louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00818857: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Official title: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Measures
Keywords: cancer screening
screening disparities
underserved populations
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2009-01-08
Enrollment: 1072
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

Detailed description: This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Eligibility criteria: Inclusion Criteria:

* Men age 50-75 yrs.
* Women age 40-75 yrs
* One primary care visit in past 2 years.

Exclusion Criteria:

* High risk for colorectal or breast cancer.

Primary outcomes:
measure: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome.
timeFrame: End of project, 12/2011
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Kevin Fiscella, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiscella K, Humiston S, Hendren S, Winters P, Idris A, Li SX, Ford P, Specht R, Marcus S. A multimodal intervention to promote mammography and colorectal cancer screening in a safety-net practice. J Natl Med Assoc. 2011 Aug;103(8):762-8. doi: 10.1016/s0027-9684(15)30417-x.
citation: Fiscella K, Yosha A, Hendren SK, Humiston S, Winters P, Ford P, Loader S, Specht R, Pope S, Adris A, Marcus S. Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice. BMC Health Serv Res. 2010 Sep 23;10:280. doi: 10.1186/1472-6963-10-280.
Clinical trial NCT00189657: 5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of the Rectum
Lead sponsor: Association Européenne de Recherche en Oncologie
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Pfizer
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.


Eligibility criteria: Inclusion Criteria:

* rectal adenocarcinoma
* R0 surgery
* T3, N0, M0 or T4, N0, M0 or N1,2, M0
* chemotherapy can be started within 8 weeks after surgery
* Age \> 18
* Performance status ECOG \< 3
* preoperative radiotherapy allowed
* preoperative chemotherapy with 5FU +/- LV allowed
* Neutrophiles \> 1 500/mm3; Pl. \> 100 000/mm3
* Transaminases \< 2 x UNL; Alcalines Phosphatases \< 2 x UNL; Bili \< 1.1 UNL
* creatininemia \< 120 µmol/l and/or clearance of creatininemia \> 60 ml/mn
* Written informed consent before inclusion

Exclusion Criteria:

* postoperative radiotherapy
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including digestive inflammatory disease
* Gilbert disease
* severe toxicity of radiotherapy
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: AERO
Study officials:
affiliation: Association Europeenne de Recherche en Oncologie
name: Pascal Piedbois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GERCOR - Multidisciplinary Oncology Cooperative Group
name: Thierry Andre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association Europeenne de Recherche en Oncologie
name: Alain Piolot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GERCOR - Multidisciplinary Oncology Cooperative Group
name: Emmanuel Achille, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Française de Cancérologie Digestive
name: Iradj Bobhani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNICANCER
name: Jean-Yves Douillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042557: Real World Study of MPM in China
Official title: Real World Study of Diagnosis, Treatment and Prognosis of Malignant Pleural Mesothelioma in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Mesothelioma
Diagnoses Disease
Treatments
Prognosis
Keywords: MPM
Prognosis
Radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-09-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were pathologically confirmed as malignant pleural mesothelioma is included in this study.

Brief summary: Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China.

Focusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed as malignant pleural mesothelioma
* Aged over 18

Exclusion Criteria:

* Follow-up less than 3 months

Primary outcomes:
measure: Overall survival
timeFrame: 2-year overall survival
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2-year progression-free survival
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Zhouguang Hui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07025057: Multilevel Community-Centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities
Official title: Multilevel Community-centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities in Non-Hispanic Black and Hispanic Medicaid-insured Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Provider Confidence
Provider Behavior
Keywords: Maternal mortality
Maternal morbidity
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-06-17
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the study involving human subjects is to train providers to address patient-provider interactions. The study will survey providers to assess pre-post knowledge, understanding, and behavior changes.

Detailed description: Provider/practice level intervention. The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including CHWs and HV, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal NHB/H women.

Eligibility criteria: Inclusion Criteria:

* Providing care to pregnant and postpartum women in Wayne, Kent, and Genesee Counties in MI

Exclusion Criteria:

* None

Primary outcomes:
measure: Provider confidence. Assessed through questionnaire.
timeFrame: Assessment immediately after the provider training intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Strong Beginings
state: Michigan
Study officials:
affiliation: Michigan State University
name: Cristian Meghea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055857: Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)
Official title: Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease: A Pioneer Multi-modal 7T MRI Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuronal Intranuclear Inclusion Disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang University Interdisciplinary Institute of Neuroscience and Technology
First posted: 2019-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects enrolled in the study shall be selected from NIID patients who are diagnosed with skin biopsy and gene detection. The Investigator is responsible for screening potential subjects and selecting those who meet the eligibility criteria for the study as described.

Brief summary: To discover the microstructure, macrostructure and functional changes with 7T multi-modal magnetic resonance imaging of Neuronal Intranuclear Inclusion Disease, and to explore new biomarkers for evaluating the severity and the progression of Neuronal Intranuclear Inclusion Disease.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with NIID
2. Older than 18 years;
3. Sign the informed consent form.

Exclusion Criteria:

1. The informed consent is withdrawn by the subject;
2. Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.

Primary outcomes:
measure: fractional anisotropy (FA)
timeFrame: baseline
measure: mean diffusivity (MD)
timeFrame: baseline
measure: Intracellular volume fraction(icvf)
timeFrame: baseline
measure: orientation dispersion index (ODI)
timeFrame: baseline
measure: fiber number(fiber pass through the lesions)
timeFrame: baseline
measure: fractional anisotropy (FA)
timeFrame: 6 months
measure: mean diffusivity (MD)
timeFrame: 6 months
measure: Intracellular volume fraction(icvf)
timeFrame: 6 months
measure: orientation dispersion index (ODI)
timeFrame: 6 months
measure: fiber number(fiber pass through the lesions)
timeFrame: 6 months
measure: short-range and long-range functional connectivity around the lesions at rest
timeFrame: baseline
measure: short-range and long-range functional connectivity around the lesions at rest
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Siemens 7T MR
state: Zhejiang
Study officials:
affiliation: Zhejiang University Interdisciplinary Institute of Neuroscience and Technology (ZIINT)
name: Ruiliang Bai, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Hui Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06138457: The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
Official title: The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Rate Variability
Stress
Medical Student
Keywords: stress
exam
medical student
heart rate variability
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical student between fourth and sixth year of med school

Brief summary: We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day.

Detailed description: French medical students have benefited from a new evaluation method since 2020 in the form of a standardized objective clinical examination (OSCE). This examination consists of an evaluation of an initial clinical situation, in relation to a pre-identified and nationally identical objective in all Medical School. During these exams, the student has one minute of preparation then seven minutes of evaluation in front of a facilitator, member of the teaching staff. An examiner is also present in the room to search in real time for keywords intended for grading. The examiner and facilitator may or may not be tenured teachers. Students benefit from annual training organized by the Medical School of Clermont-Ferrand in which they all participate. This exam appears to be excessively stressful for students. However, there is currently no data regarding the objective measurement of the stress of these students. Heart rate variability is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc...).

Eligibility criteria: Inclusion Criteria:

* All medical student that agree to participate

Exclusion Criteria:

* All medical student that disagree to participate

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 24 hours
Secondary outcomes:
measure: Sociodemographic
timeFrame: Once
measure: Subjective stress
timeFrame: 12 hours
measure: Stress correlation
timeFrame: Once
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Medical School of Clermont-Ferrand
state: Auvergne-Rhone-Alpes
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Baptiste BOUILLON-MINOIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04896957: Perceptions and Representations of Vaccination Against COVID-19
Official title: Perceptions and Representations of Vaccination Against COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: vaccination perception
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Intercommunal Villeneuve Saint Georges
First posted: 2021-05-21
Enrollment: 14
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 with or without comorbidities consulting the Villeneuve Saint Georges Hospital for COVID-19 vaccination or for a scheduled consultation

Brief summary: SARS COV2, the virus that causes COVID-19, was first described in Wuhan, China. For this pathology, which causes severe respiratory infections, preventing the transmission of the virus has become fundamental, that is why vaccines have been developed. In France, this vaccination campaign took place in a context where the lack of confidence in vaccination is high:

According to a November 2020 IFOP poll, only 41% of French respondents were willing to be vaccinated against COVID-19.

To our knowledge, there are still few qualitative studies on vaccination on the current issue of vaccination against COVID-19.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Patient with a scheduled appointment in consultation or at the vaccination centre
* Not opposed to participation in the protocol

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient unable to give free and informed consent
* Patient under court protection
* Patient without the cognitive capacity to ensure an interview

Primary outcomes:
measure: Perceptions, representations and experiences of Covid-19 vaccination
timeFrame: 1 hour
Secondary outcomes:
measure: Key elements to improve the medical discourse on vaccination
timeFrame: 1 hour
Other outcomes:
Locations:
city: Villeneuve-Saint-Georges
country: France
facility: CHI Villeneuve-Saint-Georges
Study officials:
References:
Clinical trial NCT04062357: Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.
Official title: Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lidocaine Spray
Keywords: Premature Ejaculation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 150
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system). Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks (One to two applications (1-2 ml) of alcohol 70% sprays).
Primary purpose: TREATMENT

Brief summary: This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.

Detailed description: This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of lifelong premature ejaculation

Exclusion Criteria:

1. renal or liver diseases,
2. diabetes mellitus,
3. thyroid diseases,
4. chronic prostatitis,
5. neurological diseases
6. allergic reactions to local anesthetics or alcohols.
7. erectil dysfunction

Primary outcomes:
measure: Arabic Index of Premature Ejaculation Scores
timeFrame: 0-8 weeks after treatment
measure: Intravaginal ejaculatory latency times
timeFrame: 0-8 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University, Egypt
Study officials:
References: