louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05803291: Evaluation of Continuity of Care of Children With Special Health Needs
Official title: Children With Special Health Needs. Evaluation of Continuity of Care and Integrated Hospital-territory Care Pathways in Friuli Venezia Giulia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children With Special Health Needs
Keywords: Special health needs
Continuity of care
Care coordination
Children
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study involves pediatric patients with special health care needs recruited at IRCCS Burlo Garofolo over a 12-month period and followed prospectively for the next 12 months (follow-up)

Brief summary: Children and adolescents with special health care needs represent a small but relevant subset of the pediatric population due to high costs for the health care system, risk of lower quality of care, unmet health care needs, and negative health outcomes. Coordination of care and continuity of care are essential issues of appropriate care for these patients, as showed also by the "Special Needs Kids" project, carried out in Emilia Romagna. This project showed the potential for family pediatricians (FP) in Italy to serve as care coordinators and facilitate the implementation of integrated care pathways for children with special health care needs. In Friuli-Venezia Giulia (FVG), a system of "continuity of care" for patients with special needs was developed and implemented. This system integrate hospital and community care in a network involving also FPs, General Practitioner and different actors of social and health services. The aim of this study is to prospectively evaluate the continuity of care provided to children and adolescents with special health needs residing in the FVG region.


Eligibility criteria: Inclusion Criteria:

* Subjects with special health care needs requiring continuity of care and integrated home care
* Age between 0 to 17 years
* Residence in FVG region
* Outpatient, inpatient or emergency care admission at the IRCCS Burlo Garofolo hospital, Trieste, Italy

Exclusion Criteria:

-

Primary outcomes:
measure: To assess health care providers activities using the Special Needs Kids instrument
timeFrame: Through study completion, an average of 12 months
measure: To assess parents' perspective on continuity of care using the Special Needs Kids Questionnaire
timeFrame: At 10 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Elisa Zanello, MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06208891: Clinical Outcomes of Robotic Myomectomy
Official title: Clinical Outcomes of Robotic Myomectomy: Comparisons of Without Versus With Temporary or Permanent Uterine Artery Occlusion.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Women With Uterine Myoma
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who received robotic-assisted myomectomy

Brief summary: To identify the predictors of perioperative outcomes in women who receive robotic myomectomy

Detailed description: Uterine myoma is the most common gynecological tumor. Current surgical management was inclusive of conventional abdominal myomectomy, laparoscopy-assisted myomectomy, robotic-assisted myomectomy. The aim of this study was to identify the predictors of perioperative outcomes in women who receive robotic myomectomy

Eligibility criteria: Inclusion criteria

* \>20 years old women
* women who received robotic myomectomy

Primary outcomes:
measure: Surgical time
timeFrame: 1 week
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: 1 week
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02614391: Tablet Distraction for Pain Control During Venipuncture
Official title: Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief
Keywords: Procedural pain
Phlebotomy
Distraction
Videogame
Computer tablet
Child
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.

The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.

Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.

The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.


Eligibility criteria: Inclusion Criteria:

* Age 4 to 13 years
* Need for venipuncture
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Children with epilepsy
* Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
* Inability to perform venipuncture on hand or arm
* Children with cognitive impairment or unable to report their pain verbally

Primary outcomes:
measure: Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
timeFrame: Intraprocedural (an average of 5 minutes)
Secondary outcomes:
measure: Success at first attempt
timeFrame: Intraprocedural (an average of 5 minutes)
measure: Adverse events
timeFrame: Up to 15 minutes after the procedure
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Franca Crevatin, RN
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo
name: Franca Crevatin, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864091: Different Manufacturing Techniques of Facial Prostheses
Official title: Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facial Defects
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction.

* (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin.
* Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern.
* Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated.
* The negative molds of both groups 2\&3 will be used in packing medical grade silicone (to cast the final prosthesis.
* All final prostheses will be colored and characterized to match the surrounding anatomy.
* Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
* Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.


Eligibility criteria: Inclusion Criteria:

1. Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
2. Patients between 20-60 years old.
3. Post traumatic patients with facial defects.
4. Patients with congenital facial defects.
5. Patients with failed facial surgical construction.
6. Compliant and cooperative patients.

Exclusion Criteria:

1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.

Primary outcomes:
measure: Esthetic Outcomes
timeFrame: 3 months
Secondary outcomes:
measure: Prosthesis Accuracy
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01584791: Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: CAD
PCI
Percutaneous Coronary Intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical co., ltd.
First posted: 2012-04-25
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.


Eligibility criteria: Inclusion Criteria:

* Korean men and women between the age of 20 and 85
* Patients who were diagnosed as having CAD
* Patients who were planned to undergo PCI

Exclusion Criteria:

* Patients who were not treated with PCI or intended to treat with PCI but failed
* Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
* Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
* Patients who were had hypersensitivity to clopidogrel or aspirin
* Patients who were had abnormal laboratory results indicative of liver disease
* Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
* Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
* Patients who were had other contraindication to study drug
* Patients who were had participated in another clinical study within 4 weeks prior to the start of this study

Primary outcomes:
measure: The percentage of P2Y12 receptor inhibition
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events after study medication
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park JB, Koo BK, Choi WG, Kim SY, Park J, Kwan J, Park CG, Kim HS. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther. 2013 Jan;35(1):28-37.e4. doi: 10.1016/j.clinthera.2012.12.004.
Clinical trial NCT03841591: Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
Official title: Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gestational Diabetes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 124
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.


Eligibility criteria: Inclusion Criteria:

* Patients aged (19-35) years
* BMI 18-30 kg/m2
* Gestational age \>24 weeks
* Singleton pregnancy
* Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG \> 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

Exclusion Criteria:

* Pregnant women with preexisting diabetes mellitus
* Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
* Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
* Fetal anomalies identified on ultrasound prior to initiation of therapy.
* Patients who refused to participate

Primary outcomes:
measure: Rate of maternal weight gain per week
timeFrame: 4 months
Secondary outcomes:
measure: 1-min APGAR score
timeFrame: 1 minute
measure: 5-min APGAR score
timeFrame: 5 minutes
measure: Incidence of neonatal hypoglycemia
timeFrame: 1 day
measure: Incidence of neonatal respiratory distress
timeFrame: 1 day
measure: Incidence of macrosomia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: S Hamdy
name: Sinaa Hamdy, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770991: Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Official title: A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Familial Adenomatous Polyposis
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Ohio State University Comprehensive Cancer Center
First posted: 2008-10-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy
* Have an endoscopically assessable rectal segment
* Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration.

Exclusion Criteria:

* Known allergies or hypersensitivity to berries
* Diabetes mellitus
* Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.

Primary outcomes:
measure: Change From Baseline to End of Study in Number of Rectal Polyps
timeFrame: Baseline and 36 weeks
measure: Change in Burden of Rectal Polyps
timeFrame: Baseline and 36 weeks
Secondary outcomes:
measure: Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
timeFrame: baseline and 36 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Carol A Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745091: MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
Official title: Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectum Cancer
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: locally advance middle and low rectal cancer

Brief summary: Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed

Detailed description: Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response

Eligibility criteria: Inclusion Criteria:

middle and low rectal cancer

Exclusion Criteria:

* Distant metastasis

Primary outcomes:
measure: Complete pathologic response
timeFrame: after surgical excision with follow up of an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alexandria
name: Khaled Madbouly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01545791: Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes
Official title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Through Intensification and Control to Target: An International Variability Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 1037
Sex: ALL
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with type 1 or type 2 diabetes mellitus was eligible for the study, including newly diagnosed patients who had never received insulin or an insulin analogue before

Brief summary: This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.


Eligibility criteria: Inclusion Criteria:

* Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before

Exclusion Criteria:

* Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
* Patients previously enrolled in this study
* Patients with a hypersensitivity to insulin detemir

Primary outcomes:
measure: Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events
timeFrame: Weeks 0-26
Secondary outcomes:
measure: Number of serious adverse events (SAEs)
timeFrame: Weeks 0-26
measure: Number of all adverse events (AEs)
timeFrame: Weeks 0-26
measure: Number of all hypoglycaemic events
timeFrame: In the 4 weeks preceeding week 26
measure: Weight change
timeFrame: Week 0, week 26
measure: Glycosylated haemoglobin (HbA1c)
timeFrame: Week 26
measure: Variability in fasting plasma glucose (FPG)
timeFrame: Week 26
measure: Average plasma glucose level
timeFrame: Week 26
measure: Quality of Life as assessed by a treatment satisfaction questionnaire
timeFrame: Week 26
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: