louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01514617: Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Official title: Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Leiomyomas
Keywords: Leiomyoma
Diffusion weighted MRI
Perfusion MRI
Uterine artery embolization
Volumetric Response
Women with symptomatic leiomyomas
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.


Eligibility criteria: Inclusion Criteria:

* women with symptomatic leiomyomas

Exclusion Criteria:

* women with known contra-indications for MRI (cardiac pacemaker, cochlear implants, claustrophobic patients)
* women with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR \< 30 mL/min)

Primary outcomes:
measure: Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization
timeFrame: Participants will be followed for the duration of hospital stay (an expected average of 3 days) and will be systematically followed during their follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Radiology Department
Study officials:
affiliation: University Hospital Gasthuisberg, department of Interventional Radiology
name: Geert Maleux, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06390917: Study on the Patient-Ventilator Asynchrony Analysis Function
Official title: Study on the Patient-Ventilator Asynchrony Analysis Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: To Study the Incidence of Patient-ventilator Asynchronization in Two Groups of Patients Under Two Conditions With PVA Unsynchronization Analysis Function
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 30
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: In this study, the incidence of patient-ventilator asynchronism in two groups of patients was studied when the ventilator was prompted by the PVA asynchronism analysis function

Detailed description: Incidence of patient-computer dyssynchrony events: defined as the proportion of patient-computer dyssynchrony events in the total number of cycles during the patient trial. The observation period began 48 hours after the participants met the inclusion and exclusion criteria and signed the informed consent, and the data collection was stopped 48 hours later.

Eligibility criteria: Inclusion Criteria:

1. Adults (≥18 years) requiring invasive mechanical ventilation
2. Patiens had spontaneous breathing;
3. Agreed to participate in the trial and signed an informed consent

Exclusion Criteria:

1. Patients with contraindications to esophageal catheter insertion and inability to monitor esophageal pressure;
2. pregnant women;
3. patients with severe central nervous system damage or neuromuscular related diseases;
4. Participating in other clinical research projects;
5. Patients deemed unsuitable by the investigator

Primary outcomes:
measure: Incidence rate of PVAs
timeFrame: 48 hours
Secondary outcomes:
measure: The proportion of PVAs that were identified by the investigator among the total PVAs during the trial
timeFrame: 48 hours
measure: Incidence of PVA within half an hour before and after the intervention
timeFrame: Half an hour before and after the intervention
measure: Accuracy of PVA recognition function
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04918641: Natural History Observational Study of MPS IIIa in SMC
Official title: Prospective, Natural History Study of Patients With Sanfilippo Syndrome Type A (MPS IIIA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sanfilippo Syndrome A
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initial patient eligibility is based on patient age and on a confirmed diagnosis of MPS IIIA.

Brief summary: To characterize the clinical course of mucopolysaccharidosis type IIIA (MPS IIIA), and identify potential endpoints for future treatment trials.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of MPS IIIA
* Has the ability to comply with protocol requirements, in the opinion of the investigator

Exclusion Criteria:

* Patient's assent is unattainable, or the patient's parent(s), or patient's legally authorized representative(s) is/are unable to understand the nature, scope, and possible consequences of the study, or do/does not agree to comply with the protocol defined schedule of assessments.

Primary outcomes:
measure: Change From Baseline in Bayley Scales of Infant Development-III/Kaufman Assessment Battery for Children-II (BSID-III/KABC-II) Age-Equivalent Scores
timeFrame: Baseline, 12 months, and 24 months
measure: Change From Baseline in Vineland Adaptive Behavior Scales-II (VABS-II) Age-equivalent Scores
timeFrame: Baseline, 12 months, and 24 months
measure: Change from Baseline in MPS health Assessment Questionnaire, Sanfilippo Behavior Rating Scale
timeFrame: Baseline, 12 months, and 24 months
Secondary outcomes:
measure: Imaging characteristics
timeFrame: Baseline, 12 months
measure: Echocardiography
timeFrame: Baseline, 6 months, 12 months, and 24 months
measure: Hearing assessments
timeFrame: Baseline, 12 months, and 24 months
measure: Sleep habits
timeFrame: Baseline, 12 months, and 24 months
measure: Ophthalmology assessments
timeFrame: Baseline, 12 months, and 24 months
measure: Change From Baseline in Quality of Life (ITQoL/PedsQL) Questionnaire
timeFrame: Baseline, 12 months, and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: SungYoon Cho
role: STUDY_DIRECTOR
References:
Clinical trial NCT02838641: Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced

Brief summary: This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.


Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years old suspected of TB clinically.
2. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
3. BAL samples obtained following standard investigation procedure
4. CXR or CT imaging available.

Exclusion Criteria:

1. Bronchoscopy is not planned as a necessary procedure for investigation.
2. Diagnosis of active TB has been made by other means.

Primary outcomes:
measure: sensitivity, specificity, positive and negative predictive values
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT01238341: Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy
Official title: Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatobiliary Disease
Altered Gastric Anatomy
Keywords: Pancreatobiliary disease in patients with altered gastric anatomy.
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.

Brief summary: In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
3. Subject has altered gastric anatomy
4. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
2. The subject is unable to give informed consent

Primary outcomes:
measure: Papilla or Duct-enterostomy Was Reached
timeFrame: During procedure, up to 3 hours
Secondary outcomes:
measure: Successful Cannulation of the Duct of Intent
timeFrame: During procedure, up to 3 hours
measure: Successful Endoscopic Therapy
timeFrame: During procedure, up to 3 hours
measure: Total Procedure Time
timeFrame: During procedure, up to 3 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at UF Endoscoppy Center
state: Florida
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagh MS, Draganov PV. Prospective evaluation of spiral overtube-assisted ERCP in patients with surgically altered anatomy. Gastrointest Endosc. 2012 Aug;76(2):439-43. doi: 10.1016/j.gie.2012.04.444. No abstract available.
Clinical trial NCT05702541: Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Official title: Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Detailed description: Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
* History of refractive surgery, or plan to have refractive surgery during the study;
* Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
timeFrame: Day 2 of each study lens type worn during the corresponding crossover period
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Johns Creek Research Clinic
state: Georgia
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00654641: Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Official title: Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound Dehiscence
Wound Infection
Keywords: Surgical Wound Dehiscence
Wound Infection
Obesity
Cesarean Delivery
Wound Closure
Negative Pressure wound closure
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: CAMC Health System
First posted: 2008-04-08
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.

Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.


Eligibility criteria: Inclusion Criteria:

1. Undergoing Cesarean delivery.
2. Patient at least 18 years of age.
3. Weight greater than 199 pounds.
4. Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.

Exclusion Criteria:

1. Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
2. Inability to give proper informed consent.
3. Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
4. Patient less than 18 years of age.

Primary outcomes:
measure: Total Number of Patients Experiencing a Wound Complication
timeFrame: 6 Weeks post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC Women and Children's Hospital
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Michael L Stitely, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05985941: Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors
Official title: Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rare Gynecological Tumors
Multi-omics Analysis
Keywords: Genomics
Transcriptome
proteomics
metabonomics
Pathological omics
Imaging omics
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rare gynecological tumors who underwent surgery in three hospitals, including Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Sun Yat-sen Memorial Hospital affiliated to Sun Yat-sen University and the First Affiliated Hospital of University of Science and Technology of China, were diagnosed as clear cell carcinoma (ovary, uterus), neural small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumors, trophoblastic tumors, or perivascular epithelioid cell tumors (PECOMA), among others.

Brief summary: The goal of this observational study is to draw the characteristic maps of genomics, transcriptome, proteomics, metabolomics, etc. in 600 patients with gynecological rare pathological types of malignant tumors. Then it is planned to explore the molecular mechanism and find some new targets for diagnosis and treatment, and design and establish the database system of the above rare tumors.


Eligibility criteria: Inclusion Criteria:

* 1)Pathological diagnosis: clear cell carcinoma (ovary, uterus), nerve small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumor, trophoblastic tumor, perivascular epithelioid cell tumor (PECOMA) and other rare gynecological tumors; 2)Received pathological results from tumor surgery; 3)The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements; 4)Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.

Exclusion Criteria:

* 1)Patients with malignant tumors in other parts of the body; 2)Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders; 3)Poor compliance and inability to cooperate and describe treatment responders.

Primary outcomes:
measure: Multi-omics feature map
timeFrame: August 2023 to May 2028
measure: Database system
timeFrame: August 2023 to May 2028
Secondary outcomes:
measure: Correlation analysis
timeFrame: August 2023 to May 2028
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05234541: Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks
Official title: To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Extremity Surgery
Keywords: infraclavicular block, perfusion index
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA1-2 50 PATIENTS BETWEEN 18-65 YEARS

Brief summary: To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.

Detailed description: In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2 PATIENTS
* PATIENTS BETWEEN 18-65 YEARS
* PATIENTS WITH INFRACLAVICULAR BLOCK

Exclusion Criteria:

* ASA3-4 PATIENTS
* PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65
* PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY
* PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK
* PATIENTS WITHOUT COOPERATION
* PATIENTS WITH DIABETES MELLITUS
* THOSE WHO HAVE PERIPHERAL ARTERY DISEASE

Primary outcomes:
measure: To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance
timeFrame: Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made.
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman University Recruitment
Study officials:
References: