louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01180699: Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
Official title: A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccine
Keywords: adult solid organ transplant patients
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 59,
* Greater than 3 months post-transplant,
* Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

Exclusion Criteria:

* Has already received influenza vaccination for 2010-2011 season;
* Egg allergy,
* Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
* Ongoing therapy for rejection,
* Febrile illness in the past two weeks,
* Unable to provide informed consent,
* Unable to comply with study protocol

Primary outcomes:
measure: Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen
timeFrame: 4 weeks
Secondary outcomes:
measure: Local and systemic adverse events to vaccination
timeFrame: 24 hours, 48 hours and 7 days after each vaccination
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Deepali Kumar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05011799: The Peer Genetic Study
Official title: Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subject
Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-08-18
Enrollment: 149
Sex: MALE
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Able to read and speak English comfortably
* With or without a personal or family history of PCA
* Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate

Exclusion Criteria:

* Do not read or speak English comfortably
* Men who participated in a focus group will be excluded from participating in the intervention

Primary outcomes:
measure: Change in of decisional conflict
timeFrame: Baseline up to 2 months
measure: Awareness of risks and benefits of genetic testing
timeFrame: Up to 2 months post study
measure: Perceptions of genetic testing
timeFrame: Up to 2 months post study
measure: Genetic testing
timeFrame: Up to 2 months post study
measure: Prostate Cancer response
timeFrame: Up to 2 months post study
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05055999: Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer
Official title: Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer Who Treated With Atezolizumab Plus Etoposide and Platinum Based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 60
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: Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Brief summary: The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy.


Eligibility criteria: Inclusion Criteria:

* 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Exclusion Criteria:

- Patients with contraindication of chemotherapy Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: April 2019- July 2021
measure: OS
timeFrame: April 2019- July 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05269199: Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
Official title: Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-exposure HIV Prophylaxis (PrEP)
Keywords: PrEP
MSM
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 56
Sex: MALE
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: men who have sex with men (MSM), using Pre-Exposure HIV Prohylaxis (PrEP)

Brief summary: Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).

Detailed description: This study is perform to study the sexual health satisfaction of men who have sex with men (MSM), since the use pre-exposure HIV prophylaxis (PrEP), compared to the time before PrEP.

Eligibility criteria: Inclusion Criteria:

* Adult patient, male having sex with men, not infected with HIV, and using HIV prophylaxis by pre-exposure treatment (PrEP) for at least 1 year, received in consultation for renewal of this prescription.
* Able to give his non-opposition to participate in the research.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Patient under curatorship/guardianship or safeguard of justice
* Refusal to participate

Primary outcomes:
measure: Sexual health satisfaction
timeFrame: 1 day during the scheduled consultation
Secondary outcomes:
measure: Sentimental satisfaction
timeFrame: 1 day during the scheduled consultation
measure: Risky behaviours
timeFrame: 1 day during the scheduled consultation
measure: Specific care
timeFrame: 1 day during the scheduled consultation
measure: Predictors of satisfaction
timeFrame: 1 day during the scheduled consultation
Other outcomes:
Locations:
city: Brioude
country: France
facility: CH Brioude
city: Clermont-Ferrand
country: France
facility: CEGIDD Clermont Ferrand
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Le Puy-en-Velay
country: France
facility: CH Le Puy en Velay
city: Montluçon
country: France
facility: CH Montluçon
city: Moulins
country: France
facility: CH Moulins
city: Vichy
country: France
facility: CH Vichy
Study officials:
References:
Clinical trial NCT05301699: Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications
Official title: Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications After Radical Gastrectomy Among Elderly Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer;postoperative complications;nomogram
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 582
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly gastric cancer patients

Brief summary: The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.


Eligibility criteria: Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology
* planned to receive radical surgery for the first time
* aged 60 or older

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy
* with other sites of malignant tumors

Primary outcomes:
measure: postoperative complications during hospitalization
timeFrame: about 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing medical university
Study officials:
References:
Clinical trial NCT00988299: Energy Expenditure Responses to Acute Exercise in Older Women (Calorie Expenditure and Exercise)
Official title: Energy Expenditure Responses to Acute Exercise in Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: older
NEAT
exercise
RMR
energy expenditure
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-10-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In older, normal-weight women (60-75 yrs, BMI=18-28 kg/m2), an acute bout of higher-intensity (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body weight for both), will result in differential:

1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after exercise;
2. increase in resting metabolic rate 48 hours after exercise;
3. increase in serum free triiodo-L-thyronine (free T3) concentrations immediately following exercise;
4. decline from pre-exercise in plasma leptin and serum free T3 concentrations 48 hours after exercise.


Eligibility criteria: Inclusion Criteria:

1. Women
2. Age 60-75 years
3. normal weight
4. Weight-stable (± 5%) within the previous 3 months
5. Non-smoking for last year
6. Able to provide own transportation to study visits
7. Not currently involved in any other research study
8. Willing and able to participate in all aspects of the trial including research testing
9. Willing to give informed consent to participate

Exclusion Criteria:

1. Self-reported significant cardiovascular disease
2. Other self-reported medical conditions such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease
3. Medications known to affect exercise performance or metabolism
4. Excess caffeine use (\> 500mg/day)
5. Any self-reported contraindications to exercise
6. Clinical depression
7. Abnormal cognitive function -

Primary outcomes:
measure: non-exercise activity calorie expenditure
timeFrame: 2 days after exercise sessions
Secondary outcomes:
measure: resting metabolic rate
timeFrame: 2 days after exercise sessions
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Xuewen Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386799: Evaluation of a Power Assistance Device for Wheelchair-DUO
Official title: Evaluation of a Power Assistance Device for Wheelchair-DUO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraplegia
Hemiplegia
Keywords: Power assistance device
Wheelchair
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 27
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: Patient with a motor deficiency (of any origin) needing a manual wheelchair

Brief summary: Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.

Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.

To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.

The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.

The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)


Eligibility criteria: Inclusion Criteria:

* with a motor deficiency (of any origin) needing a manual wheelchair
* propelling his wheelchair with both arms or with one foot and one arm.
* covered by the French national health insurance.
* living at less than 30km form the investigation center

Exclusion Criteria:

* subject of a guardianship or tutelage measure
* owning already a power wheelchair or a powered assisted wheelchair
* with cognitive impairments that affect the steering capacity or the understanding of the instructions.
* Patient unable to use a manual wheelchair indoor without help,
* Contraindication in keeping a seating position especially the occurrence of ulcers.

Primary outcomes:
measure: ESAT questionnaire
timeFrame: at 12 days
Secondary outcomes:
measure: Success rate during the indoor test (wheelchair skill program)
timeFrame: at 12 days
measure: Time to perform the wheelchair skill program
timeFrame: at 12 days
measure: Time run
timeFrame: at 12 days
measure: Maximal heart rate
timeFrame: at 12 days
measure: Effort assessment by the Borg scale
timeFrame: at 12 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swynghedauw, CHU
Study officials:
affiliation: University Hospital, Lille
name: André Thevenon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086499: Clustering Among the Clinical Profiles of Patients With Pectus Excavatum
Official title: Clustering Among the Clinical Profiles of Patients With Pectus Excavatum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Funnel Chest
Keywords: pectus excavatum
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pectus excavatum having consulted at the Montpellier University Hospital and who have had corrective surgery.

Brief summary: The primary objective of this study is to describe the relative distances between patient clinical profiles (i.e. patient clustering) in multivariate space.

Detailed description: Observational data will be collected from patient files and submitted to clustering analyses. Then clusters will be compared.

Eligibility criteria: Inclusion Criteria:

* Adult patient with pectus excavatum
* The patient has had corrective surgery

Exclusion Criteria:

* The patient has expressed opposition to the study

Primary outcomes:
measure: The number of clusters found
timeFrame: Day 0 (transversal, retrospective study)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Jean Philippe Berthet, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00901199: Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Official title: Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thalassemia
Iron Overload
Keywords: Thalassemia
Chelation
Iron Overload
Thalassemia patients with Iron overload
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

Detailed description: This was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. The duration of combined therapy was 12 months. Changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored.

Eligibility criteria: Inclusion Criteria:

* Transfusion Dependent Thalassemia
* If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
* Older than 8 years

Exclusion Criteria:

* Participating on another interventional clinical trial

Primary outcomes:
measure: Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months
timeFrame: 12 months
measure: Change in Serum Creatinine During 12 Months Combined Chelation Therapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: CHRCO
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Elliot Vichinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lal A, Porter J, Sweeters N, Ng V, Evans P, Neumayr L, Kurio G, Harmatz P, Vichinsky E. Combined chelation therapy with deferasirox and deferoxamine in thalassemia. Blood Cells Mol Dis. 2013 Feb;50(2):99-104. doi: 10.1016/j.bcmd.2012.10.006. Epub 2012 Nov 11.
Clinical trial NCT04217499: Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm
Official title: Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were hospitalized or consulted in the Orthopedic Surgery service of the Paris Saint-Joseph Hospital Group, for the management of a pelvic ring fracture from January 2015 until September 2019.

Brief summary: Pelvic ring fractures are common and often the result of high energy trauma but also sometimes of lower energy trauma in older patients. A good classification and description of the fracture is essential to the choice of treatment.

The classifications used to describe these fractures are numerous (Tile modified AO, Young and Burgess, Letournel, Rommens) and of a descriptive order more or less depending on the lesion mechanism allowing some to orient the surgical reduction technique. However, none of them helps with the choice of surgical or functional treatment, which is currently based on obvious notions of instability and / or displacement of lesions and, by habit, all different services.

In addition, the complexity of these classifications leads to poor reproducibility of these.

A new method for analyzing unitary lesions has been developed in the Orthopedic Surgery department of the Paris Saint-Joseph Hospital Group with a rating system which determines the indication according to the score.

Teaching this new method of analyzing pelvic ring fractures would simplify decision making between surgical and functional treatment.


Eligibility criteria: Inclusion Criteria:

* Patient aged\> 18 years
* Patient treated or followed within the Orthopedic Surgery service of the GHPSJ for a pelvic ring fracture
* complete initial imaging patient record (scanner)
* French speaking patient

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients objecting to the use of their data for this research
* Patient with isolated sacral or acetabular fracture
* Absence of scanner during the initial assessment

Primary outcomes:
measure: State of play of the decision for surgical sanction of pelvic ring fractures
timeFrame: Day 1
Secondary outcomes:
measure: Impact of the teaching of the new method of analysis on the surgical decision within each group
timeFrame: Day 1
measure: Reproducibility of this intra and inter-group decision before and after teaching
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Guillaume RIOUALLON, MD
role: PRINCIPAL_INVESTIGATOR
References: