louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04522401: Performance Evaluation Platform for Seniors.
Official title: Prevention of the Loss of Autonomy in the Old People: Factors Favoring or Limiting the Respect of Recommendations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: old people
gerontological assessment
loss of autonomy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: seniors who have had a gerontological assessment

Brief summary: Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.

Detailed description: Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.

The main objective is to investigate the factors limiting or encouraging adherence to recommendations in a population aged over 65, fragile or pre-fragile, autonomous and living at home or in a shelter.

Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.

Patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day at the day hospital, then at 6 and 9 months. The study will take place over a period of approximately 24 months.

Eligibility criteria: Inclusion Criteria:

* Person affiliated or entitled to a social security scheme
* People aged 65 and over who participated in a consultation to age well at the day hospital of the St-Etienne university hospital during the study period.
* Elderly people who received an information about the study and who co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

* Seniors who refused to participate
* Elderly people under legal protection measures
* Severe cognitive impairment

Primary outcomes:
measure: rate of implementation of recommendations concerning mobility (adapted physical activity).
timeFrame: Months: 9
Secondary outcomes:
measure: Overall rate of implementation of the recommendations at 9 months
timeFrame: Months: 9
measure: Satisfaction rate of the platform's users
timeFrame: Months: 9
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Romain JUGAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06330701: Stone Access and Removal (STAR) Study
Official title: Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Keywords: Nephrolithotomy
Percutaneous
Ureteroscopy
Robotic
Monarch
Kidney Calculi
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.


Eligibility criteria: Inclusion Criteria:

* Simple renal caliceal and/or pyelo stone(s) with stone burden =\> 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines
* Normal upper tract anatomy, amenable to PCNL and ureteroscopy
* Participants with a percutaneous tract length \< 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan
* Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment.

Exclusion Criteria:

Pre-Procedure:Exclusion Criteria:

* Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
* Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
* A solitary functioning kidney
* Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
* Presence of ureteral impacted stones

Intra-Procedure Exclusion Criteria:

- Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.

Primary outcomes:
measure: Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed
timeFrame: Procedure Visit (Day 0)
Secondary outcomes:
measure: Stone Free Rate (%)
timeFrame: Post-operative Day 30
measure: Number of Adverse Events
timeFrame: Up to post-operative Day 90
measure: Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event
timeFrame: Procedure Visit, Day 0
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Margaret A. Knoedler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064501: Impact of COVID19 on Asthma
Official title: Impact of COVID19 on Lung Function and Control of Asthma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Covid19
Keywords: asthma
asthma control
COVID19
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2021-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 12 and 80 diagnosed with asthma according to current guidelines (GEMA/GINA), of any level of severity, will be recruited and followed up in Pneumology consultations at participating hospitals. The study cohort would be patients with these criteria who have needed to consult the Emergency Department or be admitted for COVID19 (suggestive symptomatology + CRP and/or positive serology) in the six months prior to the visit. The control group would be a cohort of asthmatic patients matched by age, severity and sex, who have not suffered COVID19 or compatible symptoms.

Brief summary: The COVID19 pandemic is having an immeasurable impact on the economy and on morbidity and mortality. Knowledge and scientific evidence about this disease is advancing rapidly, but it is not yet known whether asthmatic patients suffering from COVID19 have an exacerbation of asthma, or whether this viral infection has an impact on control and lung function in the short to medium term.

The aim of this study is to define the changes that occur in these two parameters in asthmatic patients suffering from COVID19. To this end, asthmatic patients who have suffered a SARS-CoV-2 infection and who have required an emergency consultation or hospitalisation will be collected in a pneumology consultation and matched by age, sex and severity of asthma with a group that has not suffered the same. Both will be followed for one year, and lung function will be tested at six months and exacerbations and changes in ACT during the following year.

These data are intended to improve the available knowledge on the impact of IDVC19 on asthma patients with a view to making appropriate recommendations, prevention and treatment adjustments in line with the results obtained.


Eligibility criteria: Inclusion Criteria:

* 12 -80 years
* Asthma diagnosis according to guidelines
* Follow up on asthma clinics in one of the participant hospitals

Exclusion Criteria:

* Other severe respiratory condition independent of asthma

Primary outcomes:
measure: Asthma control
timeFrame: 6 months
Secondary outcomes:
measure: Asthma function
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT06246201: The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
Official title: An Investigation of The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Exercise Test
Fatigue
Cognitive Function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are 18 years old and older and are diagnosed with coronary artery disease.

Brief summary: The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients.

Detailed description: Exercise training for patients with coronary artery disease is an essential element of multicomponent cardiac rehabilitation. For the successful implementation of exercise-based cardiac rehabilitation programs, adequate cognitive function (e.g. executive function, selective attention, memory) is an important prerequisite. In patients with atherosclerotic coronary artery disease, the presence of coronary microvascular dysfunction as determined by low coronary flow reserve is associated with abnormal cerebral flow hemodynamics and mild but significant impairment in cognitive function. In the literature, there is no study examining the relationship between cognitive level and fatigue perception.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* Being diagnosed with coronary artery disease
* To cooperate with the tests to be performed
* Signing a consent form

Exclusion Criteria:

* Presence of neurological disease that may affect cognitive status
* Presence of clinically unstable cardiac disease
* Left ventricular ejection fraction \<30%
* Being diagnosed with end-stage renal failure
* Diagnosed with active myocarditis or pericarditis
* Being diagnosed with rhythm disorder
* Having amputation, peripheral arterial disease, musculoskeletal and/or neurological diseases that will prevent participation in functional capacity tests
* Not volunteering to participate in the study

Primary outcomes:
measure: Cognitive State Assessment
timeFrame: August 2023-August 2024
measure: Assessment of Exercise Capacity
timeFrame: August 2023-August 2024
measure: Assessment of Perceived Fatigue Severity After Exercise Test
timeFrame: August 2023-August 2024
Secondary outcomes:
measure: Physical Activity Assessment
timeFrame: August 2023-August 2024
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hikmet Yorgun, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00038701: Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
Official title: Phase II Study of Gemcitabine-Based Chemoradiation and TNP-470 for Patients With Locally Advanced, Nonmetastatic Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Metastatic Pancreas Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-06-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal is to assess survival and patterns of failure in patients treated with Gemzar-based chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.


Eligibility criteria: Patients must have cytologic or histologic proof of adenocarcinoma of the pancreas.

All patients must be staged with a physical exam and CXR. Patients must have locally advanced disease defined as tumor extension to the celiac axis or SMA, or occlusion of the SMPV confluence (on contrast-enhanced CT). There must be no radiographic evidence of metastatic disease.

Patients must have had no prior chemotherapy or irradiation.

Patients must have a baseline Karnofsky performance status of at least 60.

Patients must have adequate bone marrow reserve platelet count \>100,000/mL, hemoglobin\>9 g/dL, absolute granulocyte count must be \>1,500 cells/mm3,serum creatinine must be \<1.6 mg/dL. Serum bilirubin must be less than 5 mg/dL prior to therapy with endoscopic or percutaneous drainage if necessary.

Patients must have estimated life expectancy of at least 12 weeks.

Patients must be at least 18 years of age. There will be no upper age restriction.

Female patients must have had childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, barrier device, or abstinence.

Patients cannot have hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.

Before receiving external beam irradiation, patients should be able to maintain adequate oral nutrition (90% to 100% of estimated need of calories and protein) and be free of significant nausea and vomiting.

Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or \>2/3 of one functioning kidney must be able to be shielded from the radiation beam.

Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.

Patients must sign an informed consent form

Primary outcomes:
measure: Patient Survival Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Douglas B. Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883201: Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer
Official title: Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
name: Umberto I Hospital, Frosinone Italy
First posted: 2025-03-19
Enrollment: 78
Sex: FEMALE
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 with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, candidates for destructive and/or reconstructive surgery.

Brief summary: Evaluation of the percentage of transfusions in patients with breast cancer undergoing surgery after preventive treatment with haematinics.

Detailed description: Preoperative anemia treatment is fundamental in Patient Blood Management (PBM) programs, a multidisciplinary and multimodal strategy that improves clinical outcomes based on the patient's blood resource, promoting strategies to optimize hematopoiesis in candidates for elective surgery, in order to significantly reduce the use of blood products, addressing all modifiable transfusion risk factors before it is even necessary to consider the use of transfusion therapy itself. Treatment with intravenous iron reduces the transfusion risk and consequently the adverse events related to the transfusion itself.

Nothing is specified in this regard for cancer patients; very often these patients come to surgery presenting an anaemic state that often requires correction with red blood cell transfusion. The aim of this clinical study is to prevent the number of perioperative transfusions in patients with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, who are candidates for destructive and/or reconstructive surgery.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy;
* patients who are candidates for destructive and reconstructive breast surgery or not;
* Hb values less than or equal to 11 g/dL and/or transferrin saturation less than or equal to 20%;
* written informed consent.

Exclusion Criteria:

* patients with known allergies to ferric carboxymaltose or its excipients;
* ferritin values greater than 500 ng/ml;
* patients unable to sign consent and comply with procedures.

Primary outcomes:
measure: Number of transfusions
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT00581867: Memory and Insulin in Early Alzheimer's Disease
Official title: Intranasal Insulin and Memory in Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Detailed description: Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Eligibility criteria: Inclusion Criteria:

* Patients with Early Alzheimer's disease

Exclusion Criteria:

* Patients with Late Alzheimer's disease

Primary outcomes:
measure: fMRI Measure of Hippocampal Activation
timeFrame: 30 minutes After Intervention Administration
Secondary outcomes:
measure: Global Cognition
timeFrame: 90 mins
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Hoglund Brain Imaging Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey M Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05224167: Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
Official title: Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoperative Anxiety
Keywords: Melatonin
Hydroxizin
Hip fracture
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

Detailed description: prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale

Eligibility criteria: Inclusion Criteria:

* All adult patients scheduled for hip fracture surgery

Exclusion Criteria:

* Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement

Primary outcomes:
measure: preoperative anxiety
timeFrame: 1 hour before surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: