louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02944539: Association Between Mitochondrial DNA Content and Risk of Gastric Cancer
Official title: Association Between Mitochondrial DNA Content and Risk of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasms
Keywords: Mitochondrial DNA copy number
Gastric cancer
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 300 eligible gastric cancer patients were anticipated to include in this study. Moreover, 300 healthy controls without previous cancer history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

Brief summary: Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of gastric cancer.The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for gastric cancer.


Eligibility criteria: Inclusion Criteria:

* 1.histological confirmed gastric adenocarcinoma; 2.receiving surgical resection; 3.no preoperative anticancer treatment; 4.alive at least 1 months after surgery.

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Primary outcomes:
measure: Relative copy number of mitochondrial DNA
timeFrame: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00257439: Vitamin Metabolism in Kidney Disease
Official title: Vitamin Metabolism in Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure
Keywords: Vitamin B12
Folic Acid
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aarhus University Hospital
First posted: 2005-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. CKD, proteinuria
2. Healthy controls

Brief summary: The purpose of this study is to evaluate the urinary excretion and renal metabolism of vitamins, in particular vitamin B12 and folate, in relation to various renal conditions involving loss of renal function and/or proteinuria.


Eligibility criteria: Inclusion Criteria:

* Admission to the Department of Nephrology, Aalborg Hospital
* Elevated serum creatinine
* Proteinuria
* Informed and written consent

Control subjects:

* Normal serum creatinine and creatinine clearance
* No proteinuria

Exclusion Criteria:

* Vitamin supplementation (exceeding predefined values)
* Renal replacement therapy (dialysis)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Nephrology, Aalborg Hospital
Study officials:
affiliation: Department of Nephrology, Aalborg Hospital
name: Henrik Birn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05236439: Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma
Official title: Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Cilioscleral Interposition Device (CID) SV22 in Glaucoma Patients Refractory to Topical Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Ciliatech
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 57
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 effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

Detailed description: 57 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Primary Glaucome Schafer 1 to 4
* Medicated IOP ≥ 21
* naive of any glaucoma surgery

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Primary outcomes:
measure: Assess post-op IOP reduction
timeFrame: 6 months
Secondary outcomes:
measure: Compare efficacy outcomes between POAG and PNAG sub-groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Malayan center
Study officials:
affiliation: Malayan Center
name: Lilit Voskanyan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544239: Virtual Reality Asymmetric Training of Technology And Tactics for Professional Basketball Players
Official title: Virtual Reality Basketball Asymmetric Training
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asymmetric Limb Muscle Stiffness
Recovery, Psychological
Body Schema
Keywords: Virtual Reality Training
Physical
Recovery
Sports Psychology
Skill
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Group (virtual reality training) \& Control Group (traditional training)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study exploring the effects of virtual reality basketball asymmetric training on the technical and tactical ability of professional basketball players (male and female) through the use of virtual reality devices.

Detailed description: The experimental conclusion of this study was obtained by comparing virtual reality basketball asymmetric training with traditional basketball asymmetric training (using cRCT random experimental grouping)

Eligibility criteria: Inclusion Criteria:

* Asymmetric limbs
* Psychological defects
* Joint stiffness
* Amyotrophic lateral sclerosis

Exclusion Criteria:

* Physically and mentally healthy individuals
* Schizophrenia patients
* Cognitive impairment patients

Primary outcomes:
measure: Effects of Asymmetric Training in Virtual Reality Basketball on The Complex Technical Completion Scores of Professional Basketball players
timeFrame: Pretest：July 27th Post-test 1：August 25th Post-test 2：September 22nd
measure: Effects of Asymmetric Training in Virtual Reality Basketball on The Complex Technical Completion Rate of Professional Basketball players
timeFrame: Pretest：July 27th Post-test 1：August 25th Post-test 2：September 22nd
measure: Effects of Asymmetric Training in Virtual Reality Basketball on Complex Tactics Scores of Professional Basketball Players
timeFrame: Pretest：July 27th Post-test 1：August 25th Post-test 2：September 22nd
Secondary outcomes:
Other outcomes:
Locations:
city: JiNan
country: China
facility: Shandong Provincial Sports Training Center
state: Shandong
Study officials:
affiliation: Universiti Putra Malaysia Research Institute Branch
name: Soh Kim Geok, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01942239: Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
Official title: Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Keywords: hypoglycemia
very low birth weight neonate
continuous glucose monitoring
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours

Exclusion Criteria:

* a serious congenital abnormality,
* a skin condition that contraindicated continuous glucose monitoring,
* a transfer toward another hospital during the first days of life
* an absence of parental agreement.

Primary outcomes:
measure: number of hypoglycemia episodes
timeFrame: at the end of the first 3 days of life
Secondary outcomes:
measure: duration of hypoglycemic episodes
timeFrame: after their 3 first days of life
Other outcomes:
Locations:
city: Tours
country: France
facility: UH Tours Clocheville hospital
Study officials:
affiliation: UH Tours
name: Aude Chemin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933239: Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients
Official title: A Phase II Study to Evaluate the Imaging Potential of 68GaNOTA-Anti-MMR VHH2 for in Vivo Imaging of MMR-expressing Macrophages by Means of Positron Emission Tomography (PET) in Patients With Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: PET/CT
MMR-PET/CT
Macrophage PET/CT
CD206
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent
* Patients at least 18 years old
* Patient with local, locally advanced or metastatic disease of non-small cell lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions
* Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
* Pregnant patients
* Breast feeding patients
* Patients with any serious active infection
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
* Patients who are unlikely to cooperate with the requirements of the study
* Patients who are unwilling and/or unable to give informed consent
* Patients at increased risk of death from a pre-existing concurrent illness

Primary outcomes:
measure: Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
timeFrame: Resection of lesion up to 21 days after PET/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Tony Lahoutte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912039: Electromyographic Assessment of the TetraGraph in Normal Volunteers
Official title: Electromyographic Assessment of the TetraGraph in Normal Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this study is normal, healthy, unpremedicated human volunteers.

Brief summary: There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.


Eligibility criteria: Inclusion Criteria

1. Age 18 years or older
2. Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
3. Volunteer has provided verbal informed consent

Exclusion Criteria

1. Presence of an underlying neuromuscular disease
2. Use of medications known to interfere with neuromuscular transmission
3. Volunteer has open sores/rashes at the locations needed for electrode application
4. Volunteer does not tolerate a trial electrical stimulation comfortably.

Primary outcomes:
measure: Comparison of train of four measurements between TOF Watch and TetraGraph
timeFrame: During stimulation
Secondary outcomes:
measure: Noise level
timeFrame: During stimulation
measure: Stimulus artifact
timeFrame: During stimulation
measure: Appearance EMG response
timeFrame: During stimulation
measure: EMG amplitude
timeFrame: During stimulation
measure: Maximal EMG amplitude
timeFrame: During stimulation
measure: Consistency in amplitude
timeFrame: During stimulation
measure: Discomfort level
timeFrame: During stimulation
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
References:
Clinical trial NCT02051439: The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Official title: A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Venous Insufficiency
Keywords: Varicose Veins
Venous Insufficiency
Doppler
Duplex
Valsava
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.

Detailed description: In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.

Eligibility criteria: Inclusion Criteria:

* Age within 18-80 years old
* Visible GSV varicose veins
* Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
* Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
* Consent to participate in the study.

Exclusion Criteria:

* - CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
* Failure to language communication
* Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
* Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
* Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)

Primary outcomes:
measure: Number of successfully identified reflux with different method of Valsava technic
timeFrame: 20 minutes
Secondary outcomes:
measure: The timing for the instruction of conventional Valsava and balloon assisted Valsava
timeFrame: 20 minutes
measure: The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava
timeFrame: 20 minutes
measure: The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03173339: Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
Official title: Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthroplasty
Keywords: intubation
pharyngitis
remifentanil
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Pregnancy
* Allergy to remifentanil
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone

Primary outcomes:
measure: Number of participants with sore throat
timeFrame: At 24 hr
Secondary outcomes:
measure: Number of participants with sore throat
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with hoarseness
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with cough
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with nausea
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with vomiting
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with additional pain medication
timeFrame: At 0, 2, 4 and 24 hr
measure: Visual analogue scale of postoperative pain
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with shivering
timeFrame: At 0, 2, 4 and 24 hr
measure: Requirements of analgesics
timeFrame: At 0, 2, 4 and 24 hr
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University
state: Non-US/Canada
Study officials:
affiliation: Keimyung University
name: Hyun-Chang Kim, MD. Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JH, Lee YC, Lee J, Kim H, Kim HC. The influence of high-dose intraoperative remifentanil on postoperative sore throat: a prospective randomized study: A CONSORT compliant article. Medicine (Baltimore). 2018 Dec;97(50):e13510. doi: 10.1097/MD.0000000000013510.
Clinical trial NCT05895539: Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool
Official title: The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation: an Iterative Plan-Do-Study-Act (PDSA) Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet-based Intervention
Web-based Intervention
Online Intervention
Erectile Dysfunction
Telemedicine
Lead sponsor: Ro
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence.

This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.


Eligibility criteria: Inclusion Criteria:

* Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month
timeFrame: 91 days
measure: Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months
timeFrame: 123 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Ro HQ
state: New York
Study officials:
affiliation: Ro
name: Lauren Broffman, PhD
role: STUDY_DIRECTOR
References: