louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06494033: Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients
Official title: Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients: a Single Center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eurofins Viracor, LLC
First posted: 2024-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants attending the Miami Transplant Institute.

Brief summary: The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.


Eligibility criteria: Inclusion Criteria:

1. Adult patients over 18 years of age
2. Lung transplant candidates with positive CMV IgG
3. Anticipated to receive a lung transplant (both double lung and single lung)

Exclusion Criteria:

1. Negative CMV IgG prior transplant
2. Pregnant or breastfeeding women
3. HIV infected patients
4. Combined organ (e.g., lung-heart, lung-kidney) transplant candidates

Primary outcomes:
measure: Positive CMV Immunoglobulin (IgG) positive lung transplant
timeFrame: Up to 1 year
Secondary outcomes:
measure: Graft Outcome status
timeFrame: Up to 1 year
measure: Number of dead participants
timeFrame: Up to 1 year
measure: Duration of CMV medication
timeFrame: Up to 1 year
measure: Number of patients with CMV-positive results
timeFrame: Up to 1 year
measure: Severity of CMV Disease
timeFrame: Up to 1 year
measure: Severity of Torque Teno virus
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Yoichiro Natori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02518633: Obstructive Sleep Apnoea and Adipose Tissue Dysfunction
Official title: Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnoea
Obesity
Hypoxia
Keywords: obesity
hypoxia
adipose tissue
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2015-08-10
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with newly diagnosed obstructive sleep apnoea and controls

Brief summary: Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.

Detailed description: Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.

Eligibility criteria: Inclusion Criteria:

* men with or without obstructive sleep apnoea

Exclusion Criteria:

* weight loss interventions
* steroid use
* active smoking

Primary outcomes:
measure: pO2 in adipose tissue by Clarke type electrode
timeFrame: 4 months
Secondary outcomes:
measure: blood flow in adipose tissue by laser Doppler techniques
timeFrame: 4 months
Other outcomes:
measure: adipose tissue gene expression of HIF-1alpha
timeFrame: 4 months
Locations:
city: Exeter
country: United Kingdom
facility: NIHR Clinical Research Facility
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
Study officials:
affiliation: University of Exeter
name: Katarina Kos, FRCP,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorn CE, Knight B, Pastel E, McCulloch LJ, Patel B, Shore AC, Kos K. Adipose tissue is influenced by hypoxia of obstructive sleep apnea syndrome independent of obesity. Diabetes Metab. 2017 Jun;43(3):240-247. doi: 10.1016/j.diabet.2016.12.002. Epub 2017 Jan 26.
Clinical trial NCT00423033: Qualitative Analysis on the Experiences of Employment Among Schizophrenic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The aim of this search is to realize the subjective experiences of employment among schizophrenic patients by qualitative analysis. We plan to recruit 50 people diagnosed with schizophrenia and divide into two groups, employment and unemployment. Every subjects will complete the demographic data, the evaluation of severity of disease, the record of medication and an intensive interview about their employment experiences. Finally, we will analysis the thick descriptions to understand how schizophrenic patients interpret their employment experiences and which factors will affect their successful employment.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia
* \> high school

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Hsin-yen Wu, Master
role: STUDY_CHAIR
References:
Clinical trial NCT06813833: Transcriptomic Analysis and Optical Coherence Tomography Combined for Patients with Basal Cell Carcinoma
Official title: Image Markers and Transcriptome Profiles: an Exploratory Study of Optical Coherence Tomography and Tape Strips for Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Basal Cell Carcinomas
Keywords: Basal Cell Carcinoma
Optical Coherence Tomography
Transcriptomics
Tape strip
Skin Cancer
Keratinocyte Carcinoma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Department of Forensic Medicine, Section of Forensic Genetics, University of Copenhagen
First posted: 2025-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histology verified basal cell carcinoma

Brief summary: The goal of this observational study is to learn if tape strip for transcriptomic (RNA) analysis and optical coherence tomography (OCT) combined can optimize noninvasive management of basal cell carcinoma (BCC) patients.

The main question of the study is to examine if the combination of these two techniques, transcriptomic and OCT, can improve noninvasive detection of human BCCs.

All included patients will undergo 1) an OCT scan and 2) a tape strip collection for transcriptomic analysis from the same BCC.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years with clinical suspicious BCC for inclusion in the study and BCC histopathology diagnosis for inclusion in our analysis.

Exclusion Criteria:

* Patients with a BCC in areas not amenable to OCT (e.g., around the eye).

Primary outcomes:
measure: Association between tape strip and OCT
timeFrame: Single time point at baseline examination
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen, Denmark
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
Study officials:
affiliation: Department of Dermatology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark
name: Merete Haedersdal, Professor, MD, DMSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772733: A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment
Official title: A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Chronic Diseases
Keywords: Quality assurance
rehabilitation
chronic care model
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 936
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed patients with COPD, verified by spirometry in general practise and/or municipalities.

Brief summary: The purpose of this study is to ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. If relevant the general practitioner (GP) will refer patients to COPD rehabilitation conducted by relevant municipality rehabilitation teams. Secondarily the purpose is to improve collaboration and communication between the local hospital pulmonologist, GPs and the municipality rehabilitation team


Eligibility criteria: Inclusion Criteria:

* COPD diagnose, verified by spirometry
* Having given informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Control visits at General practitioners
timeFrame: 6-12 months
measure: Lung function measured by spirometry
timeFrame: 6-12 months
Secondary outcomes:
measure: Dyspnoea on MRC scale
timeFrame: 6-12 months
measure: Smoking status
timeFrame: 6-12 months
measure: Rehabilitation completed in the municipality rehabilitation team
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Bjerringbro
country: Denmark
facility: Research Site
state: Viborg
city: Moldrup
country: Denmark
facility: Research Site
state: Viborg
city: Skals
country: Denmark
facility: Research Site
state: Viborg
city: Aalborg
country: Denmark
facility: Research Site
city: Arhus
country: Denmark
facility: Research Site
city: Klarup
country: Denmark
facility: Research Site
city: Orum
country: Denmark
facility: Research Site
city: Skive
country: Denmark
facility: Research Site
city: Spottrup
country: Denmark
facility: Research Site
city: Stoholm
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
Study officials:
affiliation: Region Hospital Viborg, DK
name: Michael Skov Jensen, MD
role: STUDY_CHAIR
affiliation: Region Hospital Horsens, DK
name: Tina Brandt Sorensen, MD
role: STUDY_CHAIR
affiliation: Aalborg
name: Ove Grann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05860933: A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole
timeFrame: Predose on day 1 up to 72 hours postdose on day 9
measure: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole
timeFrame: Predose on day 1 up to 72 hours postdose on day 9
measure: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole
timeFrame: Predose on day 1 up to 72 hours postdose on day 9
measure: PK: Cmax of LY3537982 administered with or without carbamazepine
timeFrame: Predose on day 1 up to 72 hours postdose on day 13
measure: PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
timeFrame: Predose on day 1 up to 72 hours postdose on day 13
measure: PK: AUClast of LY3537982 administered with or without carbamazepine
timeFrame: Predose on day 1 up to 72 hours postdose on day 13
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Development Services
state: Texas
city: Salt Lake City
country: United States
facility: ICON Early Development Services
state: Utah
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06958133: Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures
Official title: The Effects of Postoperative Kinesio Taping on Pain, Range of Motion, and Edema in Weber Type B Lateral Malleolar Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Syndesmotic Injuries
Postoperative Rehabilitation
Keywords: ankle fractures, kinesiology
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aimed to evaluate the effects of postoperative Kinesio taping on pain, range of motion, and edema in patients undergoing surgical fixation for Weber type B lateral malleolar fractures.

Detailed description: Patients with Weber type B lateral malleolar fractures treated surgically were randomized into two groups: a control group receiving standard rehabilitation and an intervention group receiving additional Kinesio taping. Outcomes assessed included visual analog scale (VAS) pain scores, dorsiflexion range of motion, and circumferential edema measurements at 1, 7, and 28 days postoperatively.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Patients diagnosed with isolated Weber type B lateral malleolar fractures requiring surgical fixation
* Surgery performed within 7 days of injury
* Written informed consent provided

Exclusion Criteria:

* Open fractures
* Associated fractures of the medial or posterior malleolus requiring fixation
* Polytrauma patients
* History of previous ankle fractures or surgeries on the affected side
* Neurological or vascular compromise of the affected limb
* Known allergy to adhesive materials

Primary outcomes:
measure: Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively
timeFrame: 28 days
Secondary outcomes:
measure: Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.
timeFrame: 28 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
state: Ataşehir
Study officials:
References:
Clinical trial NCT03604133: Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Official title: Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia
Lead sponsor: QuesGen Systems Inc
Sponsor class: OTHER
Collaborators: name: Cardio Surgical Partners
First posted: 2018-07-27
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who require ICD to maintain optimal health.

Brief summary: The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.


Eligibility criteria: Inclusion Criteria:

* Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Successful Implantation
timeFrame: Two-week follow-up assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Lehi
country: United States
facility: Cardio Surgical Partners, LLC
state: Utah
Study officials:
References:
Clinical trial NCT04638933: Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA
Official title: Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Exhaled breath analysis
Mass spectrometry
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS \>10, age ≥18 years) and initiation of CPAP treatment

Brief summary: Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed OSA (AHI ≥20/h)
* Patient is willing to start CPAP therapy
* ESS \> 10 points
* 18 years or above

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Use of oxygen therapy or home ventilation
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR \< 15 mL/min)
* Pregnant patients

Primary outcomes:
measure: Exhaled breath pattern
timeFrame: twice during 1 month
Secondary outcomes:
measure: OSA severity parameter
timeFrame: twice during 1 month
measure: Vital signs
timeFrame: twice during 1 month
measure: Sleepiness
timeFrame: twice during 1 month
measure: Spirometry
timeFrame: twice during 1 month
measure: CPAP therapy
timeFrame: twice during 1 month
measure: Therapy feedback
timeFrame: twice during 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT05910333: Four Locator Attachment Mandibular Overdentures
Official title: Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Resorption
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients in each group. total number of patients 20.

Brief summary: . There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Detailed description: Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Eligibility criteria: Inclusion Criteria:

* Patients with 4 implants in the inter-foraminal region.
* Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
* Edentulous maxilla and mandible for at least 1 year.
* Problems with retention and stability of the mandibular denture.
* Mandibular bone height between 15 and 25 mm.

Exclusion Criteria:

* Patients with relative contraindications, such as
* A history of para functional habits.
* Smokers more than 10 cigarettes per day.
* alcoholism.
* Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.

Primary outcomes:
measure: Posterior mandibular ridge resorption (PMandRR)
timeFrame: 10 years retrospective study
Secondary outcomes:
measure: Anterior maxillary ridge resorption (AMaxRR)
timeFrame: 10 years
Other outcomes:
measure: Crestal bone loss around implants
timeFrame: 10 years
Locations:
city: Multiple Locations
country: Egypt
facility: Mohammed El Sawy
Study officials:
affiliation: Mansoura University
name: Mohammed E Sawy
role: STUDY_DIRECTOR
References: