louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06528236: Research and Application of Ultrasonic Intelligent Diagnosis System for Ovarian Mass
Official title: Research on Automatic Detection of Ovarian Mass and Intelligent Auxiliary Diagnosis System Based on Multimodal Ultrasound Images
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Neoplasms
Adnexal Mass
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: Sichuan provincial maternity and child health care hospital
name: The Affiliated Hospital of Qingdao University
name: Aksu First People's Hospital
name: Women's Hospital School Of Medicine Zhejiang University
First posted: 2024-07-30
Enrollment: 100000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During gynecological ultrasound examination, at least one patient with persistent ovarian tumor was found. The patient underwent surgical treatment and the histopathological results.

Brief summary: Research on automatic detection of ovarian mass and intelligent auxiliary diagnosis system based on multimodal ultrasound images.

Detailed description: Investigators aimed to develop an ultrasonic intelligent diagnosis system for ovarian mass based on multimodal ultrasound images.

Eligibility criteria: Inclusion Criteria:

1. During gynecological ultrasound examination, at least one patient with persistent ovarian tumor was found.
2. The patient underwent surgical treatment and the histopathological results.

Exclusion Criteria:

1. Histopathological analysis confirms non-ovarian tumor;
2. Histopathological results are inconclusive;
3. Issues with image quality: the ovarian mass is incomplete and does not show some surrounding tissues (but the mass is too large to exclude completely); the images are overly blurry, making it difficult to determine the characteristics of the ovarian mass (possible reasons include hardware quality issues with the ultrasound machine, motion blur, focusing problems, presence of intestinal gas in the patient); gain settings make it difficult to judge the characteristics of the ovarian mass (such as low contrast, excessively dark images, or saturation); the presence of artifacts affects the assessment of ultrasound characteristics of the ovarian mass and should be excluded.

Primary outcomes:
measure: Area under the curve
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 1 year
measure: Accuracy
timeFrame: Through study completion, an average of 1 year
measure: Positive predicative value
timeFrame: Through study completion, an average of 1 year
measure: Negative predictive value
timeFrame: Through study completion, an average of 1 year
Locations:
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Litao Sun, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01735149: Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-55 years old
* Total Cholesterol 200\~260 mg/dl or LDL-C 110\~190 mg/dl
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Total Cholesterol
timeFrame: 12 weeks
measure: Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Triglyceride
timeFrame: 12 weeks
measure: Changes in HDL-C(High Density Lipoprotein-cholesterol)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT00851149: Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair
Official title: Pro-inflammatory Cytokines (IL-1beta,IL-6, IL-8 and TNF-α) and Complement Activation (C3a) in Blood Collected From Surgery Field From Patients Undergoing Orthopedic Surgery Compared to Patients Undergoing Abdominal Aneurysm Repair.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Diseases
Osteoarthritis, Hip
Keywords: aorta
disease
abdominal
surgery
Osteoarthritis, Hip
replacement
blood
autolog
transfusion
cytokines
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Dentsply Sirona Implants and Consumables
First posted: 2009-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to investigate the contents in blood sampled from surgery site during hip replacement compared with blood sampled from abdominal aortic surgery. Is there any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement activation (C3a)?

Detailed description: Patient (n= 10) scheduled for total hip replacement or hemiprosthesis and patient (n=10) scheduled for abdominal aortic surgery.

Primary outcome:

Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.

Secondary outcome:

Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* ASA 1-4

Exclusion Criteria:

* Patient using corticosteroids, NSAIDs or Cox-II inhibitors
* Patients under 18 years
* Patients who are included in pharmaceutical studies
* Opioids-, benzodiazepines-, antiepileptic drugs-, alcohol- and α2-agonists abuse
* Pregnant and breastfeeding women
* Patients with known hypersensitivity for opioids, propofol or volatile anesthetics
* Patients with serious arrhythmias (atrial fibrillation/flutter is acceptable)
* Uncontrolled hypertension, serious psychiatric disease
* Patients with unstable angina pectoris or myocardial infarction the last month before inclusion
* Acute abdominal aortic surgery (acute dissection or rupture)
* Planned laparoscopic abdominal aortic aneurysm surgery
* Transfusion of blood products last month before surgery
* Glucocorticoid users

Primary outcomes:
measure: Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.
timeFrame: 30 days
Secondary outcomes:
measure: Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
timeFrame: 30 days
Other outcomes:
Locations:
city: Tonsberg
country: Norway
facility: Sykehuset i Vestfold HF
Study officials:
affiliation: Sykehuset i Vestfold HF
name: Espen Lindholm, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441149: Individualized Data-based High Simulation of Bronchoscopy Operations in Preoperative Bronchoscopy Informed Consent
Official title: The Impact of a Personalized Data-Based Bronchoscopy Simulation Operation System on Perioperative Anxiety and Satisfaction in Bronchoscopy：a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Keywords: Communication
Informed Consent
Physician-Patient Relations
AI
bronchoscopy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 122
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: A prospective randomized controlled study was conducted to investigate whether preoperative replacement of patients based on AI training instruments could alleviate preoperative anxiety.

Patients who met the criteria were randomly assigned to either the personalized data-based group or the control group. Prior to the preoperative account examination, each patient's anxiety level was assessed, after which a 30-40-minute informed consent form was read.

The traditional group underwent a preoperative account and question-and-answer session with an experienced bronchoscopy laboratory physician, after which the scale was reassessed.

The experimental group underwent a simulated surgical procedure on an AI simulation instrument based on the patient's CT personalized data, performed by an experienced bronchoscopist. The bronchoscopist explained the surgical precautions and answered the patient's questions throughout the procedure. Following the responses to the questions, the scale was reassessed. Following surgery, patients are invited to complete a satisfaction survey prior to discharge or following the discussion of bronchoscopy findings.


Eligibility criteria: Inclusion Criteria:

* requiring elective bronchoscopy
* Older than 18 years

Exclusion Criteria:

· Dementia, limited speech, or other problems affecting communication

Primary outcomes:
measure: The level of the patient's anxiety
timeFrame: 1 days before Bronchoscopic procedures
Secondary outcomes:
measure: The level of the patient's satisfication
timeFrame: 1 days after Bronchoscopic procedures
Other outcomes:
Locations:
city: BeiJing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00511849: Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors
Official title: Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 43
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: The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent
* Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens
* ECOG performance status 0 or 1

Exclusion Criteria:

* Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions
* Diagnosis of any second malignancy within the past 3 years

Primary outcomes:
measure: Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing)
timeFrame: 3 yrs
Secondary outcomes:
measure: Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination.
timeFrame: 3 yrs
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05094349: Influence of Pneumonia on Delayed Cerebral Ischemia After Subarachnoid Hemorrhage . SAH-CIP (SubArrachnoid Hemorrhage - Cerebral Infarction Pneumonia)
Official title: Influence of Pneumonia on Delayed Cerebral Infarction After Subarachnoid Hemorrhage: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Pneumonia, Bacterial
Keywords: Subarachnoid hemorrhage
pneumonia
delayed cerebral ischemia
vasospasm
delayed cerebral infarction
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient admitted to ICU for subarachnoid hemorrhage (SAH). in our institution every patient diagnosed with non traumatic SAH are admitted for at least 24 hours in ICU.

Brief summary: Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH.

Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI.

We plan to include between 200 and 250 patients in the analysis.


Eligibility criteria: Inclusion Criteria:

* admitted in ICU in Brest University Hospital
* for non traumatic subarachnoid hemorrhage
* between july 2015 and december 2018

Exclusion Criteria:

* continuation of care out of Brest University Hospital after initial ICU stay
* refusal to participate

Primary outcomes:
measure: delayed cerebral infarction
timeFrame: 3 months from subarachnoid hemorrhage
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT00695149: Treatment for Acute Spinal Cord Injury
Official title: Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal cord Injury
Central nervous system
Regeneration
Bone marrow stromal cells
Transplantation
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 5
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.


Eligibility criteria: Inclusion Criteria:

* Spinal cord injury is confirmed with MRI
* Methylprednisolone therapy according to this study can be started within 8 hours after the injury
* Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury
* Age between 15 and 60
* With the informed consent of obtaining bone marrow and injecting incubated BMSCs.

Exclusion Criteria:

* Complete disruption of spinal cord
* Central spinal cord injury
* Spinal canal stenosis before the injury
* Brain or spinal cord disease before the injury
* Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody
* Pregnancy

Primary outcomes:
measure: Motor function
timeFrame: six months
Secondary outcomes:
measure: Sensation
timeFrame: six months
Other outcomes:
Locations:
city: Moriguchi
country: Japan
facility: Kansai Medical University
state: Osaka
Study officials:
References:
citation: Ohta M, Suzuki Y, Noda T, Ejiri Y, Dezawa M, Kataoka K, Chou H, Ishikawa N, Matsumoto N, Iwashita Y, Mizuta E, Kuno S, Ide C. Bone marrow stromal cells infused into the cerebrospinal fluid promote functional recovery of the injured rat spinal cord with reduced cavity formation. Exp Neurol. 2004 Jun;187(2):266-78. doi: 10.1016/j.expneurol.2004.01.021.
citation: Saito F, Nakatani T, Iwase M, Maeda Y, Murao Y, Suzuki Y, Fukushima M, Ide C. Administration of cultured autologous bone marrow stromal cells into cerebrospinal fluid in spinal injury patients: a pilot study. Restor Neurol Neurosci. 2012;30(2):127-36. doi: 10.3233/RNN-2011-0629.
Clinical trial NCT00002249: A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Official title: A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Anti-Infective Agents, Quinolone
Ofloxacin
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

HIV infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active opportunistic infection or neoplasm.
* High likelihood of death during study.
* Significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric,respiratory, or metabolic disease.
* Donation of \> 1 unit blood or acute loss of blood within one month of study entry.

Patients with the following prior conditions are excluded:

* History of opportunistic infection.
* Previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone.

Prior Medication:

Excluded:

Use of any investigational agent within 7 days of entry into study. Use of any medication within 3 days prior to entry (7 days for AZT). Alcohol or drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: R W Johnson Pharmaceutical Research Institute
state: New Jersey
Study officials:
References:
citation: Goodwin SD, Gallis HA, Chow AT, Wong FA, Flor SC, Bartlett JA. Pharmacokinetics and safety of levofloxacin in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1994 Apr;38(4):799-804. doi: 10.1128/AAC.38.4.799.
Clinical trial NCT03400449: Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization
Official title: Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization: The COMSE Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Contraception Behavior
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Universidad de Antioquia
First posted: 2018-01-17
Enrollment: 240
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups randomized to counseling type.
Primary purpose: PREVENTION

Brief summary: A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.

Detailed description: This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.

Eligibility criteria: Inclusion Criteria:

* Live pregnancy \>20 weeks gestation
* Admission to maternity ward for labor
* Age \>14

Exclusion Criteria:

* Pain \>=8 on Wong-Baker FACES pain scale

Primary outcomes:
measure: Total Counseling Time
timeFrame: Immediately following the intervention, an average of less than 30 minutes
Secondary outcomes:
measure: Knowledge Scores
timeFrame: One hour
measure: Number of Participants Initiating Postpartum LARC Uptake
timeFrame: Assessed at the time of hospital discharge, on average less than 2 days
Other outcomes:
Locations:
city: Cartagena
country: Colombia
facility: Maternidad Rafael Calvo
city: Medellín
country: Colombia
facility: Metrosalud Manrique
Study officials:
References:
citation: Hersh AR, Munoz LF, Rincon M, Alvarez C, Tolosa JE, Moreno DJ, Rubio M, Vargas JC, Edna F, Taborda N, Baldwin MK. Video compared to conversational contraceptive counseling during labor and maternity hospitalization in Colombia: A randomized trial. Contraception. 2018 Sep;98(3):210-214. doi: 10.1016/j.contraception.2018.05.004. Epub 2018 May 9.