louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05770830: Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients
Official title: Correlation Between Esophageal Temperature and Skin Temperature Measured by 3M™ Bair Hugger™ in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Core Temperature
Trauma
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021

Brief summary: The goal of this retrospective data-based study is to investigate the correlation between esophageal temperature and skin core temperature in trauma patients who underwent emergency surgery.

Based on the medical records of patients who applied both temperature measurements simultaneously, the correlation between the skin core temperature and the esophageal temperature was investigated

Detailed description: Hypothermia is known to be one of the factors that increase mortality rate in trauma patients. Therefore it is important to measure and manage the core temperature in trauma patients.

Esophageal temperature is common method to measure core temperature in patients undergoing surgery under general anesthesia. However, it is not applicable in patients who have not been intubated or in patients with suspected esophageal damage. In addition, esophageal temperature probe is twisted in the mouth and does not reflect core temperature properly.

3M™ Bair Hugger™ temperature monitoring system was developed to measure the core temperature by attaching to the skin using zero heat flow mechanism. It is simple to apply, and available at the trauma scene.

Previous studies have reported that skin core temperature reflects core temperature well, but no studies have been conducted on trauma patients with rapid changes in the core temperature and poor perfusion state.

This retrospective data-based study investigate the medical records of trauma patients who underwent emergency surgery. Patients who applied two temperature measurements at the same time were targeted. Since this center has the system that automatically transfer the hemodynamic data of the monitor to the anesthesia record, the investigators use the anesthesia records.

Eligibility criteria: Inclusion Criteria:

* Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021
* Who applied both a esophageal thermometer and a 3M™ Bair Hugger™ temperature monitoring system at the same time

Exclusion Criteria:

* When more than half of the data is missing

Primary outcomes:
measure: accuracy
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00257530: Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Official title: Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Drugs for Neglected Diseases
Sponsor class: OTHER
First posted: 2005-11-23
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.


Eligibility criteria: Inclusion Criteria:

* Males/Females between 5 and 65 yrs
* CL diagnosis confirmed
* \>4 weeks time disease
* no prior anti-leishmanial therapy for CL
* negative pregnancy test
* informed written consent or parent consent for \<18yrs patients

Exclusion Criteria:

* \>25cm2 lesion(s)
* \>6 cutaneous lesions
* mucosal lesion
* previous exposure to Imiquimod or anti-leish treatment
* participation in another protocol within 30 days prior study
* other acute or chronic illness / medication that may interfere
* significant psychiatric illness
* anaphylaxis or severe allergic reaction to proposed drugs
* patients unlikely to cooperate
* concomitant infection
* pregnancy or breast feeding

Primary outcomes:
measure: Time to healing
measure: Reduction of scaring
Secondary outcomes:
measure: Safety (measured by AE reporting) during treatment and follow up to 12 months
Other outcomes:
Locations:
city: Cusco
country: Peru
facility: UPCH
city: Lima
country: Peru
facility: IMT Alexander Von Humboldt
Study officials:
affiliation: Drugs for Neglected Diseases initiative
name: Catherine Royce, Dr
role: STUDY_CHAIR
References:
citation: Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491. doi: 10.1371/journal.pntd.0000491.
Clinical trial NCT01634230: Emergency Use of OCR-002 in Acute Liver Failure (ALF)
Official title: Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Acute Liver Failure
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2012-07-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.

Detailed description: This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.

Eligibility criteria: Inclusion Criteria:

* International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
* Venous ammonia level of ≥ 100 μmol/L

Exclusion Criteria:

* Patients who are pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: Ocera Therapeutics
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT03377530: Contamination of Bacillus Species Sepsis.
Official title: Contamination of Bacillus Species Sepsis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacillus Cereus Infection
Keywords: Bacillus Cereus
Premature neonates
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 11
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns infected with Bacillus Species.

Brief summary: Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant. However, Bacillus Species can cause severe systemic infections in immunocompromised patients including preterm infants.

The purpose of this study is to identify the risk factors of these infections.

Detailed description: Non-anthrax Bacillus Species bacteria can be responsible for food poisoning and local infections. Rarely, they lead to severe infections like blood stream infections and meningitis especially in immunocompromised patients like preterm infants.

Bacillus Cereus is the most common members of the genus Bacillus. Only few reports studied these systemic infections in premature neonates. In order to identify the risk factors for severe Bacillus Species infections, we studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature.

Eligibility criteria: Inclusion Criteria:

* cases of Bacillus Species sepsis
* cases of Bacillus species meningitis
* with significant change in clinical status
* Bacillus Species is the only organism isolated

Exclusion Criteria:

* Bacillus Species isolated with other organisms and Bacillus Species without clinical change were considered to be contaminants

Primary outcomes:
measure: Severe infection rate due to Bacillus Sp germ
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: To collecte the incriminated modes of contamination.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital NOVO
name: Mohamed Amine YANGUI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03915730: Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy
Official title: The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Keywords: Chronic periodontitis
gingival crevicular fluid
initial periodontal therapy
peptidoglycan recognition proteins
smoking
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 80
Minimum age (years): 22
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40 periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80 subjects, were included in this study. Baseline GCF samples were obtained from all subjects and clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had received initial periodontal therapy, GCF samples were obtained and all clinical periodontal measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by enzyme-linked immunosorbent assay.

Detailed description: Peptidoglycan recognition proteins (PGRPs) are one of the antimicrobial peptides that play a role in innate immunity and act against the bacterial cell wall. Smoking is the most important environmental risk factor for periodontitis. This study determined the effect of smoking on PGRP-1 levels in gingival crevicular fluid (GCF) in smokers and nonsmokers with chronic periodontitis (CP) following initial periodontal therapy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of severe chronic periodontitis
* Clinical diagnosis of periodontal health

Exclusion Criteria:

* have any systemic disease,
* to be alcohol consumer,
* to receive any periodontal therapy in the past 6 months,
* to take any drugs regularly
* to be pregnant and/or lactate.

Primary outcomes:
measure: Change in peptidoglycan recognition protein-1
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in periodontal clinical parameter
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03252730: In-Use Test With a Cosmetic Product
Official title: In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Dry scalp
Itchy scalp
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: SIT Skin Investigation and Technology Hamburg GmbH
First posted: 2017-08-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.


Eligibility criteria: Inclusion Criteria:

* age: ≥ 18 years
* sex: approx. 50% male and approx. 50% female
* users of hair tonic for dry scalp
* dry, itchy scalp prone to atopic eczema / atopic dermatitis

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* users of sour hair rinse
* subjects who wash their hair more than once a day
* other dermatological disorders (scars, moles) on the scalp
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study
* systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study
* systemic illness of the subject at the beginning of the study
* pregnancy and period of breastfeeding

Primary outcomes:
measure: Tolerance of the Test Product on the Scalp
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Skin Hydration of the Scalp
timeFrame: before product treatment; after 2 and 4 weeks of treatment
measure: Performance of the Test Product
timeFrame: after 4 weeks of treatment
measure: Tolerance of the Test Product on the Scalp
timeFrame: after 2 weeks of treatment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: SIT Skin Investigation and Technology Hamburg GmbH
Study officials:
affiliation: SIT Skin Investigation and Technology Hamburg GmbH
name: Mona Mazinani, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03658330: Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Official title: Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Alcohol Use Disorder
Keywords: Ketamine
Naltrexone
Depression
Alcohol
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2018-09-05
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

Detailed description: The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 21-65 years old
2. Current major depressive disorder without psychotic features by DSM-5
3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
4. Current alcohol use disorder by DSM-5
5. Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
6. Abstinence from alcohol drinking for \> 5 days prior to ketamine infusion
7. Able to provide written informed consent

Exclusion Criteria:

1. Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
2. Current or past history of psychotic features or psychotic disorder
3. Current or past history of delirium or dementia
4. Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
5. Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
6. Imminent suicidal or homicidal risk
7. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
8. Positive opioid or illicit drug screen test (except marijuana)
9. Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
10. Liver enzymes that are three times higher than the upper limit of normal

Primary outcomes:
measure: Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Day 21
Secondary outcomes:
measure: Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: Day 21
Other outcomes:
Locations:
Study officials:
affiliation: VA Connecticut Healthcare System
name: Gihyun Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03543930: Physiologic Effects of CPAP After Vascular Surgery
Official title: Physiologic Effects of CPAP After Vascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Respiratory Failure
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach

Brief summary: This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.


Eligibility criteria: Inclusion Criteria:

* Open or endovascular surgery on the abdominal aorta
* Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
* Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)

Exclusion Criteria:

* Prolonged post-operative invasive ventilation
* Invasive or non-invasive ventilation or oxygen therapy in the last month
* ASA class IV or V
* Emergency procedures
* Pneumothorax or active pulmonary infection
* Any contraindication to CPAP
* Prolonged bed rest
* Patient refusal to participate or to receive preventive CPAP

Primary outcomes:
measure: PaO2/FIO2 ratio
timeFrame: Two hours after the administration of CPAP
Secondary outcomes:
measure: Esophageal pressure-time product (PTPes)
timeFrame: Two hours after the administration of CPAP
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Policlinico San Martino
Study officials:
affiliation: Università degli Studi di Genova
name: Lorenzo Ball, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04256330: Cardiometabolic Health and Inflammatory Resolution
Official title: Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Volunteers
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are recruited either via open adds of after having indicated in previous study registers that they are interested in participating as volunteers in future studies.

Brief summary: The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (\>30.0 kg/m2).


Eligibility criteria: Inclusion Criteria:

* Informed signed consent has been obtained from the volunteer.
* The volunteer has a BMI greater than 18.5 kg/m2

Exclusion Criteria:

* The study staff contacting a potential participant perceives that the individual has difficulty understanding the information.
* An MD determines that the individual is on too many medications to participate
* The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw.
* The individual is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts)
* The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
* The individual has some form of chronic inflammation.
* The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin).
* The individual uses immunosuppressive drugs (eg, methotrexate).
* The individual regularly consumes fish oils (omega 3).
* The individual has significant gastrointestinal problems.
* The individual smokes or uses chewing tobacco.
* The individual has been drinking alcohol two days before the study visit.
* The individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination.
* The individual does not follow instructions given in the research study.

Primary outcomes:
measure: Inflammatory status
timeFrame: 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg university
state: Vastra Gotaland
Study officials:
References: