louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691881: 68Ga-labeled NY105 PET Imaging in Patients
Official title: 68Ga-labeled NY105 PET Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 10
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: DIAGNOSTIC

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY105 PET Imaging in patients


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0\~3.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Evaluation of tissue distribution of 68Ga-NY105
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: Chunjing Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958681: Changes in Physical Activity Status: Comparison of Older Adults With Versus Without a History of Covid-19 Infection
Official title: Changes in Physical Activity Status: Comparison of Older Adults With Versus Without a History of Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: physical activity
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were matched with a control group of 76 community-dwelling older individuals without a Covid-19 diagnosis in the same period.

Brief summary: The negative impact of the Covid-19 pandemic on the physical activity behavior of overall adults has been reported. But much less is known in older adults. Alterations in physical activity among Covid-19 survivors have not been investigated so far. The present study aimed to evaluate the physical activity status of older adults in terms of a history of Covid-19 infection.


Eligibility criteria: Inclusion Criteria:

* 65 years non-dementia community dwelling older adults

Exclusion Criteria:

* The exclusion criteria were: (1) intensive care unit admission due to Covid-19 infection, (2) neurodegenerative or psychotic disease, (3) delirium, (4) terminal illness (malignancy, advanced organ failure), and (5) hearing impairment that disrupts conducting the telephone survey

Primary outcomes:
measure: physical activity
timeFrame: 1 year fellow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane training and research hospital
Study officials:
References:
Clinical trial NCT00218881: An Effective Alternative to the Standard Referral System for HIV Testing in the Emergency Department During Off Hour Tours: A Randomized Trial
Official title: An Effective Alternative to the Standard Referral System for HIV Testing in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Counseling and Testing
HIV Infections
Keywords: HIV prevention
HIV screening
Emergency Medicine
HIV counseling and Testing
HIV Seronegativity
Lead sponsor: North Bronx Healthcare Network
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief summary: To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.

Detailed description: ED-based HIV counseling and testing (C\&T) is in its early stages of development. Most urban ED patients requesting or requiring HIV testing are referred to C\&T sites that are usually available only during regular business hours. Patient compliance with these referrals has been disappointing.

To improve ED access to HIV testing, we developed a video alternative to in-person pre-test counseling to provide the fundamental elements of the counseling. The video was based on the educational elements required by the New York State Department of Health (DOH) for HIV pre-test counseling. In a previous study, we demonstrated that the educational video performed as well as live counselors in conveying the information needed for inner city ED patients to consent to HIV testing. The present study was designed to compare HIV testing rates in ED patients offered video-assisted informed consent for HIV testing versus the standard referral for live C\&T the next business day.

Eligibility criteria: Inclusion Criteria:

* All patients 18 years and older were approached while waiting for ED provider.

Exclusion Criteria:

* Patients who were clinically unstable
* Unable to understand the consent process
* Had been HIV tested within 6 months and were informed of the result, or had a confirmed diagnosis of HIV were excluded from the study.

Primary outcomes:
measure: HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.
Secondary outcomes:
measure: Comparing return rates for HIV results in both groups.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: North Bronx Healthcare Network, Jacobi Medical Center
name: Yvette Calderon, MD<MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007981: A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony
Official title: A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 0
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: Patients followed in cardiology clinic will be included.

Brief summary: The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.

Detailed description: Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.

In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.

Eligibility criteria: Inclusion Criteria:

* Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.

Exclusion Criteria:

* Acute decompensated congestive heart failure.
* chronic permanent atrial fibrillation

Primary outcomes:
measure: 4D echo is the best modality to measure systolic dyssynchrony index
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Firas H El Sabbagh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815581: Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009
Official title: Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amblyopia
Keywords: children between 1 to 10 years old
amblyopy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-12-30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.


Eligibility criteria: Inclusion Criteria:

* Amblyopy
* Children between 1 to 10 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophtalmic Research Centre
Study officials:
References:
Clinical trial NCT03827681: To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
Official title: A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).

Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.

Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.


Eligibility criteria: Inclusion Criteria:

- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.

Exclusion Criteria:

* Bleeding from non-variceal source
* Coagulopathy related bleed
* Bleeding from Gastric varices
* Any malignancy including HCC
* Main Portal vein thrombosis
* Patients in refractory shock
* Patients with severe cardiopulmonary disease
* Grade 4 Hepatic encephalopathy
* MELD \> 25
* Multiorgan failure
* Active sepsis
* Pregnancy
* Failure to give consent

Primary outcomes:
measure: Survival in both groups
timeFrame: 6 weeks
Secondary outcomes:
measure: Re-bleeding in both groups for 5 days from end of therapy
timeFrame: 5 days
measure: Rebleeding in both groups
timeFrame: 6 weeks
measure: Decompensation in both groups in the form of ascites or Hepatic Encephalopathy
timeFrame: 6 weeks
measure: Adverse events in both groups
timeFrame: 6 weeks
measure: Worsening of liver severity score in both groups.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT03719781: Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
Official title: Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Tumor
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Undergoing elective pituitary tumor removal surgery

Brief summary: As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Undergoing elective pituitery tumor removal surgery

Exclusion Criteria:

* \>II ASA scores
* Using antidepressant agents
* Patient refusal
* Mental diseases

Primary outcomes:
measure: minimental test score
timeFrame: preoperative 24th hour
measure: minimental test score
timeFrame: postoperative 4th hour
measure: minimental test score
timeFrame: postoperative 24th hour
measure: minimental test score
timeFrame: one month after discharged
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Cennet Tor Kılıç
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056181: "MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
Official title: "MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Mental Disorder
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this project is to establish the acceptability of the PAI (physical activity intervention) to service users by evaluating if participants can be recruited into the study and if they complete the intervention.

Secondary aims are to estimate if, compared with treatment as usual (TAU), the PAI intervention (1) positively impacts on subjects' psychiatric symptoms (2) succeeds in improving cardiovascular fitness performance. In addition, will be considered the impact of the PAI versus TAU on sleep behavior, quality of life, drug consumption, reduces sedentary behaviour and unscheduled readmissions to the department within 30 days and within 7 days after their dismission.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of any SMI
* Meeting any one of the following criteria as determined by a care co-ordinator:

  1. Overweight
  2. At risk for or have type 2 diabetes mellitus
  3. In the clinician's view, have a sedentary lifestyle
  4. Smoke tobacco
* Ability to provide informed consent
* Ability to understand Italian

Exclusion Criteria:

* under the age of 18
* not having a diagnosis of SMI
* be unable to do exercises
* be unable to give informed consent

Primary outcomes:
measure: Percentage of patients that will complete the study (Acceptability)
timeFrame: 24-26 weeks
Secondary outcomes:
measure: Anthropometric measures
timeFrame: 24-26 weeks
measure: Anthropometric measures
timeFrame: 24-26 weeks
measure: Anthropometric measures
timeFrame: 24-26 weeks
measure: Anthropometric measures
timeFrame: 24-26 weeks
measure: Self-report sedentary behaviour and physical activity
timeFrame: 24-26 weeks
measure: Cardiorespiratory Fitness
timeFrame: 24-26 weeks
measure: Sleep behavior
timeFrame: 24-26 weeks
measure: Quality of life (QoL)
timeFrame: 24-26 weeks
measure: Motivation to engage in physical activity
timeFrame: 24-26 weeks
measure: Psychiatric symptoms
timeFrame: 24-26 weeks
measure: Psychiatric symptoms
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
measure: Blood samples
timeFrame: 24-26 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01648881: Imaging of Dissection of the Descending Aorta
Official title: Dissection of Aorta: Descending Part, Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dissection of the Descending Aorta
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-07-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with dissection of the descending aorta

Brief summary: Patients with dissection of the descending aorta will be followed up according to a precise timeline.

Detailed description: NMR baseline A PET Scanner will be performed minimum 3 months post dissection 6 months and every year during three years after PET scanner : CT scanner and blood sample

Eligibility criteria: Inclusion Criteria:

* 18 years
* Seen for dissection of the descending aorta
* Dissection of the descending aorta within the last three months
* Affiliation to social security
* Signed informed consent

Exclusion Criteria:

* intervention programmed in relation with dissection of the descending aorta
* Pregnant female
* Adults without legal capacity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pr Guillaume JONDEAU . Cardiologie. Hôpital Bichat
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume JONDEAU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646681: Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes
Official title: Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: patient portals
treatment adherence
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.

Detailed description: This study is being done in 3 phases. First 2 phases were observational with total enrollment of 300 subjects. The final 3rd phase is interventional and we are anticipating to enroll 50 subjects. It is described below.

Patients being treated for depressive symptoms at the University of Iowa, Department of Psychiatry are invited to participate. Participants will complete a remote (phone or video) visit. After being informed about the study and potential risks, those who consent to being in the study will be assigned to one of two groups. They will complete an online survey and receive some basic training on patient portals. After the visit. both groups will be followed for 6 months. Depending on their group assignment, they will complete:

* two to five phone calls with a study team member and
* two to five online questionnaires

Eligibility criteria: Inclusion Criteria:

* English speaking,
* PHQ-9 score of 10 or higher (questions 1-8 only),
* Taking medication for depressive symptoms,
* 1 or more appointments scheduled or planned with University of Iowa psychiatry provider in next 6 months,
* Home computer w/internet access,
* MyChart (University of Iowa Healthcare's patient portal) account/MyChart enrollment

Exclusion Criteria:

* Psychotic disorder/symptoms,
* Current substance use disorders (other than alcohol, tobacco, marijuana),
* Active suicidal ideation within past 1 year,
* Cognitive impairment

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Once per month for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine, Dept. of Psychiatry
state: Iowa
Study officials:
affiliation: University of Iowa
name: Carolyn Turvey, phD
role: PRINCIPAL_INVESTIGATOR
References: