louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06159920: Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.
Official title: Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Tumors
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, adult patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC at the U.0 of Nuclear medicine at the RCCS San Raffaele will be considered for clinical reasons both in the staging and restaging phases.

Brief summary: Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. In particular, the traditional work-up for these pathologies includes endoscopy, magnetic resonance imaging (MRI) and computed tomography (CT). Furthermore, the integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting. In particular, PET is taking on an increasingly relevant role for the study of neuroendocrine tumors, also thanks to the introduction of increasingly accurate radiopharmaceuticals (targeted towards somatostatin receptors), thus opening the way to new possibilities for the diagnosis andcharacterization of these tumors, is in the staging and restaging phase .


Eligibility criteria: Inclusion Criteria:

* Adult patients affected by neuroendocrine tumors; Patients who have performed at least one PET study with 18F-FDG and/or 68Ga- DOTATOC for the staging or diagnosis of their pathology.

Exclusion Criteria:

* Patients \< 18 years old;
* Lack of availability of clinical data and PET imaging useful for analyses.

Primary outcomes:
measure: 800 patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
state: Italia
Study officials:
References:
Clinical trial NCT04778020: International COVID-19 Clinical Evaluation Registry -2 (HOPE-2)
Official title: International COVID-19 Clinical Evaluation Registry -2 (HOPE-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: St Carlos Hospital, Madrid, Spain
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 9299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Same inclusion/exclusion as HOPE COVID-19. We propose the long-term follow-up of patients discharged after a COVID-19 admission up to 31st august 2020.

Consecutive inclusion and the completion of patients previously included in HOPE registry is strongly warranted.

Brief summary: PURPOSE. The main objective of the present study is to carefully characterize the clinical profile of individuals with lasting sequelae after a COVID-19 admission.

As secondary objectives, the analysis of the risk-adjusted influence of COVID-19 severity, previous comorbidities and management of patients discharged after COVID-19 will be performed.

DESIGN AND STATISTICAL ANALYSIS Cross-sectional and prospective registry, a real life "all comers" type, with voluntary participation, without specific funding or conflicts of interest.

It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation (Institute for the Improvement of Health Care, Madrid, Spain) and the Cardiovascular Research Foundation (FIC, Madrid, Spain).

International level.

PARTICIPANTS PROTOCOL. The study has been approved by Hospital Clinico San Carlos Ethic´s Committee (21/128-E) and the institutional board of each participating center.

The present study proposes the continuation in time of the work previously carried out in the HOPE registry.

It proposes to select all the patients attended in any health center (with in hospital beds), who have been discharged or have died up to 31st august 2020.

All will be considered eligible with a positive COVID-19 test (any type) or if their attending physicians consider them highly likely to have presented the infection.

Given the anonymous characteristics of the registry and the health alarm situation generated by the virus, in principle, it is not considered necessary to provide written informed consent.


Eligibility criteria: Inclusion Criteria:

* Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis.

Exclusion Criteria:

* There are no exclusion criteria, except for the patient's explicit refusal to participate.

Primary outcomes:
measure: DEATH
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Any POSTCOVID-19 symptom
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References:
Clinical trial NCT06167720: Suicide Risk Prediction in Cancer Patients
Official title: Suicide Risk Prediction in Cancer Patients: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer patients
Suicide risk
Prediction model
Meteorological factors
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 176000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients in the Surveillance, Epidemiology, and End Results (SEER) program database and Shandong Multi-Center Healthcare Big Data Platform (SMCHBDP).

Brief summary: Previous studies have found that the suicide risk of cancer patients is influenced by socioeconomic factors, clinical characteristics, and environmental factors. But prediction model with multiple predictors for suicide risk in cancer patients is limited.

The aim of this study is to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, based on retrospective cohorts, and to establish a suicide risk prediction model with multiple predictors for cancer patients.

Detailed description: Cancer is a serious public health concern, with almost 10 million people dying from cancer in 2020. Previous studies have reported that cancer patients are more likely to die by suicide than the general public, especially in the six months to one year following cancer diagnosis. Since suicide is a result of the interaction of various factors such as socioeconomic factors, clinical characteristics, and environmental factors, it is necessary to construct a multivariate prediction model to predict the suicide risk in cancer patients.

A retrospective cohort of cancer patients based on the Surveillance, Epidemiology, and End Results (SEER) program database was used to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, and to establish prediction model with multiple predictors for cancer patients. Another retrospective cohort conducted from Shandong Multi-Center Healthcare Big Data Platform (SMCHBDP) was used to verify the predictive ability and generalization ability of the prediction model.

Eligibility criteria: Inclusion Criteria:

1. Cancer patients in SEER database and SMCHBDP

Exclusion Criteria:

1. No certain cause of death
2. Missing area code
3. Lost to follow-up

Primary outcomes:
measure: Mortality attributed to suicide or self-inflicted injury
timeFrame: 1979-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Fang Tang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310620: Computer Games to Prevent Mild Cognitive Impairment and Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 109
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia.

The secondary aim of the study is to find correlations between the results of the games and the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.


Eligibility criteria: Inclusion Criteria:

* Both gender
* Older than 50 years of age

Exclusion Criteria:

* Subjects with history of head trauma, epilepsy or stroke.
* Diagnosis of schizophrenia
* Acute manic episode

Primary outcomes:
measure: Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years)
timeFrame: 3 years
measure: Conversion to dementia (Proportion of participants who develop dementia after 3 years)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Psychiatry and Psychotherapy
Study officials:
References:
Clinical trial NCT02557620: Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
Official title: A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
* Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* History of pancreatitis (acute or chronic)
* Screening calcitonin equal or above 50 ng/L
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

Primary outcomes:
measure: Area under the semaglutide concentration-time curves
timeFrame: At steady-state from 0 to168 hours after dosing on day 78
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: At steady-state derived from the concentration-time curves, within 168 hours from day 78
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (day 1, post-dose) to last follow-up visit (day 120)
measure: Area under the the single dose concentration-time curve
timeFrame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 51
measure: Area under the the single dose concentration-time curve
timeFrame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 79
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00320320: Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer
Official title: A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Metastases
Keywords: No prior chemotherapy
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Detailed description: For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of colon and rectum
* No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
* Advanced, metastatic or recurrent not amenable to curative local therapy
* Measurable lesion(s)
* ECOG performance status 0 to 2
* Normal marrow, hepatic and renal function
* Provision of written informed consent

Exclusion Criteria:

* Active infection and/or severe comorbidity
* Known history of anaphylaxis of any origin

Primary outcomes:
measure: Response rate after FOLFIRI reintroduction
Secondary outcomes:
measure: Progression-free survival
measure: Overall survival
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010920: Preventing Cognitive Decline With Alternative Therapies
Official title: Preventing Cognitive Decline With Alternative Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia
Memory Disorders
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Can identify a collateral informant who has frequent contact with the subject
* No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition
* Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised
* Mini-Mental State Examination Score \>23
* Clinical Dementia Rating (CDR) of zero

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University/Neurology
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Dr. Jeffrey Kaye
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694720: Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients
Official title: A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Sleep Apnea Syndromes
Cheyne-Stokes Respiration
Keywords: Cheyne-stokes breathing
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.


Eligibility criteria: Inclusion Criteria:

* Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and \<60 and majority of the apneas to be ≥60% central in origin.

Exclusion Criteria:

* Subject on supplemental oxygen

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in the Apnea Hypopnea Index (AHI)
timeFrame: 2 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 5 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Hôpital Michallon - Grenoble - France
name: Patrick LEVY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00737620: Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
Official title: Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis Fistula Thrombosis
Keywords: Renal Failure, End Stage
Blood Vessel Grafting
Hemodialysis
Surgical Arteriovenous Shunt
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.


Eligibility criteria: Inclusion Criteria:

* All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial
* Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

Exclusion Criteria:

* Anticoagulation therapy

Primary outcomes:
measure: Patency of AV fistula
timeFrame: Study period
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Jerusalem
Study officials:
References:
citation: Shemesh D, Goldin I, Hijazi J, Zaghal I, Berelowitz D, Verstandig A, Olsha O. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg. 2015 Jul;62(1):115-22. doi: 10.1016/j.jvs.2015.01.056. Epub 2015 Mar 12.