louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03418207: The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer
Official title: The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: TPS system
trans-perineal template-guided mapping biopsy
prostate cancer
spatial distribution
large tissue slice
Lead sponsor: Subei People's Hospital of Jiangsu Province
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.

Detailed description: Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.

Eligibility criteria: Inclusion Criteria:

1.Male patients;

2.18 yrs and older, and 90 yrs and younger;

3.Rectal examination reveal prostate nodules;

4.B ultrasound, CT or MRI find abnormal images;

5.PSA\>4ng/ml, abnormal f/t ratio and PSAD

Exclusion Criteria:

1. Abnormal coagulation function;
2. Severe urinary tract infection;
3. Serious cardiovascular and cerebrovascular disease

Primary outcomes:
measure: the spatial distribution based on the biopsy tissue
timeFrame: 2 years
Secondary outcomes:
measure: the spatial distribution based on the large tissue slice technique
timeFrame: 2 years
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
Study officials:
affiliation: Subei People's Hospital of Jiangsu Province
name: Xuefei Ding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran M, Thompson J, Bohm M, Pulbrook M, Moses D, Shnier R, Brenner P, Delprado W, Haynes AM, Savdie R, Stricker PD. Combination of multiparametric MRI and transperineal template-guided mapping biopsy of the prostate to identify candidates for hemi-ablative focal therapy. BJU Int. 2016 Jan;117(1):48-54. doi: 10.1111/bju.13090. Epub 2015 May 11.
Clinical trial NCT02428907: Simulation Training of Endoscopy Staff to Improve Patient Experience in Colonoscopy
Official title: Simulation Based Team Training of Endoscopy Staff May Improve Patients' Perception of Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: simulation training
minimal sedation
colonoscopy
patient satisfaction
teamwork
team training
patient safety
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients for colonoscopy under minimal sedation

Brief summary: Some patients experience a degree of pain and discomfort during endoscopic examination of the large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or intense pain may lead to hypotension and impaired level of consciousness. The purpose of the present study was to determine if simulation training of endoscopy staff in preventing pain and handling acute complications through effective teamwork could improve the quality of colonoscopy from the patients' perspective.

Detailed description: The study was carried out in a surgical department, where colonoscopies were performed on an out-patient basis under minimal sedation. The intervention consisted of a simulation based course for endoscopy staff. All endoscopy nurses and doctors participated (n=43). The course consisted of three short lectures followed by simulation training. The lectures dealt with technical aspects of colonoscopy, usage of medication and management of unexpected emergency events during the procedure, and finally with interprofessional teamwork and team communication. The lectures were followed by in situ simulation in an endoscopy room. For 2 months before and after the course a questionnaire based survey was carried out. The respondents were consecutive patients who had undergone colonoscopy under minimal sedation or no sedation (according to their own preference ). The questionnaire was filled out when the patient was fully recovered after sedation and ready to go home. The relevant nursing staff and doctor for the procedure also filled out their part of the questionnaire. Patients were invited to participate and gave written consent after oral and written information according to the Helsinki declaration .

Eligibility criteria: Inclusion Criteria:

* All patients for colonoscopy under minimal sedation who are able to understand imformation

Exclusion Criteria:

* Unable to understand information

Primary outcomes:
measure: patient perception of colonoscopy
timeFrame: 3 months
Secondary outcomes:
measure: Staff perception of teamwork
timeFrame: 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: NordSim, Aalborg University Hospital
Study officials:
affiliation: Medical Doctor and head of department at Aalborg University Hospital
name: Karen L Larsen, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06748807: Physiological Effects of APRVplus and TCAV in ARDS
Official title: Physiological Effects of Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV) in Acute Respiratory Distress Syndrome (ARDS): a Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.


Eligibility criteria: Inclusion Criteria:

* intubated and mechanically ventilated patients
* meet the 2023 global new definition of ARDS

Exclusion Criteria:

* Pregnancy
* The expected duration of mechanical ventilation was less than 48 hours
* Intracranial hypertension (suspected or confirmed)
* Neuromuscular disorders that are known to prolong the need for mechanical ventilation
* Known or suspected chronic obstructive pulmonary disease(COPD)
* Terminal stage of disease
* Pneumothorax (drained or not)at enrollment
* Treatment with extracorporeal support (ECMO) at enrollment
* There was a lack of commitment to life support

Primary outcomes:
measure: △PL（PLThigh - PLTlow)
timeFrame: during the mechanical ventilation procedure
Secondary outcomes:
measure: EtCO2
timeFrame: during the mechanical ventilation procedure
measure: GI
timeFrame: during the mechanical ventilation procedure
measure: PaO2(mmHg)
timeFrame: during the mechanical ventilation procedure
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT00931307: Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Official title: Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.


Eligibility criteria: Inclusion Criteria:

* On examination, have ocular findings considered to be "normal" and which would not prevent a subject from safely wearing contact lenses.
* Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
* History of corneal refractive surgery.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Comfort After Insertion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05481307: A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203
Official title: An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects


Eligibility criteria: * Inclusion Criteria:

  1. Healthy adults in the age between 19 and 50 years old
  2. Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
  3. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  4. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
* Exclusion Criteria:

  1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax,ss of RLD2202
timeFrame: 0~24 hours
measure: AUCtau,ss of RLD2202
timeFrame: 0~24 hours
measure: Cmax,ss of RLD2203
timeFrame: 0~24 hours
measure: AUCtau,ss of RLD2203
timeFrame: 0~24 hours
measure: Inhibition of Platelet Aggregation(%)
timeFrame: 0~6 days
measure: Inhibition of Thromboxane B2(%)
timeFrame: 0~6 days
Secondary outcomes:
measure: Tmax,ss of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: t1/2,ss of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: Cmin,ss of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: Cavg,ss of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: CLss/F of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: Vdss/F of RLD2202 and RLD2203
timeFrame: 0~24 hours
measure: PTF of RLD2202 and RLD2203
timeFrame: 0~24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04806607: 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
Official title: 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
Primary purpose: DIAGNOSTIC

Brief summary: To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

Detailed description: The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.

This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing EUS-LB
* Platelet Count \> 50,000
* International normalized ratio (INR) \< 1.5
* Age \> 18 years of age
* Non-Pregnant Patients

Exclusion Criteria:

* Age \< 18 Years of Age
* Pregnant Patients
* Inability to obtain consent
* Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
* Platelet count \< 50,000
* Presence of Ascites
* Known Liver Cirrhosis

Primary outcomes:
measure: Length of Longest Piece
timeFrame: Up to 5 Days
Secondary outcomes:
measure: Aggregate Specimen Length
timeFrame: 3 to 5 Days
measure: Degree of Fragmentation
timeFrame: 3 to 5 Days
measure: Number of Portal Tracts in the Specimen
timeFrame: 3 to 5 Days
measure: Adverse Events and Serious Adverse Events
timeFrame: 7 to 10 Days Post Procedure
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: David L Diehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03237507: Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer
Official title: Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage IV Gastric Cancer With Metastasis
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis

Brief summary: This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world


Eligibility criteria: Inclusion Criteria:

* 18 ≤ age
* Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
* Didn't received any prior systemic chemotherapy
* Signed informed consent

Exclusion Criteria:

* History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
* Pregnancy or lactation women,
* Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
* Inadequate organ function which is defined as below:

Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);

* Symptomatic peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidines
* Fluoropyrimidines (DPD) congenital absence
* Other Situations which physicians suggesting are inadaptable for enrollment

Primary outcomes:
measure: PFS: Progression Free Survival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: OS:overall survival
timeFrame: 3 years
measure: Safety
timeFrame: 3 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
affiliation: Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department
name: Kuan Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520207: Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Official title: Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intra-dialytic Hypotension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.


Eligibility criteria: Inclusion Criteria:

* Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

Exclusion Criteria:

* Hyponatremia \<130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol

Primary outcomes:
measure: Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
timeFrame: First three hemodialysis sessions (5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Sushrut S Waikar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Finnian R Mc Causland, MB, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mc Causland FR, Claggett B, Sabbisetti VS, Jarolim P, Waikar SS. Hypertonic Mannitol for the Prevention of Intradialytic Hypotension: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Oct;74(4):483-490. doi: 10.1053/j.ajkd.2019.03.415. Epub 2019 Apr 27.
Clinical trial NCT03128788: Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Official title: Comparison of Extent of Epidurography and Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Epidural Injection
Keywords: epidurography epidural pressure patient posture
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is reported that the distribution of contrast medium had an obvious correlation with the extent of sensory analgesia after injection of LA. Our previous study showed that different posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread. We supposed that differences of epidural pressure between diverse postures might be one factor contributing those differences of epidurography.

This study was designed to compare the epidural pressure and extent of spread of epidurography between prone and lateral decubitus position

Detailed description: It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore, intraoperative or postoperative pain management using continuous thoracic epidural catheterization is suggested good option to prevent this potential complication.

The spread of local anesthetics is influenced by various factors including volume, location of needle insertion, speed of injection, patient position, age, weight and height. However, there are few studies about the effect of different patient position affeting the epidural pressure and the extent of spread of contrast medium during thoracic epidural catheterization.

Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment more to the dependent position compared to the supine position. When the same amount of local anesthetic was injected in supine of sitting position, the most cephalad level of spread was indifferent. Recent studies showed that neck flexion demonstrated significant cephalad spread of contrast dye in high thoracic epidural blockade. The purpose of this study was to compare and evaluate the changes of epidural pressure with extent of spread of contrast medium between different posture

Eligibility criteria: Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level

Primary outcomes:
measure: Epidural pressure
timeFrame: 15 minutes after the completion of the intervention
Secondary outcomes:
measure: Contrast dye assessment
timeFrame: 5 minutes after the completion of the intervention
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hee Hong
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References: