louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06934759: Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus
Official title: Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus: A National Qualitative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Melanocytic Nevi
Congenital Melanocytic Nevus
Parent
Psychology, Social
Keywords: parents
congenital melanocytic nevus
congenital melanocytic nevi
psychology
lived experience
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include parents of children with a large or giant congenital melanocytic nevus who are being followed at the university hospitals (CHRU) of Nancy, Marseille, Nantes, Dijon, Necker, Nice, Brest, Annecy, and Toulouse.

Brief summary: The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Willing to participate in a semi-structured interview
* Has received full information about the research and has not objected to participating or to the use of their data
* Able to understand and speak French
* Parent of a child under 18 years of age

Exclusion Criteria:

* Under 18 years of age
* Not willing to participate
* Currently under legal protection (e.g., guardianship or curatorship)
* Cognitive and/or psychological impairments preventing participation in a semi-structured interview
* Poor understanding and/or expression of the French language
* Parent of a child over 18 years of age

Primary outcomes:
measure: Results of the Semi-Structured Interviews with Parents
timeFrame: Socio-demographic data and interview transcripts will be collected during the semi-structured interviews (lasting between 30 minutes and 1.5 hours), thus at a single time point (Day 1). No follow-up is required.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
References:
Clinical trial NCT00137059: Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatotoxicity
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2005-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.


Eligibility criteria: Inclusion Criteria:

* Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
* Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

Exclusion Criteria:

* Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
* Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
* Individuals who have ingested \> 4 grams of acetaminophen/day in any of the previous 7 days.
* Individuals \< 18 years of age.
* Individuals with abnormal liver function at baseline (defined as AST or ALT \> 120 IU/L, International Normalized Ratio \[INR\] \> 1.5, and a-GST \> 7.5 7 :g/L).
* Individuals who have an allergy or sensitivity to acetaminophen.

Primary outcomes:
measure: serum a-GST relative to baseline
Secondary outcomes:
measure: conventional liver function tests (LFTs)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Marco LA Sivilotti, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartels S, Sivilotti M, Crosby D, Richard J. Are recommended doses of acetaminophen hepatotoxic for recently abstinent alcoholics? A randomized trial. Clin Toxicol (Phila). 2008 Mar;46(3):243-9. doi: 10.1080/15563650701447020.
Clinical trial NCT04021459: Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.
Official title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
circulating tumor cells
laparoscopy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: women with endometrial cancer
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.

Detailed description: The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.

The main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).

Eligibility criteria: Inclusion Criteria:

* Patients with endometrial cancer
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

* Patients with an other cancer

Primary outcomes:
measure: Qualitative assessment
timeFrame: During surgery (at the ligature of the ovarian ligament)
Secondary outcomes:
measure: Quantitative assessment
timeFrame: Before surgery and during surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: University of Montpellier
name: Gauthier RATHAT, PHD
role: STUDY_DIRECTOR
References:
citation: Francini S, Duraes M, Rathat G, Macioce V, Mollevi C, Pages L, Ferrer C, Cayrefourcq L, Alix-Panabieres C. Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study. Biomolecules. 2023 Feb 24;13(3):428. doi: 10.3390/biom13030428.
Clinical trial NCT03374059: Exercise and Life Modification for Text-Neck
Official title: Exercise and Life Modification Approaches for Text-Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Exercise
Posture
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled
Primary purpose: TREATMENT

Brief summary: Objectives: The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".

Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.

Detailed description: Objectives: Smartphones or tablets have made an important place in our lives. However long-term use of technological tools causes postural disorders and neck pain called "text neck". The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".

Methods: Eighty-five participants with "text-neck" were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). First group received a home exercise program treatment for 4 weeks. Second group received life modification suggestions additional to home exercise treatment program. Control group did not receive any treatments. Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Participants who were aged between 18 and 30, using technological devices as tablets and smartphones for more than 5 hours and having neck pain for more than 3 months were included in our study.

Exclusion Criteria:

* The exclusion criteria included those:

  1. who had any diagnosed pathology for neck region diagnosed by MR or BT,
  2. who had any shoulder pathology,
  3. with any neck or shoulder surgery,
  4. had whiplash syndrome,
  5. had fibromyalgia, Myofasial Pain Syndrome or vascular pathology and
  6. women who are breastfeeding.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Neck disability index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT01292759: Non-invasive Assessment of Arterial Blood Pressure and Functional Hemodynamic Parameters
Official title: An Evaluation of a New, Non-invasive Monitoring Device in Major Abdominal Surgery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure, Unspecified
Keywords: stroke volume
cardiac output
validation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective abdominal surgery

Brief summary: Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). To evaluate this new device the investigators compared esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 80 years old
* Written informed consent obtained

Exclusion Criteria:

* Renal failure
* Heart failure (EF \< 25%)
* Peripheral artery occlusion disease
* M. Raynaud
* Rhythms other than sinus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Klinik für Anaesthesiology der Universitätsmedizin Mainz
Study officials:
References:
Clinical trial NCT06847659: Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy
Official title: Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing HoLEP (Holmium Laser Prostatectomy) Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prewarming
Holmium Laser Prostate Surgery
Hypothermia Following Anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the effectiveness of prewarming methods in preventing intraoperative hypothermia in patients undergoing HoLEP surgery. Designed as a randomized controlled study, patients who receive prewarming will be compared with those in the control group.


Eligibility criteria: Inclusion Criteria:

* Male patients aged 18 years and older
* Patients undergoing HoLEP surgery under general anesthesia
* Patients who consent to participate in the study

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients unable to read, understand, or sign the informed consent form.
* Hemodynamically unstable patients.
* Patients with a preoperative or intraoperative body temperature \>37°C.

Primary outcomes:
measure: Time to onset of intraoperative hypothermia.
timeFrame: intraoperatively
Secondary outcomes:
measure: Hemodynamic parameters
timeFrame: intraoperatively
measure: Volume of irrigation fluid used
timeFrame: intraoperatively
measure: Changes in body temperature
timeFrame: intraoperatively
measure: Hemodynamic parameters
timeFrame: intraoperatively
measure: respiratory parameter
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
References:
Clinical trial NCT02880059: Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms
Official title: Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms - IESA-Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h)
Intracranial Aneurysm Size
Blood Pressure Medication
Comorbidities
Complications (Subarachnoid Hemorrhage)
Keywords: Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18yrs. and older with intracerebral aneurysm.

Brief summary: Patients with intracerebral aneurysm will be screened for sleep apnea using out of center polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and changes in medication.

Detailed description: Patient presenting to the outpatient center for neurological of neurosurgical management of intracerebral aneurysm will be recruited. Sleep apnea will be assessed by questionnaire and out of center polygraph/polysomnography. Medication, comorbidities and blood pressure will be recorded. Change in aneurysm size and blood pressure medication will be evaluated annually for up to 5 years. Frequency of subarachnoid hemorrhage and increase in aneurysm size will be assessed.

Eligibility criteria: Inclusion Criteria:

* Intracerebral aneurysm
* Age \>= 18yrs.
* Ability to give informed consent

Exclusion Criteria:

* Stroke within 3 month of study inclusion.

Primary outcomes:
measure: Blood pressure medication
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
Secondary outcomes:
measure: Subarachnoid hemorrhage
timeFrame: 5 years
measure: Increase in size of aneurysm
timeFrame: 5 years
measure: Change in blood pressure medication
timeFrame: 5 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Neurology and Department of Neurosurgery
Study officials:
affiliation: Vice Chair of Department of Neurosurgery
name: Erdem Gueresir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Staff Physician
name: Sebastian Zaremba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaremba S, Albus L, Hadjiathanasiou A, Vatter H, Wullner U, Guresir E. Aneurysm size and blood pressure severity in patients with intracranial aneurysms and sleep apnea. J Clin Sleep Med. 2022 Jun 1;18(6):1539-1545. doi: 10.5664/jcsm.9906.
Clinical trial NCT01586559: Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study
Official title: Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastasis Recti
Lead sponsor: Bulovka Hospital
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 65
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with interval after rectus sheath plication

Brief summary: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Detailed description: Background: Rectus sheath plication within abdominoplasty is a standard treatment for diastasis of the recti muscles. Previous studies assessing the efficacy and endurance of the correction of recti diastasis have mostly been performed with small groups of patients, short follow-up periods and/or with questionable methodology

Methods: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture. The investigators assess the outcomes by physical and ultrasonographic examinations and a patient questionnaire, which asks about the number of pregnancies and the types of deliveries, other abdominal surgeries before or after the abdominoplasty, the interval of time required to return to full activity, postoperative pain, and the overall satisfaction with the final result. During the examination, the inter-recti distances are measured at 3 levels: halfway between the xyphoid and umbilicus, just above the umbilicus and halfway between the umbilicus and pubis. The same examination is done on a control group of nulliparous women.

Eligibility criteria: Inclusion Criteria:

Women after rectus sheath plication for diastasis recti

Exclusion Criteria:

Abdominal wall defect other then umbilical hernia

Primary outcomes:
measure: Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles
timeFrame: 12-41 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague 8
country: Czech Republic
facility: Bulovka Hospital
Study officials:
References:
Clinical trial NCT01131559: Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
Official title: Adjunctive Lisdexamfetamine in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar
Depression
Keywords: bipolar disorder
manic depression
depression
Bipolar I or II
Lead sponsor: Lindner Center of HOPE
Sponsor class: OTHER
Collaborators: name: Shire
name: University of Cincinnati
First posted: 2010-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

Exclusion Criteria:

* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Primary outcomes:
measure: Change in MADRS score
timeFrame: 30-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Lindner Center of HOPE
state: Ohio
Study officials:
References:
Clinical trial NCT00975559: The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
Official title: The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Endothelial Dysfunction
Apical Ballooning Syndrome
Myocardial Infarction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-09-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Normal volunteers
2. Apical Ballooning syndrome as proven during coronary angiogram
3. Coronary Endothelial Dysfunction as proven during coronary angiogram
4. Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention

Brief summary: The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.


Eligibility criteria: Inclusion Criteria:

* Patients must be identified in one of the four groups outlined in "study population description."

Exclusion Criteria:

* Other co-morbidities that would make the testing not possible.
* Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: