louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06856096: PET/MRI Artificial Intelligence Reconstruction Algorithm AIR Recon DL Image Quality Evaluation and Clinical Study
Official title: PET/MRI Artificial Intelligence Reconstruction Algorithm AIR Recon DL Image Quality Evaluation and Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson&#39;s Syndrome
Keywords: Artificial Intelligence Reconstruction Algorithms
AIR Recon DL
PET/MRI
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Comparison between different patients
Primary purpose: DIAGNOSTIC

Brief summary: PET/MRI artificial intelligence reconstruction algorithm AIR Recon DL image quality evaluation and clinical study

Detailed description: This is a diagnostic pilot study in which 50 patients with disorders of consciousness, Parkinson's syndrome and 15 prostate cancer patients were recruited to undergo PET/MRI imaging to evaluate the impact of AIR Recon DL on scanning and imaging time in different diseases and imaging sites, to determine its efficiency in clinical applications and to analyse its potential advantages in the diagnosis of specific diseases.

Eligibility criteria: Inclusion Criteria:

* 1. Adults between the ages of 18 and 75 who are autonomous; 2. persons with good compliance; 3. those who are mentally alert and able to move around on their own; 4. Those who agree to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

* 1. Persons who do not have full capacity for civil behaviour; 2. Women during pregnancy and breastfeeding; 3. other implants, prostheses, foreign bodies and patches with electronic implants such as pacemakers, insulin pumps and cochlear implants that are not suitable for MRI; 4. patients with claustrophobia; 5. those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Primary outcomes:
measure: Signal to Noise Ratio
timeFrame: 1 day from injection of the tracer
measure: Contrast to Noise Ratio
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province
state: Shaanxi
Study officials:
References:
Clinical trial NCT02818296: Computerized Cognitive Bias Intervention for Intolerance of Uncertainty
Official title: Computerized Cognitive Bias Intervention for Intolerance of Uncertainty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intolerance of Uncertainty; Anxiety
Keywords: Intolerance of uncertainty
Anxiety
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology.


Eligibility criteria: Inclusion Criteria:

* Elevated IU interpretation bias at pre-intervention.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Change in Intolerance of Uncertainty Scale-Short Form
timeFrame: Post-Intervention (directly following the intervention during their baseline appointment) to Month 1 Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
References:
Clinical trial NCT01614496: Rule-Based Closed Loop System for Type 1 Diabetes Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2012-06-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast.

The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes
* Insulin pump treatment
* Undetectable C-Peptide

Exclusion Criteria:

* Autonomous system neuropathy

Primary outcomes:
measure: Time spent with glucose in the target range
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
state: Barcelona
Study officials:
References:
citation: Capel I, Rigla M, Garcia-Saez G, Rodriguez-Herrero A, Pons B, Subias D, Garcia-Garcia F, Gallach M, Aguilar M, Perez-Gandia C, Gomez EJ, Caixas A, Hernando ME. Artificial pancreas using a personalized rule-based controller achieves overnight normoglycemia in patients with type 1 diabetes. Diabetes Technol Ther. 2014 Mar;16(3):172-9. doi: 10.1089/dia.2013.0229. Epub 2013 Oct 23.
Clinical trial NCT04595396: Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1
Official title: Gastric Bypass as Metabolic Surgery in Obesity Class 1: a Prospective Study of the Short, Mid and Long Term Results Among Mexicans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Bariatric Surgery Candidate
Laparoscopic Gastric Bypass
Obesity
Keywords: bariatric surgery
obesity class 1
metabolic surgery
laparoscopic gastric bypass
type-2 diabetes mellitus
Lead sponsor: Hospital General Tlahuac
Sponsor class: OTHER_GOV
First posted: 2020-10-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican patients with T2DM submitted to laparoscopic gastric bypass

Brief summary: Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).


Eligibility criteria: Inclusion criteria Any sex \>18 years-old \<60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass

Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months
measure: Weight Loss
timeFrame: 24 months
measure: Weight Loss
timeFrame: 36 months
measure: Weight Loss
timeFrame: 12 months
measure: Weight Loss
timeFrame: 24 months
measure: Weight Loss
timeFrame: 36 months
measure: Weight Loss
timeFrame: 12 months
measure: Weight Loss
timeFrame: 24 months
measure: Weight Loss
timeFrame: 36 months
measure: Weight Loss
timeFrame: 12 months
measure: Weight Loss
timeFrame: 24 months
measure: Weight Loss
timeFrame: 36 months
Secondary outcomes:
measure: Complete Diabetes Remission
timeFrame: 12 months
measure: Complete Diabetes Remission
timeFrame: 24 months
measure: Complete Diabetes Remission
timeFrame: 36 months
measure: Late complications
timeFrame: After 30 days from surgery
measure: Early complications
timeFrame: First 30 days after surgery
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General Tlahuac
Study officials:
References:
citation: Cevallos L, Rodriguez FM, Herrera A, Sepulveda EM, Donatini G, Guilbert L, Zerrweck C. Metabolic Surgery and Class 1 Obesity (< 35 kg/m2): a Prospective Study with Short-, Mid-, and Long-term Results Among Latinos. Obes Surg. 2021 Jun;31(6):2401-2409. doi: 10.1007/s11695-021-05275-3. Epub 2021 Feb 17.
Clinical trial NCT02138396: Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
Official title: Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.


Eligibility criteria: Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Good access to veins on both sides
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Intolerance to venipuncture or injections
* Presence or history of oral disease, irritation or piercings
* Allergy or adverse response to fentanyl, naltrexone, or related drugs
* Tattoos, scarring, or other skin abnormality at planned injection sites
* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Primary outcomes:
measure: Maximum concentration (Cmax) by mode of administration
timeFrame: within 36 hours after dosing
Secondary outcomes:
measure: Area under the concentration-time curve [AUC(last)] by mode of administration
timeFrame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
measure: Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration
timeFrame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services, LLC
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials Early Phase Services, LLC
name: George J Atiee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03643796: Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Official title: The Effect of a Narcotic Free Total Intravenous Anesthesia on the Outcome and Patient Safety During Anterior Cervical Discectomy and Fusion (ACDF) Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cervical Discectomy and Fusion (ACDF)
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 32
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: This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.


Eligibility criteria: Inclusion Criteria

* Men and women 18- to 80-years old
* ASA 1, 2, 3
* 1 or 2 levels ACDF

Exclusion Criteria

* ASA 4
* Seizure disorders
* Chronic narcotic use
* Opiate abuse
* Major cardiac comorbidity, or significantly elevated blood pressure
* Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable emulsions.
* Known allergy to eggs, egg products, soybeans, or soy products

Primary outcomes:
measure: Incidence of Unacceptable Movement Under General Anesthesia
timeFrame: duration of surgery
Secondary outcomes:
measure: Hemodynamic Stability
timeFrame: up to 24 hours
measure: Time to Extubation
timeFrame: up to 24 hours
measure: Quality of Recovery
timeFrame: 24 hours post-op
measure: Narcotic Consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mohamed Abdeldayem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333696: Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
Official title: Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Squamous cell carcinoma of head and neck
Pemetrexed
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Detailed description: The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-65 years old
* Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
* Prior exposure of at least one line of platinum-containing regimen
* At least one site of measurable disease according to RECIST criteria
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧45ml/min

Exclusion Criteria:

* With curable treatment option
* Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Significant active infection
* Pregnant or lactating women

Primary outcomes:
measure: Overall response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Median progression-free survival
timeFrame: 1 year
measure: Median overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512796: In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes
Official title: In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gadolinium Toxicity
Keywords: Liver transplantation
Renal transplantation
Pancreas transplantation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gadolinium exposed patients. We will use age- and sex-matched controls with and without organ transplants and not exposed to gadolinium contrast agents (within the last 3 years) as controls.

Brief summary: Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.

Detailed description: Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.

Eligibility criteria: Inclusion Criteria:

* Renal, pancreas or liver transplant OR those without organ transplant OR controls
* Age 18-70
* Both gender
* Exposure to gadolinium contrast agents (no exposure in controls)
* Have had a transplant, have had a contrast dye with an MRI
* Have not had a transplant and have had a contrast dye with an MRI
* Healthy person who has not had an MRI or gadolinium for any other reason.

Exclusion Criteria:

* End stage kidney disease or Stage 5
* Previous diagnosis of Nephrogenic Systemic Fibrosis

Primary outcomes:
measure: total number of circulating fibrocytes
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sundararaman Swaminathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06455696: Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit
Official title: Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Transportation Accidents
Intensive Care Unit
Keywords: Intra-hospital transport
Critical ill patients
Intensive care unit
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 645
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: All patients hospitalized in an ICU and requiring an intra-hospital transport with a departure from ICU and arrival to ICU will be eligible.

Brief summary: Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small, heterogeneous, and probably subject to methodological bias.

The aim of this study observational prospective observatoinal study is to determine:

* the different practices existing between ICUs ("practice survey")
* the occurrence of adverse events during intra-hospital transport provided by intensive care units (epidemiological study)

Detailed description: This is a multicenter prospective observational study on evaluation of practices between ICUs and to describe the occurence of adverse events during intra-hospital transport provided by ICUs (epidemiological study)

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old
* Hospitalized in ICU
* Requiring an intra-hospital transport (e.g imagery, operating room, etc) by the ICU team
* With a departure from ICU and arrival to ICU

Exclusion Criteria:

* Person under guardianship
* Protected Majors
* Already included in the study
* Transport for an ICU discharge in a medical or surgical ward
* Transport with another team than the ICU team
* Not affiliated to French social security

Primary outcomes:
measure: Incidence of adverse events during intra-hospital transport in critical ill patients managed by an ICU team
timeFrame: During the intra-intrahospital transport [maximum 3 hours]
Secondary outcomes:
measure: Incidence of non-serious adverse events occurring during intra-hospital transport.
timeFrame: During the intra-intrahospital transport [maximum 3 hours]
measure: Incidence of serious adverse events occurring during intra-hospital transport.
timeFrame: During the intra-intrahospital transport [maximum 3 hours]
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU de Strasbourg
Study officials:
References: