louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04917510: Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy
Official title: Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy: A Prospective Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Disease
Postoperative Pain
Keywords: Hip
Pain
Arthroscopy
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either the study group or control group prior to undergoing surgery
Primary purpose: TREATMENT

Brief summary: The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.

Detailed description: The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. The control group will not receive a preoperative block prior to surgery, but will receive local anesthetic at the surgical site at the conclusion of the surgery. The study group will receive a preoperative block and local anesthetic. The primary outcomes will be pain levels and opioid consumption in the post-operative care unit. The secondary outcomes will be pain levels and opioid consumption post-operatively, and functional outcome measures.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing hip arthroscopy for femoroacetabular impingement
* Ages 13-50
* Individuals who have the capacity to provide consent or assent for themselves

Exclusion Criteria:

* Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty)
* Revision surgery
* Known narcotic use in the 6 months prior to surgery
* Workman's compensation patient
* Pregnancy

Primary outcomes:
measure: Post Anesthesia Care Unit Opioids
timeFrame: 6 hours post-operatively
measure: Post Anesthesia Care Unit Pain
timeFrame: 6 hours post-operatively
Secondary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score
timeFrame: 1 year post-operatively
measure: Patient Reported Outcomes measurement Information System Score
timeFrame: 1 year post-operatively
measure: Range Of Motion
timeFrame: 1 year post-operatively
measure: Outpatient Opioids
timeFrame: 4 weeks post discharge
measure: Outpatient Visual Analog Scale scores
timeFrame: 4 weeks post discharge
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Institute for Orthopedics and Neurosciences
state: Virginia
Study officials:
affiliation: Carilion Clinic Ortho Surgeon
name: Benjamin Coobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01858610: Drug Interaction Between Irbesartan and Hydrochlorothiazide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fixed dose combination
Pharmacokinetics
Irbesartan
Hydrochlorothiazide
Pharmacodynamics
Normotensive Participants
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.


Eligibility criteria: Inclusion Criteria:

At least 18 years old and not more than 45 healthy normotensive male volunteers Who had passed all the screening parameters

Exclusion Criteria:

A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion

Primary outcomes:
measure: Blood pressure (systolic/diastolic)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
timeFrame: After collection of all blood samples, an expected average of 4 weeks
measure: Heart rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
timeFrame: After collection of all blood samples, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhour
country: Egypt
facility: Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Study officials:
References:
citation: Hedaya MA, Helmy SA. Modeling of the pharmacokinetic/pharmacodynamic interaction between irbesartan and hydrochlorothiazide in normotensive subjects. Biopharm Drug Dispos. 2015 May;36(4):216-31. doi: 10.1002/bdd.1935. Epub 2015 Feb 4.
Clinical trial NCT03859310: Precision of OCT and OCTA-based Ocular Measurements
Official title: Precision of OCT and OCTA-based Ocular Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes and Ocular Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 144
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: Seeing eye doctor for routine care

Brief summary: Precision of OCT- and OCTA-based Ocular Measurements

Detailed description: The purpose of this study is to assess precision of measurements of vascular structures and the anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to assess measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Eligibility criteria: Inclusion Criteria:

* Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
* Glaucoma - Have glaucoma and no history of other retinal pathology.
* Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
* Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria:

* Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
* Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
* Retina - Unable to complete required exams.
* Cornea - Unable to complete required exams.

Primary outcomes:
measure: Repeatability and Reproducibility Standard Deviation of ocular measurements
timeFrame: Day 1
Secondary outcomes:
measure: Repeatability and Reproducibility Coefficient of Variation of ocular measurements
timeFrame: Day 1
Other outcomes:
Locations:
city: Marysville
country: United States
facility: AMA
state: Ohio
Study officials:
References:
Clinical trial NCT01126710: Optical Detection of Intravenous Infiltration
Official title: Optical Detection of Intravenous Infiltration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravenous Infiltration
Extravasation of Diagnostic and Therapeutic Materials
Keywords: infiltration
extravasation
optical monitoring
Lead sponsor: CW Optics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-05-20
Enrollment: 263
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects recruited from the patient population at Virginia Commonwealth University Health System will be enrolled in the Study.

Brief summary: The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.


Eligibility criteria: Inclusion Criteria:

* Subjects will have peripheral IV catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. The IVs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this Study. The rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the IV infusion is taking place.
* Subjects are admitted to one of the institution's intensive care or intermediate care units, including Adult Emergency Department, Pediatric Emergency Department, Adult Medical Intensive Care Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unity, Surgical-Trauma Intensive Care Unit, Cardiothoracic Surgery Intensive Care Unit, Neuroscience Intensive Care Unit, Burn Intensive Care Unit, Transplant Intensive Care Unit, Coronary Care Intensive Care Unit, Post-Anesthesia Recovery Unit, Pediatric Intermediate Care Unity, Surgical Intermediate Care Unit, and Medical Intermediate Care Unit.

Exclusion Criteria:

* Inability to consent
* Lack of a peripheral IV

Primary outcomes:
measure: Test performance of novel optical device for monitoring intravenous infusion site for infiltration.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
References:
Clinical trial NCT00228410: Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections
Official title: A Multicenter, Randomized, Double-Blind Comparison of the Safety and Efficacy of Tigecycline With Those of Vancomycin With Aztreonam to Treat Complicated Skin and Skin Structure Infections in Hospitalized Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Diseases, Infectious
Keywords: Skin Infections
Skin Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections.


Eligibility criteria: Inclusion Criteria:

* Anticipated need for intravenous antibiotic therapy of 5 days or longer.
* Patients known or suspected to have a complicated skin and skin structure infection. Complicated skin/skin structure infection includes infections either involving deeper soft tissue or requiring significant surgical intervention or a significant underlying disease state (such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy, lower venous insufficiency) that complicates response to treatment.

Other inclusion applies

Exclusion Criteria:

* Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
* Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely.
* Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.
* Necrotizing fasciitis or gangrene.

Other exclusion applies.

Primary outcomes:
measure: The primary efficacy endpoint was the clinical response in the co-primary populations of the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) subjects at the test-of-cure assessment.
Secondary outcomes:
measure: Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Teras J, Gardovskis J, Vaasna T, Kupcs U, Pupelis G, Dukart G, Dartois N, Jouve S, Cooper A; 305 Study Group. Overview of tigecycline efficacy and safety in the treatment of complicated skin and skin structure infections - a European perspective. J Chemother. 2008 Oct;20 Suppl 1:20-7. doi: 10.1179/joc.2008.20.Supplement-1.20.
Clinical trial NCT04948710: Sonographic Venous Doppler Imaging in Acute Kidney Injury
Official title: Diagnostic Accuracy of Sonographic Venous Doppler Imaging in Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department patients with acute kidney injury

Brief summary: The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality.

Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.

In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.


Eligibility criteria: Inclusion Criteria:

* AKI diagnosis

Exclusion Criteria:

Patients

* with end-stage renal failure (stage 4),
* who received 500 mL IV fluid or 40 mg diuretics,
* who are pregnant,
* with renal transplantation,
* with cirrhosis and liver malignancy,
* with postrenal AKI,
* who were referred from another center after starting treatment,
* who do not give consent for the study.

Primary outcomes:
measure: The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Facaulty of Medicine
Study officials:
References:
Clinical trial NCT03932110: Metabolic Syndrome in Psoriasis and Psoriatic Arthritis and Correlation With Serum Omentin and Visfatin Levels
Official title: The Prevalence of Metabolic Syndrome in Patients With Psoriasis and Psoriatic Arthritis and Its Correlation With Disease Severity and Serum Omentin-1 and Visfatin Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Psoriatic Arthritis
Metabolic Syndrome
Keywords: psoriasis vulgaris
psoriatic arthritis
metabolic syndrome
omentin
visfatin
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis patients as well as the parameters of metabolic syndrome will be examined. At the same time, the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity will be measured by measuring the disease severity (by PASI psoriasis, clinical activity score for psoriatic arthritis). The patients who accepted to participate in the study , who were admitted to the dermatology outpatient clinic were included in the study. For the blood tests required after the examination, 2 tubes of blood will be taken for the measurement of omentin and visfatin. 80 psoriasis, 40 psoriatic arthritis and 60 healthy volunteers were planned to be studied. AHA / NHLBI, 2005 (revised ATP III criteria) criterion for the diagnosis of metabolic syndrome will be used. Omentin and visfatin levels are compared with the severity of the disease for psoriasis and psoriatic arthritis, and it will be examined whether it is proinflammatory or antiinflammatory.


Eligibility criteria: Inclusion Criteria:

1. Patients followed up for psoriasis and psoriatic arthritis in dermatology and rheumatology clinic
2. Patients older than 18 years
3. Patients who accept dermatological and rheumatic examination
4. Patients not receiving systemic treatment related to the disease in the last 1 month

Exclusion Criteria:

1. Patients with autoimmune and rheumatic diseases other than psoriasis and psoriatic arthritis
2. Patients under 18 years
3. Patients who do not accept dermatological and rheumatic examination Patients receiving systemic therapy for the last 1 month pregnant and nursing moms

Primary outcomes:
measure: omentin
timeFrame: 6 months
measure: visfatin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University, Department of dermatology
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT00608010: Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
Official title: Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization in Vitro
Preservation of Supernumerary Embryos
Keywords: Preservation of supernumerary embryos in an IVF program
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.


Eligibility criteria: Inclusion Criteria:

* ICSI with own gametes
* Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
* Donating excess embryos for research purposes

Exclusion Criteria:

* Embryos derived from surgically retrieved spermatozoa
* Blastocysts
* Embryos of low quality (Grade 3 or 4 according to Hardarson)

Primary outcomes:
measure: Blastocyst development rate
timeFrame: 3 days after thawing
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: American Hospital of Istanbul
Study officials:
affiliation: American Hospital of Istanbul
name: Basak Balaban, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.
Clinical trial NCT05216510: Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
Official title: A Dose Finding Study for the Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens in Uninfected Healthy Subjects, COVID-19 Convalescent Subjects, and COVID-19 Vaccinated Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2022-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.

Detailed description: Three IPs (TNX-2110, TNX- 2120, TNX-2130) will be administered by intradermal injection (0.1 mL) in two concentration strengths (Stage 1: "1:10 dilution" and Stage 2: "undiluted"). Subjects will also receive one intradermal injection (0.1 mL) of a positive control (CANDIN®), and one intradermal injection (0.1 mL) of a negative control "diluent".

Eligibility criteria: Inclusion Criteria:

Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit

Exclusion Criteria:

Subjects will be excluded if they have clinically significant underlying conditions associated with high risk for severe COVID-19 infections as identified by the Centers for Disease Control and Prevention (CDC) (Appendix 2). These conditions include, but are not limited to: chronic obstructive pulmonary disease, diabetes mellitus (Type 1 and 2), obesity, hypertension, heart disease, and cerebrovascular disease.

Primary outcomes:
measure: Assessment of Delayed-type Hypersensitivity Reactions
timeFrame: Up to 96 hours post skin test administration
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: United States
facility: Clinical Site
state: New Jersey
Study officials:
affiliation: Tonix Pharmaceuticals
name: Herb Harris, MD
role: STUDY_DIRECTOR
References: