louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05982639: Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
Official title: Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thoracic Diseases
Surgery
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is:

• Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure? Participants will be divided in the classic one lung ventilation or two lung ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will be measured after procedures.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
* Written consent to participate

Exclusion Criteria:

* Pregnant women;
* Patients on mechanical ventilation prior to the procedure;
* Patients classified by the American Society of Anesthesiology (ASA) as class 4;
* Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the two pulmonary technique is superior;
* Impossibility of using a double-lumen tube or difficult intubation;
* Patient does not support one-lung ventilation;
* Patient with previous lung resection surgery

Primary outcomes:
measure: Bronchoalveolar lavage fluid (BALF) levels of IL-6
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
Secondary outcomes:
measure: Bronchoalveolar lavage fluid (BALF) levels of IL-8
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
measure: Bronchoalveolar lavage fluid (BALF) levels of IL-1
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
measure: Bronchoalveolar lavage fluid (BALF) levels of TNF
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
measure: Bronchoalveolar lavage fluid (BALF) levels of oxidative stress
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
measure: Post-procedure pulmonary complications
timeFrame: Until hospital discharge
measure: Systemic levels of inflammatory and oxidative markers
timeFrame: at a maximum 2 hours after the end of the thoracic procedure
Other outcomes:
Locations:
city: Brusque
country: Brazil
facility: Hospital Azambuja
state: Santa Catarina
Study officials:
affiliation: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
name: Eduardo Balleter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04964739: Gender/Sex & CUD Remission
Official title: Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cannabis Use Disorder, Mild
Cannabis Use Disorder, Moderate
Cannabis Use Disorder, Severe
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-07-16
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.


Eligibility criteria: Inclusion Criteria:

1. Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care).
2. Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder.
3. Submit a positive urine cannabinoid test during screening.
4. Interested in treatment for cannabis use disorder.

Exclusion Criteria:

1. Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation.
2. The presence of any substance use disorder requiring a higher level of care.
3. Significant risk of homicide or suicide.
4. Pregnant, trying to become pregnant, or breastfeeding.

Primary outcomes:
measure: Proportion of participants in remission
timeFrame: Week 4
measure: Proportion of participants in remission
timeFrame: Week 8
measure: Proportion of participants in remission
timeFrame: Week 12
measure: Proportion of participants in remission
timeFrame: Week 16
measure: Proportion of participants in remission
timeFrame: Week 20
measure: Reduction in cannabis use days
timeFrame: 8 weeks of treatment
measure: Reduction in cannabis use episodes
timeFrame: 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Rachel L Tomko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Aimee L McRae-Clark, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04620122: Effects of Progressive Muscle Relaxation Training With Music Therapy on Sleep Quality and Trait Anger/Anger Expression Style of Patients at Community Mental Health Center
Official title: Adiyaman University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Anger
Psychiatric Disorder
Keywords: sleep quality
Anger
Psychiatric Disorder
therapy
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of the study was to examine the effects of progressive muscle relaxation training with music therapy on sleep quality, trait anger, and anger expression style of patients at the community mental health center.

Method: The study is conducted as the pretest-posttest control group design. The study population consisted of chronic psychiatric patients who continue in a Community Mental Health Center located in southeastern Turkey. The days when the participants came to the Community Mental Health Center were selected and the participants divided into two groups as an intervention and control group.


Eligibility criteria: Inclusion Criteria:

* Having a chronic psychiatric diagnosis according to DSM-V diagnostic criteria,
* Open and cooperate for communication,
* living in the city center,
* age was between 18-60

Exclusion Criteria:

* Patients who have just started the Community Mental Health Center
* patients diagnosed with axis 1,
* patients diagnosed with mental retardation,
* patients with drug or alcohol addiction,
* patients diagnosed with organic brain syndrome,

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 minutes
measure: The Trait Anger/Anger Expression Inventory
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Community Mental Health Center
Study officials:
References:
citation: Icel S, Basogul C. Effects of progressive muscle relaxation training with music therapy on sleep and anger of patients at Community Mental Health Center. Complement Ther Clin Pract. 2021 May;43:101338. doi: 10.1016/j.ctcp.2021.101338. Epub 2021 Feb 19.
Clinical trial NCT02119039: Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus
Official title: Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratoconus
Keywords: Cross-linking
RGTA OTR4120 (CACICOL20)
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies.

Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin.

The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Presence of keratoconus
* Scheduled for corneal cross linking
* No ophthalmic surgery in the 3 months preceding the study

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Topical use of aminoglycosid antibiotics
* Use of therapeutic or refractive contact lenses after surgery
* Known hypersensitivity to any component of the study medication or heparinoids or heparin
* Active ocular infection
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Time to closure of the epithelial wound
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
citation: Bata AM, Witkowska KJ, Wozniak PA, Fondi K, Schmidinger G, Pircher N, Szegedi S, Aranha Dos Santos V, Pantalon A, Werkmeister RM, Garhofer G, Schmetterer L, Schmidl D. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1169-1176. doi: 10.1001/jamaophthalmol.2016.3019.
Clinical trial NCT00564239: Psychological Prevention of Internalizing Disorders
Official title: Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Somatoform Symptoms
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg
name: Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
First posted: 2007-11-27
Enrollment: 77
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.

Detailed description: Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.

Eligibility criteria: Inclusion Criteria:

* age 8- 12 years and
* anxiety symptoms and/or
* depressive symptoms and/or
* somatoform symptoms

Exclusion Criteria:

* psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
* IQ \< 85

Primary outcomes:
measure: Child Behavior Checklist (german version)
timeFrame: 3, 6, 18 months
Secondary outcomes:
measure: Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
timeFrame: 3, 6, 18 months
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: 3, 6, 18 months
measure: Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
timeFrame: 3, 6, 18 months
measure: Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
timeFrame: 3, 6, 18 months
measure: Culture Fair Intelligence Test (CFT 20-R)
timeFrame: initially
measure: Symptom-Checklist (SCL-90-R), german version
timeFrame: 3, 6, 18 months
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Institut für Verhaltenstherapie und -medizin (IVV)
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Jan Pauschardt, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Sylvia D Eimecke, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Fritz Mattejat, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03624439: Duble Lumen Intubation
Official title: Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Intubation; Difficult or Failed
Difficult Airway
Keywords: double-lumen tube
ETView
medical simulation
anesthesiologist
difficult airway
Lead sponsor: Lazarski University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.


Eligibility criteria: Inclusion Criteria:

* anesthesiologist or a person in the course of specialization
* consent voluntary participation in the study

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: intubation time
timeFrame: 1 day
Secondary outcomes:
measure: time to visualize the glottis
timeFrame: 1 day
measure: success of the first intubation trial
timeFrame: 1 day
measure: overall success rate
timeFrame: 1 day
measure: the degree of visibility of the glottis
timeFrame: 1 day
measure: Cormack - Lehane grade
timeFrame: 1 day
measure: ease of use
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Faculty of Medicine, Lazarski University
state: Masovian
Study officials:
affiliation: Lazarski University
name: Lukasz Szarpak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Medical University
name: Jacek Smereka, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.
citation: Szarpak L, Kurowski A, Zasko P, Karczewska K, Czyzewski L, Bogdanski L, Adamczyk P, Truszewski Z. Double-lumen tube tracheal intubation in a manikin model using the VivaSight Double Lumen: a randomized controlled comparison with the Macintosh laryngoscope. Am J Emerg Med. 2016 Jan;34(1):103-4. doi: 10.1016/j.ajem.2015.10.018. Epub 2015 Oct 23. No abstract available.
Clinical trial NCT04113239: Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
Official title: Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Metagenome
Genetic Predisposition
Keywords: Gut Metagenetics
Diabetes Mellitus, Type 2
Genetics
Microbiome
FFQ
GPAQ
Lead sponsor: Atlas Biomed
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow

Brief summary: A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.

Detailed description: Two groups of people, one composed of healthy volunteers and the other of patients with incident type 2 diabetes mellitus who never received treatment for their condition, fill in the food frequency questionnaire and the physical activity questionnaire. DNA microarray genotyping is used to process the DNA samples of the participants. The data on the composition of the participants' gut microbiota is obtained through sequencing of their stool samples.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of incident type 2 diabetes mellitus

Exclusion Criteria:

* Hypoglycaemic therapy prescribed for the correction of any type of hyperglycaemia
* Diabetic ketoacidosis
* Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, coeliac disease)
* Rheumatoid arthritis
* Tuberculosis
* Acute gastrointestinal conditions
* Irritable bowel syndrome
* Multiple intestinal polyposis
* Gallstone disease
* Acute pancreatitis
* Oncological diseases
* Serious mental disorders
* Recent (\< 6 months) antimicrobial therapy
* Recent (\< 3 months) proton pump inhibitors therapy
* Recent (\< 3 months) surgical intervention
* Recent (\< 3 weeks) use of probiotics, prebiotics, antacids, nonsteroidal anti-inflammatory drugs
* Pregnancy or breastfeeding
* Current alcohol/drug abuse or addiction within 12 months prior to screening
* Planned relocation from the study area during the study
* Other somatic pathologies or any factors that prevent the inclusion in the study

Primary outcomes:
measure: HbA1C
timeFrame: Baseline
measure: Glucose
timeFrame: Baseline
measure: Gut microbiome composition of participants
timeFrame: Baseline
measure: Genotypes of participants
timeFrame: Baseline
Secondary outcomes:
measure: Physical activity questionnaire
timeFrame: Baseline
measure: Food frequency questionnaire
timeFrame: 12 months before baseline
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital V.P. Demikhova
Study officials:
References:
Clinical trial NCT02841839: A Study to Evaluate Sampling Methods for Subgingival Plaque
Official title: A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subgingival Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To identify a sampling method for collecting subgingival plaque


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent to participate in the study;
* Be 18 years of age or older;
* Agree not to participate in any other oral/dental product studies during the course of this study;
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
* Agree to use the acclimation toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening and Baseline Visit;
* Agree to use the treatment products and refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss, mouth rinse, or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Must have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
* Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have 10-20 bleeding sites; and
* Have minimum 6 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.

Exclusion Criteria:

* Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine;
* Need an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing hydrogen peroxide or stannous fluoride;
* A history of hypersensitivity to products containing sodium lauryl sulfate (SLS);
* Are pregnant (Self-reported) or lactating; or
* Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Primary outcomes:
measure: Subgingival plaque
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: