louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02882373: Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury
Official title: L-Arginine For Anti-VEGF Induced Kidney Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Drug-Induced Nephropathy
Hypertension
Proteinuria
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up within 1 month.

Eligibility criteria: Inclusion Criteria:

* On or enrolled for anti-VEGF therapy
* Systolic Blood Pressure \>= 140 mm Hg
* Diastolic Blood Pressure \>= 90 mm Hg
* Proteinuria \>= 500 mg/day or worsening glomerular filtration rate (GFR) (\> 0.3 mg/dl in 48 hours \[hrs.\] or \> 50% decline from baseline creatinine in 1 week)

Exclusion Criteria:

* Allergy to L-arginine
* Systolic Blood Pressure \< 140 mm Hg
* Diastolic Blood Pressure \< 90 mm Hg
* Proteinuria \< 500 mg/day
* Continuous tube feeds (since the medication will be given in-between meals)

Primary outcomes:
measure: Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
timeFrame: Baseline up to 3 months
Secondary outcomes:
measure: Improved glomerular filtration rate (GFR) >= 25%
timeFrame: Baseline up to 3 months
measure: Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg
timeFrame: Baseline up to 3 months
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: Farhad Danesh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06839573: Effectiveness of Immersive Virtual Reality in Nursing Students' Learning
Official title: Effectiveness of Immersive Virtual Reality to Improve Learning Outcomes in Nursing Degree Students: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Informed Consent
Keywords: Virtual reality
nursing students
Learning Outcomes
Inmersive virtual reality
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Barcelona
name: Universidad Complutense de Madrid
First posted: 2025-02-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.
Primary purpose: OTHER

Brief summary: Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.


Eligibility criteria: Inclusion Criteria:

- having completed the scheduled in-person simulation in previous years of the degree .

Exclusion Criteria:

-the student does not sign the informed consent to participate in the study.

Primary outcomes:
measure: Compare the satisfaction
timeFrame: Five months
measure: Compare the self-confidence
timeFrame: Five months
Secondary outcomes:
measure: To compare the acquisition of knowledge in each teaching group.
timeFrame: Five months
measure: To compare the acquisition of skills in each teaching group.
timeFrame: Five months
measure: To evaluate students' tolerance to VR headset technology.
timeFrame: Five months
measure: To assess the usability of VR headsets by students.
timeFrame: Five months
measure: To analyze the costs of traditional teaching with in-person simulation compared to teaching with VR.
timeFrame: Five months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06994273: Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries
Official title: Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesic
Sedative
Fentanyl
Dexmedetomidine
Infusion
Postoperative
Mechanical Ventilation
Children
Open Abdominal Surgeries
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.

Detailed description: Appropriate sedation and analgesia are essential components in the post-operative care of critically ill children in the pediatric intensive care unit (PICU), especially those who need mechanical ventilation.

Fentanyl is an opioid analgesic that is 50-100 times more potent than morphine. It is used frequently because of its ability to provide rapid analgesia. A single dose of fentanyl significantly reduced pain behaviors and changes in heart rate. It also increased the growth hormone level.

Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with significant sedative and analgesic effects. Some studies have investigated its role in adult and pediatric intensive care, as a primary sedative or a second line following failure of benzodiazepines or opioid sedation, as a bridge for extubation, for substance withdrawal, and to decrease intensive care unit (ICU) delirium.

Eligibility criteria: Inclusion Criteria:

* Age from 4 to 11 years.
* Both sexes.
* Children who required a minimum of 24 hrs of mechanical ventilation following open abdominal surgeries

Exclusion Criteria:

* Patients with significant congenital anomalies.
* Chromosomal abnormalities.
* Neurologic conditions prohibiting sedation evaluation.
* Neuromuscular diseases.
* Those receiving neuromuscular blockers

Primary outcomes:
measure: Weaning eligibility
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Time from eligibility to extubation
timeFrame: 60 min postoperatively
measure: Mean arterial pressure
timeFrame: 48 hours post-infusion initiation
measure: Heart rate
timeFrame: 48 hours post-infusion initiation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03784573: Canine-Assisted Anxiety Reduction In Emergency Care
Official title: Canine-Assisted Anxiety Reduction In Emergency Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Opioid Use
Children
Therapy Dog
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. We will also measure galvanic skin response (resistance to electrical current).

Detailed description: This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient stress. The organization "Paws of Love" estimates that it has 180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer their time in emergency care. The benefits may include improved perception of wellness, less opioid use, and decreased use of physical and chemical restraints. As a further extrapolation, this secondary effect may extend to improved patient-doctor communication and patient experience. This will in turn improve patient safety in the Emergency Department, decreasing the number of adverse events, and decreasing the risk of medical malpractice by improving the patient-provider relationship. (6, 7)

Eligibility criteria: Inclusion Criteria:

* 4-17 years old;
* Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety

Exclusion Criteria:

- violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.

Primary outcomes:
measure: Change in anxiety level of subject
timeFrame: 45 minutes
Secondary outcomes:
measure: Perception of anxiety level from physician
timeFrame: 60 minutes
measure: Perception of pain level from physician
timeFrame: 60 minutes
measure: Perception of anxiety level from parent(s)
timeFrame: 60 minutes
measure: Perception of pain level from parent(s)
timeFrame: 60 minutes
measure: Meds
timeFrame: 4 hours
measure: Physical restrain use
timeFrame: 4 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Riley Children's Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT05512273: Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density
Official title: Evaluation of Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density. (Randomized Controlled Clinical Trial- Split Mouth Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Osteotomy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth
Primary purpose: TREATMENT

Brief summary: The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral missing premolars
* Remaining bone height more ≥ 10mm.
* Remaining bone width ≥ 6mm

Exclusion Criteria:

* patients that smoke more than 10 cigarettes/day
* Patients with uncontrolled systemic disease.
* Presence of bone pathology within the future osteotomy site

Primary outcomes:
measure: Time of surgery
timeFrame: through operation completion
measure: Change in implant stability
timeFrame: at baseline and 4 months
measure: Change in bone density
timeFrame: at baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Arab University
Study officials:
References:
Clinical trial NCT01647373: Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling
Official title: Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhegmatogenous Retinal Detachment
Keywords: retinal detachment
scleral buckle
silicone sponge
axial length
surgery included silicone sponge scleral buckling
retina currently attached
at least 6 months after surgery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 6 months after succesful retinal detachment surgery, with silicone sponge scleral buckling, currently attached, and with IOL Master pre-surgery Axial Length measurement .

Brief summary: All existing medical literatue regarding axial length (AL) changes after scleral buckling surgery for retinal detachment, descibes changes after solid silicone buckling. In this hospital, the investigators use only silicone sponge buckling, which has different properties and a different buckle profile. there are no studies in the literature describing tha AL changes after sponge buckling, or whether the AL change is less or more than with solid silicone buckles. The investigators wish to determine whether the AL change profile with their silicone sponge is significantly different, and if so, whether this is clinically important in determining the better choice of buckle material to be preferred.


Eligibility criteria: Inclusion Criteria:

* Patients at least 6 months after succesful retinal detachment surgery
* with silicone sponge scleral buckling
* currently attached
* with IOL Master pre-surgery Axial Length measurement

Exclusion Criteria:

* patients with failed surgery and currently detached
* patients with vitreos silicone oil tamponade
* patients with radial or other non-circumference buckles
* patients with unclear media not amenable to IOL Master exam

Primary outcomes:
measure: Axial length in eye as measured by Zeiss IOL Master.
timeFrame: Single non-invasive measurement at 1 time point.
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir hospital, dept. Of ophthalmology
city: Kfar Saba
country: Israel
facility: Retina Service, Meir Hospital
Study officials:
affiliation: Retina Service, Meir Hospital
name: Alex Rubowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366873: Evaluation of Mineral Absorption in Infants Fed Infant Formula
Official title: Evaluation of Mineral Absorption in Infants Fed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Infant
Term
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 44
Sex: ALL
Minimum age (years): 56
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Detailed description: Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.

Eligibility criteria: Inclusion Criteria:

* Healthy, term infants

Exclusion Criteria:

* Breast fed infants
* Use of vitamin/mineral supplements
* Currently on medication

Primary outcomes:
measure: Calcium absorption
timeFrame: 14 days
Secondary outcomes:
measure: Vitamin D levels
timeFrame: 14 days
Other outcomes:
Locations:
city: Coralville
country: United States
facility: Fomon Infant Nutrition Unit
state: Iowa
city: Louisville
country: United States
facility: Pediatric Clinical Trials Unit
state: Kentucky
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Children's Research and Nutrition Center
state: Texas
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: James Heubi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180673: Counseling Older Adults to Control Hypertension
Official title: Counseling Older Adults to Control Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Hypertension
Older Adults
Motivational Interviewing
Lifestyle Counseling
Senior Centers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Columbia University
First posted: 2010-08-12
Enrollment: 251
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention delivered through group-based counseling and motivational interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a randomized control trial.


Eligibility criteria: Inclusion Criteria:

* Age 60 years or older
* Diagnosis of HTN
* Taking at least one anti-hypertensive medication
* Self-identified Black, African American, or Latino

Exclusion Criteria:

* Unable to comply with the study protocol
* Participation in other hypertension studies
* Severe hearing impairment
* Severe visual impairment
* Arm circumference \> 42 cm for large cuff, or arm circumference \> 52 cm for extra large cuff (if extra large cuff is available)

Primary outcomes:
measure: Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in physical activity level from baseline to 12 months
timeFrame: 12 months
measure: Percent change in weight from baseline to 12 months
timeFrame: 12 months
measure: Change in number of daily servings of fruits and vegetables from baseline to 12 months
timeFrame: 12 months
measure: Proportion of participants with adequate blood pressure control at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Senior Centers affiliated with NYC Department for the Aging
state: New York
Study officials:
affiliation: NYU Langone Health
name: Olugbenga Ogedegbe, MD, MS, MPH, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogedegbe G, Fernandez S, Fournier L, Silver SA, Kong J, Gallagher S, de la Calle F, Plumhoff J, Sethi S, Choudhury E, Teresi JA. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults. Contemp Clin Trials. 2013 May;35(1):70-9. doi: 10.1016/j.cct.2013.02.008. Epub 2013 Feb 24.
Clinical trial NCT04576273: Enterobius Vermicularis Infestation of the Appendix
Official title: Enterobius Vermicularis in Appendectomy Specimens; Clinicopathological Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parasitic Disease
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 1150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Saudi and non- Saudi patients suffering from acute appendicitis symptoms

Brief summary: This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.

Detailed description: All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.

Eligibility criteria: Inclusion Criteria:

All routine examined appendectomy specimens

Exclusion Criteria:

Cases with clinical suspicion of tumor Cases attached to the colectomy specimens

Primary outcomes:
measure: Association between acute inflammation and Enterobius vermicularis infestation
timeFrame: 3 years
measure: Incidence of Appendiceal Enterobius vermicularis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baljurashi
country: Saudi Arabia
facility: Abdulkarim Hasan
Study officials:
References:
Clinical trial NCT03775473: PROgastrine COlon DEpistage
Official title: Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer Screening
Healthy Person
Keywords: progastrin
screening
bio-marker
healthy person
early stage
Lead sponsor: ECS-Progastrin SA
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Princesse Grace
First posted: 2018-12-14
Enrollment: 260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional Research, at Risk and Minimal Constraints, Category 2
Primary purpose: DIAGNOSTIC

Brief summary: Dosage of progastrin in asymptomatic person participating in colon cancer screening

Detailed description: For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco and who has signed the informed consent document. A blood test will be performed in addition to the screening test to assess the rate of progastrin.

Eligibility criteria: Inclusion Criteria:

* participant in colon cancer screening
* signing informed consent

Exclusion Criteria:

* any major medical, psychiatric or addictive illness that would affect the informed consent process
* The consent of a representative is not allowed in this study

Primary outcomes:
measure: progastrin rate
timeFrame: from 15 days to 2 months (until results are obtained)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Princesse Grace, Monaco
state: MC
Study officials:
affiliation: Centre Hospitalier Princesse Grace
name: Georges GARNIER
role: PRINCIPAL_INVESTIGATOR
References: