louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04826965: VAC Bioburden Wound Care Assessment
Official title: Does Negative Pressure Wound Therapy With Instillation Reduce the Bioburden of Infections of the Upper and Lower Extremity?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Extremity Wound
Lower Extremity Wound
Soft Tissue Abscesses
Traumatic Wounds
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2021-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Screen 60 subjects in hopes to enroll 40. There will be 20 subjects per arm. All subjects will have a wound vac applied. The randomization will be whether or not irrigation is included.
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the microbiologic burden and need for further operative debridement of patients undergoing primary surgical debridement of infected tissue, soft tissue abscesses, or traumatic wounds of the upper and lower extremity.

Detailed description: Bacterial bio-burden as measured by quantitative microbial PCR prior to debridement, immediately following initial debridement, after 2 days of VAC veraflo (or conventional VAC) therapy, and at the time of repeat operative debridements, if needed. We will use the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX.) to report on the bacterial burden (reported on a log scale of bacteria per gram) present at the time of debridement. Our goal is to be able to assess the bioburden quantitatively at each time point to discern a change.

Exploratory outcomes to be measured: number of operative debridements required prior to reconstruction, number of days until final reconstruction, number of days until decision is made by surgeon that further debridements are no longer necessary, length of hospital stay, wound surface area will be monitored from enrollment through when the veraflo is removed. This is likely a 3-month interval.

Eligibility criteria: Inclusion Criteria:

* 18+yo with an injury or infection of the upper or lower extremity for which surgical debridement (in the operating room) followed by VAC application is planned.

Exclusion Criteria:

- Patient with wounds distal to the ankle.

Primary outcomes:
measure: Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement
timeFrame: Day 1 (day of first operative debridement)
measure: Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
timeFrame: Day 1 (day of first operative debridement)
measure: Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
timeFrame: Day 2 (day of second operative debridement)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Health System
name: Suhail Mithani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150865: Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery
Official title: Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Postoperative
Keywords: ropivacaine
posterior lumbar plexus block
hip arthroplasy
analgesia
postoperative
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.

Expectation : sizeable reduction of pain with block, of duration.

Detailed description: Compare lumbar plexus block (randomized)

* ropivacaine 0.475%, 0.4 ml/kg
* saline 0.4 ml/kg . Each group includes 30 patients.

Block performed preoperatively.

Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.

Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.

Adverse effects (nausea, vomiting, etc) recorded

Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

Eligibility criteria: Inclusion Criteria:

* adults
* ASA 1-3

Exclusion Criteria:

* cognitive impairement
* ASA IV

Primary outcomes:
measure: decrease of postoperative pain
Secondary outcomes:
measure: decrease in morphine consumption
measure: duraration of analgesic effect
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: laurent beydon, MD
role: STUDY_DIRECTOR
affiliation: Clinique St Leonard
name: ibrahim okais, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00211965: StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infections
Keywords: Knee replacement surgery
hip replacement surgery
nosocomial infections
Arthroplasty
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Public Health England
First posted: 2005-09-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Candidate for knee or hip replacement
* Expectation of protocol compliance
* Negative pregnancy test, where appropriate

Exclusion Criteria:

* Known S. aureus infection in the prior 3 months
* Infection in the prior 2 weeks
* Known HIV infection
* Immunomodulatory drugs
* Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early prostate cancer)
* Hypersensitivity to components of StaphVAX

Primary outcomes:
measure: Sero-type specific antibody concentrations
timeFrame: 6 weeks after study dose
Secondary outcomes:
measure: Sero-type specific antibody concentrations
timeFrame: various other time points after study dose, up to 26 wk
measure: adverse events
timeFrame: throughout 6 months observation after study dose
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: National Royal Orthopaedic Hospital
state: Middlesex
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Matt Hohenboken, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06624865: Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors
Official title: Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small-intestine Neuroendocrine Tumors
Keywords: Small-intestine neuroendocrine tumor
microbiota
tumorigenesis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 75
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: Consecutive patients followed at the Edouard Herriot University Hospital with small-intestine neuroendocrine tumors of the small intestine and indication for surgery.

Brief summary: The aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations.


Eligibility criteria: Inclusion Criteria:

* Patient with one or more small-intestine neuroendocrine tumor with indication of surgery
* Patient with consent for the collection, storage and reuse of data associated with his/her disease
* Age ≥ 18 years at the time of inclusion
* Non-objection statement obtained for participation in the study

Exclusion Criteria:

* Patients with poorly differentiated neuroendocrine carcinoma or NET (neuroendocrine tumors) of non-intestinal origin or mixed tumors (MiNEN)
* Pregnant, parturient or breast-feeding women
* Minors
* Persons deprived of liberty by judicial or administrative decision
* Adults under legal protection (guardianship, curatorship)

Primary outcomes:
measure: Composition of microbiota
timeFrame: At day 1 and month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot University Hospital
Study officials:
References:
Clinical trial NCT06280365: MWM Technique in Patients With Knee OA
Official title: Effects of Mulligan Mobilization With Movement (MWM) Technique in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobilization
Keywords: Knee Osteoarthritis
Mobilization
Proprioception
Pain
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA).

Detailed description: The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, muscle strength, proprioception, mobility, balance, functionality and quality of life in patients with knee OA.

Eligibility criteria: Inclusion Criteria:

* being diagnosed with knee osteoarthritis,
* being diagnosed with knee OA at the earliest 6 months ago

Exclusion Criteria:

* Participants who were pregnant,
* had knee surgery, had an infection,
* had a pacemaker, had an infraction,
* had cancer, or were receiving corticosteroid treatment were excluded from the study

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 week change in pain intensity
measure: Short form-36 (SF-36)
timeFrame: 4-week change in quality of life
measure: Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 4-week
measure: Evaluation of proprioception
timeFrame: 4-week change in proprioception
measure: The range of motion
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Emine Atıcı
state: İstanbul
Study officials:
References:
Clinical trial NCT05479474: Platelet Rich Plasma Testis Treatment for Infertile Men
Official title: Platelet Rich Plasma Testis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Infertility
Nonobstructive Azoospermia
Azoospermia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.


Eligibility criteria: Inclusion Criteria:

* Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy

Exclusion Criteria:

-

Primary outcomes:
measure: sperm present
timeFrame: 3 months after PRP injection
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Urology Clinic
state: California
Study officials:
References:
Clinical trial NCT06809374: Investigation of the Optimal Duration of Neoadjuvant Therapy for Resectable Pancreatic Cancer
Official title: Investigation of the Optimal Duration of Neoadjuvant Therapy for Resectable Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer Resectable
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: radiologically resectable pancreatic cancer patients

Brief summary: Investigating the Optimal Duration of Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer to Determine the True Surgical Indication.


Eligibility criteria: Inclusion Criteria:

* radiologically resectable pancreatic cancer patients

Exclusion Criteria:

* a body weight loss of greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal, or heart disease

Primary outcomes:
measure: Investigating the Presence of Occult Metastatic Lesions Detected During Neoadjuvant Therapy.
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02754674: Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques
Official title: Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.
2. Subjects: anterior cruciate ligament (ACL) injury 66 patients

   * Double bundle transportal technique with flexible reamer: 33
   * Single bundle outside in technique with remnant preservation: 33

Detailed description: Anterior cruciate ligament (ACL) injury patients : Total 66

1. Double bundle transportal technique with flexible reamer: 33

   * Advantage: more normal ACL reconstruction than single bundle technique
   * Disadvantage: to make the two bone tunnel must remove all the residual tissue.
2. Single bundle outside in technique with remnant preservation: 33

   * Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery.
   * Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.

Eligibility criteria: Inclusion Criteria:

1. Lachman test grade II,III and Pivot shift test grade II,III in physical examination
2. ACL rupture in MRI
3. Age 20\~60
4. within 6 months after trauma

Exclusion Criteria:

1. osteoarthritis (OA) change in X-ray
2. History of other ligament injury or ACL reconstruction in uninjured knee.
3. operation history of either ipsilateral or contralateral knee(fracture, etc)

Primary outcomes:
measure: Vascularity of Graft Tendon
timeFrame: 1yr after surgery
Secondary outcomes:
measure: Arthroscopy Grading
timeFrame: 1yr after surgery
measure: Clinical Knee Scoring
timeFrame: 2 yr after surgery
measure: Instability
timeFrame: 2 yr after surgery
measure: Graft Maturity (SNQ)
timeFrame: 1 yr after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joon Ho Wang, MD, Ph D
role: STUDY_CHAIR
References:
citation: Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.
Clinical trial NCT04785274: The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries
Official title: The Effect of Non-invasive Hemoglobin Measurement on Blood Transfusion and Mortality in Hip Surgeries: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Hemorrhage
Hemodynamic Instability
Keywords: Perioperative Bleeding
Mortality
Hemoglobin
Non-invasive monitoring
Transfusion;
SpHb
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General anesthesia undergoing hip surgery

Brief summary: Bleeding is one of the most important causes of mortality and morbidity in patients.

Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.


Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* General anesthesia undergoing hip surgery
* American society of anesthesiology (ASA) scores I-II-III

Exclusion Criteria:

* Receiving inotropic support
* Uncontrolled diabetes
* Arrhythmia
* Hypothermia
* Hyperbilirubinemia
* Jaundice
* Dark skin pigmentation
* Without voluntary consent
* Hypovolemia,
* hypotension,
* sepsis,
* blood diseases

Primary outcomes:
measure: Hemodynamic Stability
timeFrame: during the surgery
Secondary outcomes:
measure: Mortality
timeFrame: until 3 months after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University Medicine Faculty
Study officials:
References:
Clinical trial NCT01285674: Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.
Official title: INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cisplatin
Ototoxicity
Intratympanic Steroids
Keywords: cisplatin
ototoxicity
intratympanic steroids
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Detailed description: Cisplatin is a potent and widely used antineoplastic drug. Ototoxicity is a serious and dose-limiting side effect. The ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. There are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. Glucocorticoids have significant potential for otoprotection. Glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, Meniere's disease and sudden sensorineural hearing loss. Intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. This method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. Local administration prevents the common systemic side effects of steroids. Previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. Asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Eligibility criteria: Inclusion Criteria:

* adults 18 years old at least who are candidates for Cisplatin treatment
* agreement to participate in the study
* have signed an informed consent.

Exclusion Criteria:

* refusal to participate
* steroid treatment during the past month
* external or middle ear disease not enabling intratympanic treatment
* inner ear disease causing hearing loss
* severe hearing loss for any reason
* conductive hearing loss

Primary outcomes:
measure: Post-Treatment change in hearing
timeFrame: approximately 1 month from 1st treatment
Secondary outcomes:
measure: Tinnitus
timeFrame: 1 month post-treatment
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References: