louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06413459: Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
Official title: Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Tuberculous Mycobacterial Pneumonia
Cystic Fibrosis Lung
Keywords: scRNASec
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2024-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cystic fibrosis

Brief summary: In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M. abscessus lung disease in patients suffering from cystic fibrosis with the aim of increasing current knowledge available on the development and progression of lung disease.

Detailed description: Main objective:

Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis.

Secondary objectives

* Identify cellular expression profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Identify biomarkers or molecular profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Expand pathogenetic knowledge to support disease progression pulmonary disease from M. abscessus in patients with cystic fibrosis and evaluate their ability to predict clinical outcome.
* Describe the reciprocal interactions between cellular and humoral components of the response inflammatory disease during M. abscessus infection with/without M. abscessus lung disease.

Eligibility criteria: Inclusion Criteria:

* Patients with a certain diagnosis of cystic fibrosis and visited during normal clinical practice, in accordance with the standard operating procedures in force at the Centres.
* Both sexes
* Age \>18 years
* Obtaining informed consent for patients (based on the procedures established by the protocol).

Exclusion Criteria:

* Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.

Primary outcomes:
measure: profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CF
timeFrame: One month after enrollment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
state: MI
Study officials:
References:
Clinical trial NCT01511159: Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
Official title: A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.


Eligibility criteria: Inclusion Criteria:

* No clinically important abnormal physical findings
* No clinically relevant abnormalities in the results of laboratory screening evaluation
* Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
* Normal (or abnormal but not clinically significant) blood pressure and heart rate
* Body Mass Index (BMI) between 20-30 kg/m\^2 or outwith range but not clinically significant
* Non-smoker
* Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
* FVC ratio at least 75% of predicted normal for age, gender and height

Exclusion Criteria:

* A clinically significant illness or infection requiring treatment within the last two months
* Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
* Subjects with first and/or second degree relative(s) with diabetes mellitus
* Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
* Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
* Current addiction to alcohol or substances of abuse
* Females
* Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies

Primary outcomes:
measure: Ratio of the areas under the plasma NN 90-1170 curves
Secondary outcomes:
measure: The maximum concentration (Cmax)
measure: The time to maximum concentration (tmax)
measure: Mean residence time (MRT)
measure: Area under the curve
measure: Terminal rate constant
measure: Adverse events
Other outcomes:
Locations:
city: Tranent
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01089959: Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD
Official title: The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With Gastroesophageal Reflux Disease (GERD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Acid re-flux,GERD
sleep related arousals due to GERD
Treatment of acid reflux during sleep in patients with GERD.
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
First posted: 2010-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.

Detailed description: Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered.

Subjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.

Eligibility criteria: Inclusion Criteria:

* Nocturnal symptoms at least twice a week.
* Ages 18-80
* Erosive esophagitis and/or abnormal pH test -
* Able to read, understand, and complete study questionnaires

Exclusion Criteria:

* Subjects with Barrett's esophagus or peptic stricture on endoscopy
* Subjects with normal endoscopy and pH test
* Subjects with previous upper gastrointestinal surgery

Primary outcomes:
measure: The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
Study officials:
affiliation: SAVAHCS
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483859: Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
Official title: Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Malignancy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS). Although recent advances in surgical techniques and perioperative management have made with established perioperative management have now made it possible to perform hepatectomies as a safe procedure with minimum mortality, the possibility of massive blood loss and resultant transfusion during hepatectomy still exist. The objective of this research was to identify the role of liver stiffness measurement for the prediction of intraoperative blood loss and postoperative recovery after elective right hepatectomy.


Eligibility criteria: Inclusion Criteria:

* patients undergoing right hepatectomy between August 2007 and July 2011

Exclusion Criteria:

* patients undergoing right hepatectomy without preoperative liver stiffness measurement

Primary outcomes:
measure: The correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy
timeFrame: Participants will be followed for perioperative period, approximate 6 weeks through chart review.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT06739759: Ovarian Hyperstimulation Syndrome Prevention
Official title: Prophylaxis Against Ovarian Hyperstimulation Syndrome in PCOS Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Hyper Stimulation Syndrome (OHSS)
Keywords: OHSS
mild
Moderate
Severe
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ovarian hyperstimulation is a very hazardous complication of ICSI

Detailed description: Ovarian hyperstimulation could be mild , moderate , severe or marked

Eligibility criteria: Inclusion Criteria:

* Women with PCOS coming for ICSI

Exclusion Criteria:

* Women who donnot have PCOS

Primary outcomes:
measure: prevention of OHSS
timeFrame: within 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeerah hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Aljazeera Hospital
name: Mahmoud Alalfy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01030159: National Cancer Institute Thai Cancer Anemia Survey
Official title: Anemia Survey in Cancer Patients Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Cancer
Keywords: Cancer Anemia Survey
Thai National Cancer Institute
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anemic patients with cancer receiving chemotherapy

Brief summary: The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Detailed description: Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

Eligibility criteria: Inclusion Criteria:

* Patients with cancer

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of patients that have anemia during cancer therapy
timeFrame: 6 months
Secondary outcomes:
measure: Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04213859: Emotional Processes in VR Exposure Treatment for Flight Phobia
Official title: Emotional Processes During a Randomized Controlled Trial of Virtual Reality Exposure Treatment for Flight Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Flying
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 84
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: This study will assess emotional processes and their relation to treatment outcomes during Virtual reality exposure therapy for Flight Phobia. The researchers hypothesize treatment outcomes will be associated with positive changes in emotional constructs

Detailed description: Emotional constructs and emotion regulation capacities play a central role in the severity of anxiety disorders and are directly related to treatment outcomes in different anxiety disorders. In this study we will examine the relation between positive and negative affect, emotion regulation, emotional instability, emotional differentiation, experiential avoidance and therapy outcomes in participants undergoing Virtual Reality Exposure Therapy for Flight Phobia. We assume that treatment outcomes will be positively related to changes in the regulation, management and experience of emotions.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Flight phobia based on a structured interview
* possession of a smartphone with an active data plan

Exclusion Criteria:

* cardiovascular disease
* neurological disorders and history of epilepsy
* psychosis
* major depression
* suicidal behavior
* substance abuse.

Primary outcomes:
measure: Changes in FAS (Flight Anxiety Situations Questionnaire) scores
timeFrame: Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks)
measure: Changes in FAM (Flight Anxiety Modality questionnaire) scores
timeFrame: Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Asaf Caspi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021759: Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
Official title: Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 4774
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.

Detailed description: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.

Eligibility criteria: Inclusion Criteria:

* Patient has a primary care physician at University of Pennsylvania Health System
* Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record

Exclusion Criteria:

* Patient has an allergy or adverse reaction to statins documented in the electronic health record
* Patient has glomerular filtration rate less than 30 mL/min
* Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin

Primary outcomes:
measure: Statin Prescribing Rate
timeFrame: Two Months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.
Clinical trial NCT06761859: Aromatherapy Inhalation in Psychiatric Nurses
Official title: The Effect of Aromatherapy Inhalation on the Therapeutic Relationship and Work Stress Levels of Psychiatric Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatherapy
Keywords: Psychiatric nursing
inhalation
aromatherapy
therapeutic relationship
work stress
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Çankırı Karatekin University
First posted: 2025-01-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study will be conducted with a total of 66 psychiatric nurses who meet the inclusion and exclusion criteria and are working at Ankara Etlik City Hospital Psychiatry Clinic between January 1, 2025 and March 31, 2025.

Detailed description: In this study, aromatherapy inhalation will be applied to psychiatric nurses in the experimental group. Aromatherapy inhalation using 2% diluted lavender essential oil will be applied to 33 psychiatric nurses in the experimental group, 30 minutes before starting work, every other day during a week. The "General Job Stress Scale (GJSS)" and "Therapeutic Relationship Evaluation Scale-Nurse Form (TRES-NF)" inventories will be filled out by 33 psychiatric nurses in the experimental group before and after aromatherapy inhalation, and by 33 psychiatric nurses in the control group simultaneously with the psychiatric nurses in the experimental group.

Eligibility criteria: Inclusion Criteria:

* Written permission was obtained before participating in the study
* Having worked in the psychiatry departments of the relevant institution for at least 1 year
* Working in the psychiatry departments of the relevant institution during the study dates
* Not sensitive to the odor of lavender essential oil

Exclusion Criteria:

* Previous experience with aromatherapy
* Sensitivity and allergy to lavender essential oil
* Willingly leaving the study while the study was ongoing
* Leaving the job during the study period
* General condition changes during the study period (developing allergies, getting sick, taking annual leave, taking leave with a health report)
* Becoming a service responsible nurse

Primary outcomes:
measure: General Job Stress Scale (GJSS)
timeFrame: Change from before implementation, after practice is completed (1th week)
measure: Therapeutic Relationship Evaluation Scale-Nurse Form (TRES-NF)
timeFrame: Change from before implementation, after practice is completed (1th week)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
References: