louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03141229: Health, Integration, Concentration: Mindfulness in Schools
Official title: Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Child Development
Burnout Syndrome
Keywords: MBSR
Children
Teacher
School
Burnout
Classroom behavior
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen
name: Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen
First posted: 2017-05-05
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Note: Either teacher and pupils are included in this study. We anticipate a number of 100 teacher and 500 pupils participating. Data from teacher and pupils will be analyzed separately.
Primary purpose: PREVENTION

Brief summary: Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children.


Eligibility criteria: Inclusion Criteria:

* reading ability
* positive declaration of consent

Exclusion Criteria:

-

Primary outcomes:
measure: Burnout (Teacher) assessed with the Burnout-Screening-Scale
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
measure: Classroom climate pupils
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Secondary outcomes:
measure: Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
measure: Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
measure: Concentration (pupils) assessed with a d2-Concentration assessment tool
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
measure: Health-related Quality of Life (pupils) assessed with the Kidscreen-10
timeFrame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Schulamt Stadt Solingen
state: Nordrhein-Westfalen
Study officials:
affiliation: Universität Duisburg-Essen, Medizinische Fakultät, Klinik für Naturheilkunde und Integrative Medizin
name: Gustav Dobos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832429: Lymph Node Mapping in Finding Metastatic Disease in Patients with Sebaceous Gland Cancer of the Eyelid
Official title: Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eyelid Sebaceous Gland Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-30
Enrollment: 20
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: This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.

Detailed description: PRIMARY OBJECTIVES:

I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.

II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.

SECONDARY OBJECTIVE:

I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.

OUTLINE:

Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Eligibility criteria: Inclusion Criteria:

* Possible or suspicious sebaceous gland carcinoma of the eyelid
* A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
* Patient provided written informed consent; in the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants

Exclusion Criteria:

* Pregnant or nursing females

Primary outcomes:
measure: Rate of sentinel lymph node (SLN) positivity
timeFrame: At day 1
measure: Rate of false negative events
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Bita M Esmaeli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260829: Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study
Official title: Evaluation of the Effect of Local Injected Vitamin C on Accelerating the Orthodontic Movement of Maxillary Canine Impaction: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palatally Impacted Canines
Keywords: vitamin C
palatally impacted canines
intraepidermal injection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: efficacy of the injectable vitamin C to reduce the time of canine traction

Detailed description: Objective. The purpose of this study is to investigate the role and efficiency of the locally injected vitamin C in the enhancement of the palatally impacted canine movement.

Design. Twelve adult patients with unilateral palatally impacted canines were included in this study. The enrolled patients were randomly allocated into the study groups; control group; orthodontic traction and he test group: orthodontic traction enhanced by intraepidermic vitamin C injection. The study duration was 12 months.

Eligibility criteria: Inclusion Criteria:

* medically free
* patient with good to fair oral hygiene (gingivitis may be included)
* both sexes were included
* unilateral palatally positioned permenant canines
* absence of previous orthodontic treatment
* absence of supernumerary teeth, odontoms, cysts, traumatic injuries
* the α angle within grade II to III

Exclusion Criteria:

* systemic diseases especially diabetes and bone diseases
* pregnant and lactating mothers
* Local causes (smoking, mouth breathing, local trauma and periodontitis).

Primary outcomes:
measure: rate of tooth movement
timeFrame: 12 months
Secondary outcomes:
measure: level of alveolar bone
timeFrame: 12 months
Other outcomes:
Locations:
city: Gizah
country: Egypt
facility: Faculty of Oral and Dental Medicine
state: Giza
Study officials:
References:
citation: Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
Clinical trial NCT05559229: Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report
Official title: Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Cancer
Lead sponsor: Oita Red Cross Hospital
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a case of AFP-producing gallbladder carcinoma with signet ring cells

Brief summary: Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.


Eligibility criteria: The study eligibility criteria for patient were as follows: AFP-producing gallbladder carcinoma (cT2aN0M0, cStage IIa, UICC 8th) or gallbladder metastasis from HCC.

Primary outcomes:
measure: To evaluate the efficacy of measuring value of AFP for patients with gallbladder cancer.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ōita
country: Japan
facility: oita Red Cross hospital
state: Oita
Study officials:
References:
Clinical trial NCT06730529: The Value of 68Ga-FAPI PET/CT in Preoperative Evaluation of Thyroid Cancer with Lymph Node Metastases
Official title: The Value of 68Ga-FAPI PET/CT in Preoperative Evaluation of Thyroid Cancer with Lymph Node Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Keywords: Thyroid Cancer
68Ga-FAPI
PET/CT
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-FAPI in the preoperative evaluation of thyroid cancer of different pathologic types.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before surgery. The imaging response measurements will be compared with the histopathological results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological and clinical diagnosis of thyroid cancer with lymph node metastases.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 16-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction.
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person.

Primary outcomes:
measure: Clinical staging of thyroid cancer with lymph node metastasis
timeFrame: Within 1 week after enrollment
Secondary outcomes:
measure: Standardized uptake value(SUV)
timeFrame: Within 1 week after enrollment
measure: Disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02565329: Serum Lactate Trend in Liver Resection
Official title: Serum Lactate Trend in Liver Resection With Intermittent Pringle Maneuver: The "Square-Root" Shape
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactase Persistence
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 133
Sex: ALL
Minimum age (years): 34
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 133 consecutive patients scheduled for liver resection for primary and secondary tumors

Brief summary: The study aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated.

Detailed description: During liver resection high serum lactate (sLac) concentration can be related to several clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing a significant increase in sLac levels during liver resection, particularly in the event of compromised liver function such as in cirrhosis.

Although the peak of sLac concentration may correlate with outcome, the lactate clearance (cLac) seems to be a better predictor. To date, this relationship has been mainly demonstrated in severe sepsis and shock septic. However, the effective correlation between the cumulative clamping time and cLac has not been clearly investigated. The correlation between cumulative hepatic ischemic time and sLac trend in the perioperative period after liver resection with intermittent PM was investigated.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for liver resection for hepatic tumors

Exclusion Criteria:

* Patients who received blood transfusion or affected by chronic renal failure were excluded

Primary outcomes:
measure: Serum lactate concentration trend after liver resection
timeFrame: within the first 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
state: Milan
Study officials:
affiliation: Humanitas Research Hospital, Humanitas University, via Manzoni 56, 20089 Milan
name: Guido Guido, Guido
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02437929: Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment
Official title: Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Pain Due to Certain Specified Procedures
Pain
Cancer
Terminal Disease
Lead sponsor: Antea Foundation
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 1079
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Terminally ill patients, cancer and non-cancer, admitted in a palliative care service (inpatients or outpatients), that are undergoing at least one procedure considered in the study, as a part of their Individual Care Plan (ICP).

Brief summary: This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.


Eligibility criteria: Inclusion Criteria:

* Patients receiving the procedures included in this study as a part of their standard care
* Patients that have expressed their consent to participate to the study by signing the informed consent document

Exclusion Criteria:

* Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) \< 20
* Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;
* Not adequately controlled background pain (average NRS in the last 24 hours is \> 4)
* Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)

Primary outcomes:
measure: 11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
timeFrame: Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Latina
country: Italy
facility: San Marco hospice
Study officials:
affiliation: Antea Foundation
name: Giuseppe Casale, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634329: Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube
Official title: Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Birth
Keywords: Preterm infants
Oro/nasogastric tube feeding
Developmental care
Parents integration
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants needing nasogastric tube feeding hospitalized at Rénaimation et médecine du nouveau né / University Hospital of Strasbourg

Brief summary: Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.

In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.

In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.


Eligibility criteria: Inclusion Criteria:

* Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
* Needing nasogastric tube feeding during at least 4 days
* With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study

Exclusion Criteria:

* ORL malformations
* Neurological dysfunction
* Sedated infant

Primary outcomes:
measure: Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.
timeFrame: 6 months
Secondary outcomes:
measure: - Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration
timeFrame: 6 monts
measure: - Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses
timeFrame: 6 monts
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Pédiatrie, CHU de Strasbourg
name: Claire ZORES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04907929: Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation
Official title: Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implants
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It has been shown that in deaf people, cortical reorganisation occurs and can accelerate age-related cognitive decline. Therefore, even though a number of Cochlear Implantation Reference Centres are setting up tests to detect cognitive disorders, these remain global and not very specific to deafness. Similarly, auditory rehabilitation could make cognitive decline reversible and bring about major changes in the cognitive functioning of patients which will be decisive for the effectiveness of speech therapy and the effectiveness of implantation. Indeed, it has been shown that, in the deaf postlingual patient, less neuronal activity in the auditory cortex and a reallocation of the cortical regions dedicated to auditory processing to visual tasks took place. This could subsequently influence the outcome of the cochlear implant. The aim of this study is therefore to evaluate the effectiveness of targeted speech therapy aimed at cognitive reorganisation on post-implant gain.


Eligibility criteria: Inclusion Criteria:

* Men or Women ≥ 18 years of age coming for consultation at the implementation centre.
* Subjects who can read and write French.
* Patients who are candidates for cochlear implantation and who have not had any contraindication to the operation following the pre-implant assessment.
* Ability to sign free and informed consent.
* Subjects with a smartphone or laptop that allows access to the application

Exclusion Criteria:

- Physical and cultural factors that may interfere with testing.

Primary outcomes:
measure: Verbal fluency test
timeFrame: 3 months
measure: Grober et Buschke's test
timeFrame: 3 months
measure: Door test
timeFrame: 3 months
measure: Hospital Anxiety end Depression scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Nicolas GUEVARA, Dr
role: STUDY_DIRECTOR
References: