louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06497777: The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer. Diagnosis of Pancreatic Cancer
Official title: The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Adenocarcinoma
MicroRNA
Keywords: MicroRNA
Pancreas Adenocarcinoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pancreatic ductal adenocarcinoma which are proven by pathology.

Brief summary: Previous research has shown that microRNAs in the blood can serve as biomarkers for early pancreatic cancer, with potential applications including detection, differential diagnosis, and prognosis prediction of pancreatic cancer. The current primary method for detecting microRNAs is RT-qPCR, but this process requires repeated temperature cycling, which demands high precision from the equipment. As an alternative, isothermal nucleic acid amplification technology does not require expensive temperature control instruments. Our research team has developed various isothermal nucleic acid amplification strategies for microRNA sensing platforms, applied to biological sample detection. This study combines the circular strand displacement amplification strategy with DNA nanomachines to develop a fluorescence sensing platform that performs dual signal amplification at a constant temperature. It is designed to detect pancreatic cancer-related microRNAs, exploring its role and potential applications in the diagnosis of pancreatic cancer patients.


Eligibility criteria: Inclusion Criteria:

* Pancreatic ductal adenocarcinoma
* Proven by pathology
* Patients who have not received anti-cancer therapies

Exclusion Criteria:

* Less than 20 years old
* Unable to provide inform and consent
* Patients who have active malignancy other than pancreatic adenocarcinoma
* Patients who have had pancreatic cancer whose anti-cancer therapies are completed or undergoing
* Life expectancy less than 3 months

Primary outcomes:
measure: Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00382577: Efficacy and Safety of Itopride vs Placebo in Heartburn
Official title: A Randomized, Double-blind, Two Period, Crossover Study to Evaluate the Effects of a Single Dose of Itopride 200 mg on Esophageal and Gastric pH and Reflux in Patients With Heartburn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of itopride in patients with heartburn.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.

Primary outcomes:
measure: 24-hour pH Monitoring
timeFrame: after 5 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The Oklahoma Foundation for Digestive Research
state: Oklahoma
Study officials:
affiliation: The Oklahoma Foundation for Digestive Research
name: Philip, Jr. B. Miner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05336877: Aveir VR Coverage With Evidence Development Post-Approval Study
Official title: Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Pacemaker
Arrythmia
Bradycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 8744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Brief summary: The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Detailed description: This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.

The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Eligibility criteria: The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Subjects with Acute Device-Related Complications
timeFrame: 30 days
measure: Number of Subjects Alive after 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Number of Subjects with Chronic Device-Related Complications
timeFrame: 6 months
measure: Number of Subjects with a Device-Related Re-Intervention
timeFrame: 2 years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
affiliation: Abbott
name: Grant Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT04949477: Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group
Official title: Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group Undergoing Adenotonsillectomy: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Keywords: Dexmedetomidine
Paracetamol
Preoperative anxiety
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.

Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.

Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.

Detailed description: Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.

Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.

Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.

The objective of this descriptive study is to compare the efficacy of dexmedetomidine and paracetamol premedication, measuring the degree of anxiety in the children prepared for adenotonsillectomy when they are separated from their parents.

Eligibility criteria: Inclusion Criteria:

* The patients who are clinically free or with controlled medical condition \[ASA I or ASA II\].
* Age between 2 to 8 years.

Exclusion Criteria:

* ASA III or ASA IV.
* Age greater than 8 years.
* Parents' refusal to participate in the study.
* Patients with obstructive sleep apnea.
* Patients with known allergy or hypersensitivity reaction to any of the drugs used in the study.
* Patients with nasal infection or nasal pathology.

Primary outcomes:
measure: Preoperative anxiety
timeFrame: After 50 minutes of drug administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha Faculity of Medicine
state: Elqalyoubea
Study officials:
References:
Clinical trial NCT02987777: Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer
Official title: Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records would be extracted from the pathology database of the Lorraine Comprehensive Cancer Center, Nancy, France

Brief summary: The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and to investigate its correlation impact with progression-free survival (PFS), and clinicopathological features including microsatellite instability and quantified stromal and intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)


Eligibility criteria: Inclusion Criteria:

* All patients consecutively enrolled from January 2004 to December 2014 treated for Endometrial cancer
* Stage III-IV endometrial cancer with available tissue blocks, including biopsies, hysterectomy specimens and resections of metastatic foci

Exclusion Criteria:

* A patient record captured outside the time frame from January 2004 to December 2014

Primary outcomes:
measure: progression-free survival
timeFrame: 84 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03593577: Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI
Official title: Saccular Dilatation, Endolymphatic Hydrops and Vestibular Schwannoma : is Vertigo Really Correlated to the Tumor ? A Retrospective Study Based on FIESTA-C Sequence Using a 3 Tesla MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Schwannoma
Keywords: Schwannoma
saccular dilatation
endolymphatic hydrops
magnetic resonnance imaging
vertigo
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,

Brief summary: Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI).

However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies.

The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops.

The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes.

The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.


Eligibility criteria: Inclusion Criteria:

* Age\> 18,
* Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,
* Subject who has agreed to the use of medical data for the purposes of this research.

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Insufficient imaging data,
* Tumors already treated,
* Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear.
* Impossibility of giving the subject informed information (difficulty understanding the subject,)
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Presence or absence of height and width of the saccule on MRI.
timeFrame: 1 hour after the realization of the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
References:
Clinical trial NCT03503877: Media, Morphokinetics, and Mosaicism
Official title: Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryonic Mosaicism
Embryo Culture Media
Embryo Morphokinetics
Infertility
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sibling embryo study
Primary purpose: TREATMENT

Brief summary: Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.


Eligibility criteria: Inclusion Criteria:

All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.

Antral Follicle Count (AFC) \>8 Male and female partner \> 18 years of age

Exclusion Criteria:

Female partner age \>42 years of age Cleavage stage biopsy

Primary outcomes:
measure: Aneuploidy Rates
timeFrame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Secondary outcomes:
measure: Embryo Quality
timeFrame: 2 weeks from start of IVF treatment
measure: Embryonic Mosaicism
timeFrame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
measure: Embryo Morphokinetics
timeFrame: 2 weeks from start of IVF treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mitchell Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05353777: Clinical Evaluation of the Levita Robotic Platform
Official title: Clinical Evaluation of the Levita Robotic Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Cholelithiases
Other Disease
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2022-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

Detailed description: Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.

Eligibility criteria: Inclusion Criteria:

* • Subject is at least 18 years of age

  * Subject is scheduled to undergo elective laparoscopic procedure
  * Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* • Subjects with pacemakers, defibrillators, or other electromedical implants

  * Subjects with ferromagnetic implants
  * Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  * Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
  * Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
  * Subject is pregnant or wishes to become pregnant during the length of study participation
  * Subject is not likely to comply with the follow-up evaluation schedule
  * Subject is participating in a clinical trial of another investigational drug or device

Primary outcomes:
measure: Adverse Events Related to the Device
timeFrame: 30 days
Secondary outcomes:
measure: Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
timeFrame: Interoperatively
measure: Conversion Rate to Open Surgery
timeFrame: Interoperatively
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Indisa
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital FACH
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital San Borja
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital Tisne
state: Metropolitana
Study officials:
affiliation: Hospital FACH
name: Ignacio Robles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05044377: Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease
Official title: Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-09-14
Enrollment: 540
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Seven cooperative hospitals with cardiovascular as the key specialty in Beijing have continuously registered patients with severe aortic valve disease aged 75 years or older.

Brief summary: Aortic valve disease (AVD) is the most common and age-related mortality in elderly patients with valvular heart disease (VHD). Although transcatheter aortic valve replacement (TAVR) has been recommended at a higher level in foreign guidelines, there are still many high-risk and severe elderly patients with VHD who have not received effective treatment because of many complications and untimely medical treatment. Different from Europe and the United States, the majority of patients with bicuspid aortic valve are in China, and the calcification is more serious. The current clinical evaluation system and treatment guidelines can not be effectively applied to the high-risk and complex elderly patients. Therefore, the investigators should train and set up a valvular heart disease team, explore the technical difficulties of TAVR treatment in such patients, establish emergency TAVR operation mechanism, build a clinical evaluation system for high-risk and complex elderly patients with aortic valve disease in China, evaluate the curative effect periodically and further optimize the treatment strategy, so as to improve the quality of life and the meaning of life cycle of elderly patients with VHD in China Great significance.


Eligibility criteria: Inclusion Criteria:

* • patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography:

  1. aortic stenosis, moderate or above, or valve area ≤1.0cm2, or maximal jet velocity ≥4.0m/sec, or mean pressure gradient ≥40mmHg,
  2. aortic regurgitation, moderate or above, or jet width ≥65% of left ventricular outflow tract, or regurgitant volume≥60ml/beat, or regurgitant fraction ≥50%,

Exclusion Criteria:

* • Patients cannot be followed up for any reasons.
* •Patients have been enrolled in this study

Primary outcomes:
measure: all-cause mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
name: yongjian wu, doctor
role: STUDY_CHAIR
References: