louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04518189: Transdermal Lidocaine for Pain Control During Hysterosalpingography
Official title: Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized trial
Primary purpose: PREVENTION

Brief summary: the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography

Detailed description: hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility criteria: Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography

Primary outcomes:
measure: Mean pain score during the procedure
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT05766189: Wastewater Surveillance to Boost COVID-19 Vaccine Uptake
Official title: Utilizing Wastewater Surveillance Data in a Communications Campaign to Boost Vaccination Uptake in New York State: a Comparison-control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaccination
Wastewater Surveillance
Lead sponsor: Syracuse University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Difference-in-differences
Primary purpose: OTHER

Brief summary: The goal of the study is to determine the effect of a communications campaign sharing wastewater surveillance data to influence vaccine uptake in a metropolitan and non-metropolitan environment. The study will be conducted in Onondaga and Cayuga counties in New York State. Individuals of all ages within the selected counties, located in metropolitan and non-metropolitan environments will receive the intervention. The evaluation study design is a comparison-control trial. The primary outcome measure is the proportion of vaccine-eligible individuals in the county that received the COVID-19 vaccine stratified by type of vaccine dosage and age group. Vaccination data will be aggregated to the county by the State Department of Health and shared with the research team. Wastewater data will be pulled from the wastewater surveillance network. A difference in differences analysis will be used to estimate the effect of the intervention on both the outcomes between intervention and comparison groups following the intervention, while adjusting for potential confounding factors.


Eligibility criteria: Inclusion Criteria:

* None - county-level vaccine uptake - no direct interaction with people getting vaccines

Exclusion Criteria:

* None

Primary outcomes:
measure: Vaccine uptake
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
Clinical trial NCT03383289: Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living
Official title: Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assisted Living, Resident to Resident Elder Mistreatment
Lead sponsor: Hebrew Home at Riverdale
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Weill Medical College of Cornell University
name: National Institute on Aging (NIA)
First posted: 2017-12-26
Enrollment: 930
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Resident-to-resident elder mistreatment (R-REM) is a significant problem in long-term services and support settings (LTSS), and likely to cause physical and or psychological distress. The proposed project tests an intervention developed for use by LTSS staff. As such, it represents an important step in the process of developing approaches for ameliorating and preventing R-REM in assisted living residences which house residents with dementia and related behavioral disorders, and is thus likely to have significant public health impact.


Eligibility criteria: Inclusion Criteria:

* all long term residents residing at each facility at baseline, for those unable to consent, proxy consent will be sought

Exclusion Criteria:

* residents receiving hospice care,
* facilities will have the option to exclude individuals for selected reasons, (e.g., severe psychosis)

Primary outcomes:
measure: Falls, Accidents, and Injuries
timeFrame: Six months before baseline through twelve month follow-up
Secondary outcomes:
measure: Affect
timeFrame: Baseline, 6- and 12- month follow-up
Other outcomes:
measure: Staff Knowledge Module 1
timeFrame: Pre and post training evaluation: Immediately before and immediately after training
measure: Staff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events
timeFrame: baseline through 1-year follow-up
measure: Staff Knowledge Module 2
timeFrame: Administered immediately before and immediately after training was provided
Locations:
city: Bronx
country: United States
facility: Hebrew Home at Riverdale
state: New York
Study officials:
affiliation: Research Division, Hebrew Home at Riverdale
name: Jeanne A Teresi, PhD, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teresi JA, Silver S, Ramirez M, Kong J, Eimicke JP, Boratgis GD, Meador R, Schultz L, Lachs MS, Pillemer KA. Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial. Trials. 2020 Aug 12;21(1):710. doi: 10.1186/s13063-020-04580-z.
Clinical trial NCT02969889: Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA
Official title: Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Intubation Complication
Keywords: Airtraq
Intubating laryngeal mask airway
BMI>35
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: bmı \> 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.

Detailed description: 80 patients, 18-65 years of aged ASA I-III, BMI\> 35 patients enrolled in this trial.

Divided into two groups ; Airtraq and ILMA .

BMI\>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.

patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.

The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.

Eligibility criteria: Inclusion Criteria:18-65 years of age

* ASA I-III
* BMI\>35

Exclusion Criteria:BMI\<35

* patients have airway tumor
* patients undergoing head and neck surgery
* upper respiratory infection less than 10 days prior the surgery

Primary outcomes:
measure: intubation time
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
affiliation: Kocaeli University Medical Faculty
name: Zehra Arslan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06871189: Age and Gender in TMJ Sounds
Official title: Age and Gender on TMJ Sound Frequencies and Mouth-Opening Distances
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders (TMD)
Keywords: age
gender
temporomandibular disorders
vibration frequencies
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: free of symptoms related to temporomandibular disorder

Brief summary: The temporomandibular joint (TMJ) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. Disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint friction, leading to vibrations or intra-articular sounds. These sounds have become an essential diagnostic tool for assessing internal derangements of the TMJ. While magnetic resonance imaging (MRI) is considered the gold standard for diagnosing TMJ disorders, its limitations in evaluating intra-articular structures have led to the development of alternative methods, such as Joint Vibration Analysis (JVA). This study explores the relationship between age, gender, and TMJ vibration frequencies using JVA in a cohort of 367 participants. We analyzed four key vibration parameters: Range of Motion (ROM), Total Integral Left (TIL), Total Integral Right (TIR), and frequency distributions in the \<300 Hz and \>300 Hz segments.


Eligibility criteria: Inclusion Criteria:

* Participants capable of achieving an inter-incisal opening of 30 to 50 mm without restrictions.
* Free from symptoms indicative of temporomandibular disorder (TMD).
* Possessing fully and/or prosthetically restored dentition.
* Demonstrating adequate mouth opening to facilitate the rotation of the condylar process.

Exclusion Criteria:

* Individuals using psychotropic or narcotic medications, regardless of medical oversight.
* Regular consumption of painkillers or anti-inflammatory agents.
* Long-term treatment with cortisone or its derivatives. Individuals who have sustained traumatic injuries to the maxillofacial region.
* Participants who have suffered the loss of organs and/or tissue in the maxillofacial area due to medical or traumatic causes.

Primary outcomes:
measure: range of motion
timeFrame: The outcome measure was assessed at baseline.
measure: Total Integral
timeFrame: The outcome measure was assessed at baseline
measure: Frequency Components
timeFrame: The outcome measure was assessed at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas Univercity
state: Anadolu
Study officials:
References:
Clinical trial NCT05035589: The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Official title: The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
ARDS
Keywords: COVID-19 Pneumonia
Tocilizumab
Procalcitonin
C-Reactive Protein
Lead sponsor: Sciberras, Stephen M.D.
Sponsor class: INDIV
Collaborators: name: Mater Dei Hospital, Malta
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients treated with tocilizumab single dose therapy in ICU

Brief summary: This study aims to establish whether tocilizumab has any significant effect on procalcitonin levels on patients diagnosed with COVID-19 pneumonia requiring intensive care admission. The effects on other biochemical and clinical markers are also considered.

Detailed description: A retrospective study, involving the first fifty patients treated with tocilizumab for acute deterioration in COVID-19 pneumonia in the Intensive Care Unit (ICU) at Mater Dei Hospital in Malta.

The following parameters will be collected from medical records:

* procalcitonin levels, daily for twenty days or until discharge or death.
* namely white cell count (WCC), neutrophils, lymphocytes,
* C-reactive protein (CRP)
* PaO2/FiO2 ratio (P/F ratio).

This group will be compared to a control group was chosen from patients admitted to the ICU who were not eligible for tocilizumab treatment, matched to the study group for age, gender, mode of ventilation required and length of stay in ICU.

Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 diagnosis
* Admitted to ITU
* Tocilizumab treatment

Exclusion Criteria:

* none

Primary outcomes:
measure: Procalcitonin
timeFrame: throughout study completion, daily for maximum of 20 days
Secondary outcomes:
measure: CRP
timeFrame: throughout study completion, daily for maximum of 20 days
measure: WCC
timeFrame: throughout study completion, daily for maximum of 20 days
measure: Neutrophils
timeFrame: throughout study completion, daily for maximum of 20 days
measure: Lymphocytes
timeFrame: throughout study completion, daily for maximum of 20 days
measure: NLR
timeFrame: throughout study completion, daily for maximum of 20 days
measure: P/F ratio
timeFrame: throughout study completion, daily for maximum of 20 days
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Mater Dei Hospital
Study officials:
References:
Clinical trial NCT01486589: Cardiac Autonomic Function For Risk Stratification in the Emergency Room
Official title: Risk Stratification in the Emergency Room by Cardiac Autonomic Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Nervous System Activity
Keywords: emergency care
cardiac autonomic function
deceleration capacity
Lead sponsor: Thebiosignals.com
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 6521
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: Consecutive patients presenting at the emergency department of the University Hospital of Tübingen

Brief summary: The aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.


Eligibility criteria: Inclusion Criteria:

- presenting at the emergency department of the University Hospital of Tübingen

Primary outcomes:
measure: In-hospital mortality
timeFrame: 10 days
Secondary outcomes:
measure: Cardiac mortality
timeFrame: 10 days
measure: transfer to intensive care unit
timeFrame: 10 days
measure: hospital discharge
timeFrame: 48 hours
measure: duration of hospital stay
timeFrame: within 30 days
measure: costs of health care
timeFrame: 30 days
measure: 180 day mortality
timeFrame: 180 days
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Medizinische Universitätsklinik Tübingen
state: Baden-Württemberg
Study officials:
References:
citation: Eick C, Duckheim M, Groga-Bada P, Klumpp N, Mannes S, Zuern CS, Gawaz M, Rizas KD, Bauer A. Point-of-care testing of cardiac autonomic function for risk assessment in patients with suspected acute coronary syndromes. Clin Res Cardiol. 2017 Sep;106(9):686-694. doi: 10.1007/s00392-017-1104-3. Epub 2017 Mar 22.
citation: Eick C, Rizas KD, Meyer-Zurn CS, Groga-Bada P, Hamm W, Kreth F, Overkamp D, Weyrich P, Gawaz M, Bauer A. Autonomic nervous system activity as risk predictor in the medical emergency department: a prospective cohort study. Crit Care Med. 2015 May;43(5):1079-86. doi: 10.1097/CCM.0000000000000922.
Clinical trial NCT03765489: Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock
Official title: Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyneuropathies
Septic Shock
Muscle Weakness
Keywords: polyneuropathies
muscle weakness
sepsis
septic shock
electrical stimulation
intensive care unit
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 23
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 aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Detailed description: Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Eligibility criteria: Inclusion Criteria:

* Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
* Diagnosis of severe sepsis or septic shock
* More than 48 hours in VMI
* With sedation and / or neuromuscular blockade
* Autovalent prior to admission to the ICU

Exclusion Criteria:

* Subjects from other hospitals / clinics or units of the hospital
* Multiple trauma
* Previous neuromuscular pathology
* Pacemaker users
* Pregnant women
* BMI\> 35
* Epilepsy
* Those who have refused to sign informed consent

Primary outcomes:
measure: intensive care unit acquired weakness
timeFrame: at awakening of the subject, an average of 8 days
Secondary outcomes:
measure: muscle strength
timeFrame: at awakening of the subject, an average of 8 days
measure: muscle mass
timeFrame: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
measure: maximum inspiratory pressure
timeFrame: at awakening of the subject, an average of 8 days
measure: days of mechanical ventilation
timeFrame: an average of 11 days
measure: Number of Participants with weaning failure
timeFrame: 48 hours post extubation day
measure: days of ICU stay
timeFrame: at ICU discharge, an average of 18 days
measure: mortality at 28 days
timeFrame: at 28 days post ICU admission
measure: gait ability at hospital discharge
timeFrame: at hospital discharge, an averange of 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01260389: Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study.
Official title: Pharmaceutical Care for COPD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: GlaxoSmithKline
First posted: 2010-12-15
Enrollment: 734
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study would like to test the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in Chronic Obstructive Pulmonary Disease (COPD) patients over a 3 month-period.

Detailed description: Effective pharmacologic management of Chronic Obstructive Pulmonary Disease (COPD) not only involves prescription of recommended medicines by the physician, but also implies correct use of the prescribed medication by the patient (ie, good drug adherence and correct inhalation technique). Community pharmacists could help to improve the latter aspect, by delivering pharmaceutical care. The present randomised controlled trial will study the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in COPD patients over a 3 month-period.

Eligibility criteria: Inclusion Criteria:

* daily use of Chronic Obstructive Pulmonary Disease (COPD)-medication: (Global initiative for chronic Obstructive Lung Disease: GOLD stadia I-IV)
* 50 years of age or older
* smoking history of at least 10 pack-years

Exclusion Criteria:

* having asthma
* analphabetism

Primary outcomes:
measure: inhalation technique baseline
timeFrame: baseline
measure: inhalation technique 1 month
timeFrame: after 1 month
measure: inhalation technique 3 months
timeFrame: after 3 months
measure: drug adherence
timeFrame: after 3 months
Secondary outcomes:
measure: health status
timeFrame: baseline
measure: health status
timeFrame: after 1 month
measure: health status
timeFrame: after 3 months
measure: exacerbations
timeFrame: after 3 months
measure: Emergency Room visits and hospitalizations.
timeFrame: after 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire du Sart Tilman
Study officials:
affiliation: University Hospital, Ghent
name: Guy Brusselle, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438789: The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Hemoglobinuria, Paroxysmal
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.


Eligibility criteria: Inclusion Criteria:

* PNH;
* At least 18 years old
* Avoid conception; and
* Willing and able to give written informed consent

Exclusion Criteria:

* Active bacterial infection
* Participation in any other drug trial
* Pregnant breast feeding, or intending to conceive
* Not vaccinated against N meningitidis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Anthony Botti
state: New Jersey
Study officials:
References: