louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02349087: EEG in Resuscitated In-hospital Patients
Official title: Integrating EEG Into Acute Medicine: EEG in Resuscitated In-hospital Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sudden Cardiac Arrest
Seizures
Keywords: EEG
cardiac arrest
resuscitation
seizures
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In- hospital resuscitated patients, who are going to be treated in ICU after ROSC. Patients with Do Not Attempt to Resuscitate -decision will not be included.

Brief summary: In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.


Eligibility criteria: Inclusion Criteria:

* Resuscitated in-hospital patients

Exclusion Criteria:

* Patients with Do Not Attempt to Resuscitate-decision
* Patients who are not going to be treated in ICU after resuscitation

Primary outcomes:
measure: 24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Clinical Neurophysiology
name: Esa Mervaala, MD, PhD,prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03552809: Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
Official title: Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frenulum; Hypertrophy, Lip
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment. Forty-eight patients with high papillary frenulum attachments were included in the study. Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P). Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS). Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days. Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days. All data were compared between groups and within each group.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Primary outcomes:
measure: Postoperative Pain Change
timeFrame: Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05625009: Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
Official title: Comparison of Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block in the Management of Postoperative Analgesia in Patients Who Had Cesarean Section Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Cesarean Section
Erector Spinae Plane Block
Transversus Abdominis Plane Block
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.


Eligibility criteria: Inclusion Criteria:

* 18 - 45 years
* ASA2
* Undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* History of chronic pain
* Body mass index \> 35
* Urgent/emergent surgeries
* Major bleeding
* Any additional surgical procedure
* Contraindication for any drugs used in the protocol
* The presence of any instrumentation in the procedure sites

Primary outcomes:
measure: Percentage of patients needed for rescue analgesic agent (diclofenac)
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of patients needed for rescue analgesic agent (opioid)
timeFrame: 24 hours
measure: the dose of the opioid used
timeFrame: 24 hours
measure: Percentage of patients experienced chronic pain
timeFrame: 2 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Basaksehir Cam and Sakura City Hospital
Study officials:
References:
Clinical trial NCT04509609: Clinical Determinants of Disease Progression in Patients With Limb Girdle Muscular Distrophy Type 2E
Official title: Clinical Determinants of Disease Progression in Patients With Limb Girdle Muscular Distrophy Type 2E
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: LGMD2E
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient affected by LGMD 2E that have received a genetical confirm of the diagnosis

Brief summary: A retrospective observational study that will enable us to collect retrospective data from the clinical records of LGMD 2E patients in order to highlight any possible correlation between:

* clinical variables and patient age,
* clinical variables and other clinical variables,
* clinical variables and clinical outcomes. The study will help to define the natural history of this rare disease and to ameliorate the management of these patients.

Detailed description: Retrospective observational study. Retrospective data from clinical charts of patients affected by LGMD 2E will be collected after the subscription of informed consent.Data considered will include any clinical variable measured, both objective and subjective. All data obtained will be anonimized before any treatment. Data will be grouped according to the age of the patient, in order to have more data for each age and to gain a trustable description of the disease progression. The possible correlation of each variable to age, to other variables and to objective clinical outcomes will be studied. Clinical outcomes considered will include age of loss of deambulation, age of introduction of respiratory assist, age of introduction of cardiological therapy. Data collected will also be divided in two groups according to different genetic diagnosis in order to evaluate phenotipical differences of genotypical clesses. First group will count all patient with the truncating mutation c.377_384duplCAGTAGGA in exon 3, both in heterozigosis and in homozigosis Second group will include all the other patients.

Both on the global data collection and on data divided according to genotype, statistical analysis will be performed. Those analysis will study linear regression both with the univariate, bivariate and multivariate model.

Eligibility criteria: Inclusion Criteria:

* Gene based diagnosis of LGMD 2E
* Subscription of informed consent when applicable

Exclusion Criteria:

* Lacking gene based diagnosis of LGMD 2E
* Lacking subscription of informed consent when applicable

Primary outcomes:
measure: Natural history
timeFrame: december 2020
Secondary outcomes:
measure: Guidelines
timeFrame: december 2020
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT06121609: ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children
Official title: The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bidirectional Endoscopy
Keywords: pediatric anesthesia
remimazolam
ED90
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 114
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

Detailed description: Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.

Eligibility criteria: Inclusion Criteria:

1. Age 0-12 years old,
2. ASA I-II level;
3. Sign an informed consent form.

Exclusion Criteria:

1. Developmental delay or neurological and psychiatric disorders;
2. Severe malnutrition or severe obesity;
3. High risk of stomach fullness and reflux aspiration;
4. Allergic to benzodiazepines and opioids;
5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
6. Severe sleep apnea;
7. Abnormal liver and kidney function;
8. Recently participated in other clinical studies.

Primary outcomes:
measure: Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S
timeFrame: 1 day
Secondary outcomes:
measure: Respiratory suppression incidence
timeFrame: 1 day
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 2 days
measure: Time records
timeFrame: 1 day
measure: Use of drugs
timeFrame: 1 day
measure: Postoperative pain assessment
timeFrame: 2 days
measure: Baxter Retching Faces (BARF) nausea scale
timeFrame: 2 days
measure: Sleep quality.
timeFrame: 2 days
measure: Daily activities
timeFrame: 2 days
measure: Parental satisfaction
timeFrame: 2 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: aihua Du, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05530109: Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.
Official title: Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Generalized Epilepsy
Keywords: Attention
Epilepsy
Connectivity
EEG
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from the clinical neurophysiology department of the Lille University Hospital, a reference centre for the follow-up of rare epilepsies.

Brief summary: Attentional disorders have been reported in neuropsychological studies evaluating patients suffering from generalized idiopathic epilepsy, but the data are disparate (in terms of test protocol). We aim to describe attentional and executive function disorder in IGE thanks to the Epitrack scale, validated in this specific population. Our secondary objective is to study the dynamic of cortical activity during an attentional task (the ANT), in order to describe the alteration of cortical networks in epileptic patients presenting with attentional disturbance.


Eligibility criteria: Inclusion Criteria:

* Idiopathic generalized epilepsy followed-up during at least 2 years
* At least one antiepileptic drug medication
* No cognitive decline (MoCA score \>26)
* Absence of concomitant pathology that could interfere with the purpose of the study.
* Be affiliated to the social security system
* Have signed an informed consent

Exclusion Criteria:

* Pregnancy
* Not able to give consent (Article 1121-8 of the CSP) Vulnerable person Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP) Have a high probability of not respecting the protocol or of abandoning the study

Primary outcomes:
measure: Epitrack scale score
timeFrame: At 1 month after inclusion
Secondary outcomes:
measure: Raven's progressive matrice scores
timeFrame: At 1 month after inclusion
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: At 1 month after inclusion
measure: D2-R test score
timeFrame: At 1 month after inclusion
measure: BDI-II score
timeFrame: At 1 month after inclusion
measure: STAI scale
timeFrame: At 1 month after inclusion
measure: quality of life using the Qolie-31 self questionnaire
timeFrame: At 1 month after inclusion
measure: High resolution Electro Encephalo Gram functional connectivity markers at rest and during the ANT task
timeFrame: At 1 month after inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe DERAMBURE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01000909: Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Insufficiency
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic venous disease with complete incompetence of the great saphenous vein

Brief summary: Part I:

Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons

Part II:

Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease


Eligibility criteria: Inclusion criteria:

Part I:

* Healthy persons without clinical signs of venous disease, informed consent

Part II:

* Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV)
* Informed consent

Exclusion criteria:

Part I:

* Clinical signs of venous disease, former deep vein thrombosis (DVT)

Part II:

* Former deep vein thrombosis, former vein surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT05852509: Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
Official title: Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Caregiver Burden
Keywords: heart failure
older adults
family caregivers
digital health
physical activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-10
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the Aim 3 study is to conduct a pilot randomized controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 60 years
* Involved in caring for a household member aged 60 years or older with the New York Heart Association Class II, III or IV HF
* Provide at least 10 hours/week of unpaid care for the past 6 months
* Physically able to engage in structured exercise such as walking, and upper body resistance exercises
* Engage in \< 30 min of moderate-intensity exercise on fewer than 3 days per week over the past 6 months
* Able to read, speak, and comprehend 5th grade English
* Own a smartphone
* Reachable by telephone, text messaging, and email

Exclusion Criteria:

* Medical or functional conditions precluding participation in the physical activity (PA) components of the intervention (e.g., inability to walk one block or climb stairs without chest pain, shortness of breath, dizziness; history of falls; or serious or unstable cardiovascular or pulmonary disease)
* Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\]52 score \< 25)
* Inability to use technology
* Participation in a PA intervention in the previous 6 months
* Current participation in a PA or behavior change trial

Primary outcomes:
measure: Daily physical activity counts
timeFrame: 4 months
Secondary outcomes:
measure: Sedentary activity
timeFrame: 4 months
measure: Physical function
timeFrame: 3 months
measure: Depression
timeFrame: 4 months
measure: Anxiety
timeFrame: 4 months
measure: Stress
timeFrame: 4 months
measure: Caregiving self-efficacy
timeFrame: 4 months
measure: Health related quality of life
timeFrame: 4 months
measure: Usability of TPA4You
timeFrame: 3 months
measure: Total sleep time
timeFrame: 4 months
measure: Wake after sleep onset
timeFrame: 4 months
measure: Sleep efficiency
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Dawon Baik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907709: Effects of In-Home Addiction Treatment for First Responders
Official title: Effects of an In-Home Treatment Program for First Responders With Substance Use Disorder: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Substance Use Disorders
Lead sponsor: In-Home Addiction Treatment Institute, Inc.
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 15 individuals with substance use disorder who are or have served as a first responder (police officer, fire fighter, corrections officer, military police, emergency medical technician, paramedic, parole or probation officer) and were enrolled in Aware Recovery Care's In-Home Addiction Treatment program between April 2017 and March 2019.

Brief summary: Retrospective analysis to evaluate impact of an in-home addiction treatment program on first responders with substance use disorder.

Detailed description: The purpose of this retrospective study is to evaluate the effects of in-home addiction treatment on first responders with substance use disorder. Treatment engagement, hospitalizations, detox and residential addiction treatment admissions, and lethal overdoses will be measured. Although not the primary focus, recidivism and relapse will be measured.

Eligibility criteria: Inclusion Criteria:

* Client is or has been a first responder
* Client enrolled in Aware Recovery Care after April 2017
* Client discharged from Aware Recovery Care before March 2019
* Client has primary substance use disorder diagnosis

Exclusion Criteria:

* Client has never been first responder
* Client moved out of service area or lost insurance during care

Primary outcomes:
measure: Rate of Retention in Treatment
timeFrame: Measured throughout 365 day duration of anticipated length of stay
measure: Brief Addiction Monitor questionnaire
timeFrame: Conducted monthly throughout 365 day anticipated length of stay in program
measure: Positive Outcomes Measures Survey
timeFrame: Completed at week 3 or 4, Week 30, Week 35, Week 44, and Week 50 throughout 52 week anticipated length of program participation
Secondary outcomes:
measure: Relapse rates
timeFrame: Randomly administered throughout 365 day anticipated length of program participation
measure: Hospitalization
timeFrame: Measured throughout 365 day anticipated length of program participation
measure: Detox and Residential Admissions
timeFrame: Measured throughout 365 day anticipated length of program participation
Other outcomes:
Locations:
city: North Haven
country: United States
facility: Aware Recovery Care
state: Connecticut
Study officials:
affiliation: In-Home Addiction Treatment Institute, Inc.
name: Sara Kaiser, MS Ed, LPN
role: PRINCIPAL_INVESTIGATOR
References: