louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00631397: A Preliminary Study of Bone Density in Neonates
Official title: A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenia Of Prematurity
Keywords: weakening of the bones
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature Infants In the Neonatal Intensive Care Unit

Brief summary: The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.

Detailed description: premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study

Eligibility criteria: Inclusion Criteria:

* premature infants born less than 33 weeks, weighing less than 1500 gms

Exclusion Criteria:

* congenital anomalies weight greater than 1500 gms

Primary outcomes:
measure: Develop ways to prevent and treat Osteopenia of Prematurity
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital/University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Terri L Ashmeade, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065883: The Community United to Challenge Asthma
Official title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.


Eligibility criteria: Inclusion Criteria:

* Puerto Rican
* In high school
* Have asthma

Exclusion Criteria:

* More than 18 years old
* In last year of school
* Mild intermittent or controlled asthma

Primary outcomes:
measure: asthma medication adherence
timeFrame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
Secondary outcomes:
measure: asthma trigger reduction
timeFrame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J Asthma. 2015 Feb;52(1):59-70. doi: 10.3109/02770903.2014.950426. Epub 2014 Aug 27.
citation: Martin MA, Thomas AM, Mosnaim G, Greve M, Swider SM, Rothschild SK. Home asthma triggers: barriers to asthma control in Chicago Puerto Rican children. J Health Care Poor Underserved. 2013 May;24(2):813-27. doi: 10.1353/hpu.2013.0073.
citation: Martin MA, Olson D, Mosnaim G, Ortega D, Rothschild SK. Recruitment, asthma characteristics, and medication behaviors in Midwestern Puerto Rican youth: data from Project CURA. Ann Allergy Asthma Immunol. 2012 Aug;109(2):121-7. doi: 10.1016/j.anai.2012.06.005. Epub 2012 Jun 26.
Clinical trial NCT06443983: Artificial Intelligence Supported Case Analysis on Nursing Education
Official title: The Effect of Artificial Intelligence Supported Case Analysis on Nursing Students' Case Management Performance and Satisfaction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence
Nursing Education
Nursing Students
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, students will be divided into two groups: those who take an AI-supported case lesson and those who take a standard case lesson.
Primary purpose: OTHER

Brief summary: Background: Rapid developments in the field of artificial intelligence have begun to necessitate changes and transformations in nursing education.

Objective: This study aimed to evaluate the impact of an artificial intelligence-supported case created in the in-class case analysis lecture for nursing students on students' case management performance and satisfaction.

Design: This study was a randomized controlled trial. Method: The study involved 188 third-year nursing students who were randomly assigned to either the AI group (n=94) and control group (n=94). An information form, case evaluation form, knowledge test, and Mentimeter application were used to assess the students' case management performance and nursing diagnoses. The level of satisfaction with the case analysis lecture was evaluated using the VAS scale.


Eligibility criteria: Inclusion Criteria:

* having taken nursing process lecture before
* having planned care for at least one surgical patient in clinical practice before
* having a mobile phone with internet connection

Exclusion Criteria:

* not attending the case analysis lecture
* not being an active student
* incomplete completion of the data collection forms
* not accepting to participate in the study

Primary outcomes:
measure: Case management performance
timeFrame: 3 hours
measure: Case Satisfaction
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Seda Akutay, Ress. Asst.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03494283: CrossFit's Injuries Study in Grand Nancy Clubs During 2018-2019
Official title: Prospective Epidemiological Study of Injuries Encountered in the Practice of CrossFit in Grand Nancy Clubs Over a Period of 8 Months.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CrossFit Injuries
Keywords: CrossFit injuries
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women

* 18 years and over
* Practicing Crossfit in a club of the Grand Nancy
* Information and non-opposition to research

Brief summary: CrossFit is a recent sport that has been democratized since the beginning of the 2000's in France. The 3 major studies of CrossFit injuries were conducted in the United States in 2014, Brazil in 2016 and the United States in 2017. They show a discrepancy in terms of injuries average, from 19.4% to 31% in relation to an upsurge in the number of CrossFit practitioners, the specific training or not of the coaches framing this activity, the practice or not in competition. The main locations of these wounds are highlighted at the shoulders, lumbar region and knees. In France, to date, no epidemiological studies have been conducted on this subject.

Hypothesis: High incidence of injuries related to a lack of framing, or bad practice and ignorance of CrossFit practitioners.

Objectives : Estimate the injuries incident due to the CrossFit practice over a 8-month period in an adult population who practice in clubs .

Research, among the anthropometric, sociodemographic, environmental, and the nature and frequency of practice and training sessions, those which are associated with the occurrence of injury in this cohort.


Eligibility criteria: Inclusion Criteria:

Men and women

* 18 years and over
* Practicing CrossFit in a club of the Grand Nancy
* Information and non-opposition to research

Exclusion Criteria:

* Opposition to study

Primary outcomes:
measure: CrossFit's injuries follow-up questionaire
timeFrame: each month during 8 months
Secondary outcomes:
measure: CrossFit's injuries inclusion questionaire .
timeFrame: At inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT03005483: Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Official title: Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Orthopedic Disorder
Keywords: GABAPENTIN POSTOPERATIVE PAIN CHILD
Lead sponsor: Hospital Infantil Albert Sabin
Sponsor class: OTHER
Collaborators: name: Fortaleza University
First posted: 2016-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.

Detailed description: This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .

Eligibility criteria: Inclusion Criteria:

Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery

Exclusion Criteria:

Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.

Primary outcomes:
measure: Reduce the pain intensity using the Face Pain Scale
timeFrame: 24 hour
Secondary outcomes:
measure: Reduce the opioid consumption through 24 hours postoperative observation
timeFrame: 24 hour
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Infantil Albert Sabin
state: Ceara
Study officials:
affiliation: Fortaleza University
name: Josenília Gomes, PhD
role: STUDY_CHAIR
References:
citation: Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
citation: Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
Clinical trial NCT06033183: Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Official title: Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiosensitivity
Pediatric Cancer
Radiation Toxicity
Lead sponsor: Neolys
Sponsor class: INDUSTRY
Collaborators: name: Centre Francois Baclesse
name: Centre Hospitalier Universitaire de Caen
name: Institut de cancÃ©rologie Strasbourg Europe
name: Centre Oscar Lambret, Lille, France
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Analysis of the individual radiosensitivity in pediatric oncology


Eligibility criteria: Inclusion Criteria:

* Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes.
* Children or adolescents \> 3 years old and \< 18 years old
* Patient with an indication for radiotherapy as part of the primary tumor local control strategy
* Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
* Patient affiliated with a social security scheme
* Patient and/or parents or holders of parental authority having dated and signed an informed consent

Exclusion criteria:

* Patients with contraindications to blood sampling
* Patients with contraindications to radiotherapy
* Palliative radiotherapy
* Patient with previous RT treatment in the same area (re-irradiation)
* Patient with an indication of hypofractionated RT
* Patient follow-up not possible
* Persons deprived of liberty or under guardianship (including curatorship)

Exclusion Criteria:

-

Primary outcomes:
measure: Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
timeFrame: 24 months
measure: Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
timeFrame: 24 months
Secondary outcomes:
measure: Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
timeFrame: 12 months
measure: Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
References:
Clinical trial NCT00509483: Three-Year Follow-up of Radioiodine Therapy for Goitre
Official title: Long-Term Follow-up and Outcome of Administering Recombinant Human Thyrotropin as an Adjuvant of Therapy With Radioiodine in the Outpatient Treatment of Multinodular Goitres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tratment of Multinodular Goitre
Keywords: multinodular
goitre
recombinant human TSH
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.

Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine therapy outcome in MNG patients.

Design: This was a long-term (36 months) observational study. Methods: The investigators measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80 years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection. Urinary iodine was measured at baseline and at 3 months after following a low iodine diet. TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48 h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume was assessed by computer tomography at baseline and every 6 months thereafter.


Eligibility criteria: Inclusion Criteria:

* Patients with multinodular goitre

Exclusion Criteria:

* Aversion to any form of treatment
* Previous radioiodine therapy
* Being unable to complete a prolonged follow-up; and
* Having serious cardiovascular disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Rossana Romão, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244983: Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?
Official title: Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Falls
Underlying Disease of Falls
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 587
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All fall patients aged 65 years and older who presented to the emergency department giving written informed consentent

Brief summary: It is the investigators goal to identify the prevalence of underlying diseases, make disposition more rational, and establish risk stratification tools in elderly patients presenting with falls. Additionally, the outcome of standard care (clinical assessment only for disposition) will be compared with a new approach combining the standard of care with biomarker assisted disposition of elderly patients presenting with falls. Therefore the investigators are looking at the following points.

Emergency department work-up

1. Prevalence of underlying disease
2. Developing algorithms for initial assessment Disposition

a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning


Eligibility criteria: Inclusion Criteria:

* All fall patients aged 65 years and older who presented to the emergency department giving written informed consent

Exclusion Criteria:

* Patients below 65 years
* Non-fall patients above 65 years
* or lack of informed consent by patients or proxies

Primary outcomes:
measure: Mortality
timeFrame: 30 Days
Secondary outcomes:
measure: Acute Morbidity
timeFrame: 30 Days
measure: Institutionalisation
timeFrame: 180 Days
measure: Disposition
timeFrame: 30 Days
measure: Mortality
timeFrame: 90 Days
measure: Mortality
timeFrame: 180 Days
measure: Mortality
timeFrame: 365 Days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin, Berlin
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
city: Basel
country: Switzerland
facility: Cantonal Hospital Baselland, Bruderholz
city: Liestal
country: Switzerland
facility: Cantonal Hospital Baselland, Liestal
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Roland Bingisser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646783: Phase IIT Trial of SNA014
Official title: Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Adenocarcinoma of the Stomach
Adenocarcinoma of GE Junction
Pancreatic Cancer Stage
Lead sponsor: SmartNuclide Biopharma
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction


Eligibility criteria: Inclusion Criteria:

* Age range of 18 to 75 years old (including boundary values);
* Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
* Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
* Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
* Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).

Exclusion Criteria:

* Merge patients with other clearly diagnosed malignant tumors:
* Uncontrolled severe infections or individuals with other serious illnesses;
* Those with an expected survival period of less than or equal to three months;
* Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
* investigators determine that patients who are not suitable to participate in this study;

Primary outcomes:
measure: Biological distribution characteristics
timeFrame: 1week
measure: Safety tolerance characteristics
timeFrame: hrough study completion, an average of 1 year
Secondary outcomes:
measure: Metabolic Dynamics Evaluation and Radiation Dose
timeFrame: 1 day
Other outcomes:
measure: Exploring the targeting ability of CLDN18.2
timeFrame: 1month
Locations:
city: Jiangsu
country: China
facility: The First Affiliated Hospital of Soochow University
state: province
Study officials:
References: