louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03929744: A Study of LY3502970 in Healthy Participants
Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part C is a crossover design.
Primary purpose: BASIC_SCIENCE

Brief summary: The main purposes of this study are to determine:

* The safety of LY3502970 and any side effects that might be associated with it.
* How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it.

This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.


Eligibility criteria: Inclusion Criteria:

* Healthy male or females, as determined by medical history
* Have safety laboratory results within normal reference ranges

Exclusion Criteria:

* Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
* Abnormal electrocardiogram (ECG) at screening
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline up to Day 42
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 96 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970
timeFrame: Predose up to 96 hours postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
timeFrame: Predose up to 96 hours postdose
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01353144: A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Official title: A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer
Keywords: aspirin
peptic ulcer
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 178
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: Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Detailed description: The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.

Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Eligibility criteria: Inclusion Criteria:

* aspirin users who have a peptic ulcer confirmed by endoscopy

Exclusion Criteria:

* serious medical illness (including cardiovascular events within 6 months before endoscopy)
* acute gastrointestinal bleeding
* a history of gastric or duodenal surgery
* allergic to the study drugs
* require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
* pregnancy

Primary outcomes:
measure: Number of Participants in Whom Peptic Ulcer Was Healed
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants Deveoping Peptic Ulcer Bleeding
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kwok-Hung Lai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06174844: Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain
Official title: Evaluation and Development of the HUMANisation of CARE in the Andalusian Public Health System in Complex User Units and Hospital Emergency Units: Attention to Frailty, Prevention of Adverse Events, and the Impact of the Nurse-patient Relationship on Health Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PROM
Satisfaction, Patient
Satisfaction, Personal
Stress
Burnout, Professional
Hospital Acquired Condition
Adverse Event
Nurse-Patient Relations
Keywords: Humanization of care
Health outcomes
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Andalusian Health Service
First posted: 2023-12-18
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time

Brief summary: Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals.

Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time.

Exclusion Criteria:

* Patients presenting with haemodynamic instability or emergencies at the time of sampling
* Patients with cognitive impairment

Primary outcomes:
measure: Health outcomes
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
Study officials:
affiliation: Andalusian Health Service and University of Seville
name: Regina Allande-Cussó, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06878144: Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project
Official title: MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project (Deciphering Immunopathogenesis of MUCORmycosis to ADVANCE Risk Stratification, Diagnosis and Management of the Disease)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mucormycosis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To collect data and samples from participants with cancer who also have invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection.

Detailed description: Primary Objective:

To establish MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project.

* To prospectively identify, collect, and store all isolates causing proven or probable MCM in adult high-risk cancer participants.
* To prospectively identify, collect, and store relevant host samples from high-risk participants developing proven or probable MCM, along with relevant biospecimens from three control groups.
* To comprehensively annotate clinical specimens and provide information regarding the course and outcome of all MCM cases and controls.

OUTLINE:

This is an observational study. Patients are assigned to 1 of 4 groups.

GROUP M: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP A: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP B: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP C: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18-100 years old and have cancer and invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection but no evidence of such infection.
* Patients must be willing to undergo routine diagnostic procedures (e.g., phlebotomy, bronchoscopy, biopsy) as part of their regular care.

Exclusion Criteria:

• Patients who are unwilling to undergo routine diagnostic procedures as part of their regular care.

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Dimitrios Kontoyiannis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233544: Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases
Official title: The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colorectal Carcinoma
Liver Metastases
Keywords: Colorectal carcinoma
Liver metastases
Stereotactic body radiation therapy
Radiofrequency ablation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
First posted: 2010-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases.

Primary end point is local progression free survival.

Detailed description: Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the colon or rectum
* Liver metastases
* Inoperable (technical or medical)
* 1-4 metastases
* Maximum 40 mm in diameter
* Suitable for both therapies, RFA and SBRT

Exclusion Criteria:

* Uncontrolled extrahepatic disease and uncontrolled primary cancer
* Liver cirrhosis

Primary outcomes:
measure: Local progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Toxicity
timeFrame: 3 years
measure: Survival
timeFrame: 3 years
measure: Progression (local or distant)
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institute, Huddinge
Study officials:
affiliation: Aarhus University Hospital
name: Morten Høyer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986544: Drain After Elective Laparoscopic Cholecystectomy
Official title: Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Keywords: Laparoscopy
cholecystectomy
drainage
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

Detailed description: After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* acute cholecystitis, cholangitis, or pancreatitis
* no contraindication for the laparoscopic
* no other additional procedure

Primary outcomes:
measure: Number of Participants With Subhepatic Collection at Ultrasonographic Examination
timeFrame: first postoperative day
Secondary outcomes:
measure: Number of Participants With Postoperative Complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Terracina
country: Italy
facility: University of Rome "La Sapienza" - Polo Pontino
state: Latina
Study officials:
affiliation: University of Rome "La Sapienza"- Polo Pontino
name: Erasmo Spaziani, PhD
role: STUDY_DIRECTOR
References:
citation: Gurusamy KS, Samraj K, Mullerat P, Davidson BR. Routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006004. doi: 10.1002/14651858.CD006004.pub3.
citation: Tzovaras G, Liakou P, Fafoulakis F, Baloyiannis I, Zacharoulis D, Hatzitheofilou C. Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial. Am J Surg. 2009 Jun;197(6):759-63. doi: 10.1016/j.amjsurg.2008.05.011. Epub 2008 Oct 16.
Clinical trial NCT06046144: Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors
Official title: Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors. Monocentric Retrospective Study of 170 Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Lentigo Maligna
Melanoma
Nevus
Seborrheic Keratosis
Lentigo
Keywords: Melanoma diagnosis
Diagnosis Imaging
Fluorescence-Advanced videodermatoscopy
Reflectance confocal microscopy
Super-high magnification dermoscopy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.

Brief summary: Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature.

In addition to Reflectance confocal microscopy (RCM), it currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

Detailed description: Several studies have demonstrated their interest in the in vivo diagnosis of melanocytic tumors, but without any comparison between these methods.

In our current practice, many patients have benefited from these 3 imaging modalities for benign and malignant lesions.

Therefore, our aim is to analyze these images and compare their performance in the diagnosis of benign and malignant pigmented lesions.

Eligibility criteria: Inclusion Criteria:

* Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.

Exclusion Criteria:

* Bad quality images
* Insufficient number of images
* Uncertain diagnosis given by the pathologist
* Refusal

Primary outcomes:
measure: To compare the the relevance of each technique for the diagnostic of pigmented lesions.
timeFrame: Day 1
Secondary outcomes:
measure: Comparison of performance of imaging techniques
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Luc PERROT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800344: The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator
Official title: The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events
Keywords: Airway Cuff
LMA
Ultra
Cuff Pressure
Ventilation
Anesthesia
Intubation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a LMA, in ambulatory surgery patients.

Detailed description: Recent evidence suggests that reduction of LMA intracuff pressure may decrease the incidence of pharyngolaryngeal symptoms. Yet, pressure manometers are not widely available limiting the application of a strategy of intracuff pressure reduction. The Ultra airway has been designed to provide continuous indication of intracuff pressure and can limit the intracuff pressure to \< 60 cm H2O. This study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the Ultra or a standard practice using a LMA, in ambulatory surgery patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III
* 18 to 65 years of age
* Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological, general surgical and eye procedures under a short general anesthesia of less than 2 hours
* Spontaneously breathing on the LMA

Exclusion Criteria:

* Reduced mouth opening less than 2.5cm
* Recent history of upper respiratory tract infection and sore throats
* Contraindications of LMA use (Morbid obesity with body mass index greater than 40kg/m2, symptomatic hiatus hernia, esophageal reflux disease)

Primary outcomes:
measure: The primary outcome, composite pharyngolaryngeal complication, is defined as the presence of either sore throat, dysphonia or dysphagia at 1, 2, and 24 h postoperatively.
timeFrame: 1, 2, 24 hours
Secondary outcomes:
measure: Intracuff pressure
timeFrame: intraoperative
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Univeristy Health Network- Toronto Western Hospital
state: Ontario
Study officials:
References:
citation: Wong DT, Tam AD, Mehta V, Raveendran R, Riad W, Chung FF. New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial. Can J Anaesth. 2013 Dec;60(12):1197-203. doi: 10.1007/s12630-013-0044-2. Epub 2013 Oct 5.
Clinical trial NCT05773144: Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Official title: Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Neoplasms
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-17
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed stage II or III colon cancer
* Completed surgical resection with curative intent
* Plan to initiate chemotherapy
* Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
* No planned major surgery during the study period
* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
* Can walk 400 meters
* Can read and speak English
* Ability to provide written informed consent
* Provide written approval by qualified healthcare professional
* Willing to be randomized

Exclusion Criteria:

* Evidence of metastatic colon cancer
* Concurrently actively treated other (non-colon) cancer
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Currently participating in another study with competing outcomes
* Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Primary outcomes:
measure: Chemotherapy Relative Dose Intensity
timeFrame: 12- or 24-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Pennington Biomedical Research Center
name: Justin C. Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Jeffrey A. Meyerhardt, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Bette J. Caan, Dr.P.H.
role: PRINCIPAL_INVESTIGATOR
References: