louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03166774: Support of the Sexual Health in Oncology
Official title: Support of the Sexual Health in Oncology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Oncology
Sexual Health
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-05-25
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: Patient followed in oncology

Brief summary: Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health.

There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner .

Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs


Eligibility criteria: Inclusion Criteria:

* all patient consulting in oncology service
* age \> 18 years
* accepting to participate

Exclusion Criteria:

* Age\< 18 years
* Refusing to participate

Primary outcomes:
measure: Benefit of the care measurement program
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Alexandra SCHULTZ, Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03734874: The Effects of Hesperidin on Metabolic Syndrome
Official title: Evaluation of the Effects of Hesperidin Supplementation in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-11-08
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: To study the effects of Hesperidin supplement in patients with metabolic syndrome, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HDL

Exclusion Criteria:

* pregnancy or lactation
* A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* Following program to lose weight in recent 3 mo

Primary outcomes:
measure: Metabolic syndrome: Number of participants with treated metabolic syndrome
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
citation: Yari Z, Movahedian M, Imani H, Alavian SM, Hedayati M, Hekmatdoost A. The effect of hesperidin supplementation on metabolic profiles in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial. Eur J Nutr. 2020 Sep;59(6):2569-2577. doi: 10.1007/s00394-019-02105-2. Epub 2019 Dec 16.
Clinical trial NCT04867174: COVID-19 Vaccination Take-Up
Official title: COVID-19 Vaccination Take-Up in a County-Run Medicaid Managed Care Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Vaccination
Keywords: COVID19
vaccination
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: Contra Costa Health Services
name: Abdul Latif Jameel Poverty Action Lab
name: University of Southern California
name: National Institute on Aging (NIA)
First posted: 2021-04-30
Enrollment: 2701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this work, the investigators are partnering with Contra Costa Health Services (CCHS), the department of health in Contra Costa County, CA, to measure COVID-19 vaccinations and other COVID-19 related preventive health behaviors in the county's Medicaid managed care population. This work will test ways to increase COVID-19 vaccine uptake. The investigators hypothesize that small financial incentives and other low-cost behavioral nudges can be used to increase vaccine uptake and reduce disparities in uptake among diverse racial/ethnic minority populations.


Eligibility criteria: Inclusion Criteria:

* age 18 and over
* member of Contra Costa Health Plan (CCHP)

Exclusion Criteria:

* contraindications to vaccination, as determined by county health plan or other medical staff.

Primary outcomes:
measure: Rate of COVID-19 Vaccination at 1 Month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
measure: Vaccine Intentions
timeFrame: 30 days
Locations:
city: Martinez
country: United States
facility: Contra Costa Health Plan
state: California
Study officials:
References:
Clinical trial NCT03300674: Intravenous Lidocaine Randomized Comparative Effectiveness Trial
Official title: Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 154
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: This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.


Eligibility criteria: Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.

Exclusion Criteria: Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration \> 0.5s, QRS duration \> 0.12s, or PR interval duration \> 0.2s), known renal (CKD \>2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing \< 60kg or \> 120kg will be excluded.

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Primary outcomes:
measure: Change in 0-10 Pain Scale Between Baseline and 90 Minutes
timeFrame: up to 90 minutes
Secondary outcomes:
measure: Rescue Medication
timeFrame: 4 hours
measure: Adverse Events
timeFrame: 4 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
citation: Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26.
Clinical trial NCT01767974: Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer
Official title: Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell lung cancer
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2013-01-15
Enrollment: 140
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: Locally advanced stage IIIB or IV (metastatic) or Relapsed Non-Small Cell Lung Cancer

Brief summary: Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Detailed description: Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Eligibility criteria: Inclusion Criteria:

* Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC
* ECOG Performance status 0\~2.
* Written Informed Consent
* Female or male patients aged 18 years or over, eligible for treatment for NSCLC

Exclusion Criteria:

* Previous exposure to EGFR-TKI
* Concomitant use of other anti-cancer drugs with EGFR-TKI
* Patients without available Tumor DNA
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Primary outcomes:
measure: Detection rate of EGFR mutation
timeFrame: two weeks
Secondary outcomes:
measure: Verification of PNA positive casese
timeFrame: Two weeks
Other outcomes:
Locations:
city: Hwasun-Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411474: Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Graft-versus-host Disease
Keywords: stem cell transplantation (SCT)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or non-pregnant female patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Brief summary: Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.


Eligibility criteria: Inclusion Criteria:

* The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Exclusion Criteria:

* The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.

Primary outcomes:
measure: tear cytokine
timeFrame: 3-12 month after SCT
measure: ocular surface status
timeFrame: 3-12 month after SCT
measure: tear film break-up time
timeFrame: 3-12 month after SCT
measure: conjunctival injection
timeFrame: 3-12 month after SCT
measure: Schirmer's test I
timeFrame: 3-12 month after SCT
measure: ocular surface disease index
timeFrame: 3-12 month after SCT
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology
Study officials:
References:
citation: Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, Parker P, Forman S, Weisdorf D, Gurney JG, Baker KS. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006 Oct 15;108(8):2867-73. doi: 10.1182/blood-2006-02-003954. Epub 2006 Jun 20.
Clinical trial NCT04846374: Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
Official title: Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apheresis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 20
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: A total of 20 adults will be enrolled to this study. The study subjects will be recruited from adults who are scheduled to receive or have received a PowerFlow™ Implantable Apheresis IV Port in Vascular Interventional Radiology for their clinical care.

Brief summary: Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis.

Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port.

Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years of age.
* Referred for change from a vortex port to a powerflow port.
* Previously placed or scheduled placement of one of two configurations of the PowerFlow port

Exclusion Criteria:

* Unable to read and understand English.
* Unable to provide informed consent.

Primary outcomes:
measure: Change in Flow Rate
timeFrame: 1 year following new port configuration placement
measure: Change in Procedure Time
timeFrame: 1 year following new port configuration placement
Secondary outcomes:
measure: Change in Use of Tissue Plasminogen Activator
timeFrame: 1 year following new port configuration placement
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Peter Bream, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011674: Early Exposure to Lead and Adolescent Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Keywords: Lead
Prenatal
Development
Children
Psychology
Toxicology
Teratology
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.


Eligibility criteria: Subjects for the Cincinnati Lead Study were recruited prenatally if their mothers resided in areas within Cincinnati, Ohio where there has historically been a high incidence of lead poisoning. Infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Findlay Street Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00882674: A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Official title: An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is \< 3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* female patients, \>=18 years of age;
* invasive, and operable, breast cancer;
* ECOG Performance Status of 0 or 1.

Exclusion Criteria:

* evidence of metastatic disease;
* inflammatory breast cancer;
* prior hormonal or systemic therapy for breast cancer;
* prior treatment with an agent targetting the IGF-1R pathway;
* patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.

Primary outcomes:
measure: Percent reduction in IGF-1R expression
timeFrame: From initial diagnosis to tumor excision
Secondary outcomes:
measure: Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
timeFrame: Days 1, 8 and 31
measure: Adverse events, laboratory parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00769574: Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
Official title: Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).


Eligibility criteria: Inclusion Criteria:

* subjects over 18 years,
* subject about having a chest pain of coronary syndrome,
* subject about not having received heparin or LMWH

Exclusion Criteria:

* subject minor
* subject without informed consent,
* subject after receiving an anticoagulant treatment,
* transplanted heart, kidney or liver

Primary outcomes:
measure: To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).
timeFrame: 24 months
Secondary outcomes:
measure: Compare the characteristics of biological markers to those of usual or innovative markers
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone- Service cardiologie A
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Jean-Louis BONNET, MD
role: PRINCIPAL_INVESTIGATOR
References: