louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03327883: Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer
Official title: Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Diagnostic Imaging
Review of Patients Records
PET MRI
Treatment Responses
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-11-01
Enrollment: 15
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: Medical records from patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. Protocols from which research data originated are 01C0129, 12C0205, 13C0063, and 15C0160.@@@

Brief summary: Background:

Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used.

Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease.

Objective:

To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer.

Eligibility:

People 18 years and older who were in studies between 2013 and 2016

Design:

Researchers will study existing records. There will be no active participants.

The records will have no data that could identify the participants. Data will be stored on secure computers.

No study participants will be contacted without approval from a review board.

Detailed description: This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.

Eligibility criteria: * INCLUSION CRITERIA:

Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center.

EXCLUSION CRITERIA:

Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.

Primary outcomes:
measure: Disease burden
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Andrea B Apolo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413083: Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis
Official title: Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cirrhosis
Acute Liver Failure
Cardiomyopathies
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 70
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: All cirrhotic patients admitted for acute decompensated cirrhosis will be screened, regardless of gender, etiology of liver disease, and age (if above 18 years).

Brief summary: This project aims to investigate cardiac function in patients with cirrhosis in the acute setting. Acute decompensation and acute-on-chronic liver failure are major events in the life of a patient as they herald disease progression and negative prognosis. Cardiocirculatory function will be assessed by serial assessments in patients admitted for acute decompensation of cirrhosis.

Detailed description: In this project we aim to investigate the dynamic role of cardiac function in the short-term evolution of patients with AD of cirrhosis through noninvasive and accessible tests and validate prognostic imaging and serum biomarkers. The main objectives are:

1. To describe changes and evolution of cardiac function in AD of cirrhosis
2. To investigate associations between echocardiographic parameters and serum biomarkers
3. To investigate the association between ACLF and cardiac dysfunction
4. To assess the short-term prognostic impact of cardiac function in AD and ACLF;
5. To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).

Eligibility criteria: Inclusion Criteria:

* proven cirrhosis with acute decompensation

Exclusion Criteria:

* screening after \> 72 hours from admission
* previous severe cardiac conditions (e.g. ischemic heart disease, atrial fibrillation, congestive heart failure, ICD)
* concomitant severe disease (e.g. active neoplasia, severe COPD, etc)
* lack of informed consent
* intubated/ comatose patient

Primary outcomes:
measure: cardiac dysfunction
timeFrame: 90 days
measure: composite outcome
timeFrame: 90 days
Secondary outcomes:
measure: biomarkers
timeFrame: 30 days
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul clinic Colentina
Study officials:
References:
Clinical trial NCT02127983: Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)
Official title: Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
HIV
Keywords: TB, HIV, case finding, access, informal providers
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Research for Equity And Community Health REACH Trust
name: Ministry of Health and Population, Malawi
name: LHL International Tuberculosis Foundation
name: University of Warwick
First posted: 2014-05-01
Enrollment: 200000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

Detailed description: A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.

Eligibility criteria: Inclusion Criteria:

* People accessing informal providers with possible TB or HIV

Exclusion Criteria:

* children
* people already with a diagnosis of TB or HIV

Primary outcomes:
measure: TB and HIV treatment initiation
timeFrame: 2 years
Secondary outcomes:
measure: TB and HIV diagnostic uptake rates.
timeFrame: 2 years
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: REACH Trust
Study officials:
affiliation: LSTM
name: Rachael Thomson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bello G, Faragher B, Sanudi L, Namakhoma I, Banda H, Malmborg R, Thomson R, Squire SB. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial. PLoS One. 2017 Sep 6;12(9):e0183312. doi: 10.1371/journal.pone.0183312. eCollection 2017.
Clinical trial NCT03034083: An Evaluation of Healthy Marriage and Relationship Education Program: Elevate
Official title: Elevate: Taking Your Relationship to the Next Level
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Family Relations
Keywords: healthy marriage
healthy relationships
parenting
healthy marriage and relationship education
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is biological and foster parents of children ages 0-18.

Brief summary: The purpose of this study is to determine whether the healthy marriage and relationship education program Elevate: Taking Your Relationship to the Next Level results in improved couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect potential.

Detailed description: The descriptive study is based on the theory that couples can learn skills through participating in the Elevate curriculum that will help them function better as a couple resulting in improved relationship quality/stability, improved co-parenting skills, improved financial management, and reduced financial stress. As a result of improved relationship skills and better management of stress, couples will then provide more supportive, safe, and stable family environments for children.

Individuals who are eligible (biological and foster parents of children 0-18) and agree to participate in the study will complete surveys at three time points--before participating in Elevate, 4-6 weeks after participating, and 8-10 months after participating in Elevate. The surveys include items related to couple functioning behaviors, relationship quality/stability, parenting/co-parenting skills, and financial management and distress.

Eligibility criteria: Inclusion Criteria:

Biological parents of children 0-18 Parents must be in a committed couple relationship

Exclusion Criteria:

Incarceration

Primary outcomes:
measure: Elevate Pre-post program survey subscale measuring change in couple functioning and stability
timeFrame: Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation.
Secondary outcomes:
measure: Elevate Pre-post survey subscale measuring change in parenting skills
timeFrame: Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Theodore Futris, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00258583: Dorothy P. and Richard P. Simmons Center for ILD Research Registry
Official title: Dorothy P. and Richard P Simmons Center for Interstitial Lung Disease Research Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases, Interstitial
Keywords: "Lung[A04.400]"
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-11-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population can be described as any adult being seen by a physician at the Simmons Center for interstitial lung disease who has been diagnosed with an Interstitial Lung Disease.

Brief summary: The purpose of this study is to place past, current, and future medical record information into the UPMC Simmons Center for Interstitial Lung Disease Research Registry.

Detailed description: This study gives participant's permission to allow the staff at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease to to place past, current, and future medical record information into a UPMC Simmons Center for Interstitial Lung Disease Research Registry. By placing the medical record information of many patients into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about interstitial lung disease. It is anticipated that the research registry will assist out investigators by allowing researchers to review and study the medical records of many individuals to answer questions about interstitial lung disease and its treatment. In addition, it will help researchers identify and recruit patients for participation in future research studies.

Eligibility criteria: Inclusion Criteria:

* Adult patients who are seeking treatment at the UPMC Simmons Center for Interstitial Lung Disease
* 18 years of age or older

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Michelle F MacPherson
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh - UPMC Simmons Center for Interstitial Lung Disease
name: Kevin F Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203683: Testing the Effectiveness of a Computer-based Program for Depression
Official title: Attention Training for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: depression
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder

Exclusion Criteria:

* Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors

Primary outcomes:
measure: Beck Depression Inventory-II
timeFrame: Week 4, Week 9
Secondary outcomes:
measure: Structured Clinical Interview for DSM-IV diagnoses
timeFrame: Week 9
measure: Neural processing of emotion stimuli
timeFrame: Week 4
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Christopher Beevers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00673283: Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
Official title: Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lung Cancer
Metastatic Cancer in the Lungs
Keywords: lung cancer
nodules
radiography
CT
Stereoscopy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired within a short time interval from slightly different posterior projections. The image data are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules present in the thoracic cavity are detected by examining the geometrical correlation of the detected signals in the two views. The data are alos viewed stereoscopically for visual diagnosis. The expected high sensitivity/specificity of the method has the potential to change the current state of practice, perhaps leading to a preventive lung cancer screening program for high-risk populations, similar to the mammography screening program currently in place for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Normal individuals
* Individuals with CT-confirmed subtle lung nodules.

Exclusion Criteria:

* Individuals with acute pulmonary abnormalities or those in poor health conditions will be excluded due to the potential impact on the results as well as difficulty of acquiring the images. Pregnant women will also be excluded to avoid the exposure of the fetus to radiation.

Primary outcomes:
measure: The technique is effective in diagnosing early lung tumors.
timeFrame: end of the study
Secondary outcomes:
measure: The relative performance of BCI with respect to chest radiography and CT for lung cancer detection.
timeFrame: end of the study
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medcal Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ehsan Samei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samei E, Stebbins SA, Dobbins JT 3rd, McAdams HP, Lo JY. Multiprojection correlation imaging for improved detection of pulmonary nodules. AJR Am J Roentgenol. 2007 May;188(5):1239-45. doi: 10.2214/AJR.06.0843.
Clinical trial NCT04310683: Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate
Official title: The Live Birth Rate in Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle in Patients Undergoing Frozen-thawed Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent sutdies indicate that the existence of corpus lutein in the ovary is a key point to prevent preeclampsia, and patients undergoing FET with hormone replaced cycle have no corpus lutein and the absence of corpus lutein significantly increases the risk of preeclampsia in these patients. We aim to conduct a single center randomized trial study to compare the preeclampsia rate between the natural cycle and the hormone replaced cycle in patients undergoing FET.


Eligibility criteria: Inclusion Criteria:

1. 18 to 42 years old women;
2. normal ovulation;
3. Scheduled to undergo frozen-thawed embryo transfer.
4. Agreeing with the informed consent.

Exclusion Criteria:

1. Those who experienced embryo transfer cycle failure for at least three times;
2. One or both of the ovaries removed;
3. Hypertention disease before embryo transfer;
4. No available embryo for transfer
5. Oocyte or sperm donated cycles

Primary outcomes:
measure: live birth rate
timeFrame: delivery
Secondary outcomes:
measure: pre-eclampsia
timeFrame: From gestational week 20 to delivery
Other outcomes:
Locations:
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Dan Zhang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02239497: Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Keywords: postoperatory pain
orthopaedic surgery
femoral block
Lead sponsor: Hospital Central Dr. Luis Ortega
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 30
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: Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4


Eligibility criteria: Inclusion Criteria:

* ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia

Exclusion Criteria:

* Patients with any anesthetic or surgical complication
* Patients with neuromuscular diseases
* Allergy to any of the drugs used in the study
* Inability to understand and use a pain scale
* Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block

Primary outcomes:
measure: Postoperatory EVA values and need for rescue analgesia with IV morphine
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porlamar
country: Venezuela
facility: Servicio de Anestesiologia Hospital "Dr. Luis Ortega"
state: Estado Nueva Esparta
Study officials:
affiliation: Hospital "Dr Luis Ortega"
name: Beatriz S Arismendi Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References: