louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06427707: The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.
Official title: The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions As an Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Intraoperative Bleeding
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.
Primary purpose: PREVENTION

Brief summary: Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

Detailed description: In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries

Eligibility criteria: Inclusion Criteria:

* ASA I-II,
* scheduled for elective nasal surgery

Exclusion Criteria:

* Patients with uncontrolled hypertension.
* Patients with cardiac disease.
* Patients with renal, hepatic or cerebral insufficiency.
* Patients with coagulopathy or receiving drugs influencing blood coagulation.
* Anaemia, haemoglobinopathies or polycythemia.
* Pregnancy.
* Patients with known sensitivity to any of the study drug.

Primary outcomes:
measure: surgical field using the average category scale (ACS).
timeFrame: During the operation
Secondary outcomes:
measure: sedation using Ramsy sedation score
timeFrame: First hour postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02766907: Optimizing the Ocular Surface Prior to Cataract Surgery
Official title: Optimizing the Ocular Surface Prior to Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Dystrophy, Epithelial Basement Membrane
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.


Eligibility criteria: Inclusion Criteria:

1. Subjects with significant EBMD that are contemplating cataract surgery.
2. Age range: 50 years and older.
3. Both Genders and all ethnic groups comparable with the local community.
4. Subjects able to understand and willing to sign a written informed consent.
5. Subjects able and willing to cooperate with the investigational plan.
6. Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

1. Subjects with known intolerance to PKS or known allergy to its preservative media.
2. Subjects with symblepharon or lid abnormality preventing PKS placement.
3. Ocular infection within 14 days prior to study entry.
4. Previous ocular surgery or injury within 3 months before enrollment.
5. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
6. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.

Primary outcomes:
measure: Change in Intraocular Lens Calculation
timeFrame: Change from Baseline to 1 month
measure: Change in Intraocular Lens Power Calculation
timeFrame: Change from Baseline to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Virginia Eye Consultants
name: Elizabeth Yeu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754507: A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.
Official title: Efficacy of WelChol as an Add-on to Atorvastatin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 65
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: To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female \> or greater than 18 years of age
* On a stable dose of atorvastatin
* LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
* TG \< or = to 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women of child-bearing potential had a hysterectomy or tubal-ligation, or
* women were post menopausal, or
* women practiced an acceptable method of contraception as specified in the protocol

Exclusion Criteria:

* BMI \> 40 kg/m2
* History of allergic or toxic reaction to colesevelam HCl
* History of swallowing disorders
* Any serious disorder that could impact the conduct of the study
* History of drug or alcohol abuse

Primary outcomes:
measure: The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.
timeFrame: 6 weeks
Secondary outcomes:
measure: The absolute change in LDL-C from baseline to endpoint
timeFrame: 6 weeks
measure: The absolute change and % change in total cholesterol
timeFrame: 6 Weeks
measure: The absolute change and % change in triglycerides
timeFrame: 6 Weeks
measure: The absolute change and % change in HDL-C
timeFrame: 6 Weeks
measure: The absolute change and % change in C-reactive protein
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Castle Rock
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Bartlett
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT06223607: Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia
Official title: Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Baseline Thrombocytopenia
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population of 18 years of age ,PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021) ,Thrombocytopenia on at least one occasion prior to PCI and at least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

Brief summary: The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).

Detailed description: Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
* Thrombocytopenia defined as platelet count \<100 x103 /µL on at least one occasion prior to PCI
* At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

Exclusion Criteria:

* Death within 48 hours post-PCI
* DAPT prior to cardiac catheterization

Primary outcomes:
measure: Incidence of bleeding
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of ischemic events
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 1 year
measure: Duration of DAPT
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Midlothian Medical Center
name: Jessica Rago Crotty, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02007707: A Family-Based Approach To Reduce Smoking in Vietnamese Men
Official title: A Family-Based Approach To Reduce Smoking in Vietnamese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Healthy Eating
Keywords: Asian American
Vietnamese American
Smoking cessation
Community Health Worker
Lay Health Worker Outreach
Family Intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of the study are to develop smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108 dyads of a smoker and a family member from the same household. The hypotheses are:

H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive the proposed -Quit Smoking For a Healthy Family Intervention, a Family-based Intervention (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking abstinence when compared to those receiving an attention control intervention (CI).

H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit attempt than those in CI.

H3. At 6-month, FI participants will be more likely to report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) than those in CI


Eligibility criteria: Inclusion Criteria:

* self-identified as Vietnamese, Vietnamese-American, or Vietnamese-Chinese;
* Vietnamese speaking;
* reside in the Santa Clara County, California
* plan to stay in the area (Santa Clara County, California) for the next 6 months
* for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
* for family member participants, the participant must live in the same household as the smoker participant to form a dyad.
* provide a valid contact telephone number for pre- and post-intervention assessments.

Exclusion Criteria:

- For smoker participants, currently engaging in assisted smoking cessation efforts

Primary outcomes:
measure: smoking abstinence
timeFrame: 6-month
Secondary outcomes:
measure: 24-hour quit attempt
timeFrame: 6-month
measure: resource utilization
timeFrame: 6-month
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Vietnamese Voluntary Foundation
state: California
city: Santa Clara
country: United States
facility: Immigrant Resettlement & Cultural Center (IRCC)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Janice Y Tsoh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660707: Patients Who Underwent Surgical Procedures State of Readiness for Discharge
Official title: Patients Who Underwent Surgical Procedures State of Readiness for Discharge: Mixed Methods Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Patients
Discharge Readiness
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the Turkish validity and reliability study, the minimum sample size for the 95% confidence interval was calculated as 1251 (t=1.96; d=0.1) by using the standard deviation value (σ=1.85) found for the Discharge Readiness Scale.

Considering that there would be missing or missing data, it was planned to take 10% more than the number of samples.

As a result, the number of samples was determined as 1376.

Brief summary: In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure.

Detailed description: Objective: In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure.

Method: Explanatory sequential mixed design will be used in accordance with the purpose of the study. The purpose of the exploratory sequential design is to clarify the relationships obtained with the quantitative data by applying the qualitative step.

This pattern is applied in two stages. The first phase begins with the collection of quantitative data that will essentially answer the research question. In the second stage, qualitative data are collected and the collected data is interpreted to help explain the quantitative results.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Willingness and willingness to participate in the study,
* Having undergone a surgical procedure,
* Healing / discharge as it is,
* Not having difficulties in understanding
* Patients who do not feel ready for discharge according to quantitative data and also agree to participate in the qualitative study

Exclusion Criteria:

* Be under the age of 18,
* Being discharged without surgical procedure,
* Transfer to another department

Primary outcomes:
measure: Readiness status of patients whose discharge is planned
timeFrame: within 24 hours before discharge
Secondary outcomes:
measure: Reasons why patients are not ready for discharge
timeFrame: within 24 hours before discharge
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Fatma CEBECİ, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Songül BİŞKİN ÇETİN, PhD.
role: STUDY_CHAIR
affiliation: Akdeniz University
name: Arzu TAT ÇATAL, RN
role: STUDY_CHAIR
References:
Clinical trial NCT00006307: Epidemiology of Body Mass Index Rebound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-09-29
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.

Detailed description: BACKGROUND:

Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound.

DESIGN NARRATIVE:

The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital & Medical Center
name: Stephen Daniels
References:
citation: Burdette HL, Whitaker RC, Daniels SR. Parental report of outdoor playtime as a measure of physical activity in preschool-aged children. Arch Pediatr Adolesc Med. 2004 Apr;158(4):353-7. doi: 10.1001/archpedi.158.4.353.
Clinical trial NCT06331507: Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch
Official title: Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips Cardiac Magnetic Resonance (CMR) Patch
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiomyopathies
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Philips Health Care
First posted: 2024-03-26
Enrollment: 292
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: This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED).


Eligibility criteria: Inclusion Criteria: have a clinically ordered cardiac MRI exam at University of Michigan -

Exclusion Criteria: pregnant; contraindication to MRI

-

Primary outcomes:
measure: Scan Speed
timeFrame: During the procedure (up to 90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Prachi Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723107: EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
Official title: Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Taewoong Medical
First posted: 2023-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and histologically confirmed PDAC by biopsy
* Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter
* ECOG performance status 0-2
* Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis
* Lesions between 1 - 4cm in size

Exclusion Criteria:

* Patients that show evidence of distant metastasis
* Endoscopically non-accessible mass
* Pregnant patients
* Inability to provide informed consent
* Lesions \<1cm, or \>4cm in greatest diameter

Primary outcomes:
measure: Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0
timeFrame: Up to Week 15
Secondary outcomes:
measure: Percentage of Participants who Complete all 3 EUS-RFA Treatments
timeFrame: Up to Week 11
measure: Disease-Free Survival from Diagnosis
timeFrame: Up to Week 24
measure: Disease-Free Survival from First Study Procedure
timeFrame: Up to Week 24
measure: Overall Survival From Diagnosis
timeFrame: Up to Week 24
measure: Percentage of Participants who Report Post-Procedural Complications
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tamas A. Gonda, MD
role: PRINCIPAL_INVESTIGATOR
References: