louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06906003: Visual Rehabilitation and Depression in Visually Impaired Patients with AMD
Official title: Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients with Advanced Age Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AMD - Age-Related Macular Degeneration
Anxiety
Depression Disorders
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
Collaborators: name: Sant'Alessio - Margherita di Savoia
First posted: 2025-04-02
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate and severe visually impaired patients affected by non exudative AMD

Brief summary: Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status.

Study design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia.

Study procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9).

Visit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings.

Visit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.


Eligibility criteria: Inclusion Criteria:

1. Subjects ≥ 55 years
2. Moderate and severe visual impairment (BCVA ≥1/10 and ≤2/10)
3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)
4. Informed consent freely granted and acquired before the start of the study
5. Ability to understand and willingness to follow the study instructions and procedures

Exclusion Criteria:

1. Visual impairment due to other ocular diseases
2. Mild visual impairment or partial or total blindness
3. Exudative age-related macular degeneration undergoing intravitreal drug treatment

Primary outcomes:
measure: Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program
timeFrame: 12 weeks
measure: Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Fondazione G.B.Bietti
Study officials:
References:
Clinical trial NCT00872703: Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Official title: Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMV
Prenatal Diagnosis
Ultrasound
MRI
Keywords: CMV
Prenatal Diagnosis
Ultrasound
MRI
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sheba Medical Center
name: Tel Aviv Medical Center
First posted: 2009-03-31
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of woman with CMV proved intrauterine infections

Brief summary: Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most likely to occur when the mother experiences a primary infection during pregnancy, and it is much less common in cases of reactivation of the disease or infection by a different CMV strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between 0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).

It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a major risk factor for perceptual deficits. However, its influence on children's future neuropsychological functioning is less well established. Symptomatic congenital CMV infection is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard 2007), but the available data regarding neuropsychological outcome for asymptomatic children is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).

We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV) infection and normal consecutive fetal neurosonographic examinations and determined whether Magnetic Resonance Imaging (MRI) provided additional information in these cases.


Eligibility criteria: Inclusion Criteria:

* CMV PCR positive in the amniotic fluid

Exclusion Criteria:

* US abnormal findings during fetal life

Primary outcomes:
measure: neuropsychological outcome
timeFrame: 1-7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. Wolfson Medical Center
Study officials:
References:
Clinical trial NCT03544203: Multicentre Observational Study on Community Acquired Intraabdominal Infections Management
Official title: Multicentre Observational Study on Community Acquired Intraabdominal Infections Management: the PERICOM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraabdominal Infections
Keywords: intraabdominal infections
peritonitis
critically ill
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery

Brief summary: Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery

Exclusion Criteria:

* primary intraabdominal infection
* health-care associated intraabdominal infection
* abdominal trauma
* patient under guardianship
* opt out consent
* patient already enrolled in the present study

Primary outcomes:
measure: length of stay
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU Angers
city: Clamart
country: France
facility: Hia Percy
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble La Tronche
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Lyon-Sud Pierre Bénite
city: Marseille
country: France
facility: AP HM La Timone
city: Marseille
country: France
facility: Ap Hm La Timone
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: CHU Bichat Claude Bernard
city: Paris
country: France
facility: Le Kremlin-Bicêtre
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References:
citation: Roger C, Garrigue D, Bouhours G, Dupont H, Bouzat P, Bardon J, Pottecher J, Montravers P, Michelet P, Perbet S, Aymart K, Incagnoli P, Lloret S, Louart B, Harrois A; ACUTE committee. Time to source control and outcome in community-acquired intra-abdominal infections: The multicentre observational PERICOM study. Eur J Anaesthesiol. 2022 Jun 1;39(6):540-548. doi: 10.1097/EJA.0000000000001683.
Clinical trial NCT01650103: Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys by Measuring Some Physiological Substances in Blood and Urines
Official title: Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypovolemia
Renal Hypoperfusion
Keywords: hypovolemia
renal hypoperfusion
major surgery
sodium
potassium
chloride
ScvO2
hemodynamic indexes
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major surgery.

Brief summary: The purpose of this study is to verify any existing relationship between mixed oxygen saturation (from central venous catheter) and urinary sodium, potassium, chloride in determining the volemic state and renal perfusion of patients undergoing major surgical interventions.


Eligibility criteria: Inclusion Criteria:

* thoracic-abdominal major surgical operations
* placing of a central venous catheter and urinary catheter
* age 18-75
* ASA class I-III

Exclusion Criteria:

* age above 75 or under 18
* ASA class IV
* trauma, sepsis and/or heart-lung failure
* liver transplantation
* kidney transplantation
* pre-existing renal failure
* pregnant patients
* patients unable to give their written consent

Primary outcomes:
measure: Determination of mixed oxygen saturation in central venous blood (ScvO2) and three urinary electrolytes (sodium, potassium, chloride)
timeFrame: During the stay of the patient in the operating room (in average 6 hours) and the eventual stay in the post-surgery intensive care unit (in average 1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
affiliation: University of Padova
name: Carlo Ori, Prof. M.D.
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera di Padova
name: Paolo Feltracco, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera di Padova
name: Andrea Bortolato, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975803: Reliability and Responsiveness of the Chinese Version of the Readiness for Return-To-Work Scale in Lost-time Claimants in Outpatient Occupational Rehabilitation in Taiwan
Official title: Reliability and Responsiveness of the Chinese Version of the Readiness for Return-To-Work Scale in Lost-time Claimants in Outpatient Occupational Rehabilitation in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Injuries
Keywords: return to work
readiness for return to work
occupational injury
work hardening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 lost-time claimants in outpatient occupational rehabilitation in 3 work hardening centers in Taiwan

Brief summary: The aim of the study is to measure the reliability and responsiveness of the Chinese version of the readiness for return-to-work (RRTW) scale. We would conduct a multiple-centered, prospective cohort study to require RRTW data in lost-time claimants in outpatient occupational rehabilitation in Taiwan.


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of occupational injuries
* Participating the work hardening program
* Age from 20-65
* Still not return to work
* Willing to participating the study

Exclusion criteria:

* Cannot read the sentences or express their own idea, which causing the cannot finish the questionnaires
* Brain injuries (e.g. traumatic brain injury, cerebrovascular acciden

Primary outcomes:
measure: Changes of the Readiness for Return-To-Work Scale scores during rehabilitation
timeFrame: The participants do the pretest of RRTW scale in the first week in their work hardening program, finishing the protest in the last week before the program ends. The duration depends on people. (In an average of 4-6 weeks)
Secondary outcomes:
measure: Change from the Readiness for Return-To-Work Scale scores at 1 week
timeFrame: The participants do the pretest of RRTW scale in the first week in their work hardening program, and they do the retest after one week.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Keh-Chung Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01661803: Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Official title: Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Spinal Anesthesia
Keywords: bupivacaine
clonidine
pediatric spinal
efficacy
duration
quality
side effects
intrathecal bupivacaine alone
bupivacaine plus clonidine
Lead sponsor: ACPM Medical College
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients undergoing surgeries below T8 dermatome upto two hours duration.

Brief summary: The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.

Detailed description: In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.

American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.

Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.

The patients studied across the group did not vary much with respect to age, weight and sex distribution.

Eligibility criteria: Inclusion Criteria:

1. ASA grade-1 physical status.
2. weight 5-35kg
3. age-3 to 10 yrs

Exclusion Criteria:

1. patients with known sensitivity to drugs to be used.
2. gross spinal deformity
3. patients in whom regional anesthesia is contraindicated.
4. patients with peripheral neuropathy.
5. patient with hemodynamic instability.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00945503: Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
Official title: An Adaptive PET Study in Healthy Volunteers Using [11C]GSK931145 to Establish the Relationship of Glycine Transporter 1 Occupancy by GSK1018921 to Plasma Concentrations Over Time.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Glycine Tranporter
MRI
PET
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A PET study using \[11c\]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.

Detailed description: This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.

Eligibility criteria: * Inclusion criteria:

  * Healthy male subjects
  * Age: 18-55 years
  * No history of physical, neurological or mental illness
* Exclusion criteria

  * History of claustrophobia or inability to lie still in the PET camera for at least 2 hours
  * Cardiac pacemakers or metal implants in the body that contraindicate MRI scan.
  * History of regular alcohol consumption (weekly intake \>21 units) within the previous six months.

Primary outcomes:
measure: PET occupancy with GSK1018921
timeFrame: 10 days
Secondary outcomes:
measure: To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests.
timeFrame: 10 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT07012603: External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair
Official title: External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: External Oblique and Rectus Abdominis Plane
Postoperative Analgesia
Umbilical Hernia Repair
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of the external oblique and rectus abdominis plane (EXORA) block for postoperative analgesia in patients undergoing umbilical hernia repair.

Detailed description: Umbilical hernias account for approximately 6-14% of adult abdominal wall hernias. These hernias are typically acquired and are mainly caused by increased abdominal pressure. Umbilical hernias do not heal on their own and usually require surgical intervention.

The external oblique and rectus abdominis plane (EXORA) block is an emerging technique providing a sensory block to the anterolateral abdominal wall. The EXORA block involves local anaesthetic injection into the fascial plane between the external oblique and rectus abdominis muscles. This method provides better dermatomal coverage, making the EXORA block particularly effective in the treatment of somatic pain in the anterolateral area of the upper and middle abdomen.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Undergoing umbilical hernia repair.

Exclusion Criteria:

* History of allergies to local anesthetics.
* Bleeding or coagulation disorders.
* Anatomical abnormalities.
* Psychiatric and neurological disorders.
* Local infection at the site of injection.
* Complicated hernial defects \[strangulated, incarcerated, or obstructed cases\].

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Heart rate
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03025503: Nipple Stimulation for Labor Induction
Official title: Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery Delayed
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.


Eligibility criteria: Inclusion Criteria:

* Week 37 + 0 and on
* PROM (premature rupture of membranes)
* Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
* Not in active labor - without regular contractions fetal monitor, cervical dilation \< 4 cm and effacement \< 80%.

Exclusion Criteria:

* Water break \> 24 hours at the time of admission to the delivery room
* Active vaginal bleeding with suspected placental abruption
* Maternal fever
* Multifetal pregnancy
* Women with contraindication for vaginal birth
* Preeclampsia
* IUGR (intrauterine growth restriction)
* Macrosomia
* Non-reassuring fetal heart tracing

Primary outcomes:
measure: progression to active labor as measured by the Bishop score
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References: