louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04630236: Ultrasound Guided Positioning of Central Venous Catheters
Official title: Ultrasound Guided Positioning of Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheter
Lead sponsor: Asklepios Neurological Clinic Bad Salzhausen
Sponsor class: OTHER
Collaborators: name: Kerckhoff Klinik
First posted: 2020-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Therefore, an alternative that is not burdensome for patients and is available on all sides would be desirable. The possibility of a sonographic CVC position control is to be investigated.

The correct position of a central venous catheter is important. Complications/failure must be detected early/immediately. In addition to the X-ray of the thorax, a position control by means of an ECG derivative (α-card derivative) is available for position control. The method is easy to perform, but an epicardial or an arterial position of the CVC cannot be detected without the use of additional imaging in case of doubt.

For the reasons mentioned above, sonography is a suitable method to show the inflow of injected 0.9% sodium chloride solution into the right atrium, which allows to conclude the correct position of the CVC.


Eligibility criteria: Inclusion Criteria:

* elective insertion of a central venous catheter.

Exclusion Criteria:

* emergency insertion of a central venous catheter

Primary outcomes:
measure: - correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter
timeFrame: up to 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Nidda
country: Germany
facility: Neurologische Klinik Bad Salzhausen
Study officials:
References:
citation: Schummer W, Schummer C, Schelenz C, Brandes H, Stock U, Muller T, Leder U, Huttemann E. Central venous catheters--the inability of 'intra-atrial ECG' to prove adequate positioning. Br J Anaesth. 2004 Aug;93(2):193-8. doi: 10.1093/bja/aeh191. Epub 2004 Jun 25.
citation: Schummer W, Herrmann S, Schummer C, Funke F, Steenbeck J, Fuchs J, Uhlig T, Reinhart K. Intra-atrial ECG is not a reliable method for positioning left internal jugular vein catheters. Br J Anaesth. 2003 Oct;91(4):481-6. doi: 10.1093/bja/aeg208.
Clinical trial NCT05779436: Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
Official title: Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Stricture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 100
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 biliary strictures who are undergoing peroral cholangioscopy (POC) during endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of a biliary strictures will be identified via review of procedure listings at Mayo Clinic Rochester, Minnesota.

Brief summary: The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
* Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
* Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.

Exclusion Criteria:

* Age \<18 years old
* No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
* Prisoner

Primary outcomes:
measure: POC-CNN Model AUC
timeFrame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Secondary outcomes:
measure: Test characteristics of POC-CNN
timeFrame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vinay Chandrasekhara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05164536: Plasma P-tau2017 and Quantitative Amyloid PET Imaging
Official title: Plasma P-tau2017 and Quantitative Amyloid PET Imaging in a Cognitively Normal Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: AD
Lead sponsor: Invicro
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels.

Detailed description: The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Other relevant AD-related investigational biomarkers may also be assessed in the provided samples. Apolipoprotein E (ApoE) genetic status will be evaluated with a serum sample.

Eligibility criteria: Inclusion Criteria (for all participants):

* Signed and dated written informed consent obtained from the subject.
* Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method for male participants for the study duration.
* Male participants must not donate sperm for the study duration.
* Willing and able to cooperate with study procedures.
* Males and females.
* Participants aged ≥ 70, inclusive, at the time of Screening.
* Judged to be cognitively normal by an Investigator based on clinical judgment.

Exclusion Criteria (for all participants):

* Subject has received an investigational drug or device within 30 days of enrollment, unless in the opinion of the Investigator such medication or device will not impair subject safety or scientific integrity of the data.
* Contraindication to amyloid PET imaging or blood sampling.
* Have ever received an experimental or approved medication targeting amyloid or tau.
* Prior participation in other research protocols or clinical care in the last year that would result in radiation exposure exceeding the acceptable annual limit established by the U.S. Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
* Pregnancy, lactating or breastfeeding.
* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease that in the Investigator's judgment may interfere with the objectives of the study.
* Unsuitable veins for venipuncture.

Primary outcomes:
measure: Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr .
timeFrame: 1 year
Secondary outcomes:
measure: Creation of a database of blood P-tau217 and other blood biomarkers.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro
state: Connecticut
Study officials:
affiliation: Invicro
name: David Russell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100736: Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)
Official title: Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pulmonary Arterial Hypertension
Vasodilation
Vasoconstriction
Keywords: Forearm Blood Flow
Vasodilation
Vasoconstriction
Endothelin System
Endothelin-1
Endothelin-3
Endothelin antagonists
Bosentan
Sitaxsentan
Endothelin
Regional Blood Flow
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Encysive Pharmaceuticals
First posted: 2010-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors. Theoretically, selective ETA blockade may be associated with greater vasodilation and clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied in humans.

We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically relevant doses:

* Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and placebo.
* These effects will be confirmed by 2 functional markers of ETB receptor antagonism: plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the forearm vasodilator response to ET-3.


Eligibility criteria: Inclusion Criteria:

* Healthy men and post-menopausal women
* Age 18-70 years
* BMI 18-35 kg/m2

Exclusion Criteria:

* Are mentally or legally incapacitated
* Have donated blood within the last 4 weeks
* Have a history of past or present drug or alcohol abuse
* Have participated in another clinical trial within 1 month
* Are considered to be at a high risk of HIV or Hepatitis B
* Are taking routine medicines
* Are women taking hormone replacement therapy
* Have significant medical or psychiatric illness

Primary outcomes:
measure: Plasma ET-1 after 7-day administration of bosentan, sitaxsentan and placebo
timeFrame: 7 days
measure: Responses to ET-3 (maximum vasodilation after ET-3 administration and area under the curve of vasodilation) after bosentan compared with the results from sitaxsentan and placebo.
timeFrame: 60 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical Research Centre, Western General Hospital
state: Scotland
Study officials:
References:
Clinical trial NCT00514436: Case Management and Environmental Control in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
children
low-income, underserved
Reduction in hospitalization
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2007-08-10
Enrollment: 189
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Controlled demonstrations of reductions in disproportionate hospital or emergency care are limited. We performed a controlled clinical trial of an "Asthma Coach" to reduce hospitalizations among low-income, African American children.


Eligibility criteria: Inclusion Criteria:

* 2-8 years of age
* Admitted to hospital for acute asthma
* African American ethnicity
* Medicaid coverage

Exclusion Criteria:

* Parent refusal to sign consent
* Living outside service area

Primary outcomes:
measure: Hospitalization
timeFrame: 2 years
Secondary outcomes:
measure: Emergency department visits
timeFrame: 2 years
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert C Strunk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06445036: Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
Official title: Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypoparathyroidism
Pseudo Hypoparathyroidism
Keywords: Hypoparathyroidism
Pseudo Hypoparathyroidism
Clinical Registry
Endocrinology
Parathyroid gland
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
First posted: 2024-06-06
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism

Brief summary: Observational, multicenter, national, cross-sectional study aiming to describe the epidemiological clinical, biological and therapeutic profile of patients suffering from defect in secretion (hypoparathyroidism) or action (pseudo-hypoparathyroidism) of parathyroid hormone.

Detailed description: Endocrinologists from both sectors (public and private) are participating in the study. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.

Eligibility criteria: Inclusion Criteria:

* Hypoparathyroidism defined by low serum calcium \< 2.2 mmol/l (\< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine

Exclusion Criteria:

* Cervical surgery \< 6 months.
* Transient (neonatal, etc.) or functional (dysmagnesemia, etc.) hypoparathyroidism.
* Other causes of hypocalcemia: vitamin D deficiency, chronic renal failure, etc.
* Familial hypocalcemia hypercalciuria.
* Pseudo-pseudo-hypoparathyroidism.

Primary outcomes:
measure: Incidence of primary hypoparathyroidism
timeFrame: Day 1
measure: Incidence of congenital hypoparathyroidism
timeFrame: Day 1
measure: Incidence of acquired hypoparathyroidism
timeFrame: Day 1
measure: Incidence of secondary hypoparathyroidism
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
Study officials:
affiliation: Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
name: Nabila Rekik Mejdoub, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00329836: A Research Study to Examine Cutaneous Allodynia and Cluster Headache
Official title: A Research Study to Examine Cutaneous Allodynia and Cluster Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-05-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with cluster headache

Brief summary: This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-75, inclusive
* Diagnosis of cluster headache, episodic or chronic.
* Patients with episodic CH can be either in active cluster period or not.
* Ability to read and understand an informed consent form, where the study protocol is described.

Exclusion Criteria:

* Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
* Patients who are cognitively impaired, as determined by investigator
* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
* Patients who had taken an acute pain medication within 24 hours prior to allodynia testing.
* Patients with skin diseases that may cause abnormal skin sensation.
* Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing
* Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing

Primary outcomes:
measure: Prevalence of Allodynia in Subjects With Cluster Headache
timeFrame: Allodynia was assessed at the screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center/ Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Jefferson Headache Center/ thomas Jefferson University
name: Abraham A. Ashkenazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162136: Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
Official title: Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Malignancies
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of a primary solid tumor
* measurable or non-measurable disease
* progressive disease
* men and women greater or equal to 18 years of age.

Exclusion Criteria:

* women of child bearing potential who are not using birth control
* women who are pregnant or breast feeding
* women with a positive pregnancy test on enrollment
* patients with brain metastasis
* prior treatment with Ixabepilone
* known history of human immunodeficiency virus (HIV)

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities at Dose Level
timeFrame: Measures taken at Cycle 01 (21-day cycle)
Secondary outcomes:
measure: Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
timeFrame: From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.
measure: Hematology Results - Worst On-Study Grade
timeFrame: Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.
measure: Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
timeFrame: through 72 hours after start of infusion
measure: Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: New Brunswick
country: United States
facility: The Cancer Institute Of New Jersey
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03500536: Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.
Official title: Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Primary Health Care
Lead sponsor: Actualize Therapy
Sponsor class: INDUSTRY
Collaborators: name: University of Arkansas
First posted: 2018-04-18
Enrollment: 146
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: The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.


Eligibility criteria: Inclusion Criteria:

* Positive screen on PHQ-9

Exclusion Criteria:

* Does not own or use a mobile smart phone

Primary outcomes:
measure: Symptoms of depression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
citation: Graham AK, Greene CJ, Kwasny MJ, Kaiser SM, Lieponis P, Powell T, Mohr DC. Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):906-914. doi: 10.1001/jamapsychiatry.2020.1011.