louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06989060: Nutritional Status in Children With Down Syndrome
Official title: Assessment of Nutritional Status and Detection of Nutritional Deficiencies in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Down Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with Down's syndrome Age between 2- 5 years of both sexes

Brief summary: To evaluate the nutritional status of children with Down's syndrome and to determine the prevalence of nutritional deficiencies among those children.

To discuss factors associated with their nutritional status, such as dietary habits and comorbid health conditions.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of children with Down's syndrome Age between 2- 5 years of both sexes

Exclusion Criteria:

Children diagnosed with any other chronic illness or any other medical problem

Primary outcomes:
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university child hospital
Study officials:
affiliation: assiut university child hospital
name: Osama M Asheer, professor of pediatrics
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371860: Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
Official title: Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
HER2-positive Breast Cancer
Keywords: HER2
partial mastectomy
lumpectomy
sentinel node biopsy
axillary node dissection
pathologic complete response
breast cancer
HER2-positive
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 40 years
* Patients must have a tissue diagnosis of HER2+ breast cancer
* Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
* Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
* Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.
* Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)

Exclusion Criteria:

* Breastfeeding
* Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
* Prior adjuvant radiation therapy
* Patients with diagnosis of inflammatory breast cancer
* Patients with known BRCA mutation or other known breast cancer related deleterious mutations

Primary outcomes:
measure: Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
timeFrame: At time of consent. Assessed up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Armando Giuliano, MD, FACS, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037660: Effects of Lipemia and Metformin on Endothelial Function
Official title: Effects of Lipemia and Metformin on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Disease
Keywords: endothelium
cardiovascular disease
dietary fat
insulin resistance
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood). A similar response is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition). The present study is designed to help us understand the effects of a fat load on blood vessel function. We will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of blood vessels during a fat load. This study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy (defined as positive urine pregnancy test)
* Diabetes Mellitus (Clinical history or random blood glucose\>140 mg/dl)
* Hypertension (Clinical history or SBP\>140 or DBP\>90 mmHg)
* History of adverse reaction to metformin
* Abnormal renal function (Serum creatinine\>1.4 mg/dl)
* Abnormal liver function (AST or ALT greater than two times the upper limit of normal)
* Administration of iodinated contrast within 7 days
* History of congestive heart failure
* Abnormal clotting parameters (INR\>1.5 or PTT\>40 sec)
* Anemia (HCT\<30%)
* Allergy to soy or egg
* Allergy to heparin
* The potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 6 hours
Secondary outcomes:
measure: blood lipid levels
timeFrame: 6 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Naomi Hamburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235560: Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients
Official title: Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AML
Rapamycin
Elderly
Elderly patients not eligible for intensive chemotherapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organisation
First posted: 2005-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.

Detailed description: Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin

Eligibility criteria: Inclusion Criteria:

* Informed consent
* de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy.
* Previously untreated

Exclusion Criteria:

* Renal impairment (serum creatinin \>2N)
* Hepatic impairment (TGO ou TGP \> 5N), une cholestase (Phosphatases Alcalines or gamma-GT \> 5N),bilirubin \> 3N

  * Blast crisis CML
  * Acute Promyelocytic Leukemia.

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: tolerability
measure: bioclinical markers of response
Other outcomes:
Locations:
city: Angers
country: France
facility: Service d'Hématologie, CHU
city: BESANçON
country: France
facility: Service d'Hématologie, Hôpital Jean Minjoz
city: Toulouse
country: France
facility: Service d'Hématologie CHU Purpan
Study officials:
affiliation: CHU Toulouse
name: RECHER Christian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Recher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. doi: 10.1182/blood-2004-06-2494. Epub 2004 Nov 18.
Clinical trial NCT06592560: Asprosin in Breast Cancer
Official title: Diagnostic Value of Asprosin As a Biomarker in Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients

Brief summary: To evaluate the clinical utility of Asprosin measurement in breast cancer patients in comparison with healthy controls and patients with benign breast lesions.

To compare between Asprosin and the routine markers (CEA, CA15-3) as biomarkers for breast cancer diagnosis


Eligibility criteria: Inclusion Criteria:

-

Females aged (40 ± 20 years) who did not receive any chemotherapy or surgical treatment and they will be divided as follow:

Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients.

Exclusion Criteria:

* 1- Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.

Primary outcomes:
measure: Diagnostic value of Asprosin as a biomarker in breast cancer
timeFrame: Baseline
Secondary outcomes:
measure: Diagnostic value of Asprosin as a biomarker in breast cancer
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00967460: Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity and Quality of Life of Children in Childcare Settings
Official title: Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity, Quality of Life and BMI of Children in Childcare Settings (Youp'là Bouge)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inactivity
Keywords: Childhood obesity
Children
Inactivity
Physical activity
Motor skills
Motor fitness
Quality of life
Nutrition
Family
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: University of Basel
name: University of Zurich
First posted: 2009-08-27
Enrollment: 1764
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (PA) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (BMI), quality of life and PA and behavior of the family.

Detailed description: The study will last one school year and includes 58 childcare centers in 3 provinces (JU, NE, VD) of the French part of Switzerland.

Eligibility criteria: Inclusion Criteria:

* Children in selected childcare centers

Primary outcomes:
measure: Motor skills
timeFrame: 1 school year
Secondary outcomes:
measure: Physical activity
timeFrame: 1 school year
measure: Enjoyment of physical activity
timeFrame: 1 school year
measure: BMI
timeFrame: 1 school year
measure: Quality of life
timeFrame: 1 school year
measure: Physical activity and behavior of the family
timeFrame: 1 school year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Ligues de la santé
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
city: Lausanne
country: Switzerland
facility: University of Lausanne
Study officials:
References:
citation: Bonvin A, Barral J, Kakebeeke TH, Kriemler S, Longchamp A, Schindler C, Marques-Vidal P, Puder JJ. Effect of a governmentally-led physical activity program on motor skills in young children attending child care centers: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2013 Jul 8;10:90. doi: 10.1186/1479-5868-10-90.
Clinical trial NCT03866460: Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children
Official title: Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Retinoblastoma
Hearing Loss
Keywords: Hearing Status
18-529
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified from the retinoblastoma clinic when the treatment plan includes IA carboplatin chemotherapy.

Brief summary: The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent indicating awareness of the investigational nature of the protocol.
* Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy.

  * Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants

Exclusion Criteria:

* Children with known and documented preexisting hearing loss.

Primary outcomes:
measure: Estimate the incidence of hearing loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary Elizabeth Davis, MSN, RN, AOCNS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528160: Pain Neuroscience Education for Older Adults
Official title: Pain Neuroscience Education for Older Adults With Pain From Primary Care: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. It will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.


Eligibility criteria: Inclusion Criteria:

* be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body.

Exclusion Criteria:

* presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.

Primary outcomes:
measure: Inclusion rate
timeFrame: 9 weeks
measure: Refusal rate
timeFrame: 9 weeks
measure: Exclusion rate
timeFrame: 9 weeks
measure: Dropout rate
timeFrame: 9 weeks
measure: Retention rate
timeFrame: 9 weeks
measure: Number of participants reporting adverse events
timeFrame: 9 weeks
measure: Perception of participants towards the intervention structure and content
timeFrame: 9 weeks
Secondary outcomes:
measure: Pain severity and interference
timeFrame: Baseline
measure: Pain severity and interference
timeFrame: 9 weeks
measure: Pain severity and interference
timeFrame: 6 months
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: 9 weeks
measure: Pain catastrophizing
timeFrame: 6 months
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: 9 weeks
measure: Depression
timeFrame: 6 months
measure: Fear of movement
timeFrame: Baseline
measure: Fear of movement
timeFrame: 6 weeks
measure: Fear of movement
timeFrame: 6 months
measure: Knowledge of pain neuroscience
timeFrame: Baseline
measure: Knowledge of pain neuroscience
timeFrame: 9 weeks
measure: Knowledge of pain neuroscience
timeFrame: 6 months
measure: Gait velocity
timeFrame: Baseline
measure: Gait velocity
timeFrame: 9 weeks
measure: Gait velocity
timeFrame: 6 months
measure: Postural control
timeFrame: Baseline
measure: Postural control
timeFrame: 9 weeks
measure: Postural control
timeFrame: 6 months
measure: Self-perceived disability
timeFrame: Baseline
measure: Self-perceived disability
timeFrame: 9 weeks
measure: Self-perceived disability
timeFrame: 6 months
measure: Perception of change
timeFrame: 9 weeks
measure: Perception of change
timeFrame: 6 months
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: School of Health Sciences
Study officials:
References:
Clinical trial NCT06866860: Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants
Official title: Evaluation of Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants in Mandibular Posterior Region (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Patient specific surgical guides (PSG) have been widely used to achieve a precise 3D implant position. However, they prevent external cooling systems from reaching the osteotomy site sufficiently. So, heat generated during guided implant surgery is greater than free hand technique. Adding internal irrigation channel to the conventional surgical guides allows better diffusion of irrigation to the osteotomy site and reduces heat generation.

Aim of the study: Is to introduce a patient specific surgical guide design with internal irrigation system and compare it to the conventional surgical guide with external irrigation clinically through bone temperature, implant stability and radiographically by CBCT through crestal bone loss and bone density.


Eligibility criteria: Inclusion Criteria:

* Patient with missing mandibular posterior premolar or molar teeth.
* Tooth extraction at the implant sites was performed at least 4 months before the surgery.
* Residual alveolar bone height more than 10 mm.
* With minimum alveolar bucco-lingual dimension of 6 mm.
* Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.

Exclusion Criteria:

* Severe atrophic alveolar ridge (height less than 10mm, width less than 6mm).
* Bad oral hygiene ( Silness-Löe index (score 2-3).
* Heavy smoker (smoke greater than or equal 25 cigarettes per day).
* Presence of acute infections or periapical lesions in adjacent teeth.
* Parafunctional habits.
* Pregnant females.

Primary outcomes:
measure: change in implant stability
timeFrame: Baseline and 4 months
measure: change in postoperative oedema
timeFrame: 2nd day, 1 week and 2 weeks
Secondary outcomes:
measure: Presence of intra or postoperative complications
timeFrame: 4 months
measure: change in crestal bone loss
timeFrame: baseline and 4 months
measure: change in bone density
timeFrame: baseline and 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References: