louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06978855: Efficacy of Wrist Acupressure Band on Sleep Quality in Medical Trainees
Official title: Efficacy of Wrist Acupressure Band on Sleep Quality in Medical Trainees: A Single-Blinded Cross-Over Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep
SLEEP DISTURBANCES Nec in ICD9CM
Anxiety
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Background: Medical trainees frequently experience sleep disturbances, with shift work being a major contributing factor impacting their performance and overall wellbeing. Traditional treatments for sleep disorders often involve medications and hypnotics with potential side effects, highlighting the need for alternative strategies. Acupressure, particularly at the P6 (Neiguan) point, has shown promise in improving sleep and reducing anxiety.

Objective: This study aimed to evaluate the efficacy of wristband acupressure applied to the P6 point in improving sleep quality, anxiety levels, and overall well-being among medical trainees.

Methods: A single-blinded, cross-over randomized controlled trial was conducted at the American University of Beirut Medical Center (AUBMC), involving 10 medical trainees. Participants were randomized in blocks to either the intervention group, receiving wristband acupressure at the P6 point, or the control group, receiving acupressure at a sham point. Standardized, validated questionnaires were used to assess sleep quality (PSQI), anxiety (GAD-7), and well-being (WHO-5) before and after each intervention period. Ethical approval was obtained from the Institutional Review Board, and participant confidentiality was maintained


Eligibility criteria: Inclusion Criteria:

Residents, Fellows and Med-4 students at AUB.

Exclusion Criteria:

* Being enrolled in another sleep study
* Currently on Sleep Medications: Benzodiazepines, antihistamines, muscle relaxants, magnesium supplements, herbal supplements that help with sleep including Chamomile, Ashwaghanda and Melatonin
* Daily alcohol consumers

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 month
Secondary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: 1 month
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: 1 month
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American university of Beirut
Study officials:
References:
Clinical trial NCT00584155: Protection From Cisplatin Ototoxicity by Lactated Ringers
Official title: Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hearing Loss
Keywords: Cisplatin Ototoxicity
Lactated Ringer's
Ear Cancer
Hearing loss
Hearing loss due to Cisplatin Ototoxicity
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Lactated Ringer's solution is effective in patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to cisplatin-induced hearing loss.

Detailed description: About one-third of people who have been given Cisplatin, as part of their chemotherapy treatment, develop hearing loss. The purpose of this study is to determine if some degree of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To study this, patients will use drops in their ears; Lactated Ringer's will be placed in one ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop antibiotic will be placed in each ear at the same time. Each participant will receive a hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after the final treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with cancer to be treated with cisplatin.
* Patients expected to receive a minimum of 3 rounds of chemotherapy.
* Patients receiving a minimum dose of cisplatin of 70 mg/m2

Exclusion Criteria:

* Patients who have had middle ear surgery.
* Patients who have active external or middle ear disease
* Patients who have preceding pure tone average of \>40 dB HL

Primary outcomes:
measure: Pre-treatment audiogram will be compared with the post treatment audiogram. The differences between the two will be calculated and compared to the differences in the opposite ear.
timeFrame: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Wayne Berryhill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406055: CHOICE: Carotid Stenting For High Surgical-Risk Patients
Official title: Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 18855
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled into this registry will be male and female patients derived from the general population who satisfy the inclusion and exclusion criteria.

Brief summary: The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. 2) Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

Detailed description: The CHOICE study will provide a mechanism for collection of data from Abbott Vascular's Carotid Stent Systems and Embolic Protection Systems when used by a broad group of physicians under commercial use conditions. The original CAPTURE and EXACT studies had built-in features that limited the ability to collect on-going real world data because they restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (up to 50 patients per site). This study will not have these restrictions. The CHOICE study will also provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

Eligibility criteria: Inclusion Criteria:

1. Patient or patient's legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA).
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
4. Patients physician intends to use an RX Acculink with either the RX Accunet or Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA approved Indications for Use as outlined.

Exclusion Criteria:

There are no exclusion criteria for this study

Primary outcomes:
measure: Composite of death, stroke, and MI (DSMI)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
name: William Gray, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05530655: A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Official title: A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Radiation Toxicity
Urinary Complication
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2022-09-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.


Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.
* Be stage M0 based on the standard of care staging imaging
* Be able to read English
* Have the psychological ability and general health that permits completion of the study requirements and required follow up
* Be ≥18 and \< 70 years of age
* Have ECOG performance status of 0 to 2 within 180 days prior to enrollment
* Have adequate renal function with creatinine clearance \> 30 mL/min within 30 days prior to registration
* Have hematologic and hepatic function deemed adequate for planned treatment by the treating investigator within 90 days prior to registration, including:
* hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors
* platelet count ≥100,000/µL independent of transfusion and/or growth factors
* Have a baseline systolic blood pressure of \>130.

Exclusion Criteria:

* Have received prior pelvic radiotherapy
* Be taking lisinopril or other RAS modifying drug within two months prior to registration
* Have had a prior allergic reaction to lisinopril

Primary outcomes:
measure: Mean change in Expanded Prostate Index Composite score
timeFrame: baseline to 12 months
measure: change in the percentage of patients with positive blood test in urine
timeFrame: baseline to 12 months
measure: percentage of participants who achieve a dose of 20 mg
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT05942755: Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
Official title: Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid haemorrhage
cerebrospinal fluid
ionic disorders
hyponatremia
normal pressure hydrocephalus
blood-brain barrier
ionogram
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SAH group : patients hospitalized in the neurological intensive care with Fisher modified aneurysmal SAH 3 or 4 requiring external ventricular drain.

Control group : patients hospitalized for normal pressure hydrocephalus

Brief summary: Hyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders.

Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown.

The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes.

The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.


Eligibility criteria: Inclusion Criteria:

SAH group :

* Adults
* Hospitalized in the neurological intensive care unit for a Fisher modified aneurysmal SAH 3 or 4 with EVD and urinary catheter.
* With a catheter (arterial or venous) for repeated sampling.

Control group :

* Adults
* Performing a perfusion test in the operating room for normal pressure hydrocephalus

Exclusion Criteria:

* Patients with SAH without EVD.
* Patients with non-aneurysmal SAH.
* Pregnant or breastfeeding women.
* Patients under legal protection, guardianship, curatorship, safeguard of justice.
* Patients participating in a study that may interfere with the present study.
* Persons under forced psychiatric care.

Primary outcomes:
measure: The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
timeFrame: The patient is included during hospitalization within 2 days of the placement of the EVD
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT05751655: Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.
Official title: Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drowning
Keywords: Drowning
Emergency medical service
Pre-hospital care
Patient outcome
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult drowning patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.

Brief summary: According to the 9th edition of "NOYADES" survey, 1480 drownings accidents occurred in France in 2021, of which 146 (i.e. nearly 10%), were in the Var department. These patient's care involve in first place the Emergency Medical Service (EMS).

To date, there is no recommendation from French or European academic societies of emergency medicine formalising pre-hospital care of these patients (except for the specific case of cardiac arrest). This absence of recommendation therefore favours heterogeneity of practices.

Detailed description: Within a three-year period from 2019 to 2022, this retrospective observational study aims to provide an inventory of pre-hospital practices by the EMS in the Var department and to describe drowning patients' characteristics as well as their outcome, according to the initial regulation and the type of care. These data could help for pre-hospital care management.

Eligibility criteria: Inclusion Criteria:

1. Drowning patient
2. Aged 18 years old or over
3. Patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.

Exclusion Criteria:

1. Diving accident
2. Patient opposition to participate in the study

Primary outcomes:
measure: Type of ventilation used in pre-hospital care
timeFrame: 3-year period from 2019-2022
measure: Ventilatory settings used in pre-hospital care
timeFrame: 3-year period from 2019-2022
measure: Pre-hospital intervention duration
timeFrame: 3-year period from 2019-2022
measure: Type of resources involved for pre-hospital care
timeFrame: 3-year period from 2019-2022
Secondary outcomes:
measure: Onset of death
timeFrame: Up to 30 days
measure: Duration of hospitalisation
timeFrame: Up to 30 days
measure: Intubation rate at hospital
timeFrame: Up to 30 days
measure: Type of ventilation used at hospital
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Célia BOUTIN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02864355: Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
Official title: Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 53
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 objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.

Exclusion Criteria:

* Patients \< 55kg or \> 140 kg, based on literature regarding accuracy of FloTrac.
* Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
* Patients with diagnosed NYHA class III-IV failure or documented EF \< 30%
* Patients who are unable/unwilling to consent for study procedures

Primary outcomes:
measure: Number of Participants With Cardiopulmonary Complications
timeFrame: 7 days
Secondary outcomes:
measure: Anastomotic Leak Diagnosed Via Radiograph
timeFrame: 7 days
measure: Number of Participants With Renal Injury
timeFrame: 7 days
measure: Death
timeFrame: 30 days
measure: Length of Intensive Care Unit Stay
timeFrame: 30 days
measure: Hospital Length of Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: George Guldan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333255: Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
Official title: Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 267
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.


Eligibility criteria: Inclusion Criteria:

* planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

* Under 10

Primary outcomes:
measure: Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary outcomes:
measure: Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation
Other outcomes:
Locations:
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
Study officials:
affiliation: Study Director
name: Andrew Maxwell
role: STUDY_DIRECTOR
References:
Clinical trial NCT05411055: Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)
Official title: Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Disease
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing aortic neocuspidal surgery

Brief summary: The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures


Eligibility criteria: Inclusion Criteria:

* severe aortic valve stenosis or insufficiency
* Written informed consent
* Willingness to carry out the follow-up visits

Exclusion Criteria:

* Other types of aortic valve surgery

Primary outcomes:
measure: postoperative complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: MCH
state: Ravenna
Study officials:
References: