louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04199546: Chewing and Swallowing Training Program in Coffin-Lowry Syndrome
Official title: Chewing and Swallowing Training Program in Coffin-Lowry Syndrome: A Case Report
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swallowing Disorder
Chewing Problem
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 1
Sex: MALE
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will report the chewing and swallowing disorders of a Coffin-Lowry Syndrome (CLS) patient, and effects of chewing and swallowing training on chewing and swallowing function.

Detailed description: Patients with CLS suffer from spinal deformities, nonconvulsive status epilepticus, obstructive sleeep apnea syndrome, pneumonia, stimulus-induced myoclonus, cases of falls, mechanical ventilation, restrictive lung disease. It was also reported that patients with CLS had problems with eating and feeding functions. However there is no study investigating chewing and swallowing functions of this patient population. Therefore, the investigators have three main purposes:

1. To chewing and swallowing function in a boy with CLS diagnosis who was referred due to coughing during eating, long-lasting wheezing, sputum and inability to intake solid food
2. To investigate the effects of two months of chewing and swallowing training program
3. To present long term follow-up effects on chewing and swallowing function.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of CLS
* Having a history of coughing during eating, long-lasting wheezing, sputum
* Inability to intake solid food.

Exclusion Criteria:

- No history of coughing during eating, long-lasting wheezing, sputum

Primary outcomes:
measure: Instrumental swallowing evaluation
timeFrame: 6 months
Secondary outcomes:
measure: Swallowing screening
timeFrame: 6 months
measure: Chewing evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: AYŞE KÜBRA ŞAHAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427046: Acute Myocardial Infarction in Native Versus Non-native Young Population in Saudi Arabia
Official title: Clinical Presentation and Outcome of Acute Myocardial Infarction in Native Versus Non-native Young Population in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Young
Saudi
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2020-06-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young adults, saudi or non-saudi, with Acute Myocardial Infarction.

Brief summary: A retrospective study collecting the data of young patients admitted with diagnosis of Acute Myocardial Infarction.

Detailed description: A retrospective study investigating young adults aged \<45 years for males and \<55 years for females admitted at Saud Al Babtain Cardiac Center with diagnosis of Acute Myocardial Infarction, determining its risk factors for Coronary Artery Disease (CAD) related to cultural characteristics and common positive consanguinity of parents as well as the prevalent diabetes and smoking.

Eligibility criteria: Inclusion Criteria:

* \<45 years old for male and \<55 years old for female
* patients admitted with diagnosis of Acute Myocardial Infarction

Exclusion Criteria:

* \<17 and \>55 years old male and female
* patients admitted with diagnosis other than Acute Myocardial Infarction.

Primary outcomes:
measure: Number of young adults hospitalized with primary diagnosis of Acute Myocadial Infarction.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud Al Babtain Cardiac Center
Study officials:
affiliation: Saud Al Babtain Cardiac Center
name: Ali Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06473610: Residual Embolism Evaluated With Single Photon Emission Computed Tomography
Official title: Residual Embolism Evaluated With Single Photon Emission Computed Tomography - The RESPECT Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Circulation Obstruction
Keywords: scintigraphy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 358
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: Patients with V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, patients admitted for a suspicion of PH, or a persistent dyspnea after PE

Brief summary: Major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (PE). These improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of Chronic Thrombo-embolic Disease (CTED). In most of the situations, it is due to a residual pulmonary vascular obstruction (RPVO) which can be assessed by pulmonary scintigraphy.

Detailed description: Planar ventilation/perfusion (V/Q) scintigraphy is the gold standard, but for several months, V/Q single photon emission computed tomography (SPECT) is recommended in the guidelines.

The aim of this study is to evaluate the performances of various SPECT protocols to quantified RPVO and compared to planar scintigraphy to evaluate the RPVO.

Eligibility criteria: Inclusion Criteria:

* Patient addressed to nuclear medicine department of Saint-Etienne public hospital for V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, admitted for a suspicion of pulmonary hypertension (PH), or a persistent dyspnea after PE
* Patient affiliated ou beneficiary of social security.

Exclusion Criteria:

* Pregnant patient.
* Patient addressed to nuclear medicine department for acute pulmonary embolism.
* Impossibility of the entire protocol acquisitions realization.

Primary outcomes:
measure: RPVO (%)
timeFrame: At inclusion
measure: Segmental visual score
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CENTRE HOSPITALIER DE SAINT-ETIENNE
name: Pierre-Benoit BONNEFOY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884910: Long Term Use of the Provox Vega 22.5
Official title: Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Laryngectomy
Keywords: laryngectomy
Provox Vega
voice prosthesis
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: The Netherlands Cancer Institute
First posted: 2009-04-21
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.

Detailed description: Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French.

Outcomes were recorded by means of patient questionnaires and device life.

It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.

Eligibility criteria: Inclusion Criteria:

* total laryngectomy
* Provox2 user
* at least two previous replacements

Exclusion Criteria:

* patients' refusal
* fistula problems
* Provox ActiValve users

Primary outcomes:
measure: Patient Preference
timeFrame: 3 months post insertion, or at end of device life (whichever comes sooner)
Secondary outcomes:
measure: Device Life Time
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Frans JM Hilgers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482910: VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Official title: A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2011-12-01
Enrollment: 304
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.

Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

Detailed description: Adverse events collection will be covered in Adverse Events section.

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent form
* Men and women ≥ 50 years of age.
* Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)
* BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye

Exclusion Criteria:

* Only one functional eye
* Presence of CNV with an origin other than wAMD
* Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline and at week 28
Secondary outcomes:
measure: Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF
timeFrame: At week 28
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Changsha
country: China
state: Hunan
city: Xi'an
country: China
state: Shaanxi
city: Qingdao
country: China
state: Shandong
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Wenzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Tianjin
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00800410: REACH Detroit Partnership Family Intervention
Official title: A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Randomized Controlled Trial
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-12-02
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Had physician-diagnosed type 2 diabetes
* Self-identified as African American or Latino/Hispanic
* Lived in the targeted zip codes.

Exclusion Criteria:

* Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: LDL cholesterol
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Diabetes self-management knowledge
timeFrame: 6 months
measure: Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)
timeFrame: 6 months
measure: Diabetes specific emotional distress
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Community Health and Social Services (CHASS)
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael S Spencer, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.
citation: Rosland AM, Kieffer E, Spencer M, Sinco B, Palmisano G, Valerio M, Nicklett E, Heisler M. Do pre-existing diabetes social support or depressive symptoms influence the effectiveness of a diabetes management intervention? Patient Educ Couns. 2015 Nov;98(11):1402-9. doi: 10.1016/j.pec.2015.05.019. Epub 2015 Jun 5.
Clinical trial NCT01896310: New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy
Official title: New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Intestinal Metaplasia
Atrophic Gastritis
Inflammation
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Brief summary: The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Detailed description: Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for pCLE examination
* aged between 18 and 80 years old

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy
* History of upper GI tract surgery
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function

Primary outcomes:
measure: The diagnostic accuracy of the new classification system
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598610: Performance Evaluation of an Investigational Blood Glucose Monitoring System
Official title: Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and older
* Type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Pregnancy
* Hemophilia or any other bleeding disorder
* Previously participated in a study using the CONTOUR PLUS system
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
* Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
* A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).

Primary outcomes:
measure: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff
timeFrame: 1 hour
measure: Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research
state: Indiana
city: Fairfield
country: United States
facility: Consumer Product Testing Co.
state: New Jersey
Study officials:
affiliation: Midwest Institute For Clinical Research
name: Phillip D Toth, MD, FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Consumer Product Testing Co.
name: Michael Caswell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06914310: Memantine as an Additive Therapy in Patients With Traumatic Brain Injury
Official title: Memantine as an Additive Therapy in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury (TBI)
Keywords: Traumatic Brain Injury (TBI)
Memantine
S100β
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. However, other trials investigating memantine's impact on long-term cognitive function in TBI patients have yielded mixed results. There is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with TBI.

Detailed description: The current study aims to evaluate the cognitive function, neuroprotective effect, and S-100β serum level effect of Memantine in patients with mild to moderate traumatic brain injury (TBI) patients.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 70 years of age
2. Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.

Exclusion Criteria:

1. Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours.
2. Acute or chronic renal insufficiency.
3. Hepatic diseases.
4. Autoimmune diseases.
5. Malignancies.
6. Pregnancy.
7. Patients unable to tolerate enteral feeding.
8. More than 24 hours (h) since traumatic injury

Primary outcomes:
measure: The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment
timeFrame: 30 days
Secondary outcomes:
measure: The differences between study groups in Glasgow Coma Scale (GCS) score.
timeFrame: 3 days
measure: The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B)
timeFrame: 3 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Daqahlia
Study officials:
References: