louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06904339: Communication About Sexual Health in Gynecologic Cancer
Official title: Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancers
Keywords: sexual health
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.

The main questions it aims to answer are:

1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?

Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone.

Participants will:

1. Fill out a consent form and survey
2. Have their next clinic visit audio recorded
3. Fill out another survey right after their clinic visit
4. Fill out a final survey 6 months after their clinic visit


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Diagnosed with any stage (I-IV) gynecologic cancer
* Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
* Attending visits in follow-up care at Fox Chase Cancer Center
* Score of at least 3 on a sexual concerns screener question

Exclusion Criteria:

* Not able to speak English
* Not willing to have clinic visit audio recorded
* Eastern Cooperative Oncology Group (ECOG) score \> 2
* Overt cognitive dysfunction or psychiatric disturbance

Primary outcomes:
measure: Clinical Communication - Raise Topic of Sexual Health
timeFrame: 2 weeks
measure: Clinical Communication - Ask a Question about Sexual Health
timeFrame: 2 weeks
measure: Clinical Communication - Express a Concern about Sexual Health
timeFrame: 2 weeks
Secondary outcomes:
measure: Self-Reported Sexual Function
timeFrame: Baseline, 2 weeks, 3 months, 6 months
measure: Self-Reported Sexual Activity
timeFrame: Baseline, 2 weeks, 3 months, 6 months
measure: Self-Reported Anxiety Symptoms
timeFrame: Baseline, 2 weeks, 3 months, 6 months
measure: Self-Reported Depressive Symptoms
timeFrame: Baseline, 2 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03110939: Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
Official title: A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Cancer
Lung Cancer
Hyperthermic Perfusion
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2017-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients must not have received any prior anticancer therapy of cancer.
2. expected R0 resection.
3. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N1. (8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM)
4. Age ranges from 18 to 80 years.
5. Without operative contraindication.
6. Eastern Cooperative Oncology Group (ECOG) 0～2.
7. Signed informed consent document on file.

Exclusion Criteria:

1. Multiple primary cancer.
2. The subject cannot understand and sign the informed consent form(ICF).
3. Patients with concomitant hemorrhagic disease.
4. Any un expected reason for patients can't get operation.
5. Pregnant or breast feeding.

Primary outcomes:
measure: local recurrent rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Total complication rate
timeFrame: 6 months after surgery
measure: The Clavien-Dindo classification
timeFrame: 6 months after surgery
measure: mortality rate during operation/intrathoracic hyperthermic perfusion
timeFrame: during operation/intrathoracic hyperthermic perfusion
measure: vital signs during treatment
timeFrame: during operation/intrathoracic hyperthermic perfusion
measure: mortality rate after treatment
timeFrame: 2 months after surgery/intrathoracic hyperthermic perfusion
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
References:
Clinical trial NCT03911739: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
Official title: NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
Neonatal Abstinence Syndrome
Neonatal Opiate Withdrawal Syndrome
Drug Abuse in Pregnancy
Keywords: CTN-0080
clinical trials network
medication assisted treatment
pharmacokinetics
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2019-04-11
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.


Eligibility criteria: Inclusion Criteria:

* The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1).

Exclusion Criteria:

-

Primary outcomes:
measure: Bayley Scales of Infant Development
timeFrame: 24 months post-partum
Secondary outcomes:
measure: Bayley Scales of Infant Development
timeFrame: 12 months post-partum
measure: Child Behavior Checklist
timeFrame: 24 months post-partum
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital HOPE Clinic
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
city: Pittsburgh
country: United States
facility: Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah SUPeRAD Clinic
state: Utah
city: Seattle
country: United States
facility: Addiction Recovery Services (ARS), Swedish Medical Center
state: Washington
city: Huntington
country: United States
facility: Marshall Health MARC Program
state: West Virginia
Study officials:
affiliation: University of Cincinnati
name: T. John Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02927639: MyDiaText Text Messaging Intervention for Diabetes
Official title: MyDiaText: Texting the Way to Better Diabetes Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-07
Enrollment: 166
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes for more than 1 year
* HbA1c greater than or equal to 8% but less than 14%.
* Have been seen in diabetes clinic in the last 6 months
* Owns a personal mobile device with unlimited text messaging plan

Exclusion Criteria:

* Non-English speaking
* Significant cognitive disability or major organ illness
* Hemolytic anemia

Primary outcomes:
measure: Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: CHOP
name: Terri Lipman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125839: Characterization and Differential Diagnosis of Vertebral Osteomyelitis
Official title: Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Osteomyelitis
Keywords: osteomyelitis
16S rRNA
spine
Magnetic resonance imaging
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that have MRI findings sugggestive of vertebral osteomyelitis

Brief summary: Vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not diagnosed in time. The etiologies of vertebral osteomyelitis include pyogenic bacteria, M. tuberculosis, Brucella species, and fungus. The aim of this study is to describe the clinical features and microbiological/radiological characteristics of patients with vertebral osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral osteomyelitis.

Detailed description: Besides description of characteristics of patients with vertebral osteomyelitis, we also will investigate the usefulness of 16S rRNA gene sequence analysis of biopsy specimen. MRI findings during the antibiotic treatment will be monitored and compared for the differential diagnosis of meningitis.

Eligibility criteria: Inclusion Criteria:

* Symptoms or signs consistent with spinal column infection
* MRI findings suggestive of infection
* Antibiotic treatment for vertebral myelitis

Exclusion Criteria:

* Patients already treated more than 2 weeks for osteomyelitis in transferring hospital

Primary outcomes:
measure: Identification of etiology of vertebral osteomyelitis
timeFrame: within 6 weeks after the diagnosis of vertebral osteomyelitis
Secondary outcomes:
measure: Unfavorable outcomes (death or permanent neurologic deficit)
timeFrame: within 6 months after the diagnosis of vertebral osteomyelitis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sang-Ho Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06635239: Massive Open Online Course (MOOC) for Women with Breast Cancer
Official title: Massive Open Online Course for Women with Breast Cancer: Development and Evaluation of an Intervention on Person-Centered Care and Digital Health Literacy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Massive Open Online Course
Digital Health Literacy
Health Literacy
Person-Centered Care
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Servicio de Evaluación del Servicio Canario de Salud
name: Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
name: University of La Laguna
name: University of Barcelona
name: FEFOC fundation
name: Parc Taulí Hospital Universitari
name: Hospital Clinic of Barcelona
name: Universitat Autonoma de Barcelona
First posted: 2024-10-10
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Adult women ( ≥18 years old)
* Speak Spanish
* With internet at home or smartphone
* Currently have or have had breast cancer (currently disease-free)
* Families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.)

Exclusion Criteria:

* No exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, Health Literacy and Digital Health Literacy level and knowledge about Person-Centred Care or breast cancer.
* In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.

Primary outcomes:
measure: Digital Health Literacy
timeFrame: Immediately after the intervention
measure: Health Literacy
timeFrame: Immediately after the intervention
measure: Knowledge acquired
timeFrame: Immediately after the intervention
measure: Acceptability of MOOC
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Servicio de Evaluación del Servicio Canario de la Salud
Study officials:
References:
citation: Alvarez-Perez Y, Duarte-Diaz A, Toledo-Chavarri A, Abt-Sacks A, Ramos-Garcia V, Torres-Castano A, Rivero-Santana A, Perestelo-Perez L. Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer. Int J Environ Res Public Health. 2023 Feb 22;20(5):3922. doi: 10.3390/ijerph20053922.
Clinical trial NCT05330039: Characterization of Intestinal Microbiota in Children With Inborn Errors of Metabolism (IEM)
Official title: Enterobacteria Strain-level Characterization in Children With Inborn Errors of Metabolism (IEM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inborn Errors of Metabolism
Propionic Aciduria
Methylmalonic Aciduria
Urea Cycle Disorder
Lead sponsor: ETH Zurich
Sponsor class: OTHER
Collaborators: name: University Children's Hospital
First posted: 2022-04-15
Enrollment: 22
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll 40 children that suffer from IEM (UCD, PA, MMA) and their siblings over the course of approximately two years.

Brief summary: Study around children with inborn errors of metabolism (IEM) and their healthy siblings. Collection of stool and urine to assess contribution of microbiota to disease severity.

Detailed description: This study aims to collect biological samples (stool and urine) from children with inborn errors of metabolism, IEM (like UCD (urea cycle disorder), PA (propionic aciduria) and MMA (methylmalonic aciduria) and their healthy siblings.

The main focus of the study is to assess the contribution of the intestinal microbiota to disease severity in children that suffer from different forms of IEM and potentially find microbiota targets that could be used in the design of therapeutic/prophylactic agents.

Eligibility criteria: Inclusion Criteria:

* Children or siblings of children that have been diagnosed with one of the following diseases: any type of UCD, PA or MMA

Exclusion Criteria:

* Children or siblings of children that have not been diagnosed with one of the following diseases: any type of UCD, PA or MMA
* use of an investigational drug or device less than 30 days prior to the study, or current enrollment in another investigational drug or device study less than 30 days prior to the study
* considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures, in the opinion of the investigator

Primary outcomes:
measure: Contribution of micriobiota to disease severity
timeFrame: 6 months
Secondary outcomes:
measure: Disease aggravating microbiota (microbiota target)
timeFrame: 6 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital
Study officials:
References:
Clinical trial NCT01301339: A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.
Official title: A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Diabetes
Diabetes
Cardiovascular Risks
Keywords: Pre-Diabetes
Diabetes
cardiovascular risks
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2011-02-23
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty Air Force personnel will be recruited from all male and female patients 18 years or older at the Mike O'Callaghan Federal Hospital. A total of 1040 subjects will be recruited (520 subjects who have failed their Air Force physical fitness test and 520 volunteers who have passed their physical fitness test both within the last 6 months from recruitment into this study).

Brief summary: The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.


Eligibility criteria: Inclusion:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* Over the age of 18 and took their AFPT within the past 1 month.

Exclusion:

* Previous diagnosis of diabetes
* Pregnant or nursing

Primary outcomes:
measure: Do Air Force personnel who fail the Air Force physical fitness test have a higher incidence of pre-diabetes than those who pass the test?
timeFrame: within 1 year
Secondary outcomes:
measure: And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel.
timeFrame: within 1 year
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
name: Andrew Timboe, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021839: Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
Official title: Bovine Carotid Artery Graft Revisited: A Prospective, Randomized Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure
Renal Dialysis
Keywords: renal dialysis
bioprosthesis
arteriovenous shunt
surgical
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Artegraft, Inc.
First posted: 2009-11-30
Enrollment: 57
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 investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access. The goal of the study was to determine differences in primary and assisted patency rates and frequency of complications between these two types of grafts. The investigators' hypothesis was that bovine carotid artery grafts more closely mimic autologous tissue and therefore, would provide better patency and fewer complications.

Detailed description: Objective: To understand how bovine carotid artery (BCA) grafts compare to cuffed polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis access in terms of patency and complications.

Background: Many hemodialysis patients do not have adequate anatomy for native arteriovenous fistulas. In these patients, synthetic conduits remain the only option for permanent hemodialysis access. We sought to compare the standard cuffed ePTFE with bovine carotid artery grafts as this has not been undertaken since the 1970's.

Methods: Following Institutional Review Board approval, a prospective, randomized controlled trial was conducted enrolling 29 patients in the BCA group and 28 patients in the ePTFE group. Univariate and multivariate analysis was undertaken to understand factors that affect complications. Patency rates were calculated using the Kaplan-Meyer method.

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease stage 4 or 5, in need of hemodialysis access

Exclusion Criteria:

* Surgically suitable for a native arteriovenous fistula

Primary outcomes:
measure: Primary and Assisted Patency
timeFrame: 6, 12, 18, 24 months
Secondary outcomes:
measure: patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome.
timeFrame: 6,12,18 and 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tatsuo Kawai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: