louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06430372: Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract
Official title: Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Gastrointestinal Carcinoma
Dysplasia
Gastrointestinal Polyp
Lead sponsor: Institute of Automation, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. We are using a VEGF-A targeting fluorescent probe and a NIR-II fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye.

The main purposes of this study include:

1. To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
2. To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
3. To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.


Eligibility criteria: Inclusion Criteria:

* Known or suspected gastrointestinal lesions.
* Scheduled for a clinically-indicated endoscopy.
* Mentally competent person, 18 years or older.
* Approved to sign the informed consent.
* Adequate potential for follow-up.

Exclusion Criteria:

* Subjects with known allergy or negative reaction to ICG or derivatives.
* Undesirable function of heart, lung, kidney, or any other organs.
* Enrolled in other trials in the past 3 months.
* Pregnant or trying to conceive.
* Unable to tolerate an endoscopy.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* The researchers considered inappropriate to be included.

Primary outcomes:
measure: Validation of NIR-II endoscope and probe targeting VEGF-A
timeFrame: During endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lidan Fu
state: Beijing
Study officials:
References:
Clinical trial NCT01166672: BCRL Prevention Pilot
Official title: Weight Loss to Prevent BCRL: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Breast Cancer
Keywords: obese women (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done
with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the
past 2 years will be invited to participate.
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Women, aged 18-70, who are obese (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the past 2 years will be invited to participate.

Brief summary: The purpose of this study is to establish feasiblity of recruiting obese breast cancer survivors at the end of treatment, getting those survivors to lose weight and attend follow-up visits for 6 months.

Detailed description: Breast cancer related lymphedema occurs in 20-30% of survivors. Weight loss could prevent onset. We seek to do a pilot study to establish feasibility of 1) recruiting survivors at risk for lymphedema to do a weight loss intervention, 2) achieving 10-15% weight loss over 26 weeks in this population, and 3) attendance at follow-up visits 6 months.

Eligibility criteria: Inclusion Criteria:

* Women
* Breast Cancer Survivors who had 5 or more lymph nodes removed and radiation to lymph nodes as part of treatment.
* Completed all treatments - no metastatic cancers
* Overweight or obese (BMI greater than or equal to 25 kg/m2)
* Medically and logistically able to participate in a weight loss and exercise program over 6 months.
* Diagnosed with breast cancer within the past 2 years.

Exclusion Criteria:

* More than 2 years since breast cancer diagnosis
* Medical status that would preclude safety of participation in a weight loss and exercise program
* Metastatic cancer
* Already enrolled in a weight loss program

Primary outcomes:
measure: Follow-up Appts.
timeFrame: 6 months
Secondary outcomes:
measure: Response Rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02896972: Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Official title: Efficacy of Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole Retinal Detachment
Keywords: vitrectomy
macular hole retinal detachment
high myopia
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Detailed description: Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months.

Primary outcomes:
measure: Visual acuity before and after surgery
timeFrame: Changes from baseline to 1, 3, 6 months
Secondary outcomes:
measure: Optical coherence tomography
timeFrame: Changes from baseline up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744972: Native Tissue Repair in Pelvic Organ Prolapse -Long-term Results and Risk of Re-operation
Official title: Native Tissue Repair in Pelvic Organ Prolapse -Long-term Results and Risk of Re-operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Cystocele
Keywords: Recurrence
Native tissue repair
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-20
Enrollment: 392
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients treated for cystocele for the first time with native tissue repair.

Brief summary: This study evaluates the recurrence of pelvic organ prolapse and the rate of re-operation after primary surgery for anterior vaginal wall prolapse with native tissue repair in long term follow-up.

Detailed description: This was a retrospective cohort study including patients undergoing their first surgical intervention for pelvic organ prolapse in Turku University Hospital gynecology department in the years 2000-2005. The point of interest was to study patients with prolapse of the anterior vaginal compartment (i.e. cystocele) with native tissue repair surgical approach as treatment. We made a search from the medical database of surgical procedures for operation codes LEF00 (i.e.anterior colporraphy and LEF13 (i.e. vaginal hysterectomy of descended uterus with/without vaginal/perineal molding) during the studied period. Initially, we found 699 patients with matching operating codes and for those, we went through their medical records. From the final study population, we excluded those who had previously had an operation for pelvic organ prolapse and those whose primary operation didn't include anterior colporraphy and those who weren't eligible for long term follow-up. Thus, the study population constituted of 392 subjects who were followed through medical records until the end of October 2018.

From the medical records, we collected the day of birth, the date of the primary operation, body mass index, history of vaginal childbirth and cesarean section (if available), history of incontinence surgery, the grade of cystocele and diagnosis and before surgery, the operation code and executed surgical procedures, possible complications, and the history of possible re-operations. Also, the date of death was reported as well as the date of changing residence outside the Hospital District of Varsinais-Suomi.

All gathered information were saved without personal details.

Eligibility criteria: Inclusion Criteria:

* cystocele treated with native tissue surgery, medical records reaching until the end of follow-up period

Exclusion Criteria:

* history of previous pelvic organ prolapse surgery

Primary outcomes:
measure: Rate of re-operations
timeFrame: Long-term, at least 5 years follow up.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05734872: Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior
Official title: Psychiatry Department of The Second Affiliated Hospital of Zhejiang University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-suicidal Self-injury
Keywords: Non-suicidal Self-injury
Virtual Reality Technology
Adolescent
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non suicidal self injury (NSSI) has become a serious social and public health problem allover the world, and the incidence rate is increasing year by year. Although the aim of NSSI is not to suicide, but its negative impact is extremely serious, which will seriously threaten the physical and mental health of adolescents. Virtual Reality (VR), a computer simulation technology, can enable people to enter and experience the artificial virtual world in an immersive way, has been used for the auxiliary treatment of anxiety disorder, post-traumatic stress disorder and other diseases. This study explored the impact of VR on the depression and mental health of NSSI adolescents, so as to reduce the incidence of non-suicide self-injury behavior in NSSI adolescent patients and improve the quality of life of such patients.


Eligibility criteria: Inclusion Criteria:

* According to the diagnostic criteria of NSSI in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
* Have a past history of non-suicidal self-injury behavior.
* No virtual reality technology intervention before enrollment.
* age: ≥ 18 to\<24.

Exclusion Criteria:

* Those who have serious physical diseases
* Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content\<50%.

Primary outcomes:
measure: Ottawa Self-injury Inventory Chinese Revision
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Fang Chen
role: STUDY_CHAIR
References:
Clinical trial NCT00534872: A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population
Official title: A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female "Non-childbearing Potential", Healthy Male and in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Insomnia
Keywords: 4 Parallel cohorts
Healthy Female
Healthy Elderly
Pharmacokinetic
Safety and Tolerability
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population


Eligibility criteria: INCLUSION CRITERIA:

* Healthy adult and elderly female and male
* Female must be of non-childbearing potential
* Body weight =50 kg

EXCLUSION CRITERIA:

* Abuse of alcohol or drugs
* Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
* Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication
* Smoking history of = 10 cigarettes a day in the last three months
* History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases
* Participation in clinical trial during the previous 6 months

Primary outcomes:
measure: Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
timeFrame: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary outcomes:
measure: Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868
timeFrame: within 7-14 days from a single dose of SB-649868
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04728672: Effects of Kinesio Taping on Hip Abductor Muscle Strength and EMG Activity
Official title: The Effects of Kinesio Taping on Hip Abductor Muscle Strength and EMG Activity in Athletes With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Keywords: Chronic ankle instability
Hip abductors
Kinesio Taping
Muscle strength
EMG
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups pretest-posttest design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Athletes with chronic ankle instability tend to develop Glutei muscle weakness. This weakness makes the lower limb prone to injuries. Kinesio Tape (KT) may assist this muscle in performing its functions thus preventing injuries.

Detailed description: The aim was to study the effects of Kinesio Tape on hip abductor muscle strength and EMG activity. Pretest-posttest experimental design was used. The study was conducted in the research lab of the University. Thirty-four athletes with a mean age of 22.08 years participated in the study. For the experimental group Kinesio Tape and for the control group Micropore Tape (MT) was applied over Gluteus Medius (GM) muscle. GM muscle's strength and EMG activity were noted in supine and during the Single-Leg Squat Test (SLST) respectively before and after the intervention. Hip abductor muscle strength measured through a maximum voluntary isometric contraction (MVIC) and GM activation measured through EMG. Handheld dynamometer (Lafayette manual muscle test system), Power Lab EMG system.

Eligibility criteria: Inclusion Criteria:

* Repeated episodes of giving way after an initial ankle sprain,
* A history of at least 2 ankle sprains to the same side without injury to the contralateral ankle in the last 2 years,
* No history of other trauma to the lower extremities for the past 3 months prior to the study,
* Participants also needed to be capable of full weight-bearing without analgia,
* Subjectively reported that functional use of ankle had plateaued since the last injury.

Exclusion Criteria:

* Participants having a history of ankle fracture, knee ligament injury, back or lower limb surgery, neuromuscular disease, or current neurological deficit,
* Currently receiving ankle rehabilitation were excluded from the study.

Primary outcomes:
measure: Maximum Voluntary Isometric Contraction
timeFrame: upto 1 month
measure: Electromyography
timeFrame: upto 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01078272: The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
Official title: The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Atherosclerosis
Percutaneous Coronary Intervention
Coronary Stenting
Coronary Stenosis
Remote Ischemic Preconditioning
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm will improve results of coronary stent implantation by:

* reducing chest pain and electrocardiogram changes during balloon inflation to place the stent
* reducing leakage of heart muscle protein(troponin) into the blood stream after stent placement, indicated reduced damage to heart muscle during stent implantation
* increases in molecules in the blood that promote dilation of arteries
* reduced evidence of heart muscle damage on MRI immediately after stenting
* improved patient outcomes over six months with fewer adverse cardiovascular events(heart attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death, stroke, transient ischemic attack)
* improved heart structure and function at 6 months after stenting


Eligibility criteria: Inclusion Criteria:

* Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.

Exclusion Criteria:

* Recent (1 month) myocardial infarction
* Acute coronary syndrome
* Chest pain at res
* Estimated glomerular filtration rate(GFR)\<45 mL/min/1.73 m2
* Frequent premature atrial or ventricular contractions or atrial fibrillation
* Any contraindication to MRI including implanted non MRI compatible medical devices or ferromagnetic materials such as shrapnel
* Inability to breath-hold
* Severe claustrophobia
* Deafness
* Persistent tremor
* Inability to follow instructions.

Primary outcomes:
measure: MACE
timeFrame: 6 months post-stenting
Secondary outcomes:
measure: troponin I
timeFrame: 24 hours
measure: chest pain during stenting
timeFrame: immediate during procedure
measure: ST segment changes during stent implantation
timeFrame: immediate
measure: MRI delayed enhancement
timeFrame: 1-7 days after stenting
measure: Late left ventricular volumes and ejection fraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St. Francis Hospital-The Heart Center
state: New York
Study officials:
affiliation: St. Francis Hospital-The Heart Center, Roslyn, NY
name: Nathaniel Reichek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03208972: Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG
Official title: Prospective Randomized Trial Comparing Ovarian Stimulation in IVF-patients With Corifollitropin Alfa in Combination With Hp-FSH Versus Corifollitropin Alfa in Combination With Low Dose hCG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
ovarian stimulation
low dose hCG
hp-FSH
Corifollitropin Alfa
costs of IVF
Lead sponsor: AZ Jan Palfijn Gent
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouw Hospital
First posted: 2017-07-06
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also the overall IVf costs significantly.


Eligibility criteria: Inclusion Criteria:

* IVF/ICSI patients
* Cycle 1, 2, 3, 4

Exclusion Criteria:

* PCOS
* Endocrinological diseases

Primary outcomes:
measure: The financial costs of the stimulation in both groups
timeFrame: 1 year
Secondary outcomes:
measure: The number of MII oocytes obtained at the occasion of the oocyte retrieval
timeFrame: 3 weeks
measure: pregnancy rate
timeFrame: 5 weeks
measure: duration of the stimulation
timeFrame: one month
measure: hormonal levels reached at time of induction of final maturation of the oocyte
timeFrame: 3 weeks
measure: the number of clinical OHSS patients
timeFrame: one month
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: Oost-Vlaanderen
Study officials:
affiliation: FERTILITY CENTER AZ JAN PALFIJN
name: Wim Decleer, MD
role: PRINCIPAL_INVESTIGATOR
References: