louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06705075: Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE
Official title: Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Uterine Fibroid
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study goals are to determine the patterns of uterine fibroid vascularity pre and post UAE using CEUS resulting in an alternative to gadolinium-enhanced MRI that is less expensive, has less contra-indications and side effects, is real time, and noninvasive helping physicians to evaluate the result of UAE procedures. Also, this study will evaluate uterine fibroid pressures using SHAPE, comparing the results with normal myometrium tissue in order to determine its characteristics and tissue differences, which we believe will lead to the development of a new biomarker for the diagnosis and treatment of uterine fibroids.


Eligibility criteria: Inclusion Criteria:

* Be a female diagnosed with endometrial cancer and scheduled for UAE.
* Be over the age of 18 years.
* If the subject is of child-bearing potential, must have a negative pregnancy test.
* Be conscious and able to comply with study procedures.
* Have read and signed the IRB approved consent form for participating in the study.

Exclusion Criteria:

* Females who are pregnant or nursing.
* Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards.
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
* Patients on life support or in a critical care unit.
* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
* Patients with recent cerebral hemorrhage.
* Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
* Patients with congenital heart defects.
* Patient with a known allergy to Definity.

Primary outcomes:
measure: Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00539370: Human Samples and Data Repository
Official title: Laboratory of Immunology/National Eye Institute Repository
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uveitis
Scleritis
Keywords: Scleritis
Intermediate Uveitis
Posterior Uveitis
Intraocular Inflammatory Disease
Data Analysis
Data Collection
Sample Analysis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2007-10-04
Enrollment: 1862
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were followed in terminated branch protocols under which data or samples were collected.

Brief summary: This protocol will enable IRB (institutional review board) review of proposed research using human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096. Data and samples may include demographic and personal health information, psychological or psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical and physiological evaluation and medical imaging.

Data and sample analyses are limited to those approved under the original protocols unless additional specific institutional review board approval is obtained.

Detailed description: Objective: This protocol will enable prospective IRB review of research using human samples and data collected under other branch protocols.

Study population: Participants that were followed in terminated branch protocols under which data or samples were collected.

Design: Samples and data will be brought under this protocol, analyzed and stored for uses specified in the original protocols and as additionally approved by the IRB.

Outcome: The outcome of this protocol will be the storage, tracking, and utilization of samples and data obtained under terminated protocols.

Purpose: The purpose of this protocol is to enable prospective IRB review of research using human samples and data collected under other branch protocols.

Participants: Participants who previously participated in NIH protocols whose wishes regarding use of their samples or data for research other than that specified in the initial protocol is not known may be enrolled in this protocol. At this time, there are no additional analyses planned outside of the original protocols, apart from those listed below. Participant consent or IRB approval for a waiver of additional informed consent will be sought prior to initiation of additional analyses.

Eligibility criteria: * Data Analysis Study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Hatice N Sen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270670: Olympus - 19-gauge Needle
Official title: A Pilot Study Evaluating the Performance of 19-gauge Needles in Testing Molecular Markers in Samples Obtained Via Endobronchial Ultrasound Guided Needle Aspiration of Lymph Nodes in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing a standard of care bronchoscopy to determine lung cancer.

Brief summary: The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.


Eligibility criteria: Inclusion Criteria:

* Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity.
* Participants must lack bleeding disorders

Exclusion Criteria:

* Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
* Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
* Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Primary outcomes:
measure: Molecular marker test
timeFrame: Day of Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Momen Wahidi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848770: Manipulation of Arterial Pressure in Acute Ischemic Stroke
Official title: Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke, Acute
Systolic Pressure of Blood
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to determine the effects of three levels of arterial pressure on death and neurological disability. After the admission in the vascular unit of the Emergency Department the patients are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study is the Modified Rankin score and mortality in three month after the discharge.

Detailed description: To maintain the tree levels of systolic arterial pressure during de first 24h we will use one of the two strategies:1) infusion of 500 to 1000ml of saline solution and/or norepinephrine solution to increase de systolic pressure or 2) infusion of esmolol or nitroprussiate solution to decrease de pressure. Every patient will have a transcranial doppler study in the first 24h to measure the mean velocity of cerebral arteries.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older, with the first Acute Ischemic Stroke within the first 6 hours of the symptoms and not candidate to thrombolysis
* We will also include patients with previous Ischemic Stroke with Ranking score 0 or 1

Exclusion Criteria:

* Improuvment of the symptoms rapidly (in the first 15 min after admission)
* Seizures not related do the acute ischemic stroke
* Previous ischemic stroke in the last 6 weeks and with Ranking score \> 1
* Haemorrhagic stroke
* Anticoagulation
* Hypoglycemia
* Shock
* Acute heart failure

Primary outcomes:
measure: Ranking score and mortality
timeFrame: Three month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre/ UFRGS
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre / UFRGS
name: Luiz A Nasi, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Potter J, Robinson T, Ford G, James M, Jenkins D, Mistri A, Bulpitt C, Drummond A, Jagger C, Knight J, Markus H, Beevers G, Dewey M, Lees K, Moore A, Paul S; CHHIPS Trial Group. CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pilot Trial: rationale and design. J Hypertens. 2005 Mar;23(3):649-55. doi: 10.1097/01.hjh.0000160224.94220.e7.
Clinical trial NCT04345770: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Neoplasm of Stomach
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.

Detailed description: To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open and parallel group study.

Eligibility criteria: Inclusion Criteria:

* Histological proved diagnosis of locally advanced gastric cancer.
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
* Eligible for radical gastrectomy with D2 lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis or peritoneal metastasis during surgery (M1).
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: progression-free survival
timeFrame: 5 years
measure: distant metastasis rate
timeFrame: 5 years
measure: peritoneal metastasis rate
timeFrame: 5 years
measure: local recurrence rate
timeFrame: 5 years
measure: complication rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00011570: Electrical Control of Bladder in Spinal Cord Injury Patients
Official title: Electrical Control of Bladder in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: defecation
electrical stimulation
penile erection
Spinal cord injury
urology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-02-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R\&D, PVA and a commercial stimulator company.


Eligibility criteria: Inclusion Criteria:

Spinal cord injury with bowel \& bladder problems

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
Study officials:
affiliation: VA Medical Center-Cleveland
name: Donald Bodner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04076670: A Psychological Intervention for Family Caregivers of Palliative Care Patients
Official title: Benefits of a Psychological Intervention in Family Caregivers of Palliative Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: Intervention study
Family caregiver
Overburden
Anxiety
Depression
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden.

A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* To be the main family caregiver of a patient at the end of life, receiven palliative care. In the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family.
* To have signed the informed consent.

Exclusion Criteria:

• To present cognitive impairment.

Primary outcomes:
measure: Change in anxiety (PRE and POST measures)
timeFrame: Baseline up to 3 months
measure: Change in depression (PRE and POST measures)
timeFrame: Baseline up to 3 months
measure: Change in burden (PRE and POST measures)
timeFrame: Baseline up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
affiliation: Universitat de València
name: Pilar Barreto Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03309670: Psychiatric Future of Young Patients Hospitalized in the Pass'Aje Service Between 2006 and 2010
Official title: Psychiatric Future of Young Patients Hospitalized in the Pass'Aje Service Between 2006 and 2010
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatry
Keywords: psychiatric outcome
psychosocial outcome
young
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 660
Sex: ALL
Minimum age (years): 23
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients hospitalized in psychiatric service

Brief summary: The emergence of adult psychic disorders occurs in about three quarters of cases before 25 years. The Pass-Aje service of Clermont-Ferrand University Hospital is a psychiatric unit specializing in the management of disorders of young adults. This unit evaluates the first episodes among the diversity of the clinical presentations of the psychic disorders. Suicidal attempts or ideations account for a large part of the reasons for entering the unit and are found transversely in many disorders. Among the reasons for hospitalization are a wide variety of situations that are not initially associated with an accurate diagnosis such as withdrawal, de-schooling, runaways, behavioral disorders (disorders of social interactions, self and hetero aggression, eating disorders).

Investigator propose to study the psychiatric outcome of hospitalized patients in the Pass-Aje unit and their psychosocial evolution in order to compare them with the data of the general population and to identify the factors influencing their future.

Detailed description: Former young psychiatric patients hospitalized in the Pass'Aje units are contacted by phone several years later to determine their psychiatric outcome.

Eligibility criteria: Inclusion Criteria:

* all patients hospitalized in the Pass'Aje unit between 2006 and 2010
* Aged from 16 to 25 years when hospitalized

Exclusion Criteria:

* Patient refusing or not understanding the purpose of the study.
* Patients who died.
* Patient phone number unavailable or non-functional

Primary outcomes:
measure: Psychiatric rehospitalisation
timeFrame: at day 1 during the phone call
Secondary outcomes:
measure: Determination of social outcomes
timeFrame: at day 1 during the phone call
measure: Percentage of patients with an occupational activity
timeFrame: at day 1 during the phone call
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Eve COURTY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00119470: EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer
Official title: EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer.

Patients will be randomized to either conventional surgical technique or EUS-FNA.


Eligibility criteria: Inclusion Criteria:

* patients with histological or cytological proof of non small cell lung cancer (NSCLC) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or CT guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention
* no distant metastases after routine clinical work up (PET is optional, not mandatory)
* provision of a written informed consent
* recent CT-scan of the thorax (\<28 days before randomization date)
* age 18 years or older
* clinically fit for surgery

Exclusion Criteria:

* proof of small cell lung cancer (SCLC) with CWU (bronchoscopy or CT guided transthoracal punction)
* stage IV NSCLC
* patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on CT and without mediastinal PET hot spots) : these do not require further mediastinal investigation
* former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
* other concomitant malignancies
* reasons for which the patient is unable to swallow the EUS-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis)
* uncorrected coagulopathy

Primary outcomes:
measure: Percentage of surgical interventions avoided
Secondary outcomes:
measure: Accuracy of EUS-FNA for mediastinal staging of lung cancer
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Kurt Tournoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tournoy KG, De Ryck F, Vanwalleghem LR, Vermassen F, Praet M, Aerts JG, Van Maele G, van Meerbeeck JP. Endoscopic ultrasound reduces surgical mediastinal staging in lung cancer: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):531-5. doi: 10.1164/rccm.200708-1241OC. Epub 2007 Oct 25.