louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02266862: Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair
Official title: Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fenestrated Endovascular Aortic Repair
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 0
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 with fenestrated endovascular aortic repair (FEVAR) will be included in this study.

Brief summary: Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Then, the renal artery segment with maximal angular displacement on each will be located and any changes described.

Participants: There will be 30 subjects recruited from UNC Hospitals.

Procedures (methods): For this study, patients will receive an additional CT sequence (end-expiration CT), which will be compared with the standard of care end-inspiration CT to calculate angular displacement and the distance from the aorta.

Detailed description: The investigators would like to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. The investigators would then locate the renal artery segment with maximal angular displacement on each and describe any changes. Because these patients would be getting pre and post-surgical CTs as part of standard of care, there would be no added charge to obtain the information for the study. There would be, however, minimal increased radiation exposure resulting from the extra scan being performed during end-expiration and the patients would have to consent to the slight added risk to participate.

Eligibility criteria: Inclusion Criteria:

* Undergoing pre-procedural CT scan for FEVAR

Exclusion Criteria:

* Has aortic/renal stent already
* Cannot receive IV contrast due to renal insufficiency or allergy
* Renal arteries are not patent

Primary outcomes:
measure: Change in angular displacement
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ari Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285762: Supermicrosurgical LVA for Lymphedema Treatment
Official title: Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective observational study was approved by the institutional review board in our hospital. From March 2016 to October 2018, 100 patients with 103 lymphedematous lower limbs (International Society of Lymphology stage I-III) were included. All the patients underwent supermicrosurgical LVA performed by a single surgeon using a high-power microscope.

Brief summary: LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.


Eligibility criteria: Inclusion Criteria:

* lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included

Exclusion Criteria:

* Patients whose data were missing will be excluded.

Primary outcomes:
measure: survival or failure
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01252862: Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subjects With Primary Open-angle Glaucoma (POAG)
Keywords: Open angle
Glaucoma
Surgery
Ocular Hypertension
eye diseases
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed description: This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on one topical hypotensive medication

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
timeFrame: 12 Months
Secondary outcomes:
measure: IOP < 18 mm Hg at Month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan's Ophthalmology Centre
Study officials:
References:
citation: Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015.
Clinical trial NCT01702662: Photopill Treatment in Healthy Volunteers
Official title: The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerated Mucosa of Colon
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.

Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.

Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Subjects who are generally healthy.
* Signed informed consent.

Exclusion Criteria:

* Subjects with any known GI related symptoms complaints or GI diseases.
* Subjects with cancer or other life threatening diseases or conditions.
* Subjects with cardiovascular or pulmonary diseases.
* Pregnant women.
* Subjects who underwent any colon surgery.
* Morbid Obesity (BMI \> 40).
* Drug abuse or alcoholism.
* Bed-ridden patient.
* Any rectal therapy.
* Participation in current clinical study or clinical study within 30 days prior to the study.

Primary outcomes:
measure: Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
timeFrame: During Study period: day 0-14
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam, department of Gastroenterology
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Geert D'Haens, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06845462: Application of Artificial Intelligence Algorithm Based on CT Imaging for Muscle Parameter Measurement
Official title: Application of Artificial Intelligence Algorithm Based on CT Imaging for Muscle Parameter Measurement in the Diagnosis of Sarcopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Learning
Sarcopenia
Computed Tomography
Body Composition
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 960 inpatients in the geriatric department of Renji Hospital, 20 patients from Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, 20 patients from The First Affiliated Hospital of Zhejiang Medical University, 50 patients from The First Affiliated Hospital of Wenzhou Medical University, and 30 patients from Huangshan People's Hospital.

Brief summary: To establish an artificial intelligence model for automated diagnosis of sarcopenia based on CT imaging

Detailed description: With the accelerating aging process, the early identification and diagnosis of sarcopenia, along with the effective prevention of its adverse outcomes, have become a focal point in medical research. However, current methods for assessing and diagnosing sarcopenia still face significant limitations, making the development of more efficient and accurate techniques for muscle mass evaluation an urgent clinical need. Although CT is considered as the most promising method for assessing muscle mass, its practical application is hindered by factors such as reliance on physician expertise and time-consuming procedures, limiting its widespread clinical adoption. In light of these challenges, this study aims to develop an artificial intelligence model for fully automated muscle mass measurement based on abdominal CT imaging and to validate its application value in assisting the diagnosis of sarcopenia.

Eligibility criteria: Inclusion criteria：

1. The population undergoing BIA and abdominal CT examinations;
2. Can cooperate to complete human body composition analysis, grip strength measurement, 6m walking time measurement, and questionnaire survey.

Exclusion criteria：

1. Age\<18 years old;
2. Existence of abdominal wall edema;
3. History of spinal surgery or vertebral fractures, or vertebral tumor lesions;
4. History of neuromuscular disorders.

Primary outcomes:
measure: To automatedly and precisely quantify three-dimensional muscle volume and fat volume.
timeFrame: 2020-2023
measure: To establish an artificial intelligence model for diagnosis of sarcopenia.
timeFrame: 2020-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
state: Shanghai
Study officials:
References:
Clinical trial NCT03709862: Global Syphilis Sequencing
Official title: Whole Genome Sequencing of Syphilis Using Routine Clinical Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Wellcome Sanger Institute
First posted: 2018-10-17
Enrollment: 726
Sex: ALL
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 presenting to sexual health services in UK with a diagnosis of syphilis.

We will identify residual T.pallidum DNA from routinely collected clinical samples held at participating clinics/hospitals. Data accompanying these samples will be anonymised and will not include patient identifiable information. Accompanying data will include: city of origin, age, gender, HIV status and sexual orientation.

Brief summary: Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab.

In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of syphilis

Exclusion Criteria:

* No PCR positive clinical sample

Primary outcomes:
measure: Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage
timeFrame: Measured at baseline - time of enrollment. There are no further samples or visits in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Brighton
country: United Kingdom
facility: Brighton and Sussex NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds University Teaching Hospital
city: London
country: United Kingdom
facility: Mortimer Market Centre
city: Manchester
country: United Kingdom
facility: Penine Acute Hospitals Trust
Study officials:
References:
Clinical trial NCT02768662: A 6-Month Extension Study of OTO-104 in Meniere's Disease
Official title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Meniere's Disease
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 142
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: This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
* Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.

Primary outcomes:
measure: Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Many sites in Europe. Refer to the contact info listed below.
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Kathie Bishop, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02810262: Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)
Official title: Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Metastases
Lung Cancer
Keywords: Lung cancer
Bone metastases
EGFR
KRAS
Bone biomarkers
Metabolic parameters
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 200
Sex: ALL
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: POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor

Brief summary: Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.

Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.

Survival analyses will be performed using a proportional hazard regression model.


Eligibility criteria: Inclusion Criteria:

* adults over 18 years
* both gender
* covered by the French National Insurance
* first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)

Exclusion Criteria:

- adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)

Primary outcomes:
measure: serum DKK1
timeFrame: day 0
Secondary outcomes:
measure: serum HbA1C
timeFrame: day 0
measure: urinary CTX
timeFrame: day 0
measure: hip bone mass (g/cm²)
timeFrame: day 0
measure: mutational profile of the bone metastases
timeFrame: day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Edouard Herriot - Centre des Métastases Osseuses (CEMOS)
Study officials:
References:
citation: Dirckx N, Tower RJ, Mercken EM, Vangoitsenhoven R, Moreau-Triby C, Breugelmans T, Nefyodova E, Cardoen R, Mathieu C, Van der Schueren B, Confavreux CB, Clemens TL, Maes C. Vhl deletion in osteoblasts boosts cellular glycolysis and improves global glucose metabolism. J Clin Invest. 2018 Mar 1;128(3):1087-1105. doi: 10.1172/JCI97794. Epub 2018 Feb 12.
Clinical trial NCT03705962: Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Official title: Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fractures, Open
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.


Eligibility criteria: Inclusion Criteria:

* Ages 18 - 70 years
* Gustilo Type I,II,IIIa open fracture (s)
* Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
* Subject should be able to follow up at the scheduled times following surgery
* Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study

Exclusion Criteria:

* Closed fracture
* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
* Aminoglycoside allergy
* Presentation greater than 48 hours after injury
* Pathologic fracture
* Preexisting infection in bone with an open fracture
* Patients with multiple trauma involving liver, kidney, or brain
* Pregnancy (self-reported)
* Current status as prisoner

Primary outcomes:
measure: Presence of Wound Infection
timeFrame: 6 weeks post op
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Seth Yarboro, MD
role: PRINCIPAL_INVESTIGATOR
References: