louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05913206: Understanding Factors in Decision Making for Children with Medical Complexity
Official title: Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Children with Medical Complexity
Keywords: Shared decision making
Health communication
Patient- and Family-Centered Care
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2023-06-22
Enrollment: 826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity.

Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.

Detailed description: Children with medical complexity, their caregivers, and their providers face a multitude of complex, high stakes medical decisions throughout their lifetime. Best practices for the provision of high quality shared decision making in the care of children with medical complexity do not exist. Unique challenges to support decision making for caregivers of children with medical complexity include communication of decision-related risks and benefits and knowledge related to the decision. This study will test the efficacy of various communication techniques in the setting of a simulated patient encounter.

Eligibility criteria: Inclusion Criteria:

* Adult caregiver of a child with medical complexity
* English- or Spanish-speaking

Exclusion Criteria:

* Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.

Primary outcomes:
measure: Decision readiness
timeFrame: Immediately after reviewing the intervention
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: Immediately after reviewing the intervention
measure: Decision intent for treatment
timeFrame: Immediately after reviewing the intervention
measure: Knowledge
timeFrame: Immediately after reviewing the intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jody L Lin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01836406: Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: ketorolac
remote ischemic preconditioning
partial nephrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.


Eligibility criteria: Inclusion Criteria:

* ASA l and ll
* age 20-65
* patients undergoing partial nephrectomy

Exclusion Criteria:

* preoperative liver or renal dysfunction,
* coagulopathy,
* chronic alcoholism,
* hypersensitivity of NSAID,
* history of warfarin,
* history of gastric ulcer

Primary outcomes:
measure: serum creatinine
timeFrame: at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
Secondary outcomes:
measure: Creatinine clearance
timeFrame: at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
measure: urinary NAG
timeFrame: at base line, 2 hr, 12 hr after clamping release
measure: serum NGAL
timeFrame: at base line, 2 hr, 12 hr after clamping release
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06646406: Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate
Official title: Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19 Immunisation
Influenza Vaccine
Keywords: Adult
Vaccination
Influenza vaccines
COVID-19 Vaccines
Primary Health Care
Reminder Systems
Clinician communication
Patient communication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: ModernaTX, Inc.
First posted: 2024-10-17
Enrollment: 117780
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines.

The study will involve adult patients at eight Mayo Clinic primary care practices in Rochester and Kasson. The study will test the two tactics together. Four clinics will get the two tactics. The other four clinics will not. The study will randomly assign the two tactics to the clinics. One tactic is to send a letter by US mail to the patient. The letter will state strong recommendations on getting both vaccines now. It will tell patients how to get the vaccines now. The second tactic is to send monthly emails to clinicians. It will remind them to use every visit to vaccinate patients against COVID-19 and influenza. The study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics.


Eligibility criteria: Inclusion Criteria:

* Patients 19 years and older
* Patients empaneled to 1 of 8 adult primary care practices as of September 2024

Exclusion Criteria:

* Patients 18 years or younger
* Patients not empaneled to 1 of 8 adult primary care practices as of September 2024

Primary outcomes:
measure: COVID-19 vaccine uptake
timeFrame: 7.5 months
measure: Influenza vaccine uptake
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lila J. Rutten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04747106: Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute-on-chronic Liver Failure
Official title: Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute on Chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 28 Day Mortality
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 390
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the past ten years, the extracorporeal liver support system has been widely used in clinical practice as a first-line treatment of liver failure. Plasma exchange (PE) can remove toxic substances in ACLF patients, reduce liver damage, and replenish coagulation factors, albumin and immunoglobulins, thereby improving the liver's microenvironment and accelerating liver regeneration and functional recovery. The ACLF study showed that PE can improve the symptoms of patients and improve the short-term prognosis of patients, but there are still studies showing that PE does not significantly improve the short-term prognosis of patients. Therefore, the therapeutic effect of PE on ACLF is still controversial. We consider that some people may benefit from plasma exchange, and new indicators are needed to guide disease stratification treatment. Our multi-center prospective data show that plasma exchange has a tendency to improve survival in ACLF-2. After stratifying with ADP inhibition rate in ACLF-2, patients with ADP inhibition rate greater than 30% will be treated 28 days after PE treatment. The prognosis is improving. Therefore, we consider that PE is expected to reduce the mortality of patients with ACLF 2 with an ADP suppression rate greater than 30%, but prospective large-sample clinical studies are still needed.


Eligibility criteria: Inclusion Criteria:

* 1) 18-80 years old; 2) Chronic HBV infection related: HBsAg positive for more than 6 months; 3) EASL-ACLF grade 2

Exclusion Criteria:

* 1) Other causes of chronic liver disease; 2) Active bleeding and diffuse intravascular coagulation; 3) Those who have been severely allergic to blood products and heparin in the past; 4) Circulatory failure; 5) Respiratory failure; 6) Patients with unstable period of cardiovascular and cerebrovascular infarction; 7) Those who have received platelet transfusion or artificial liver within 1 week; 8) Patients with liver cancer or other malignant tumors; 9) Pregnant and lactating women; 10) Those with other serious chronic diseases; 11) Fail to sign the informed consent form; 12) Circumstances that the researcher considers inappropriate to participate in the research.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06469606: Study on Female Patients' Mammographic Texture Features
Official title: A Cohort Study on feMale Patients' mammogRaphic texturE featureS: the COMPRESS Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Artificial Intelligence
Mammography
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Kuopio University Hospital
name: University of Eastern Finland
name: University of Turku
name: University of Oulu
First posted: 2024-06-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mammography is the most common method for breast imaging, and it provides information for model building and analysis. Radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. Despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. There is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust AI-based or AI-aided decision-making. Furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of AI. The objective of this study is to evaluate AI methods for clinical practice and to study how it relates to clinical factors and biological features.


Eligibility criteria: Inclusion Criteria:

* Candidate is a biological female aged 18 years or above;
* Candidate is willing and able to give informed consent and gives their written consent for the participation in the study;
* There is a clinical indication for a uni- or bilateral mastectomy

Exclusion Criteria:

* Candidate lacks the capacity to provide informed consent;
* Candidate has breast implants

Primary outcomes:
measure: Mammographic texture features
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
measure: Biological features
timeFrame: through study completion, an average of 10 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00975806: Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
Official title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 16
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 was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Metastatic Renal Cell Carcinoma.
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Exclusion Criteria:

1. Prior chemotherapy.
2. Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.
3. Laboratory values outside normal ranges.
4. Myocardial infarction (MI) within past 12 months.
5. Current congestive heart failure.

Primary outcomes:
measure: Phase 1: Maximum Tolerated Dose (MTD)
timeFrame: Within 21 days of first dose of treatment
measure: Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
timeFrame: After at least 3 cycles of treatment
Secondary outcomes:
measure: Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib
timeFrame: First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
measure: Phase 1 : Tumor Response Rate According to RECIST 1.1
timeFrame: Every 3 cycles; up to month 25
measure: Progression Free Survival (PFS)
timeFrame: Day 1 of study drug to disease progression or death
measure: Duration of Response
timeFrame: Day 1 of initial response date to progressive disease
measure: Overall Survival (OS)
timeFrame: Day 1 of study drug to death
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: Celgene Corporation
name: Debora Barton, MD
role: STUDY_DIRECTOR
References:
citation: Rini B, Redman B, Garcia JA, Burris HA 3rd, Li S, Fandi A, Beck R, Jungnelius U, Infante JR. A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma. Ann Oncol. 2014 Sep;25(9):1794-1799. doi: 10.1093/annonc/mdu212. Epub 2014 Jun 8.
Clinical trial NCT05531006: Anesthesia Preferences in the COVID-19 Pandemic: General Anesthesia or Regional Anesthesia?
Official title: Anesthesia Preferences in the COVID-19 Pandemic: General Anesthesia or Regional Anesthesia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Regional anesthesia
General anesthesia
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The number of operations in the hospital and the anesthesia methods applied to the operations were examined retrospectively.

Anesthesia application preferences were compared between the COVID-19 pandemic period and the non-pandemic period.

Brief summary: As the COVID-19 pandemic continues, humanity has started to adapt to it. In our study, we aimed to examine the adaptation of anesthetists to the pandemic and its behavioral reflection on their work.

Detailed description: All surgeries and anesthesia methods performed in the university hospital were examined. The cases and anesthesia practices of the departments were examined. Years with and without pandemics were compared.

Eligibility criteria: Inclusion Criteria:

* all operations

Exclusion Criteria:

* those who refuse to have surgery
* non-operational

Primary outcomes:
measure: Anesthesia Preferences in the COVID-19 Pandemic: General or Regional Anesthesia?
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hulya TOPCU
Study officials:
References:
Clinical trial NCT06153706: Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis
Official title: Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.
* Patients showing good oral hygiene.
* No history of periodontal therapy (surgical and non-surgical) for the past 6 months.

Exclusion Criteria:

* Patients with known systemic and debilitating diseases.
* Patients who had any previous adverse reactions to the products (or similar products) used in this study.
* Patients who have any autoimmune diseases.
* Patients who have any known disease that interfere with periodontal procedure.
* Smokers.
* Pregnancy and lactating women.
* Use of antibiotics during the last 6 months.

Primary outcomes:
measure: Plaque accumulation
timeFrame: up to 6 months
measure: Gingival inflammation
timeFrame: up to 6 months
measure: Bleeding on probing
timeFrame: up to 6 months
measure: Probing depth
timeFrame: up to 6 months
measure: Clinical attachment loss
timeFrame: up to 6 months
measure: Quantitative assessment of Porhyromonas gingivalis
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Yasmeen K Omar, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Mohy A El Rashidy, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Ghada Bassiouny, PhD
role: STUDY_CHAIR
affiliation: University of Alexandria
name: Aliaa G Aboulela, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03795636: Allium Sativum Extract as an Irrigant
Official title: Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infected Root Canals of Primary Molars
Keywords: Primary molars
Garlic extract
Sodium hypochlorite
Pulpectomy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 91
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

Detailed description: Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.

Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.

Eligibility criteria: Inclusion Criteria:

1. Class I or II according to American Society of Anesthesiologists (ASA)
2. Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain
3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
4. Pathological tooth mobility
5. Percussion sensitivity
6. Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures

1. Normal radiographic findings

2. Interruption of lamina dura

3. Furcation radiolucency

Exclusion Criteria:

* Specifications of exclusion

  1. Uncooperativeness of child and/or parents or caregivers behavior
  2. Unrestorable tooth
  3. Presence of internal root resorption
  4. Presence of calcific metamorphosis inside root canals
  5. Presence of root resorption exceeding one third of its length

Primary outcomes:
measure: oral examination
timeFrame: 12 months
measure: radiographic success or failure
timeFrame: 12 months
Secondary outcomes:
measure: Types of failures
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.