louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06405620: Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
Official title: Mixed Observational Study Evaluating the Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Isolation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.


Eligibility criteria: Inclusion Criteria:

* Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.
* Children who have accepted the robot and whose parents have accepted its use in their home.
* Agreement of holders of parental authority for the inclusion of the hospitalized child.

Exclusion Criteria:

* Patient or two parents who do not have a sufficient level of French for research.
* Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.
* Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.

Primary outcomes:
measure: Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation
timeFrame: 1 month
Secondary outcomes:
measure: Psychological impact of the use of a social assistance robot on the child, his parents and his siblings
timeFrame: Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45
measure: Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service
timeFrame: Visit 2 between Day 21 and Day 45
Other outcomes:
Locations:
Study officials:
affiliation: Toulouse Hospital
name: Rémi IZOULET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06958120: Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block
Official title: Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CHD - Congenital Heart Disease
Keywords: CHD
Regional anaesthesia
Pain management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3.

Group (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Detailed description: Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment

Eligibility criteria: Inclusion Criteria:

* RACHS-1: Categories 1, 2 and 3
* Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
* Redo surgeries.

Exclusion Criteria:

* Patients whose parents or legal guardians refuse to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Coagulopathy.
* Allergy to any of the studied drugs.
* Severe pulmonary hypertension (\> 70 mmHg).

Primary outcomes:
measure: Pain assessment
timeFrame: Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abu Al reesh hospital
Study officials:
References:
Clinical trial NCT06181682: Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy
Official title: Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy


Eligibility criteria: Inclusion Criteria:

* Children of preschool age (2-6 years old).
* American scocity of anaesthesiology (ASA) I - II children.
* Expected duration of the procedure is less than 50 minutes.

Exclusion Criteria:

* Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.
* Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
* Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
* Parent's refusal.
* Emergency case.
* Allergy to any of the used drugs

Primary outcomes:
measure: Sedation status at separation from the parent
timeFrame: within 30 minutes after drugs administration
Secondary outcomes:
measure: Onset of sedation
timeFrame: within 30 minutes after drugs administration
measure: awakening time
timeFrame: within 15 minutes after end of anaesthesia
measure: post-operative emergence delirium and agitation.
timeFrame: within 30 minutes from recovery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02601482: Optimization of Interval-training in Patients With Type 2 Diabetes
Official title: Optimization of Interval-training in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Glycemic control
exercise
Interval Training
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.

This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.

Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. Sixty minutes of rest (CON)
2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).

After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* BMI \> 25

Exclusion Criteria:

* Pregnancy
* Smoking
* Contraindication to increased levels of physical activity
* Eating disorder
* Insulin dependence

Primary outcomes:
measure: Glycemic control
timeFrame: Within the first 4 hours after the intervention
Secondary outcomes:
measure: Matsuda insulin sensitivity index
timeFrame: Within the first 4 hours after the intervention
measure: Stumvoll insulin sensitivity index
timeFrame: Within the first 4 hours after the intervention
measure: Cederholm insulin sensitivity index
timeFrame: Within the first 4 hours after the intervention
measure: HOMA-2 insulin resistance index
timeFrame: Within the first 4 hours after the intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Physical Activity Research (CFAS)
Study officials:
References:
Clinical trial NCT05365282: Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
Official title: Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Nerve Injury
Carpal Tunnel Syndrome
Keywords: Transradial access
Ischemic Heart Disease
Hand Dysfunction
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of ischemic heart disease scheduled for radial CAG/PCI at Aarhus University Hospital

Brief summary: Evaluation of potential nerve damage after radial CAG/PCI.

Detailed description: Prospective patients scheduled for radial CAG/ PCI will be enrolled in the study. Prior to the procedure, sensory and motor nerve examination is performed at the wrists in both arms / hands. The examination is performed on both the median nerve and the ulnar nerve. Each patient acts as their own control. The nerve test is repeated bilaterally 1 month after the procedure. This creates 2 groups, A and B.

Patients will be asked to complete 2 questionnaires in relation to hand and arm symptoms. The patients ability to perform certain activities before and after the CAG/PCI procedure are also addressed. In addition, a diagnostic tool (Katz chart) will be completed, also before and after the CAG/PCI procedure.

Hypothesis:

Radial access is associated with an increased risk of pain and an increased incidence of nerve damage similar to the median nerve at the carpal tunnel or the ulnar nerve at the Guyon's canal.

Eligibility criteria: Inclusion Criteria:

* The patient must be able to give informed consent

Exclusion Criteria:

* Pregnancy
* Negative Barbeau test

Primary outcomes:
measure: Neurophysiological measurements
timeFrame: Aprox 1 hour
Secondary outcomes:
measure: Severity of hand symptoms and hand dysfunction
timeFrame: 10min
measure: Severity of hand symptoms and hand dysfunction
timeFrame: 10 min
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital in Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Christian J Terkelsen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04661982: Long Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer
Official title: Long Term Follow Up After Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage 0-IIIC breast cancer

Brief summary: This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.

Detailed description: PRIMARY OBJECTIVES:

I. To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.

II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.

III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.

OUTLINE:

Patients undergo long term follow-up and complete questionnaires.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer, stage 0-IIIC
* Partial or entire treatment at City of Hope
* Must be registered before adjuvant therapy and ideally before definitive local therapy

Exclusion Criteria:

* Stage IV breast cancer
* Recurrent breast cancer
* Prior cancers, chemotherapy or radiation \* (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)

Primary outcomes:
measure: Incidence rates of the study end-points
timeFrame: Up to 12 years
measure: FACT- Cog
timeFrame: Change from pre-treatment baseline over a 2-year period
measure: Cancer induced immune dysfunction
timeFrame: Up to 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Joanne Mortimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04010682: Late Pregnancy Sample Collection Study
Official title: Late Pregnancy Sample Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy pregnant volunteers

Brief summary: This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. All urine samples will be stored and used for research or product validation purposes.

The study will also gather information from volunteers regarding a woman's health during her pregnancy.

Detailed description: This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. It is anticipated 20-40 pregnant women will be recruited to the study.

Urine samples will be delivered to SPD either via post, or by hand and form part of the SPD BioBank. All urine samples will be stored and used for research or product validation purposes.

The study will also gather information from volunteers regarding a woman's health during her pregnancy, including any bleeding, discharge, discomfort, contractions/ Braxton Hicks via the use of a daily diary.

Pregnancy outcome details including labour specifics and birth outcomes such as birth date, weight, and sex of the baby will be obtained 4-6 weeks after the volunteer has given birth via email correspondence between the volunteer and study co-ordinator.

Eligibility criteria: Inclusion Criteria:

* Pregnant female in 3rd trimester of pregnancy

Exclusion Criteria:

* Prescribed bed-rest during third trimester or any other pregnancy
* complication that would affect the ability to participate in the study
* more than 38 weeks pregnant
* Have a planned caesarean section

Primary outcomes:
measure: late pregnancy urine samples
timeFrame: 4 weeks
Secondary outcomes:
measure: pregnancy complications
timeFrame: 6 weeks
measure: Live birth
timeFrame: 6 weeks
measure: Spontaneous vaginal delivery
timeFrame: 6 weeks
measure: weight of baby
timeFrame: 6 weeks
measure: multiple births
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development company Ltd.
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT04143282: Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
Official title: Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: metformin
non metastatic breast cancer
non-diabetic
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

Detailed description: the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Eligibility criteria: Inclusion Criteria:

* The non-diabetic patients will be included in the study if they meet the following criteria:

  1. Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
  2. Age between 18- 70 years.
  3. Life expectancy at least 6 months

Exclusion Criteria:

* The patients will be excluded from the study if they have the following criteria:

  1. Bad prognosis disease: Criteria defined as the following

     * If patient \>70 years
     * If patient has bad site metastasis (brain)
  2. Hypersensitivity for metformin: if happened patient will be treated as following

     • Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days \[16\].
  3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
  4. Diabetic patients.

Primary outcomes:
measure: The radiologic response rate
timeFrame: 3 months
measure: Overall survival (OS)
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.
timeFrame: 3 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Seuf University Hospital
Study officials:
affiliation: Faculty of Medicine, Beni Suef University
name: ahmed a berry, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Beni Suef University
name: ahmed h shaaban, MD
role: STUDY_DIRECTOR
affiliation: Faculty of pharmacy, Beni Suef University
name: hoda m rabea, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04321382: Subjective Perception of Ocular Prosthesis Wear
Official title: Subjective Perception of Ocular Prosthesis Wear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anophthalmos, Unilateral
Prosthesis User
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unilateral anophthalmic patients wearing an ocular prosthesis

Brief summary: The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.


Eligibility criteria: Inclusion Criteria:

* acquired anophthalmia
* Informed consent
* ocular prosthesis wear for minimum of 2 years

Exclusion Criteria:

* congenital anophthalmia
* microphthalmia

Primary outcomes:
measure: Quality of care
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
citation: Ruiters S, De Jong S, Mombaerts I. Measuring quality of care and life in patients with an ocular prosthesis. Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):2017-2025. doi: 10.1007/s00417-021-05088-1. Epub 2021 Feb 6.