louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06694532: EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders
Official title: Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Joint Disorders
Arthrocentesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.

Detailed description: The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.

, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.

3-The presence of absence of clicking and cracking in jaw .

Eligibility criteria: Inclusion Criteria:

* Pain or tenderness of the jaw
* Pain in one or both of the temporomandibular joints
* Aching pain in and around your ear
* Difficulty chewing or pain while chewing
* Aching facial pain
* Locking of the joint,

Exclusion Criteria:

* Muscular TMJ disorders
* Bleeding tendency

Primary outcomes:
measure: EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
timeFrame: 36 months
Secondary outcomes:
measure: comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
timeFrame: 36 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Univeristy
Study officials:
affiliation: Assiut Univeristy
name: Basel K Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779932: Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA
Official title: Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioelectrical Impedance Measurement of Healthy Adults
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 38 healthy obese adults

Brief summary: The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.


Eligibility criteria: Inclusion Criteria:

* healthy adults in an
* age range of 18 to 65 years
* BMI \> 30 kg/m2

Exclusion Criteria:

* acute and chronic diseases
* regular intake of medications (except for contraceptives)
* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* artificial joints
* metallic implants (except tooth implants)
* claustrophobia
* pregnancy or breastfeeding period
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* current alcohol abuse
* frequent hypersensitivity reactions/allergies determ. anamnestically
* extensive tattoos at arms or legs

Primary outcomes:
measure: BIA 5 and 50 kHz
timeFrame: 15 minutes
measure: BIA 50 kHz
timeFrame: 15 minutes
measure: Total body water
timeFrame: 15 minutes
measure: Extracellular water
timeFrame: 15 minutes
measure: Fat-free mass
timeFrame: 1 hour
measure: Skeletal muscle mass
timeFrame: 1 hour
measure: Visceral adipose tissue
timeFrame: 1 hour
Secondary outcomes:
measure: Complete BIA
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition and Food Science
Study officials:
affiliation: Christian-Albrechts-University of Kiel
name: Manfred J Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.
Clinical trial NCT02063932: Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome
Official title: Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucosal Microbiome
H.Pylori
Intestinal Metaplasia
Gastric Neoplasia
Keywords: mucosal microbiome
H.pylori
intestinal metaplasia
gastric neoplasia
endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Brief summary: There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

Detailed description: The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.

Eligibility criteria: Inclusion criteria:

* Patients scheduled for gastroendoscopy examination
* Aged between 18 and 80 years old

Exclusion criteria:

* Antibiotic, probiotic or prebiotic usage within 2months
* Esophageal, gastric or duodenal cancer or other malignancy
* History of upper GI tract surgery
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function

Primary outcomes:
measure: The operational taxonomy units in gastric mucosal microbiome
timeFrame: 6 months
Secondary outcomes:
measure: The diagnostic accuracy of endomicroscopy compared to pathology.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT04370132: Segment IV Hypertrophy After Liver Venous Deprivation
Official title: Segment IV Hypertrophy After Liver Venous Deprivation Compared to Portal Embolization in Patient Before Major Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Hepatectomy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with liver tumors selected for surgery with insufficient futur liver remnant

Brief summary: before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. Recently liver venous deprivation has been described in some pioneer centre. The results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization.

In major hepatectomy, and specially in right or extended right hepatectomy the segment IV plays an important role in the proportion of future liver remnant.

Despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of hypertrophy of segment IV after liver venous deprivation compared to portal embolization.


Eligibility criteria: Inclusion criteria:

- patient with liver tumor selected for right hepatectomy with insufficient future liver remnant who have undergoes portal embolization or liver venous deprivation

Exclusion criteria:

- left / extended left hepatectomy

Primary outcomes:
measure: segment IV degree of hypertrophy
timeFrame: 1 day
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: recurrence free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Fabrizio PANARO, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01412632: Comparing Two Types of Sedation to Gynaecological Patients
Official title: Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transcervical Resection of Endometrium
Transcervical Resection of Fibroids
Transcervical Resection of Polyp
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Horsens
First posted: 2011-08-09
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Detailed description: Investigate the difference between two types of anesthesia.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* females
* are having a TCRE, TCRF or TCRP
* speak and understand Danish
* no mental problems

Exclusion Criteria:

* \<18 years old
* don´t speak or understand Danish
* mental problems
* Lung problems
* BMI \>40
* Big fibroma: \>3x3 cm
* abuser
* Allergy towards i Propofol, Remifentanil and/or Citanest
* pregnant

Primary outcomes:
measure: pain on a NRS-scale from 0 to 10
timeFrame: up to 14 days
Secondary outcomes:
measure: PONV
timeFrame: postoperative and 2 weeks after discharge
measure: Time
timeFrame: 1 day
measure: Medicin
timeFrame: 1 day
measure: After discharge outcome measures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Regionshospitalet Horsens
state: Region Midt
Study officials:
affiliation: Regionshospital Horsens
name: Igor Filipovski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287832: Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bacteremia
Keywords: Methicillin-resistant
Staphylococcus aureus
Lead sponsor: St. John Health System, Michigan
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2011-02-01
Enrollment: 11
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: There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Signed informed consent
* All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature \< 36.0º C), tachycardia (heart rate \> 100 beats/minute), hypotension (systolic blood pressure \< 90 mm Hg) or other clinical features of sepsis.
* All cases of right-sided native valve endocarditis due to MRSA
* Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study
* Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses

Primary outcomes:
measure: Number of Participants With Clinical Success at Test of Cure Visit.
timeFrame: 30-42 days post-treatment
Secondary outcomes:
measure: Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity
timeFrame: 30-42 days post-treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05315232: The Experiences of People Who Live With Glanzmanns Thrombasthenia.
Official title: Glanzmanns 360. The Lived Experience of People With Glanzmanns.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glanzmann Thrombasthenia
Lead sponsor: Haemnet
Sponsor class: OTHER
Collaborators: name: Hemab ApS
First posted: 2022-04-07
Enrollment: 122
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns Thrombasthenia.

Brief summary: To understand the lived experiences of people with Glanzmanns Thrombasthenia

Detailed description: A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia

Exclusion Criteria:

Acquired Glanzmanns Thrombasthenia

Primary outcomes:
measure: to understand the impact of GT on quality of life of affected individuals and their families.
timeFrame: one year
Secondary outcomes:
measure: Identify levels of acceptability of current treatments and management approaches
timeFrame: one year
measure: Identify areas of unmet need among people with GT
timeFrame: one year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: Haemnet
name: Mike Holland, BSC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05636332: The Intrepid Clinical Engineering Study
Official title: Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Arrest
Keywords: Monitor
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 29
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

Detailed description: The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.

Eligibility criteria: Inclusion Criteria:

* Able to read, write, speak, and understand English
* Age: 29 days to 89 years
* Willing and able to provide informed consent and complete study procedures
* Willing to have Philips representatives present during study procedures.

Exclusion Criteria:

* Known allergy to medical adhesives, silicone, or latex (per self-report)
* Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)
* At the time of enrollment, current enrollment in any other interventional research study
* An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)

Primary outcomes:
measure: Validation of Algorithm Software Update
timeFrame: day 1
measure: Diagnostic Quality
timeFrame: day 1
Secondary outcomes:
measure: Adverse Events
timeFrame: day 1
measure: Unanticipated Adverse Device Effects (UADE)
timeFrame: day 1
Other outcomes:
Locations:
city: Lehigh Acres
country: United States
facility: Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
state: Florida
Study officials:
affiliation: Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
name: Alaa El-Gendy, MD, MSc, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871232: Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
Official title: Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid-related Disorders
Opioid Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: ER/LA Opioid REMS Program Companies (RPC)
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 26500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school

Brief summary: To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.


Eligibility criteria: Inclusion Criteria:

Any patient with data in the RADARS system

Exclusion Criteria:

None

Primary outcomes:
measure: Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
timeFrame: Review over period from January 2010 to December 2016
Secondary outcomes:
measure: Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group
timeFrame: Review over period from January 2010 to December 2016
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05537532: Intern Health Study 2021
Official title: Intern Health Study: 2021 Micro-Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 1486
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization scheme
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.

Detailed description: Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and compete with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.

The primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score.

Eligibility criteria: Inclusion Criteria:

* Medical intern during the 2021-2022 internship year
* Enrolled in study by the start of internship (7/1/22)

Exclusion Criteria:

* None

Primary outcomes:
measure: Average daily step count
timeFrame: Daily, throughout intern year (1 year)
Secondary outcomes:
measure: Average daily mood score
timeFrame: Daily, throughout intern year (1 year)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: