louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03109262: Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
Official title: High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Malignant Liver Neoplasm
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 42
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: This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.

SECONDARY OBJECTIVES:

I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.

This study compares the experimental images to the regular medical care images in the same participant.

Eligibility criteria: Inclusion Criteria:

* Patient provides written informed consent
* Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)

Exclusion Criteria:

* Patient is pregnant or nursing

Primary outcomes:
measure: Image Quality for 90-Y PET/CT Scans
timeFrame: 1 day
Secondary outcomes:
measure: Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
timeFrame: 1 day
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14.
Clinical trial NCT02421562: Training Nurses in Basic Hypnoanalgesia Techniques
Official title: Training Nurses in Basic Hypnoanalgesia Techniques to Reduce Procedural Distress and Pain in Children: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia techniques, and this new tool will translate into a reduction of procedural distress and pain in their patients, thereby opening the way to larger clinical trials in various pediatric settings.


Eligibility criteria: Inclusion Criteria:

* children followed in the hematology-oncology outpatient clinic at least 4 times per year
* good understanding in French
* use of topic anesthesia or distraction object allowed, as long as used at all venipuncture measured sessions

Exclusion Criteria:

* prior use of hypnoanalgesia
* patients coming for emergency or non-scheduled appointment
* patients with acute pain on their scheduled appointment to the clinic
* acute psychiatric disease

Primary outcomes:
measure: Practice performance of pediatric nurses after a 4-day training in hypnonalgesia techniques. Practice performance will be evaluated by two external evaluators on videotapes using a standardized scale.
timeFrame: 12 months
Secondary outcomes:
measure: Main secondary outcome measure : self-reported distress (fear) on VAS (visual analog scale).
timeFrame: 12 months
measure: Distress evaluated with the Faces, Legs, Activity, Cry, Consolability scale by two external evaluators on video recordings.
timeFrame: 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Ste-Justine Hospital
state: Quebec
Study officials:
affiliation: Ste-Justine Hospital
name: Michel Duval, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04111562: Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
Official title: Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cranioplasty
Disability Physical
Trauma
Keywords: Cranial defect
skull bone defects
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability.

Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.

Detailed description: Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect

Eligibility criteria: Inclusion Criteria:

• Patients with traumatic skull bone defects

Exclusion Criteria:

• Patients were not working before trauma

Primary outcomes:
measure: Number of participants with complications
timeFrame: 6 months up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emanaalah shaltouy@yahoo.com
Study officials:
References:
Clinical trial NCT06292962: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain
Official title: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain - A Randomized, Double-Blinded, Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Neuropathies
Type2diabetes
Neuropathic Pain
Lead sponsor: Shifa International Hospital
Sponsor class: OTHER
Collaborators: name: Al Ain University
First posted: 2024-03-05
Enrollment: 165
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.

Detailed description: The study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain.

Participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation.

The study will investigate the effects of short-term, high-intensity tVNS treatment on peripheral pain.

The primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.

Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes mellitus \> 1 year
* Patients experiencing neuropathic pain

Exclusion Criteria:

* Patients with co-morbidities such as chronic pain from other conditions
* Patients with serious complications of diabetes such as nephropathy and retinopathy

Primary outcomes:
measure: Neuropathic pain scores
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Quality of life score
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shifa Hospital
Study officials:
References:
Clinical trial NCT00181662: Pharmacokinetics of Curcumin in Healthy Volunteers
Official title: Evaluation of Naturally Occurring Inhibitors of UDP-glucuronyltransferase on the Oral Bioavailability of Curcumin in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Curcumin
Piperine
Silybin
Healthy volunteer
Female
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of curcumin is also studied.

Detailed description: Healthy volunteers are seen on three separate visits and receive 4 gm of curcumin as a single oral dose either alone or with piperine or with silybin. Serial timed blood draws then are collected for pharmacokinetic analysis.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* On no medications except for birth control pills
* Signed informed consent

Exclusion Criteria:

* Pregnant
* Comorbid disease

Primary outcomes:
measure: Curcumin pharmacology
Secondary outcomes:
measure: Interactions between piperine and curcumin
measure: Interactions between silybin and curcumin
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael Seiden, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04716062: Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients
Official title: Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Colorectal Cancer
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 138 overweight or obese subjects. Fifty-one (37%) subjects underwent open-air surgery and 87 (63%) to VL surgery.

Brief summary: A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Detailed description: A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Eligibility criteria: Inclusion Criteria:

* Body mass index \>25 Kg/m2
* Colorectal cancer (CRC)

Exclusion Criteria:

* Current emergency conditions (i.e., perforation and\\or occlusion)
* Pregnancy,
* Co-existing peritoneal carcinomatosis
* Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
* Prior transverse resections

Primary outcomes:
measure: Hospitalization
timeFrame: baseline
measure: Lymph Nodes number
timeFrame: baseline
measure: Clavien Dindo score (post-operative complications)
timeFrame: baseline
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline
measure: Lenght of specimen
timeFrame: Baseline
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Gastroenterology IRCCS S. de Bellis
state: Bari
Study officials:
References:
Clinical trial NCT04177862: Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Official title: Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Pain, Acute
Anesthesia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.

Detailed description: This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.

Eligibility criteria: Inclusion Criteria:

* undergoing outpatient ambulatory surgery
* recipient of general anesthesia
* pain score of 4 or greater in the PACU

Exclusion Criteria:

* non-english speaking patients
* cancer surgeries
* patients who have allergy or intolerance to the study drugs or derivatives
* patients on chronic opioids (defined as daily opioids for 3 months or longer)

Primary outcomes:
measure: Recovery Room Time
timeFrame: 1 day
Secondary outcomes:
measure: Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
timeFrame: 1 day
measure: Adverse Events
timeFrame: 1 day
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 1 day
measure: Supplemental Oxygen
timeFrame: 1 day
measure: Overall Benefit of Analgesic Score (OBAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron M Berg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01312662: Towards Worldwide Comparability of Visual Acuity Assessment
Official title: Towards Worldwide Comparability of Visual Acuity Assessment A Pilot Study Comparing ETDRS Visual Acuity Charts, Projected Landolt Charts and the Freiburg Visual Acuity Test (FrACT) With a View to Developing a Mathematical Transformation Routine Between the Results From These Three Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Comparison of Visual Acuity Tests.
ETDRS. FrACT. Landolt Rings.
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University of Freiburg
First posted: 2011-03-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University eye Hospital Tuebingen

Brief summary: Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Detailed description: Assessment of distant visual acuity is the most frequently used procedure for estimation of visual performance. However, there exist a vast number of markedly differing visual acuity tests worldwide; furthermore there are differing report formats to express acuity. This variety may critically interfere with standardization and comparability of this basic visual test method.

Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, i.e., the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, a conventional projected distant visual acuity test according to DIN 58220 part 3, and the Freiburg visual acuity test (FrACT), to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of:

* normal ophthalmological status,
* opacity of the refractive media,
* maculopathy,
* optic neuropathy
* chiasmal and postchiasmal visual pathway pathologies,
* amblyopia (deprivation),
* amblyopia (strabism)

Exclusion Criteria:

* underage person
* concomitance of different eye-diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Institute for Ophthalmic Research, University of Tuebingen
Study officials:
References:
Clinical trial NCT04596462: Characterizing SAPHO With 68Ga-FAPI PET/CT
Official title: Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: SAPHO Syndrome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of SAPHO than 18F-FDG PET/CT.

Detailed description: Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed untreated SAPHO patients;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Metabolic parameters
timeFrame: through study completion, an average of 1 year
measure: FAPI expression and SUV
timeFrame: through study completion, an average of 1 year
measure: Disease burden assessement
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Dongcheng
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongli Jing, MD
role: PRINCIPAL_INVESTIGATOR
References: