louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05264246: Evaluation of an Anti-Shivering Protocol Cardiac Arrest
Official title: Evaluation of an Anti-Shivering Protocol for Targeted Temperature Management Following Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Arrest
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to conduct the retrospective chart review of all patients identified during the study period (from June 1, 2017 to May 31, 2021) that meet the inclusion and exclusion criteria.

Brief summary: This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019.

Detailed description: This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019. To allow for an adequate washout period, patients who were initiated on TTM before April 22, 2019 will be in the "before" group and patients initiated on TTM on or after June 1, 2019 will be in the "after" group. Patients will be identified based on electronic medical records search of order sets utilized in TTM and confirmed with manual chart review. Statistical analysis will be performed as detailed below.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosis of cardiac arrest
* Initiation of TTM via Arctic Sun® device

Exclusion Criteria:

* Initiation of TTM \> 12 hours after cardiac arrest
* Receiving NMBs for an indication other than TTM
* Early termination of TTM (less than 24 hours)

Primary outcomes:
measure: NMB usage
timeFrame: June 1, 2017 - May 31, 2021
Secondary outcomes:
measure: NMB usage
timeFrame: June 1, 2017 - May 31, 2021
measure: Patients discharged home
timeFrame: June 1, 2017 - May 31, 2021
measure: Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation
timeFrame: First 72 hours of TTM initiation
measure: Proportion of patients cooled to 33°C versus 36°C
timeFrame: June 1, 2017 - May 31, 2021
measure: Time to target temperature from initiation of TTM
timeFrame: June 1, 2017 - May 31, 2021
measure: ICU length of stay
timeFrame: June 1, 2017 - May 31, 2021
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist
name: Tamara Reiter, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01115946: A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of Enalapril
Keywords: ASP1585
Drug-drug interaction
enalapril
Healthy volunteer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.


Eligibility criteria: Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases

Primary outcomes:
measure: Plasma concentration of enalapril
timeFrame: for 48 hours after administration
Secondary outcomes:
measure: Safety assessed by AE, vital signs 12-lead ECG and lab tests
timeFrame: for 7 days after administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02594046: The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
Official title: The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks.

Detailed description: This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks. Hair count and thickness will be primary outcomes.

Eligibility criteria: Inclusion Criteria:

* androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher

Exclusion Criteria:

* patient of scalp disease

Primary outcomes:
measure: change of total hair counts by phototrichogram
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06388746: Arresting Carious Lesions With Minimal Intervention Techniques
Official title: Minimal Intervention Techniques for Arresting Caries in Primary Molars: a Randomized Clinical Trial With 12 Months Follow-up.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries,Dental
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.

Detailed description: Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers.

Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement.

Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.

Eligibility criteria: Inclusion Criteria:

* Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.

Exclusion Criteria:

* Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.

Primary outcomes:
measure: clinical success
timeFrame: 6 and 12 month post-treatment
measure: radiographic success
timeFrame: 12 month post-treatment
Secondary outcomes:
measure: Longevity and the quality of the final restoration
timeFrame: 6 and 12 months post-treatment
measure: Patient's acceptance
timeFrame: immediately post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens
name: Sotiria Gizani, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547646: The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
Official title: The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia: NOSOREA2 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cross Infection
Prevalence
Epidemiology
Critical Care
Keywords: Iatrogenic Disease
Cross Infection
Intensive Care Units
Prevalence
Risk Factors
Critical Care
Lead sponsor: Abderrahmane Mami Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: One-day point-prevalence study (September 27th, 2022) All medical ICUs across Tunisia are invited to participate, excluding cardiologic and paediatric care units.

All patients occupying an ICU bed over a 48-hour period are eligible.

Brief summary: We aimed to determine the prevalence of HAI in medical Tunisian ICUs. Secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of HAIs.

Detailed description: In Tunisia, there is no national or regional monitoring system of HAI. It is worth noting that HCAIs in intensive care unit (ICU) are more common and life threatening than in general ward because of the frequent use of invasive procedures and multiple therapies.

Controlling this fatal scourge should begin with greater awareness of HAI frequency and ICU ecology. That is why conducting multi-center Tunisian studies is necessary to guide control measurements against HAI and to improve surveillance and infection-control practices. NOSOREA1 study (Tunis Med. 2018 Oct-Nov;96(10-11):731-736) was conducted in 2017 and showed that HAI prevalence within Tunisian ICUs was 25.2% CI 95% \[15-35\]. Five years later, it is high time to update our finding.

Eligibility criteria: Inclusion Criteria:

* All patients occupying an ICU bed over a 48-hour period
* Age \>=18 years

Exclusion Criteria:

* no criteria

Primary outcomes:
measure: Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs
timeFrame: September 27th, 2022
Secondary outcomes:
measure: Identify independent risk factors of HAIs.
timeFrame: September 27th, 2022
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Medical ICU
state: Ariana
Study officials:
affiliation: Ministery of Health
name: Amira JAMOUSSI, pROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324246: Feasibility Study of the NEW NORMA-SENSE
Official title: Feasibility Study of the NEW NORMA-SENSE Indicator Strip and Vaginal Secretion Buffer Capacity Measurement - IN-VITRO Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Infection
Keywords: vaginal infection
color appearance
new developed indicator strips (NEW NORMA-SENSE)
in-vitro
vaginal secretion
elevated pH
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: Lin Medical Center, Haifa
name: Common Sense
First posted: 2006-05-10
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women, age between 18 years and 45 years with or without symptoms of vaginal infection.

Brief summary: * In-vitro study
* Collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE), in contact with vaginal secretion with elevated pH
* Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects
* Detect these indicator strips' performance, in contact with urine

Detailed description: This in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

Eligibility criteria: Inclusion Criteria:

1. Women, aged between 18 and 45, with or without symptoms of vaginal infection.
2. Subjects are ready to sign the informed consent form.

Exclusion Criteria:

1. Subjects are unable or unwilling to cooperate with the study procedures.
2. Subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study.
3. Subjects that suffer from vaginal bleeding or menstruate.
4. Subjects that have had sexual relations within the last 12 hours.
5. Subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days.
6. Subjects that applied vaginal douching within 12 hours prior to the visit at the clinic.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Women Health Care Center - Lin Medical Center
Study officials:
affiliation: Women Health Care Center - Lin Medical Center, Haifa, Israel
name: Adam Geva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906346: Impact of a Non-Drug Choice on Cocaine Reinforcement
Official title: Impact of a Non-Drug Choice on Cocaine Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Dependence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.


Eligibility criteria: Inclusion Criteria:

* Cocaine dependence, otherwise healthy

Exclusion Criteria:

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Primary outcomes:
measure: The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
timeFrame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joshua A Lile, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06254846: Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
Official title: Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Cervical Cancer
Keywords: HPV
Cervical cancer
Cancer screening
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 350
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-centre study to assess the diagnostic performance (sensitivity and specificity) of HPV PCR on 1st-draft urine compared with cervico-vaginal sampling (= gold standard).
Primary purpose: OTHER

Brief summary: Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (\<60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.


Eligibility criteria: Inclusion Criteria:

* Female
* Age between 30 and 65
* Consulting in the Gynecology-Obstetrics department for primary cervical cancer screening
* Patient affiliated or entitled to a social security regimen
* Patient who has received information about the study and expressed non-opposition

Exclusion Criteria:

-

Primary outcomes:
measure: specificity
timeFrame: Month : 12
measure: Sensitivity
timeFrame: Month : 12
Secondary outcomes:
measure: HPV genotype concordance
timeFrame: Month : 12
measure: Women with a positive evaluation
timeFrame: Month : 12
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Louise MONIOD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800069: Validation of Point of Care Liver Function Tests
Official title: Biomedical Device Trial of Validation of Point of Care Liver Function Tests
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Diseases
Healthy
Cirrhosis, Liver
Fibrosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Group K Diagnostics Inc.
First posted: 2019-01-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.

Brief summary: This study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.

Detailed description: Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.

Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital

Eligibility criteria: Inclusion Criteria:

* Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein)
* 18 years or older

Exclusion Criteria:

* Inadequate blood sample obtained from finger stick
* Inconclusive liver function testing
* Not all 6 liver tests completed on the same sample
* Liver tests not drawn for normal method at same time as finger stick.

Primary outcomes:
measure: Regression curve and correlation coefficient
timeFrame: 1 year
Secondary outcomes:
measure: The consistent accuracy of the diagnostic device
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennslyvania
state: Pennsylvania
Study officials:
affiliation: Director of Inpatient Hepatology
name: Vandana Khungar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: