louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02187068: Dexmedetomidine Pharmacokinetics in the Obese
Official title: Dexmedetomidine Pharmacokinetics in the Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Anaesthetics iv
Dexmedetomidine
Pharmacokinetic
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to characterize, using two different modeling approaches, one based on purely statistic concept and one using a more mechanistic analysis, the influence of body weight and composition on the pharmacokinetic of dexmedetomidine.

Detailed description: Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed using nonlinear mixed-effects model.

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiologist classification I-III patients
* between 18 and 60 years of age
* scheduled for elective laparoscopic surgery
* obese patients with a BMI \>35 kg m-2 (20 patients)
* non-obese patients (BMI 18.5-25 kg m-2)(20 patients)

Exclusion Criteria:

* known allergy to study drugs
* uncontrolled hypertension
* heart block greater than first degree
* those who had taken any drug acting in the central nervous system 24 h before surgery

Primary outcomes:
measure: dexmedetomidine serum concentration
timeFrame: During the intraoperative period and 360 min after stopping dexmedetomidine infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad Catolica
state: Región metropolitana
Study officials:
affiliation: Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
name: Luis I Cortínez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333268: Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
Official title: Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 369
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 purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.


Eligibility criteria: Inclusion Criteria:

* Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent change in endothelial cell density
Secondary outcomes:
measure: Best corrected logMAR visual acuity
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: United States
state: Texas
Study officials:
References:
Clinical trial NCT06577168: Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion
Official title: The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females at reproductive age (18-45)

Brief summary: The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

Detailed description: The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.

Eligibility criteria: Inclusion Criteria:

* Included participants with normal regular menses prior to LNG-IUS

insertion

* Included participants of any age, race, ethnicity, or parity
* Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
* Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days

Exclusion Criteria:

* Heavy or prolonged menstrual bleeding (menorrhagia)
* Actively breastfeeding
* Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
* Hormonal injectable contraceptive use within 6 months of enrollment
* First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
* Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern

Primary outcomes:
measure: Mean number of days with menstrual bleeding changes
timeFrame: Six months after insertion of levonogestrel Intrauterine system
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
affiliation: Assiut University
name: Seif E Ahmed, Professor
role: STUDY_DIRECTOR
References:
citation: Maldonado LY, Sergison JE, Gao X, Hubacher D. Menstrual bleeding and spotting with the Levonorgestrel Intrauterine System (52 mg) during the first-year after insertion: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 May;222(5):451-468.e9. doi: 10.1016/j.ajog.2019.09.044. Epub 2019 Oct 4.
Clinical trial NCT05265468: Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain
Official title: Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Trigger Point Pain, Myofascial
Keywords: Physiotherapy
Rehabilitation
Treatment
Active Trigger Point
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.

Detailed description: The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.

Eligibility criteria: Inclusion Criteria:

* persistent neck pain or headache for more than 3 days
* presence of active trigger point in upper trapezius

Exclusion Criteria:

* Participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck;
* who present infection or febrile state at the time of performing the test;
* with anxiety and/or extreme emotional tension;
* who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)

Primary outcomes:
measure: Neck Disability Index
timeFrame: 10 minutes
measure: Pain intensity
timeFrame: 10 minutes
measure: Pression algometer
timeFrame: 10 minutes
Secondary outcomes:
measure: Cervical Test
timeFrame: 10 minutes
measure: Proprioceptive Test
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica de Murcia
Study officials:
References:
Clinical trial NCT05617768: Enhanced Recovery After Surgery (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
Official title: Enhanced Recovery After Surgey (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ERAS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 267
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Anesthesia department, Cairo university hospitals, kasr al-ainy.
* Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy.
* Anesthesia department, National Heart Institute.
* Cardiothoracic surgery department, National Heart Institute.

Brief summary: ERAS after cardiac surgery is a well known protocol ,However the investigators study if it is applied at our institute

Detailed description: Enhanced recovery after surgery (ERAS) is a term that include a series of evidence-based perioperative care pathways designed to reduce physiological and psychological stress in surgical patients and to achieve rapid recovery.

In 2016, the first pilot study was published, which analyzed enhanced recovery after cardiac surgery (ERACS). Weaning from mechanical ventilation is considered one of the items that forms the concept of enhanced recovery in cardiac surgery.

Pain is an undesirable consequence of surgery especially cardiac surgery as pain during and following cardiac surgery has been shown to be a risk factor for increased morbidity. Systemic opioids have been the main stay for the management of perioperative pain in cardiac surgery. Lower doses of opioids has been related to early extubation and minimizing opioid-related side effects, such as prolonged ventilation, tolerance, nausea, vomiting, gut dysfunction, and immunosuppression.

On the other hand the investigators find cases of morbidity and mortality not related to the surgical procedure. ERAS protocol discuss the optimum condition that can be used to avoid the morbidity and mortality complications.

the investigators aim to know how well ERAS protocol is known and applied

Eligibility criteria: Inclusion Criteria:

* Cardiac anesthesiologists.
* Cardiac intensivists.
* Cardiothoracic surgeons.
* All stuff members from resident to consultant are included inside this study

Exclusion Criteria:

-

Primary outcomes:
measure: Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Unviersity
Study officials:
References:
Clinical trial NCT06400368: Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
Official title: Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: retinal image
CAA
Leqembi
lecanamab
Lead sponsor: NeuroVision Imaging
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects ages 50 and up eligible for treatment with LEQEMBI.

Brief summary: This is a proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA.

Detailed description: Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.
2. Male and female subjects ages ≥50 years old.
3. Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.
4. Patient or patient's legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.

Exclusion Criteria:

1. History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.
2. Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.
3. Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,
4. Unable or unwilling to comply with the protocol requirements.

Primary outcomes:
measure: Investigational and Research- retinal vessel and tortuosity
timeFrame: From enrollment to the end of the treatment at 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Health
state: California
Study officials:
affiliation: Sutter Health
name: Shawn Kile, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03051568: Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma
Official title: Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography /Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, T-Cell, Peripheral
Keywords: Lymphoma, T-Cell, Peripheral
Positron-Emission Tomography
Prognosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2017-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in PTCL.

Detailed description: In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in PTCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed PTCL
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.

Primary outcomes:
measure: Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
timeFrame: baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)
Secondary outcomes:
measure: 3 year progression-free survival
timeFrame: up to 3 years after initial diagnosis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06023368: Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
Official title: Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pediatric Cancer
Keywords: Port access pain
pediatric
oncology
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Bimeco Group
First posted: 2023-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.

Participants will receive either the spray or cream prior to port access and rate pain on a scale.

Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
* EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
* Previous allergic reaction or skin irritation due to EMLA
* Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy

Exclusion Criteria:

* Child has a legal guardian or non-parent family member as the only adult with them for the visit.
* Children less than 4 years of age
* Children with altered mental status
* History of traumatic brain injury, developmental delay or autism
* Child is nonverbal
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect.

Primary outcomes:
measure: Port Access Pain
timeFrame: Within 5 minutes of port access
measure: Clinic Wait Time
timeFrame: Day of visit, up to 8 hours
measure: Duration of Visit
timeFrame: Day of visit, up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Marianne Hutti, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694768: Implementation of Rehabilitation Program for Post COVID-19
Official title: The Effect of Implementing a Nursing Program Intervention on Improvement of Health Quality of Post Covid-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post COVID-19 Syndrome
Rehabilitation
Keywords: nursing program
health quality of life
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recovered from SARs-CoV-2 after 4 weeks

Brief summary: Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term.

Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people.

A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.


Eligibility criteria: Inclusion Criteria:

* Post acute COVID-19 patients

Exclusion Criteria:

* Acute COVID-10
* Non- COVID-19 patients
* Recent myocardial infarction
* Recent pulmonary embolism
* Neurologic diseases

Primary outcomes:
measure: Optimizing health and functioning outcomes
timeFrame: 6 months
measure: improve recovery and reduce disability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
Study officials:
References: