)
timeFrame: upto 24 hours after treatment
measure: Pain as assessed by number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain
timeFrame: upto 24 hours after treatment
Secondary outcomes:
measure: Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool
timeFrame: pre-treatment and immediately post-treatment(about 5 minutes)
measure: Change in pain as assessed by a Visual Analogue Scale (VAS) for control group
timeFrame: Baseline, 24 hours after treatment
measure: Pain as assessed by a Visual Analogue Scale (VAS) for experimental group
timeFrame: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Brett Chiquet, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100333: GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)
Official title: Observational Study GONAL-f® Consort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Reproductive technologies, Assisted
r-hFSH
Gonal-f
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 2552
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany

Brief summary: This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.

Detailed description: Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.

OBJECTIVES

Primary Objective:

* To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator

Eligibility criteria: Inclusion Criteria:

* Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication
* Subjects below 35 years of age
* Subjects who have a Body mass index below 30
* Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol

Primary outcomes:
measure: Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator
timeFrame: 6 month
Secondary outcomes:
measure: Efficacy parameters
timeFrame: 6 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Charitè Berlin, Schumann Straße 20/21
Study officials:
affiliation: Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: W. Bilger
role: STUDY_CHAIR
References:
Clinical trial NCT00514033: A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Official title: Open, Multicentric, PMS Study to Monitor Safety and Reactogenicity of GlaxoSmithKline Biologicals' Poliomyelitis Vaccine (Inactivated)-Poliorix, Administered in Korean Children as a Primary Vaccination in Healthy Subjects Aged 2 to 6 Months or as a Booster Vaccination in Subjects Aged 4 to 6 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poliomyelitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-09
Enrollment: 349
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean children between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.

Brief summary: Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).

Detailed description: An open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals. Poliomyelitis vaccine (inactivated) -PoliorixTM., administered in Korean children as a primary vaccination in healthy subjects aged two to six months or as a booster vaccination in subjects aged four to six years.

Eligibility criteria: Inclusion Criteria:

* A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)
* Written informed consent obtained from the parent/ guardian of the subject

Exclusion Criteria:

* At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk

Primary outcomes:
measure: Occurrence of unsolicited adverse events.
timeFrame: During 7 days (Day 0 - 6) following vaccination.
measure: Occurrence of serious adverse events (SAEs).
timeFrame: During the entire study period.
Secondary outcomes:
measure: Occurrence of solicited local and general adverse events.
timeFrame: During 7 days (Day 0 to 6) after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01482533: Tissue Culture Versus Swab Culture in Prosthetic Joint Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Revision Total Hip Arthroplasty
Revision Total Knee Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2011-11-30
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 revision surgery for an infection in their knee or hip components.

Brief summary: The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection.


Eligibility criteria: Inclusion Criteria:

1. Patients are scheduled for revision TJA surgery.
2. Subjects are willing to sign the informed consent document.

Exclusion Criteria:

1. Subject not willing to sign the informed consent document.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01257633: Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Official title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Neoplasms
Keywords: da Vinci surgical robot
laryngeal cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is aimed at all patients with early stage (T1 or T2) glottic and / or supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with robotic assistance is indicated following a multidisciplinary meeting.

Brief summary: The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.


Eligibility criteria: Inclusion Criteria:

* The subject has signed consent
* The subject must be a member or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The subject has a cancer of the larynx:
* classified T1 or T2 in the TNM
* glottic localization and / or supraglottic regardless of node status
* with or without a history of head and neck cancer
* The subject does not have distant metastasis (M0)
* A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting

Exclusion Criteria:

-

Primary outcomes:
measure: The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
timeFrame: 1 day
Secondary outcomes:
measure: Time to prepare the surgical setting (min)
timeFrame: 1 day
measure: Time necessary to dock the robot (min)
timeFrame: 1 day
measure: Total surgical time (console time) (min)
timeFrame: 1 day
measure: Intervention time taking into account cervical ganglions (min)
timeFrame: 1 day
measure: Was a tracheotomy necessary? yes/no
timeFrame: 1 day
measure: Presence / absence of bleeding complications
timeFrame: 1 day
measure: Was a conversion to an open procedure necessary? yes/no
timeFrame: 1 day
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Benjamin Lallemant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028833: Effects of Power Mobility on Young Children With Severe Motor Impairments
Official title: Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Arthrogryposis
Spinal Muscular Atrophy
Other Central Nervous System or Musculoskeletal Disorders
Keywords: power wheelchairs
power mobility
young children
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 41
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.


Eligibility criteria: Inclusion Criteria:

* Must be between 14- and 30-months of age
* Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
* Must have adequate vision and hearing to use power mobility device safely
* Must have cognitive abilities equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted

Primary outcomes:
measure: Merrill-Palmer-Revised
timeFrame: Entry, 6-months, and 12-months
measure: Pediatric Evaluation of Disability Inventory
timeFrame: Entry, 6-months, 12-months
Secondary outcomes:
measure: Child Health Status
timeFrame: Entry
measure: Two-position object permanence test
timeFrame: Entry, 6 months, 12 months
measure: Nonspeech Test
timeFrame: Entry, 6 month, 12 months
measure: Home Observation Measure of the Environment
timeFrame: Entry, 6 months, 12 months
measure: Parenting Stress Inventory
timeFrame: Entry, 6 months, 12 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Entry, 6 months, 12 months
measure: Hollingshead Scale
timeFrame: Entry
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Maria A. Jones, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.
Clinical trial NCT03738033: Mobile Education for Emergency Ultrasound
Official title: Mobile Education for Emergency Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Keywords: emergency medicine ,emergency ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The junior physicians of the department of emergency medicine of the National Taiwan University Hospital.

Brief summary: The investigators aim to investigate the feasibility of using mobile application platform for sonographic education.

Junior physicians at the National Taiwan University Hospital will be enrolled in this study. To design and develop a secure mobile application platform (consisting of mobile device and a cloud-based server) for interactive teaching, remote social-based consultation and discussion. The information exchange through the platform carries images and simulated cases.

This pioneer study can provide experience of mobile sonographic education and contribute to current medical education. Moreover, it can improve decision-making process and quality of care, and could lessen crowdedness at emergency departments. Furthermore, the integrated platform can be used in other educational programs in the future.

Detailed description: As usual, it takes time for junior emergency physicians to have good diagnostic accuracy through traditional sonographic education. Applying the technology built in this project, junior emergency physicians will be provided with intelligent learning programs anywhere and anytime.

Junior physicians at the National Taiwan University Hospital will be enrolled in this study.

Eligibility criteria: Inclusion criteria:

The junior physicians of the department of emergency medicine of the National Taiwan University Hospital.

Exclusion criteria:

The junior physicians of the department of emergency medicine of the National Taiwan University Hospital, refused to enter the study.

Primary outcomes:
measure: assessment for ultrasound scanning
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Meng Che Wu, Dr
role: PRINCIPAL_INVESTIGATOR
References: