louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01124760: Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers
Official title: A Phase I, Single Center, Open Label, 2-consecutive-group, 2-period, 1-sequence Crossover Study to Assess the Effect of Diltiazem (Cardizem), a Moderate CYP3A4 Inhibitor, or Ketoconazole, a Potent CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Intravenous Dose of 150mg of AZD9742.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: open label
2-consecutive-group
2-period
1-sequence crossover study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 28
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.


Eligibility criteria: Inclusion Criteria:

* non-childbearing potential, with suitable veins for cannulation or repeated venipuncture
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening.
* Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Primary outcomes:
measure: Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine.
timeFrame: For diltiazem group - up to 18 days of pre-defined study days for pk profiling. For keoconazole - up to 14 days of pre-defined study days for pk profiling.
Secondary outcomes:
measure: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry)
timeFrame: Collected prior to treatment, during treatment, and follow-up for a maximum of 57 days for group 1 and 53 days for group 2 (this includes up to 28 days for screening).
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Ralph Schutz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Colleen Jensen
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Brendan Smyth
role: STUDY_CHAIR
References:
Clinical trial NCT02803060: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay ,UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00708760: Moderate Sedation Educational Software
Official title: Moderate Sedation Education Software
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Moderate Sedation Training
Keywords: web based learning
moderate sedation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nurses providing moderate sedation

Brief summary: We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.

Detailed description: The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.

1) Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain.

Eligibility criteria: Inclusion Criteria:

* general nursing staff at the University of Utah
* currently required to obtain moderate sedation training
* an equal basis all clinicians in the respective departments

Exclusion Criteria:

* nurses and other personnel who do not administer moderate sedation

Primary outcomes:
measure: to determine which group - web based or paper based is more effective
timeFrame: at the end of simulation
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: James Agutter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724760: Pedometers for the Enhancement of Post Cesarean Mobility
Official title: Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-10-30
Enrollment: 291
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.


Eligibility criteria: Inclusion Criteria:

* Patients following cesarean delivery
* Consent to participation
* No medical recommendation for bed rest and limited mobility
* Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker \> 10 cigaretts a day, age \>35, substantial limb varicose, multiple gestation, multiparity (\> deliveries), emergent surgery, thrombophilia.

Exclusion Criteria:

* Refusal to participate
* Medical recommendation to limit mobility

Primary outcomes:
measure: Number of steps
timeFrame: 48 hours
Secondary outcomes:
measure: Number of participants with a postpartum complication composite
timeFrame: 48 hours
measure: Number of analgesic doses
timeFrame: 48 hours
measure: Length of hospitalization
timeFrame: From 72 hours to one week
measure: Number of thromboembolic events
timeFrame: Six weeks
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Obstetrics and Gynecology
name: Hadas Ganer Herman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
Clinical trial NCT06917560: Serological Autoantibodies in Early Kidney Cancer Diagnosis and Prognosis: A Multicenter Study
Official title: The Role of Serological Autoantibody Profiles in the Early Diagnosis and Prognosis of Renal Carcinoma: A Multicenter, Retrospective Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Carcinoma
Serology
Autoantibody Profile
Keywords: Renal Carcinoma
Autoantibody Profile
Serology
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Xiamen University
First posted: 2025-04-08
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed renal cell carcinoma

Brief summary: This project aims to construct a multicenter retrospective study by retrospectively collecting clinical, serological, and pathological data from patients. A comprehensive data management system will be established to facilitate the integration and analysis of multicenter data, alongside antibody profiling characteristics. A predictive model based on serological autoantibody profiles will be developed and validated using both internal and external cohorts. This model will predict clinical prognostic factors in renal carcinoma and identify patient populations likely to respond to immunotherapy. By enabling personalized treatment decisions and minimizing unnecessary treatment risks, the model aims to improve patient quality of life and overall prognosis.


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of ccRCC;
* Availability of complete clinical, pathological, and follow-up data;
* Sufficient preoperative serum available for collection;
* Well-preserved pathological slides for subsequent immunohistochemical (chip) analysis;
* At least one post-treatment follow-up/efficacy evaluation.

Exclusion Criteria:

* Therapeutic contraindication cohort: Individuals presenting with severe comorbidities rendering them medically ineligible for therapeutic interventions;
* Oncological multiplicity: Subjects with either (a) antecedent therapeutic regimens targeting non-index malignancies or (b) concurrent diagnosis of untreated active malignancies;
* Biospecimen integrity violation: Cases demonstrating serum hemolysis or compromised specimen integrity;
* Data insufficiency cohort: Patients exhibiting incomplete clinical/pathological records or insufficient longitudinal follow-up data for comprehensive analysis.

Primary outcomes:
measure: serum autoantibodies
timeFrame: Prior to any treatment or surgery, 5 mL of venous blood was collected from each individual and allowed to stand at room temperature (RT) for 1 hour to facilitate coagulation.
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: first hospital affiliated of Fujian medical university
state: Fujian
Study officials:
References:
Clinical trial NCT06493760: A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: SSGJ-707
colorectal cancer
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented metastatic colorectal cancer confirmed .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=12 weeks.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: ORR
timeFrame: 12 months
measure: Safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Liu Tianshu
state: Shanghai
Study officials:
References:
Clinical trial NCT05127460: CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection
Official title: Computer-assisted Atrial Fibrillation Risk Detection In Oral-anticoagulant Use, Lowering Stroke Risk, and Optimizing Guidance With an Intelligent Screening Tool (CARDIOLOGIST): a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation New Onset
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 25732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of Atrial Fibrillation.


Eligibility criteria: Inclusion Criteria:

* Patients in emergency department or inpatient department
* Patients had at least 1 ECG
* Patients cared by non-cardiologist

Exclusion Criteria:

* Patients without history of atrial fibrillation diagnosis.
* Patients without history of long-term NOAC or warfarin usage.
* Patients without history of hemorrhagic stoke or ishemic stroke.
* Patients with low eGFR (\<30 ml/min)

Primary outcomes:
measure: Proportion of taking AF treatment medications
timeFrame: Within 90 days
measure: Proportion of ischemic Stroke
timeFrame: Within 90 days
Secondary outcomes:
measure: Proportion of cardiologist consultation
timeFrame: Within 90 days
measure: Proportion of new-onset AF diagnosis
timeFrame: Within 90 days
measure: Proportion of echocardiogram performed after ECGs
timeFrame: Within 90 days
measure: Proportion of new-onset heart failure
timeFrame: Within 90 days
measure: Proportion of gastrointestinal bleeding
timeFrame: Within 90 days
measure: Proportion of hemorrhagic stroke
timeFrame: Within 90 days
measure: Proportion of all cause mortality(death)
timeFrame: Within 90 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Defense Medical Center
Study officials:
References:
Clinical trial NCT03213860: The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
Official title: The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 80
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: Environmental factors such as noise and light have been cited as important causes of sleep deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol. Another studies indicated that using eye masks can improve REM sleep in healthy subjects in simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to determine the effects of using eye masks on sleep and thus on pain quality in postoperative cardiac surgery patients in ICU.


Eligibility criteria: Inclusion Criteria:

* (1) age ≧18 years; (2) no history of neurological or psychiatric disorders; (3) ability of patients to communicate verbally and understand the sleep questionnaires administered in the ICU; (3) length of ICU stay ≥48 hours; (4) Glasgow coma score (GCS) \>8 in the first to third day. Postoperative Extubation of MV within few hour (before the time of 9 pm for postoperative patients.

Exclusion Criteria:

* Patients over age 65 were excluded from the study because of potential age-related differences in sleep. Patients reporting frequent nighttime awakenings, snoring, or chronic use of benzodiazepines or opioids were excluded because of potential confounding influences of these factors on postoperative sleep, pain, or opioid requirement.

Primary outcomes:
measure: postoperative pain
timeFrame: 3 postoperative days
Secondary outcomes:
measure: Quality of sleep
timeFrame: 3 postoperative days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT01635660: Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
Official title: Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Intratracheal
Airway Management
Emergency Treatment
Keywords: Out-of-hospital
airway management
intubation
video laryngoscope
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Karl Storz Endoscopy, Germany
name: King Systems Corporation
name: LMA, Germany
name: Venner Medical, Germany
First posted: 2012-07-09
Enrollment: 182
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 research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.


Eligibility criteria: Inclusion Criteria:

- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary

Exclusion Criteria:

* Age under 18 years
* Laryngoscopy according to the algorithm of airway management not being indicated

Primary outcomes:
measure: Intubation success
timeFrame: Immediately after intubation
Secondary outcomes:
measure: Intubation on first attempt
timeFrame: Immediately after intubation
measure: Intubation time
timeFrame: Immediately after intubation
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Klinikum LDW / NEF Bremen Süd
city: Greifswald
country: Germany
facility: Uniklinikum Greifswald / DRF Luftrettung
city: Rendsburg
country: Germany
facility: Uniklinikum Kiel / DRF Luftrettung
Study officials:
References:
citation: Cavus E, Janssen S, Reifferscheid F, Caliebe A, Callies A, von der Heyden M, Knacke PG, Doerges V. Videolaryngoscopy for Physician-Based, Prehospital Emergency Intubation: A Prospective, Randomized, Multicenter Comparison of Different Blade Types Using A.P. Advance, C-MAC System, and KingVision. Anesth Analg. 2018 May;126(5):1565-1574. doi: 10.1213/ANE.0000000000002735.