louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06182618: Retrospective Analysis for Patients With Metabolic Syndrome
Official title: Retrospective Analysis of Outpatient Intervention Effects in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Syndrome
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective study of the weight loss effect in 1 to 3 months in overweight or obese individuals at the department of clinical nutrition in the Second Affiliated Hospital of Zhejiang University, School of Medicine in China between 1 January 2020 and 1 Janu-ary 2024.

Brief summary: The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.


Eligibility criteria: Inclusion Criteria:

• individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.

Exclusion Criteria:

* patients did not follow-up on a monthly basis;
* patients followed-up less than 1 times within 3 months;
* patients having incomplete data;
* patients changing their interventions during fol-low-ups

Primary outcomes:
measure: weight
timeFrame: 0month/1month/2months/3 months
Secondary outcomes:
measure: visceral fat area(VFA)
timeFrame: 0month/1month/2months/3 months
measure: skeletal muscle mass(SMM)
timeFrame: 0month/1month/2months/3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03229018: Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study
Official title: Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cone-Beam Computed Tomography
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes

Detailed description: The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas.

CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.

Eligibility criteria: Inclusion Criteria:

* Selection of the human dry mandibles will be independent of age, gender and ethnicity.
* They should be intact, free from any bone defects, fractures, pathology.
* Dentate state of the mandibles is not an element in selection criteria; either dentulous or edentulous mandibles are acceptable

Exclusion Criteria:

-

Primary outcomes:
measure: Diagnostic accuracy of linear measurement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT06624618: Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
Official title: Rapid Molecular Detection of Sepsis in Whole Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Bloodstream Infection
Keywords: Culture-free
Whole blood
Molecular diagnosis
Sepsis
Bloodstream infection
Bacterial DNA
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Health Holland
First posted: 2024-10-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Intensive Care Unit (ICU) of Maastricht University Medical Center (MUMC) are eligible.

Brief summary: Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.


Eligibility criteria: Inclusion Criteria:

-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.

Exclusion Criteria:

-N/A

Primary outcomes:
measure: Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis
timeFrame: 2 years
measure: Patterns of bacterial DNA dynamics over time
timeFrame: 2 years
Secondary outcomes:
measure: Distinguishing between the causative pathogen and contamination by a physician evaluation panel, both for the current gold standard (blood cultures) and the results of new microbiological tests for detecting sepsis pathogens
timeFrame: 2 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
Clinical trial NCT01813318: Study of Acamprosate in Autism
Official title: Double-Blind Placebo-Controlled Study of Acamprosate in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autistic Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2013-03-18
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.

Detailed description: Each subject with ASD will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.

Eligibility criteria: Inclusion Criteria:

* 5-17 year-old outpatients
* Diagnosis of ASD
* General good health (determined by exam, history, and laboratory work up)
* Use of up to two concomitant psychotropic drugs (stable dosing for \>60 days) not impacting glutamate or gamma-aminobutyric acid A (GABA) neurotransmission is allowed
* Stable seizure disorder (no seizures in 6 months; on same anti-convulsant dose for \>60 days)
* Clinical Global Impression Scale Severity score (CGI-S) of 4 (Moderately III)
* Score of 13 on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW) at screen and baseline

Exclusion Criteria:

* Potential subjects with a creatinine clearance \< 50 mL/min or evidence of a previous trial of acamprosate will be excluded

Primary outcomes:
measure: Change from baseline to week 10 on the Social WIthdrawal subscale of ABC
timeFrame: Week 10
measure: Change Clinical Global Impression- Improvement
timeFrame: Week 10
Secondary outcomes:
measure: Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10
timeFrame: Week 10
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Craig A Erickson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209518: Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Official title: Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premenopausal Breast Cancer
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 312
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuprorelin for Injection Kit 22.5 mg in the routine medical care.

Brief summary: The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

Detailed description: The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.

This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

The survey will enroll approximately 300 patients.

- Leuprorelin

This multi-center survey will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

- Participants with premenopausal breast cancer will be included.

Exclusion Criteria:

* Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
* Pregnant or potentially pregnant participants and breastfeeding participants

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Events
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Reactions
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00207818: Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Official title: Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Venous Ulcers
Keywords: tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

Detailed description: The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

Eligibility criteria: Inclusion Criteria:

1. Men or women from 18 to 85 years old
2. Have a venous ulcer or a mixed ulcer

Exclusion Criteria:

Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy

Primary outcomes:
measure: wound closure
Secondary outcomes:
measure: % of healing at 6 months of treatment
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre hospitalier affilie universitaire de Quebec
Study officials:
affiliation: Centre hospitalier affilié universitaire de Québec
name: Francois A Auger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier affilié universitaire de Québec
name: Lucie Germain, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Pouliot R, Larouche D, Auger FA, Juhasz J, Xu W, Li H, Germain L. Reconstructed human skin produced in vitro and grafted on athymic mice. Transplantation. 2002 Jun 15;73(11):1751-7. doi: 10.1097/00007890-200206150-00010.
citation: Michel M, L'Heureux N, Pouliot R, Xu W, Auger FA, Germain L. Characterization of a new tissue-engineered human skin equivalent with hair. In Vitro Cell Dev Biol Anim. 1999 Jun;35(6):318-26. doi: 10.1007/s11626-999-0081-x.
Clinical trial NCT06044818: Validation of Accexible as a Tool for Screening and Monitoring Depression.
Official title: Validación Del Sistema de Cribaje y Seguimiento de acceXible Para depresión.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Accexible
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases: adults with suspected depression.

Controls: healthy controls without depression criteria.

Brief summary: Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

The present study has the objective of validating Accexible as a tool for Screening and Monitoring Depression.


Eligibility criteria: Inclusion Criteria:

* Adult 18-65 years of age.
* Participants must have Spanish as their first language (able to speak and understand verbal messages).
* Participants must have mobile phone with internet.
* Participants must have the ability to understand AcceXible's basic instructions.
* Participants must agree to participate in the study and have voluntarily signed the informed consent.

Exclusion Criteria for patients:

* To have received a diagnosis of neurodegeneration.
* To have significant vision problems that would affect the ability to perceive visual stimuli.
* To have significant hearing problems that would affect the ability to understand verbal cues.
* To be unable to give informed consent to participate in the study.

Primary outcomes:
measure: Prevalence of Depression
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Institut de Investigación (VHIR)
Study officials:
References:
Clinical trial NCT01171118: Phamacological Reversal of Airway Instability During Sedation
Official title: Phamacological Reversal of Airway Instability During Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Airway Obstruction
Keywords: Breathing
Sedation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study in physostigmine versus placebo.

Detailed description: One of the most serious side effects of drugs administered for sedation is untoward respiratory events. The relative prevalence of such events is thought to be high, occurring in up to 41% of patients in some cohorts. Many specific drugs and combinations have been recommended for moderate sedation, particularly when provided by a non-anesthesiologist. The use of an opioid and a benzodiazepine is the most frequent combination, partly because the availability of antagonists for both drugs may make a "rescue" easier. However, this combination results in frequent respiratory arrhythmias (combinations of obstructions, pauses and changes in respiratory patterns).There has not been a comprehensive study of the mechanisms underlying the disruptions of respiratory rhythm caused by agents commonly used for moderate sedation. This specific research, and the line of research it opens, has the potential to make the administration of anxiolytics and analgesics safer for patients at high risk for respiratory events.

Eligibility criteria: Inclusion Criteria:

* Ages 18-45
* BMI below 25
* Healthy males

Exclusion Criteria:

* Psychiatric illness
* Substance abuse
* Airway disorders
* Bleeding abnormatlities
* Claustrophobia
* Sleep apnea.

Primary outcomes:
measure: AHI - Apnea Hypopnea Index
timeFrame: 2- 2 1/2 hours during study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Suzanne B Karan, Medical
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097118: Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Official title: Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Appendicitis Acute
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine


Eligibility criteria: Inclusion Criteria:

* 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia

Exclusion Criteria:

* Patient refusal
* drug abuse
* Patient with neurological, psychiatirc or neuromuscular disease
* chronic pain on medicine
* known allergy to the study medicine
* Infection at the site of infiltration

Primary outcomes:
measure: Comparison study between Ketamine and Bupivacaine for post operative analgesia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
citation: Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
citation: Barrington JW, Dalury DF, Emerson RH Jr, Hawkins RJ, Joshi GP, Stulberg BN. Improving patient outcomes through advanced pain management techniques in total hip and knee arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10 Suppl):S1-S20.
citation: Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.