louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02857556: Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure
Official title: Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End-stage Chronic Kidney Failure
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.


Eligibility criteria: Inclusion Criteria:

* Patient who have been informed about the research
* Patients with national health insurance cover
* Patients aged between 18 and 75 years
* Patients with stage 3 kidney failure (30 ml/min \< cl creat \< 59 ml/min) diabetic or not
* Patients with stage 5 kidney failure (cl creat \< 15 ml/mn) diabetic or not and requiring dialysis.

Exclusion Criteria:

* Patients under guardianship
* Pregnant or breast-feeding women
* Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
* Neoplastic disease,
* Systemic diseases in flare,
* Patients positive for Human Immunodeficience Virus (HIV),
* Patients on immunosuppressants
* Patients taking antioxidants (selenium, vitamin C and/or E)
* Patient on statins

Primary outcomes:
measure: Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.
timeFrame: at the beginning of the period Day 0, at 1 month and at 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05376956: Comparison of Effect of Muscle Energy Technique vs PNF in Individuals With Hamstring Shortness
Official title: Comparison of Effect of Muscle Energy Technique vs PNF in Individuals With Hamstring Shortness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hamstring Shortness
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison between the Effect of Muscle Energy Technique in Individuals with Hamstring Shortness and PNF in Individuals With Hamstring Shortness


Eligibility criteria: Inclusion Criteria:

* Subjects with age group between 20 to 60 years with sedentary lifestyle will be included.
* both males and females will be included.
* Patients with diagnosed Tight hamstrings having knee extension less than 160º with the hip at 90º flexion.
* Patients with decreased ROM at the knee joint.
* Patients with reduced straight leg raise.
* Patients with pain in posterior compartment of thigh.
* Asymptomatic patients will be included.
* Patients with restricted mobility of lower limb due to Hamstring shortness.
* Symptomatic patients with hamstring tightness like of low back pain, pelvic tightness, knee osteoarthritis (grade 1 and 2) are included in the research.

Exclusion Criteria:

* Patients with prolapsed disc will excluded.(14)
* Patients with lower extremity injuries (strain, sprain, ligament injuries, etc.) in last 6 months will be excluded.
* Patients with severe hamstring injury either acute or chronic will be excluded.
* Patients with visual acute swelling in the region of hamstring muscle
* Patients with fracture of any type and area.
* Patients with dislocations or subluxations present will be excluded.
* Patient recommended for TKR of knee joint.
* Patients with any neurological disease like lumbar/cervical herniation, polyneuropathy, scoliosis etc.)
* Patient with any tumor of hip or knee with traumatic brain injury, spinal cord injuries will be excluded.

Primary outcomes:
measure: Individuals With Hamstring Shortness
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Study officials:
References:
Clinical trial NCT02315456: Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser
Official title: Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsulorhexis
Keywords: capsulorhexis
IOL centration
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: OptiMedica Corporation
First posted: 2014-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.

Detailed description: 50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.

Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.

Eligibility criteria: Inclusion Criteria:

* Patients with cataracts
* Same variety of IOL inserted in all eyes

Exclusion Criteria:

* Previous glaucoma or retinal surgery
* Pupil not dilating beyond 6mm
* Zonular weakness or pseudoexfoliation
* Extensive corneal scarring
* High refractive error: Myopia greater than 10D, Hyperopia greater than 5D

Primary outcomes:
measure: Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL
timeFrame: 10-30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Surendra Basti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
Clinical trial NCT05681156: Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
Official title: Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus Pneumoniae Infection
Legionella Pneumophila Serogroup 1 Infection
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients arriving at hospital with suspected pneumonia

Brief summary: Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.

Detailed description: This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.

Eligibility criteria: Inclusion Criteria:

* Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician.
* At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing
* Only one (1) specimen per patient will be included in the study
* Materials used within their expiration date
* Storage time and conditions within requested indications listed on RUO Package Insert

Exclusion Criteria:

* Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered
* Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert
* Urine samples provided in unsatisfactory conditions

Primary outcomes:
measure: Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
citation: Yasuo S, Murata M, Nakagawa N, Kawasaki T, Yoshida T, Ando K, Okamori S, Okada Y; Japanese ARDS clinical practice guideline systematic review task force. Diagnostic accuracy of urinary antigen tests for pneumococcal pneumonia among patients with acute respiratory failure suspected pneumonia: a systematic review and meta-analysis. BMJ Open. 2022 Aug 11;12(8):e057216. doi: 10.1136/bmjopen-2021-057216.
citation: Schimmel JJ, Haessler S, Imrey P, Lindenauer PK, Richter SS, Yu PC, Rothberg MB. Pneumococcal Urinary Antigen Testing in United States Hospitals: A Missed Opportunity for Antimicrobial Stewardship. Clin Infect Dis. 2020 Sep 12;71(6):1427-1434. doi: 10.1093/cid/ciz983.
Clinical trial NCT03135756: Mechanisms of Anxiety and Depression Study
Official title: Transdiagnostic Endophenotypes of Anxiety and Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Lead sponsor: Palo Alto University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators expect to enroll 50 right-handed, English as first language, adults will be recruited from the community through various advertisements. The investigators expect that 25 will be healthy controls and 25 will be a clinical sample exhibiting clinically significant symptoms of anxiety and depression.

Brief summary: Eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks, (2) participants with anxiety and depression will likely show differences in brain functionality compared to the healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.

Detailed description: In order to determine eligibility, a brief phone screen lasting approximately 15 minutes will be conducted. If participants are eligible, they will be asked to come in for three separate visits. During the first visit, participants will complete questionnaires as well as a structured interview with one of the study's staff members at Palo Alto University in Los Altos. During the second visit, participants would come to Palo Alto University in Los Altos and complete questionnaires as well as a testing session involving various tasks. During the third visit, participants would undergo a non-invasive brain scan in which participants would complete a task as well as various questionnaires at Stanford University in Stanford.

The investigators have flexible hours and can work around participants' schedules! To inquire more about participation, participants can either email the investigators at paloalto.study@gmail.com or call the investigators at (650) 417-2000 ext. 3642

Eligibility criteria: Inclusion Criteria:

* Right-handed
* Healthy with no medical conditions OR have a history of anxiety and/or depression
* Ability to travel to both Palo Alto University and Stanford University

Primary outcomes:
measure: Brain imaging
timeFrame: Day 1
measure: Assessment of symptoms and daily functioning
timeFrame: Day 1
measure: Cognitive assessment
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Palo Alto University
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Palo Alto University
name: Stacie Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01644656: Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
Official title: Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Chronic Liver Disease
Keywords: portal hypertension
cirrhosis
ARFI
diagnostic study
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2012-07-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

Detailed description: DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.

METHODOLOGY

* The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
* Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Eligibility criteria: Inclusion Criteria:

* age 18-85 years
* compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care
* signed informed consent

Exclusion Criteria:

* known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy
* portal thrombosis
* previous surgical or transjugular portosystemic shunt
* previous total or partial splenectomy
* presence of comorbid conditions conferring a life expectancy of less than 1 year

Primary outcomes:
measure: correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
timeFrame: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Guadalupe Garcia-Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04681456: Skin Cancer Oncology Radiation Evidence Registry
Official title: Skin Cancer Oncology Radiation Evidence Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-melanoma Skin Cancer
Lead sponsor: GenesisCare USA
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited based on their potential eligibility to receive VMAT widefield radiotherapy treatment of their NMSC. The RO will assess if the condition is suitable for VMAT treatment, and if so, will discuss the Registry with the participant.

Brief summary: To collect and analyze long term safety and efficacy outcomes of patients undergoing radiotherapy for non-melanoma skin cancer. A target of 400 VMAT-treated sites is set which is estimated to be identified in approximately 350 participants. Participants referred for radiotherapy for the management of non-melanoma skin cancer.

Detailed description: The Registry will collect information on key clinical indications and patient reported outcomes to assess the safety and efficacy of VMAT radiotherapy. Data that will be collected includes baseline data of demographic, relevant medical history, photographs, treatment schedule, and treatment outcomes. Data may be collected retrospectively in regard to previous relevant medical history, prior treatments and outcomes as well as prospectively, including treatment schedule and treatment outcomes of radiotherapy treatment.

The Registry aims to assess the safety and outcomes of treatment for up to 5 years. This Registry will be the first of its kind in the US and will provide a basis for a number of potential research publications. The Registry will also give insights into treatment delivery and potentially facilitate future improvements in patient care.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Diagnosed with a treatable non-melanoma skin cancer by referring medical practitioner
* Eligible to be treated using widefield (\>50cm2) VMAT radiotherapy as determined by RO
* Patient has provided written informed consent.

Exclusion Criteria:

♦ Patients who do not consent to their involvement in the Registry.

Primary outcomes:
measure: Participants will have their responses to radiotherapy after treatment of non-melanoma skin cancer measured and reported as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: GenesisCare USA
state: Florida
Study officials:
affiliation: GenesisCare USA
name: Constantine Mantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04383756: Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
Official title: Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Transfusion Related Complication
Liver Transplant
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 recipients receive donor whole blood 20 historic match controls are compared to the 20 study participants
Primary purpose: TREATMENT

Brief summary: We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers


Eligibility criteria: Inclusion Criteria:

* - Recipients 18 years or older.
* Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
* ABO-matched recipient and donor.
* Donor Hb level \>/= 8 g/dL
* Recipients with negative ABO antibody screen

Exclusion Criteria:

* - Pediatric recipient.
* HBS Antigen+ donors
* HCV NAT+ donors
* Donors of A2 blood type
* Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement

Primary outcomes:
measure: Use of allogenic banked blood products
timeFrame: perioperative up to 72 hours post operative
measure: Economic cost
timeFrame: perioperative up to 72 hours post operative
Secondary outcomes:
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Baseline to discharge (approximately 4-5 days)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Clayne Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772456: Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas
Official title: Correlation of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging and Tumor Histopathology in Patients With Infiltrating Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Glioma
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging

The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study.

Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).


Eligibility criteria: Inclusion Criteria:

* • Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection.

  * Ages 18-80, including male and female
  * Suitable to undergo contrast-enhanced MRI
  * Negative serum pregnancy test

Exclusion Criteria:

* Inability to undergo MRI scan
* Inability to receive IV contrast secondary to severe reaction or renal insufficiency.

Primary outcomes:
measure: Accuracy of metabolic MRI to diagnose Glioma
timeFrame: Within three years post treatment
Secondary outcomes:
measure: Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer
timeFrame: Within three years post treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Rosy Njonkou Tchoquessi
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Dirk Mayer, Dr. rer. nat
role: PRINCIPAL_INVESTIGATOR
References: