louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05758701: CT TAVR Abdomen Study
Official title: Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacement
Keywords: Dual energy CT
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)
Primary purpose: DIAGNOSTIC

Brief summary: A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.


Eligibility criteria: Inclusion Criteria:

* scheduled to receive TAVR abdominal CT

Exclusion Criteria:

* cannot undergo CT scan
* Allergy to intravenous contrast not controlled by steroids or benadryl
* GFR\<30

Primary outcomes:
measure: Diagnostic Quality of Images
timeFrame: 18-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References:
citation: Lai MZ, Duzgunes N, Szoka FC. Effects of replacement of the hydroxyl group of cholesterol and tocopherol on the thermotropic behavior of phospholipid membranes. Biochemistry. 1985 Mar 26;24(7):1646-53. doi: 10.1021/bi00328a012.
citation: Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
Clinical trial NCT00005501: Hypertensive Treatment and Epidemiological Analyses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Heart Diseases
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

Detailed description: BACKGROUND:

With the use of antihypertensive medication increasing steadily over the last 25 years, treatment for hypertension is now common. Given the high prevalence of treatment for hypertension, researchers can no longer assume that participants in epidemiologic studies represent natural blood pressure measures, as opposed to treated blood pressure measures. The effect of this high prevalence of treatment, however, has not been fully investigated. Although it might seem that studies of "natural history" are no longer relevant, great interest currently exists in establishing both environmental and genetic determinants of blood pressure. Additionally, there currently is a renewed interest in refining treatment guidelines. For example, the need to account for absolute as well as relative risk has been hotly debated in recent years. The need will continue to exist, therefore, to analyze observational data sets to meet the evolving interest in the determinants of blood pressure and to meet the requirements for more refined risk estimates.

DESIGN NARRATIVE:

To investigate the effect of blood pressure treatment on the analysis of epidemiologic studies, the investigators conducted two interrelated analyses using simulation studies and data from five observational studies: The Framingham Heart Study; the NHANES I, II, and III cohorts; and The International Collaborative Study of Hypertension in Blacks (ICSHIB). They first conducted simulation studies to examine the behavior of different methodologies in each of two common analytic settings: relating body mass index to level of systolic blood pressure and relating level of systolic blood pressure to coronary heart disease mortality. They planned to use the data from the five studies to derive the parameters for use in the simulation studies. In these studies they quantified the level of bias that results from ignoring the presence of blood pressure treatment in observational data. After conducting their simulations studies, they repeated the analysis of the relationship between body mass index and systolic blood pressure using available empirical data.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05553067: Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms
Official title: Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be applied on archived formalin-fixed, paraffin embedded ovarian tissue blocks from women who had ovarian benign, borderline and invasive malignant neoplasms and admitted to Obstetrics and Gynecology Department, Sohag University Hospital where they underwent oophorectomy operations because of benign and/ or malignant indications, from 2015 to 2021.

Brief summary: Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.

Detailed description: Epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. Treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. Detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications.

Engrailed-2 is a protein encoded by a gene located on chromosome 7. Engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that Engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. Now estimatiion of urinary and serum levels of Engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. We aim to evaluated immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.

Eligibility criteria: Inclusion Criteria:

* All types of epithelial ovarian neoplasms (benign, borderline and malignant).

Exclusion Criteria:

* Non-epithelial and/ or secondary ovarian tumors.
* Cases with poor clinical data.
* Cases who had history of pre-operative chemotherapy.

Primary outcomes:
measure: compare levels of Engrailed-2 expression in different ovarian specimens.
timeFrame: December, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag University
name: Maisa H Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00446667: A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
Official title: A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COPD
Exacerbation
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.


Eligibility criteria: Inclusion Criteria:

* FEV1 \> 35% predicted
* COPD
* Exacerbation
* Inpatient

Exclusion Criteria:

* Pneumonia
* CO2 retention

Primary outcomes:
measure: FEV1
timeFrame: 2 days
Secondary outcomes:
measure: safety
timeFrame: 2 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
Study officials:
affiliation: Royal Prince Alfred Hospital NSW Australia
name: David Barnes, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03519867: Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
Official title: A Multi-center, Randomized, Assessor-blinded, Phase II, Parallel Dose-finding Trial in Subjects of ASA Class 1 - 3 to Assess the Efficacy and Safety of 5 Doses of Org 25969 When Administered at 1-2 PTCs After Administration of Zemuron®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 50
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 primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).


Eligibility criteria: Inclusion Criteria:

* Has an ASA Class of 1 to 3
* Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron®

Exclusion Criteria:

* Is undergoing dental or neck surgery
* Has anatomical malformation that would impede intubation
* Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction
* Is known or suspected to have a family history of malignant hyperthermia
* Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia
* Is pregnant
* Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (\<6 months), intrauterine device (IUD), or abstinence
* Is breast-feeding
* Has already participated in the study
* Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study

Primary outcomes:
measure: Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Percentage of Participants Experiencing ≥1 Adverse Events (AEs)
timeFrame: Up to 7 days following MK-8616 administration
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00081367: Community-Based Cognitive Therapy for Suicide Attempters
Official title: Community-Based Cognitive Therapy for Suicide Attempters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suicide, Attempted
Keywords: Minority Groups
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-04-12
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.

Detailed description: Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.

Participants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.

Eligibility criteria: Inclusion Criteria:

* Suicide attempt within 48 hours prior to being evaluated at the hospital
* English speaking
* Able to provide 2 verifiable contacts

Exclusion Criteria:

* Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy

Primary outcomes:
measure: Repeat suicide attempts
timeFrame: Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Clinical trial NCT05129267: Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis
Official title: Evaluation of Injectable PRF With Vitamin C as an Adjunct to Non-surgical Therapy in the Treatment of Stage II Grade A Periodontitis. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 45
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: Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients.

Detailed description: The conventional approach:

Group 1: Scaling and root planing alone using Gracey curettes and ultrasonic scalers.

Group 2: Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of injectable PRF using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered injectable PRF.

The intervention approach:

Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of vitamin C (250 μM) and injectable PRF, using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered vitamin C and injectable PRF for a longer time.

Eligibility criteria: Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. Patients with Stage II Grade A periodontitis.
4. Patients accept 6-months follow-up period (cooperative patients).
5. Patients provide an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns.
2. Extensive restorations.
3. Periodontal therapy within the last 12 months.
4. Having surgical therapy or undergoing orthodontic treatment.
5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
7. Smokers.
8. Pregnant females.

Primary outcomes:
measure: Bleeding on Probing (BOP)
timeFrame: 3 months
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months
measure: Gingival Marginal Level (GML)
timeFrame: 6 months
measure: Plaque Index (PI)
timeFrame: 6 months
measure: Intraoral Radiographs
timeFrame: 6 months
measure: Post-Operative Pain
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medecine-CU
Study officials:
References:
Clinical trial NCT05272267: Transforming ED Throughput With AI-Driven Clinical Decision Support System
Official title: Transforming ED Throughput With AI-Driven Clinical Decision Support System (TEDAI): The Impact on the Delivery of Care and Patient Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Emergency Treatment
Triage
Readmission
Keywords: Critical Care
Emergency Treatment
Triage
Readmission
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 4016
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aims of this study is to integrate real-time data flow infrastructure between hospital information system and AI models and to conduct a cluster randomized crossover trial to evaluate the efficacy of the AI models in improving patient flow and relieving ED crowding.


Eligibility criteria: Inclusion Criteria:

* ED patients aged 20 years or older
* Patients were treated by the recruited 16 ED attendings.

Exclusion Criteria:

* Patients aged less than 20 years.
* Patients were not treated by the recruited 16 ED attendings.

Primary outcomes:
measure: ED length of stay
timeFrame: From ED arrival to 3 days after ED discharge. For hospitalized patients with cardiac arrest, the outcome ascertainment continues until hospital discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Dr. Huang
role: STUDY_CHAIR
References:
Clinical trial NCT00502567: A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors
Official title: A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: advanced solid tumors
AZD2171
Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 104
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: A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).


Eligibility criteria: Inclusion Criteria:

* histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
* measurable lesion by CT or other techniques according to RECIST

Exclusion Criteria:

* Inadequate bone marrow reserve
* history of poorly controlled hypertension

Primary outcomes:
measure: Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel
timeFrame: After 5 weeks of treatment
Secondary outcomes:
measure: Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate.
timeFrame: Assessed at each visit
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Nashville
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Bijoyesh Mookerjee, MD
role: STUDY_CHAIR
affiliation: Wayne State University
name: Patricia LoRusso, DO
role: PRINCIPAL_INVESTIGATOR
References: