louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00954616: Inappropriate Medications Associated With Anticholinesterase and/or Memantine Treatment in the Elderly
Official title: Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Inappropriate Medications Associated
Alzheimer's disease
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 636
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient of 75 and more years old affected by the Alzheimer's disease

Brief summary: In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.


Eligibility criteria: Inclusion Criteria:

* Patients aged 75 years and over identified as having Alzheimer disease and who have been treated for more than 3 months with anticholinesterase and/or memantine

Exclusion Criteria:

* Patients with decompensated chronic condition or acute phase disease

Primary outcomes:
measure: To evaluate the prevalence of PIM use in patients aged 75 years and over treated with anticholinesterase and/or memantine
timeFrame: 2 years
Secondary outcomes:
measure: To identify factors associated with PIM use. To study the relationship between PIM exposure and adverse effects occurrence.
timeFrame: 2 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
state: Bois guillaume
city: Pessac
country: France
facility: CHU Bordeaux
state: Bordeaux
city: Le Mans
country: France
facility: CH Le Mans
state: Le Mans Cedex 1
city: Montpellier
country: France
facility: CHU Montpellier
state: Montpellier Cedex 5
city: Ivry sur Seine
country: France
facility: APHP Charles Foix
state: Paris
city: Saint Etienne
country: France
facility: CHU Saint Etienne
Study officials:
References:
Clinical trial NCT06314516: Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes
Official title: Influence of Nutrition and SarcoPenia on Esophageal Cancer ouTcomes (INSPECT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Sarcopenia
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2024-03-18
Enrollment: 1717
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: International cohort of patients presenting with regional {Stage 2 and 3} esophageal cancer who are considered appropriate candidates for surgical therapy.

Brief summary: Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.

Detailed description: Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.

Eligibility criteria: Inclusion Criteria:

* Patients with the following characteristics will be eligible for inclusion in this study:

  * Age 18-90 years
  * Newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma)
  * Planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy

Exclusion Criteria:

* Patients with the following characteristics will not be eligible for inclusion in this study:

  * Pregnant females
  * Without malignant esophageal disease
  * Inability or unwillingness to provided informed written consent

Primary outcomes:
measure: Longitudinal variation in body composition
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Patient and disease-specific factors
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Donald E Low, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06730516: Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate
Official title: Optic Nerve Head Perfusion Following Treatment with Latanoprost 0.005% Versus Brimionidin Tartrate 0.2% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Glaucoma
Keywords: Latanoprost
Brimonidine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group. Nine patients, five in group (1) and four in group (2) were excluded due to poor quality OCTA images or non-compliance). Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % while 24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2).
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group

Detailed description: This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral POAG equally divided into two groups with 28 patients in each group. The whole VD was increased and also increased in all four nasal, temporal, superior, and inferior quadrants around optic disc from the initial vessel density before treatment (p\<0.001) in both groups significantly with superior improvement in group (1) compared to group (2) that was statistically significant

Eligibility criteria: Inclusion Criteria:

* age more than 18 years newly diagnosed naive patients with POAG

Exclusion Criteria:

* optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery

Primary outcomes:
measure: OPTIC NERVE PERFUSION using OCT angiography numerical analysis system presented in %
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Yasmine A Deiaeldin, MD
role: STUDY_DIRECTOR
affiliation: Zagazig University
name: Hani elbialy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04395716: A Study of ResCure™ to Treat COVID-19 Infection
Official title: A Phase I Study of ResCure™ to Treat COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: COVID
Covid-19
Corona Virus Infection
Sars-CoV2
Coronavirus-19
SARS Pneumonia
SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
Collaborators: name: Rinati Skin, LLC
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

Detailed description: In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.

Eligibility criteria: Inclusion Criteria:

1. Critically ill patients with SARS from COVID-19 infection on respirators OR
2. Patients with SARS from COVID-19 infection prior or after being placed on respirator
3. Male or female patients 18 years of age and older

Exclusion Criteria:

1. Patients less than 18 years of age

Primary outcomes:
measure: The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
timeFrame: 12 Weeks
measure: Reduction or progression of symptomatic days
timeFrame: 12 Weeks
measure: Assess the safety of ResCure™ via pulse
timeFrame: 12 Weeks
measure: Assess the safety of ResCure™ via oxygen saturation
timeFrame: 12 Weeks
measure: Assess the safety of ResCure™ via EKG
timeFrame: 12 Weeks
measure: Assess Tolerability of ResCure™
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06912516: PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam'
Official title: PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulse Oximetry
Keywords: Oxygen saturation
remote photoplethysmography
pulse oximetry
Lead sponsor: Vitacam
Sponsor class: INDUSTRY
Collaborators: name: Tampere University
name: Tampere University Hospital
First posted: 2025-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. It analyses digital video recorded using a smart device with a camera to locate a subject's face and chest region. From both these regions of interest, the video is further analysed to obtain the heart rate, heartbeat intervals, respiratory rate and oxygen saturation. These measurements are used as inputs to clinical decision making. Vitacam uses remote photoplethysmography to obtain the heart rate and heartbeat intervals, and will build on this to obtain oxygen saturation using information from red-green-blue channels.

The main focus of this study is to validate the oxygen saturation, heart rate and heartbeat intervals measured by Vitacam against gold standard references, applying the ISO 80601:2019 standard.


Eligibility criteria: Inclusion Criteria:

* Age: 18-40 years
* ASA category 1
* Positive Allen's test
* Passing the physical examination
* Ability to give informed consent
* Volunteering for the study
* Fluent Finnish or English

Exclusion Criteria:

* Age under 18 years or over 40 years
* Smoker
* Pregnancy
* Does not pass the physical examination
* Negative Allen's test
* Relevant medical illnesses
* Cardiovascular disease
* Pulmonary disease
* Inability to give informed consent
* Denial

Primary outcomes:
measure: Accuracy of oxygen saturation measurements - Root Mean Square Error
timeFrame: A 30-45 minute period during which the participant is subjected to the de-saturation process
measure: Accuracy of oxygen saturation measurements - Mean absolute error
timeFrame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Secondary outcomes:
measure: Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram
timeFrame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University
Study officials:
References:
Clinical trial NCT04810416: Effect of Texting and Writing on Grip and Pinch Strength
Official title: Effect of Texting and Writing on Hand Grip and Key Pinch Strength Among Collegiate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness Condition
Hand Grasp
Keywords: Hand grip strength, key pinch, risk factors, students
Key pinch
Risk factors
Students
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
Collaborators: name: King Saud University
First posted: 2021-03-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the parallel four groups
Primary purpose: PREVENTION

Brief summary: Texting and writing are common hand activities among college students. Students tend to spend increasing hours of texting and writing for every day activities in addition to the academic assignments that are mainly on line and through distance education. The effect of such daily activities on hand grip and key pinch strength has not been studied among college students.

Detailed description: Students will be recruited from physical therapy department of college of medical rehabilitation sciences after satisfying the inclusion and exclusion criteria. Participants will be randomly assigned to one of the four groups (texting 10 minutes, texting 15 minutes, writing 10 minutes and writing 15 minutes). Participants will be blinded to the outcome measures and the evaluator will be blinded to the participants assigned group. Hand grip strength and key pinch strength will be the main outcome measures. Participants demographics will be gathered in addition to recreational status, risk factors, pain body diagram and number of hours spent for texting and writing in every day life.

Eligibility criteria: Inclusion Criteria:

* Active college student
* Healthy
* Willing to participate
* Using smart phones\& electronics
* Hand writing for \> 10 minutes/day

Exclusion Criteria:

* Recent upper limbs injury (sprain\& strain)
* Chronic neurological disorder
* Carpal tunnel syndrome
* De Quervain's disease
* Diabetic neuropathy

Primary outcomes:
measure: Hand grasp Hand grasp
timeFrame: Up to 12 weeks
measure: Key pinch
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Borg CR-10
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: College of Medical Rehabilitation Sciences
city: Medina
country: Saudi Arabia
facility: College of medical rehabilitation sciences
Study officials:
References:
Clinical trial NCT01703416: Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
GOLD group C and D
CDLM questionnaire
visual scale - physician evaluation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-10
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease (COPD) patients group C and D

Brief summary: This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.

Detailed description: CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
* Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
* Current or past smokers, of at least 10 pack years

Exclusion Criteria:

* History of exacerbation of COPD symptoms within the last month before visit 1, inclusive.
* History of asthma or allergic rhinitis.
* History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.

Primary outcomes:
measure: Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.
timeFrame: Baseline and 3 months
measure: Change from baseline of patient's general health status upon physical evaluation - visual scale
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)
timeFrame: Day 0 (visit 1)
measure: Number of daily walking steps (by using pedometers)
timeFrame: up to 3 months
measure: Patient adherence to treatment (by using visual 5 point scale)
timeFrame: up to 3 months
measure: Number of unscheduled visit (exacerbations, emergency visits)
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
Study officials:
References:
Clinical trial NCT04108416: Unilateral Cleft Repair in One Surgery With Pure Primary Healing
Official title: Unilateral Cleft Repair in One Surgery With Pure Primary Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Keywords: cleft lip
cleft palate
cleft lip and palate
orofacial cleft
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 11
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland

Brief summary: Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre


Eligibility criteria: Inclusion Criteria:

* newborn patients with complete unilateral cleft lip and palate

Exclusion Criteria:

* with associated syndrome
* previous lip/ palate repair
* previous presurgical orthopaedics other than passive palatal plate

Primary outcomes:
measure: Cleft size measurement
timeFrame: Measured on a model after birth and at surgery with 8 month of age
Secondary outcomes:
measure: Wound healing
timeFrame: 1, 3 and 6 month after surgery
measure: Adverse events
timeFrame: 6 month
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: University of Basel and University Hospital Basel
name: Benitez Benito, MD DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available.
citation: Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23.
citation: Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1.
citation: Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1.
citation: Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3.
Clinical trial NCT05918016: Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction
Official title: Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction in Preterm Infants With Gestational Age <30 Weeks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterms
Infarction Cerebral
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn with gestational age \< 30 weeks

Brief summary: Observational study of preterm infant with a gestational age \< 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years.


Eligibility criteria: Inclusion Criteria:

* Gestacional Age \< 30 weeks

Exclusion Criteria:

* Brain malformation
* Genetic syndrome
* Metabolic disorders
* Chromosomal abnormality
* None cranial ultrasound

Primary outcomes:
measure: Periventricular Hemorrhagic Infarction
timeFrame: first month
measure: Characteristic Sonographic
timeFrame: first month
measure: Neurodevelopmental outcome at age 2 years
timeFrame: first month
Secondary outcomes:
measure: Medical records
timeFrame: first month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
Study officials:
References: