louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06831890: Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data
Official title: Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data - A Cross-sectional Study in Apparently Healthy Women Aged 40 to 69 Years (Frauenherzen)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Menopause
Keywords: Menopause
Cardiovascular disease risk
Wearables
SCORE2
Health monitoring
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include women aged 40 to 69 years who meet the inclusion and exclusion criteria.

Brief summary: The goal of the clinical trial is to assess whether the data collected from wearable devices can reduce the uncertainty in predicting the cardiovascular disease (CVD) risk in women aged 40-69 years in a situation where information about the blood pressure and blood lipids are unavailable.

Participants will:

* Complete a screening and baseline assessment, including blood sample collection and vital parameter measurement.
* Wear a wearable device for one week.
* Fill in a work and sleep journal.
* Complete a last visit assessment.


Eligibility criteria: Inclusion Criteria:

* Fluency in German (written and oral).
* Ownership of a smartphone.
* Signing the informed consent form.

Exclusion Criteria:

* Diagnosis of cardiovascular disease.
* Diagnosis of diabetes mellitus.
* Diagnosis of chronic kidney disease.
* Diagnosis of familial hypercholesterolemia.
* Incapable of providing informed consent.
* Current employment at the Section Gynecological Endocrinology and Reproductive Medicine of the Department for Obstetrics and Gynecology at the Inselspital Bern or any other professional relation to one of the study project leaders / investigators.
* Concurrent participation in a clinical intervention study.
* Inability to comply with the study procedures for any reason, including language comprehension, psychiatric illness, general inability to get to the study site.
* Participant's smartphone not compatible with Fitrockr.
* Technical inability of participant's smartphone to connect to the smartwatch.

Primary outcomes:
measure: Reduction in CVD Risk Prediction Uncertainty Using Wearable Data
timeFrame: After 7-day wearable data collection period.
Secondary outcomes:
measure: Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs
timeFrame: After 7-day wearable data collection period.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Study officials:
affiliation: University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
name: Petra Stute, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212090: Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Official title: Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is being conducted to assess measurement correlations on different X-ray views on patients who have undergone or will undergo hip reconstruction surgery.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent.
* 40 patients: 20 preoperative THA, 20 postoperative THA;
* Sex: 20 men, 20 women;
* Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA.

Primary outcomes:
measure: Change in pelvic incidence (PI)
timeFrame: Baseline, 8 hours, 4 weeks
measure: Change in symphysis to sacrococcygeal junction distance (PSCD)
timeFrame: Baseline, 8 hours, 4 weeks
measure: Change in pelvic tilt (PT)
timeFrame: Baseline, 8 hours, 4 weeks
measure: Change in sacral slope (SS)
timeFrame: Baseline, 8 hours, 4 weeks
measure: Change in lumbar lordosis (LL)
timeFrame: Baseline, 8 hours, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Abdel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02712190: Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
Official title: Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-invasive Ventilation
High-frequency Ventilation
Healthy Volunteer
Lung Diseases
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.

Detailed description: High frequency ventilation (HF-V) allows to ensure oxygen delivery and carbon dioxide clearance despite the absence of thoracic movement in anesthetized, invasively ventilated subjects. This same technique could be applied by a non-invasive interface (HF-NIV), allowing to obtain a prolonged apnea (absence of thoraco-abdominal respiratory movements) in awaken subjects. Such an application would be of interest for several clinical applications, e.g. lung imaging and radio-therapy treatment on lung cancer. The purpose of the study is to assess the effect of different HF-NIV setting on the apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung diseases.

Eligibility criteria: Inclusion Criteria:

* healthy subjets : normal respiratory function and no known lung disease
* lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
* age \>=18y

Exclusion Criteria:

* increased pneumothorax risk under positive pressure ventilation
* pregnancy

Primary outcomes:
measure: Duration of apnea
timeFrame: 1 study session (2 hours)
Secondary outcomes:
measure: Transcutaneous carbon dioxide partial pressure
timeFrame: 1 study session (2 hours)
measure: Oxygen saturation of arterial blood
timeFrame: 1 study session (2 hours)
measure: Lung volume
timeFrame: 1 study session (2 hours)
measure: Subjective tolerance
timeFrame: 1 study session (2 hours)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service de Pneumologie - Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Service de Pneumologie - CHUV
name: Alban Lovis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00034190: Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma
Official title: A Phase IIa Multicenter Evaluation of The Safety And Efficacy of Weekly Administration of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment of Patients With Stage III or IV Colorectal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Adenocarcinoma
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
First posted: 2002-04-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV colorectal adenocarcinoma.

Detailed description: The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Eligibility criteria: Inclusion Criteria:

Histologic diagnosis of colorectal adenocarcinoma

Stage III or IV (Dukes's stage C or D)

One and only one prior cytotoxic chemotherapy regimen which must have included 5-FU

Adult (18 years of age or older) patients

Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)

Serum creatinine less than 2.0 mg/dL

Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values

ECOG performance status of 0 - 2

Bidimensional measurable disease

Patients who have signed an IRB / Ethics Committee approved informed consent

Life expectancy at least 12 weeks

Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)

Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)

Females who are pregnant or lactating

Patients with peripheral neuropathy NCI-CTC grade 2 or greater

Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry

Patients who have had an investigational agent within 4 weeks of study entry

Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes

Primary outcomes:
measure: Determine the Objective Response Rate
timeFrame: When all patients have completed treatment
Secondary outcomes:
measure: To determine time to disease progression
timeFrame: When all patients have completed treatment
Other outcomes:
Locations:
city: 3 Cities
country: Russian Federation
facility: 5 Clinical Sites
Study officials:
References:
Clinical trial NCT00639990: Respiratory Mechanics in Brain Injured Patients
Official title: Effects of PEEP in Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injury
Acute Lung Injury
Keywords: Intraabdominal pressure
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients.

Detailed description: We investigate the mechanical properties of the respiratory system, partitioned into its lung and chest wall components, the functional residual capacity, the gas-exchange and alveolar recruitment in brain injured patients.

The measurements will be performed under sedation at different levels of PEEP. The following groups will be included: a) control patients withot lung injury and brain injury; b) brain injured patients without lung injury within the first 72 hours; c) brain injured patients without lung injury after 72 hours; d) brain injured patients with lung injury. Brain injury was defined as primary or secondary. Respiratory functional data will be related to intra-abdominal pressure.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* Age \> 18 yrs
* Mechanical ventilation
* No smoker
* No lung injury at entry
* Brain injury (traumatic or postoperative or spontaneous bleeding) in brain injury group

Exclusion Criteria:

* Pregnancy
* Hemodynamic instability
* Immunodepression

Primary outcomes:
measure: Improvement of respiratory function with PEEP
timeFrame: 30 min
Secondary outcomes:
measure: Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
timeFrame: 30 min
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
Study officials:
affiliation: University of Insubria, Varese
name: Paolo Pelosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522090: Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts
Official title: Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Supraclavicular Lymphadenopathy
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
Collaborators: name: University Hospital Plymouth NHS Trust
First posted: 2018-05-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients initially seen with suspected lung cancer

Brief summary: This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it improves the detection of cervical lymph nodes involvement by lung cancer.

Detailed description: Two practices currently exist regarding the role of lower neck CT in patients with suspected lung cancer but with little evidence for either. Routine lower neck CT is potentially associated with benefits of higher detection of neck lymphadenopathy leading to better staging, less invasive procedure with positive implications for patients experience and care. The potential harms are delay in diagnosis due to false positive findings and radiation exposure. There is limited evidence in this area so this study will potentially provide evidence to inform health policy decisions based on the risk benefit balance.

This is a retrospective comparative study to assess the real-life impact of routine lower neck CT on the diagnostic and staging work up of patients with suspected lung cancer across two cohorts.

Eligibility criteria: Inclusion Criteria:

* Male or female age \> 18 years
* Pathologically confirmed primary lung cancer
* Intrathoracic N2 and or N3 disease on CT defined as lymph node with short diameter \> 10 mm

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of pathologically confirmed malignant supraclavicular lymph node
timeFrame: 60 days from initial CT
Secondary outcomes:
measure: Number of diagnostic procedures performed per patient
timeFrame: 60 days from initial CT Thorax
measure: Proportion of patients who underwent more than one diagnostic procedures
timeFrame: 60 days from initial CT Thorax
measure: Proportion of patients who underwent Endobronchial Ultrasound (EBUS)
timeFrame: 60 days from initial CT Thorax
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06491290: Modelling of Correlation Between Emergency Department Admissions and Location-specific Air Quality and Weather in the Florence Urban Area
Official title: Modelling of Correlation Between Emergency Department Admissions and Location-specific Air Quality and Weather in the Florence Urban Area
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergency Service, Hospital
Air Pollution
Weather
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 480000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of consecutive patients presenting to the Emergency Departments (ED) of the participating hospital.

Brief summary: The goal of this observational study is to evaluate the impact of primary air pollutants and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

Detailed description: This is a retrospective, single-center, observational cohort study aimed at investigate the impact of primary air pollutant concentrations and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

Anonymous data for each individual ED visit is retrieved from the hospital medical record. The daily concentrations of PM2.5, PM10, NO2, SO2 and O3 and the levels of atmospheric pressure, humidity and temperature are recorded by stations of the dedicated local agencies. The relationship between ED daily visits and pollutant concentrations or weather parameters are investigated.

Eligibility criteria: Inclusion Criteria:

* Consecutive emergency department visits within the study period

Exclusion Criteria:

* Patients resident outside the metropolitan area investigated
* Patients admitted to the emergency department for traumatic injuries

Primary outcomes:
measure: number of daily emergency department visits
timeFrame: through study completion, 1 year
Secondary outcomes:
Other outcomes:
measure: number of patients with Levels of Urgency (I-V) of emergency department visits
timeFrame: through study completion, 1 year
measure: Number of patients with the most frequent primary complaints of emergency department visits
timeFrame: through study completion, 1 year
measure: Number of patients hospitalised
timeFrame: through study completion, 1 year
measure: In-hospital mortality
timeFrame: through study completion, 1 year
Locations:
city: Florence
country: Italy
facility: SOD Medicina e Chirurgia d'Urgenza ed Accettazione, Azienda Ospedaliera-Universitaria Careggi
Study officials:
References:
Clinical trial NCT01075490: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Official title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Anesthesia
Neonates
Keywords: spinal anesthesia
neonates
clonidine
post operative apnea
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 120
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

Detailed description: Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.

Eligibility criteria: Inclusion Criteria:

* Newborns less than 60 weeks old post-conceptional, former premature or not
* Newborns requiring inguinal hernia or lower limbs surgery,
* infants needing no more critical care assistance
* Informed consent of parents

Exclusion Criteria:

* Spinal malformation,
* Coagulopathy,
* critical hemodynamics,
* uncontrolled neurologic or metabolic pathology.
* infection at injection point.

Primary outcomes:
measure: number of "rescue" general anesthesia
timeFrame: end of surgery
Secondary outcomes:
measure: apnea and desaturation occurrence
timeFrame: during 24h
measure: duration of spinal anesthesia
timeFrame: during 24h
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: CHU de Montpellier, France
name: Xavier Capdevila, PhD
role: STUDY_CHAIR
affiliation: CHU de Montpellier, France
name: Alain Rochette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.
citation: Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7. doi: 10.1111/j.1460-9592.2005.01664.x.
Clinical trial NCT06557590: 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Official title: Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
FAP
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected or new diagnosed or previously treated malignant tumors.

Brief summary: To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Detailed description: Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging either for an initial assessment, recurrence detection or assessment of pathologic response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and tumor to background (TBR). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

Eligibility criteria: Inclusion Criteria:

patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Diagnostic Performance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References: