louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06086327: Application of 68Ga-Pentixafor PET/CT for Thymoma
Official title: Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Thymoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.

Detailed description: Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed untreated thymoma patients
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance.

Primary outcomes:
measure: SUVmax and SUVmean
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1.5 years
measure: Diagnostic value in special type of thymoma
timeFrame: through study completion, an average of 1.5 years
measure: Diagnostic value in thymoma and other masses
timeFrame: through study completion, an average of 1.5 years
measure: CXCR4 expression and SUV
timeFrame: through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Zhaohui Zhu
role: STUDY_CHAIR
References:
Clinical trial NCT04179227: Focus Group in Collecting Feedbacks From Indoor Tanning Bed Users for Social Media-Delivered Intervention Development
Official title: Developing a Social Media-Delivered Intervention
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Health Status Unknown
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Facebook users use of an indoor tanning bed at least 10 times in the past 12 months

Brief summary: This research trial collects feedbacks from indoor tanning bed users via focus group for the development of social media-delivered intervention. Conducting a focus group with people using indoor tanning bed and having access to Facebook may help doctors to better understand people's perspective and thoughts about the various Facebook messages.

Detailed description: PRIMARY OBJECTIVES:

I. To elicit feedback from young adult women who use indoor tanning beds on preliminary intervention content.

OUTLINE:

Participants attend a focus group session and review printed copies of planned posts for the to-be-developed Facebook intervention over 90 minutes to 2 hours.

Eligibility criteria: Inclusion Criteria:

* Use of an indoor tanning bed at least 10 times in the past 12 months
* At least daily use of Facebook

Primary outcomes:
measure: Participants feedback
timeFrame: Up to 2 years
measure: Participants feedback
timeFrame: Up to 2 years
measure: Participants feedback
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760327: Electrochemotherapy of Gynecological Cancers
Official title: Electrochemotherapy of Gynecological Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gynecological Cancers
Keywords: Electrochemotherapy
Cisplatin
Bleomycin
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.


Eligibility criteria: Inclusion Criteria:

1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
2. Age more than 18.
3. Life expectancy more than 3 month.
4. Performance status Karnofsky ≥ 70 or WHO \< or 2.
5. Treatment free interval minimum 2 weeks.
6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
7. Patient must give informed consent.
8. Patient must be discussed at the multidisciplinary team before entering the trial.
9. Patient should be suitable for anesthesia.

Exclusion Criteria:

1. Visceral, bone or diffuse metastases.
2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
3. Significant reduction in respiratory function.
4. Age less than 18 years.
5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
6. Cumulative dose of ≥ 400 mg/m2 bleomycin received.
7. Impaired kidney function (creatinin \> 150 µmol/l).
8. Patients with epilepsy.
9. Pregnancy.
10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Primary outcomes:
measure: Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
timeFrame: Changes from baseline regularly up to 24 months
Secondary outcomes:
measure: Safety of electrochemotherapy according to CTCAE v5.0 criteria.
timeFrame: during hospitalization and up to 24 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of oncology Ljubljna
Study officials:
References:
Clinical trial NCT02818127: Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)
Official title: Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method In Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Angiography
Coronary Artery Disease
Coronary Artery Ectasia
Slow-Flow Phenomenon
Coronary Heart Disease
Lead sponsor: Vascular and Molecular Cardiology Society
Sponsor class: OTHER
Collaborators: name: Private Yenisehir Hospital
name: Private Gozde Hospital
name: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
First posted: 2016-06-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. This study also evaluates the relationship between the diseases in arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease and coronary venous pathologies.


Eligibility criteria: Inclusion Criteria:

* Patients whom performed coronary angiography with a suspicion of coronary artery disease

Exclusion Criteria:

* History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic disease

Primary outcomes:
measure: Evaluation of total coronary circulation time by using TIMI frame count method
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Military Medical Academy
state: Kecioren
city: Malatya
country: Turkey
facility: Private Gozde Hospital
city: Mersin
country: Turkey
facility: Private Yenisehir Hospital
Study officials:
References:
citation: von Ludinghausen M. The venous drainage of the human myocardium. Adv Anat Embryol Cell Biol. 2003;168:I-VIII, 1-104. doi: 10.1007/978-3-642-55623-4.
citation: Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.
Clinical trial NCT05450627: Registry of Pancreatic Exocrine Insufficiency.
Official title: Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exocrine Pancreatic Insufficiency
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.

Brief summary: A prospective, cross-sectional, observational study has been designed with the aim of the study is to evaluate the diagnosis and management of patients with pancreatic exocrine insufficiency secondary to different pancreatic diseases and conditions in clinical practice.

A registry has been develop to include patients older than 18 years diagnosed with pancreatic exocrine insufficiency, sho are willing to participate in the study and sign the informed consent.

Registry includes demographics, toxic habits,pharmacological therapies, underlying disease that causes pancreatic exocrine insufficiency.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
* Willingness to participate in the study.

Exclusion Criteria:

* Patients with pancreatic diseases without PEI.
* Pregnancy
* Known allergy to oral pancreatic enzymes
* Any condition avoiding adequate clinical management of PEI.
* Patients who are not willing to participate in the study.

Primary outcomes:
measure: Dose of oral pancreatic enzymes
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruña
Study officials:
References:
Clinical trial NCT00545727: Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes
Official title: Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Impaired Glucose Metabolism
Keywords: Diabetes
Children
Adolescents
Diet
Glycemic index
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-10-17
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Research to date suggests that the selection of lower glycemic index foods, that is, foods provoking a slower, more sustained blood sugar response, may result in improved glycemic control in youth with diabetes. However, there is currently insufficient data to support practice recommendations. The purpose of this pilot study is to test the blood glucose response to low and high glycemic index meals in youth with diabetes using continuous blood glucose monitoring, and to determine whether the effect of glycemic index differs by regimen or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will participate in 5 days of continuous blood glucose monitoring during which they will receive both low and high glycemic index meals. Children will be provided with 1 full day of low glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in randomized order. Each of these test days will be preceded by a standard evening meal and snack. Continuous blood glucose monitoring will also be conducted during regular food intake ad libidum away from the clinic, as well as during one day of instructed low glycemic meals at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While in the clinic, measures of satiety and acceptability of the food will also be obtained. Data analysis will include indices of blood glucose levels and variability.


Eligibility criteria: Inclusion Criteria:

* diagnosed with type 1 diabetes for a minimum of 1 year with insulin dose greater than or equal to 0.5 u/kg/day, or diagnosed with elevated fasting glucose, insulin resistance, or type 2 diabetes
* age 7 to 16

Exclusion Criteria:

* dietary restrictions that would preclude eating the study diet
* comorbid chronic illness requiring daily medical management
* comorbid major psychiatric diagnosis
* non-English speaking/writing

Primary outcomes:
measure: Blood glucose level
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Tonja R. Nansel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03729427: Rib Microtia and the Erector Spinae Plane (ESP) Block
Official title: Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Microtia, Congenital
Microtia
Anesthesia, Local
Anesthesia
Keywords: Erector Spinae Plane
Erector Spiane Plane Block
Rib Cartilage
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.


Eligibility criteria: Inclusion Criteria:

* Ages 2-17
* Able to consent (if greater than 7 years) and have parental consent
* Pediatric patients undergoing rib cartilage resection surgeries

Exclusion Criteria:

* Participants who do not consent or have parental consent
* Patients who are clinically unstable or requires urgent/emergent intervention

Primary outcomes:
measure: Opiate Intake in Morphine Equivalents in Both Control and Treatment Group
timeFrame: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
measure: Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
timeFrame: Duration of Study (Typically 4-5 days)
measure: Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
timeFrame: Duration of Study (Typically 4-5 days)
measure: Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
timeFrame: Duration of Study (Typically 4-5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
citation: Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
citation: Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
citation: Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
Clinical trial NCT04231227: The Validity and Reliability of the Turkish Version of TASC and the Relationship Between SMC and Motor Functions
Official title: Validity and Reliability of the Turkish Version of Test of Arm Selective Control and the Relationship Between Upper Limb Selective Motor Control and Motor Functions in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Spastic
Cerebral Palsy
Cerebral Palsy Spastic Diplegia
Cerebral Palsy Quadriplegic
Cerebral Palsy, Monoplegic
Keywords: cerebral palsy
selective motor control
upper limb
upper limb functions
gross motor functions
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in Special Education Centers

Brief summary: Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children with spastic CP) and in order to provide more understanding of the relationship between SMC and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to evaluate the gross motor function of children, GMFCS and the ability to hold objects with their hands in daily activities were evaluated with Manual Ability Classification System (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale was used to evaluate the upper extremity SMC of children.


Eligibility criteria: Inclusion Criteria:

* having a diagnosis of spastic CP
* being able to understand the commands required for the test,
* being between the ages of 3-18,
* being GMFCS level I to IV.

Exclusion Criteria: • Having undergone orthopedic surgery or Botulinum Toxin A (BTX-A) within the last 6 months

Primary outcomes:
measure: Test of Arm Selective Control
timeFrame: from July to September 2018
measure: Abilhand- Kids Questionnaire
timeFrame: from July to September 2018
measure: Manual Ability Classification System
timeFrame: from July to September 2018
measure: Gross Motor Function Classification System
timeFrame: from July to September 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT04216927: NO During CPB in Neonates to Reduce Risk of AKI
Official title: Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: AKI
CHD - Congenital Heart Disease
Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
name: Indiana University
First posted: 2020-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: • This pilot study is a single center, double-blind, randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.


Eligibility criteria: Inclusion Criteria:

* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria:

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than \<2 kg,
11. Gestational age \<36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

Primary outcomes:
measure: AKI
timeFrame: 72 hours
Secondary outcomes:
measure: Biomarker evidence of AKI - NGAL
timeFrame: 72 hours
measure: Biomarker evidence of AKI - KIM-1
timeFrame: 72 hours
measure: Biomarker evidence of AKI - IL-18
timeFrame: 72 hours
measure: Biomarker evidence of AKI - L-FABP
timeFrame: 72 hours
measure: Biomarker evidence of AKI - urinary nitrite
timeFrame: 72 hours
measure: Impact on GFR
timeFrame: 72 hours
measure: Low Cardiac Output
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: