louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05394246: Fluorescent-labeled IgG for Liver Tumor Detection
Official title: Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2022-05-27
Enrollment: 60
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: This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).

The main purposes of this study include:

* To validate the safety and effectiveness of using FluoAB in hepatic surgery.
* To raise the surgical precision with guidance by FluoAB fluorescence imaging.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with liver tumor.
2. Planned to receive hepatectomy.
3. Liver function Child-Pugh A/B.
4. The expected lifetime is longer than 6 months.
5. Approved to sign the informed consent.

Exclusion Criteria:

1. Enrolled in other trials in the past 3 months.
2. Metastatic lesions were found.
3. Undesirable function of heart, lung, kidney, or any other organs.
4. Unable to tolerate a hepatectomy.
5. The researchers considered inappropriate to be included.

Primary outcomes:
measure: Tumor imaging precision
timeFrame: Update with an average of 2 weeks.
measure: Tumor lesions
timeFrame: Immediately after the hepatic surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
affiliation: The Affiliated Hospital Of Southwest Medical University
name: Bo Li, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03398746: The LOOP Trial in Treatment of Skin Abscesses
Official title: The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abscess
Keywords: soft tissue infection
MRSA
Lead sponsor: Orlando Regional Medical Center
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.

Detailed description: This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.

Eligibility criteria: Inclusion Criteria:

* Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

* Abscess was on the hand, foot, or face
* Requiring admission or operative intervention

Primary outcomes:
measure: Treatment Failure
timeFrame: 10 Days
Secondary outcomes:
measure: Procedure Pain
timeFrame: At time of procedure
measure: Ease of procedure
timeFrame: At time of procedure
measure: Ease of care
timeFrame: During 10 days
measure: Pain on follow-up
timeFrame: 10 days
measure: Patient satisfaction
timeFrame: During 10 days
Other outcomes:
Locations:
Study officials:
References:
citation: Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16.
citation: Ladde J, Baker S, Lilburn N, Wan M, Papa L. A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses. Acad Emerg Med. 2020 Dec;27(12):1229-1240. doi: 10.1111/acem.14106. Epub 2020 Oct 11.
Clinical trial NCT01940146: Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Official title: Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
* Participants able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
* Pregnant or nursing women
* Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
* Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.

Primary outcomes:
measure: Change in Total Nasal Symptom Score From Baseline to Day 14.
timeFrame: Baseline to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: SPARC Site 1
Study officials:
affiliation: Sun Pharma Advanced Research Company Limited
name: Shravanti Bhowmik, MD
role: STUDY_DIRECTOR
References:
citation: Ellis AK, Steacy LM, Joshi A, Bhowmik S, Raut A. Efficacy of the novel nasal steroid S0597 tested in an environmental exposure unit. Ann Allergy Asthma Immunol. 2016 Sep;117(3):310-7. doi: 10.1016/j.anai.2016.07.018.
Clinical trial NCT06815146: The Effects of ESP Block and Mid-Transverse Process to Pleura Block on Postoperative Opioid Consumption and Quality of Recovery
Official title: Comparison of the Effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on Postoperative Opioid Consumption and Quality of Recovery in Lumbar Spinal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Consumption
Quality of Recovery(QoR-40), Preoperative and Postoperative
Keywords: opioid consumption
quality of recovery
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have not been compared in terms of the quality of recovery and opioid consumption after lumbar spinal surgery.

The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on quality of recovery and opioid consumption in patients scheduled for lumbar spinal surgery. The effects of the 2 blocks on postoperative pain will also be compared and recorded.


Eligibility criteria: Inclusion Criteria:

* Elective Lumbar Spinal surgery performed
* ASA I-III
* 18-75 years old

Exclusion Criteria:

1. Refusal at enrollment
2. Request for withdrawal from the study
3. Inability to give informed consent
4. Emergency surgery
5. Bleeding diathesis
6. Presence of contraindications to the LA agents used in this study
7. Use of chronic opioids
8. Psychiatric disorders
9. Presence of infection at the injection site

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: PCA results will be recorded at the 1st, 6th, 12th, 24th hours postoperatively.
Secondary outcomes:
measure: quality of recovery
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Eskin MB, Ceylan A, Ozhan MO, Atik B. Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery. Anaesthesist. 2020 Oct;69(10):742-750. doi: 10.1007/s00101-020-00848-w. Epub 2020 Sep 21.
Clinical trial NCT06091046: Discomfort in Intensive Care Patients - IPREA-N
Official title: Assessment of Discomfort in Intensive Care Patients and Psychometric Testing of the Applied Questionnaire IPREA-N
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Illness
Discomfort
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
name: The Hospital of Vestfold
name: Ostfold Hospital Trust
name: Sykehuset Telemark
First posted: 2023-10-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care units at five different hospitals in the South-East Norway will participate in the study. Each hospital will include approximately 50 patients.

Brief summary: The purpose of this study is to investigate discomforts experienced by intensive care patients during their critical illness period. We will use the Norwegian version of the questionnaire Inconforts des Patients de REAnimation (IPREA), the IPREA-N.Patients will be asked to rate18 questions about different possible discomforts on a 0-10 scale after their intensive care stay. Furthermore we aim to test whether the questionnaire when translated into Norwegian is useful in the Norwegian patient population.

The aim of the study is

* to assess perceived discomfort in intensive care patients using the IPREA-N questionnaire
* to test psychometric properties of the questionnaire


Eligibility criteria: Inclusion Criteria:

* Adult intensive care patients (\> 18 years),
* Understanding Norwegian
* Having spent more than 48 hours in the intensive care unit.
* Ability to consent to participation and self-report discomfort

Exclusion Criteria:

* Patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.

Primary outcomes:
measure: Discomfort measured by IPREA-N questionnaire
timeFrame: Within 24 hours following Intensive care unit stay
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Helene Berntzen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03953846: NUsurface Implant Registry
Official title: A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Meniscus; Degeneration
Knee Osteoarthritis
Knee Pain Chronic
Lead sponsor: Active Implants
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria

Brief summary: The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting

Detailed description: Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score \& WOMET; Western Ontario Meniscal Evaluation Tool.

Eligibility criteria: Inclusion Criteria:

* New or current treatment with the NUsurface® meniscus implant
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry.

Exclusion Criteria:

* There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.

Primary outcomes:
measure: KOOS (Knee Osteoarthritis Outcome Score) Pain improvement
timeFrame: 24 months
measure: WOMET (Western Ontario Meniscus Evaluation Tool) score improvement
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: AZ Monica vzw
city: Berlin
country: Germany
facility: Sporthopaedicum
city: Brandenburg an der Havel
country: Germany
facility: University of Brandenburg
city: München
country: Germany
facility: Klinikum der Universität München
city: Zerifin
country: Israel
facility: Shamir Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
affiliation: Active Implants LLC
name: Richard W Threharne, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00545246: A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
Official title: A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: VEGF Trap
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2007-10-17
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cancer patients without standard of care
* ECOG performance status 0 or 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Need for a major surgery or radiation therapy during the study
* History of hypersensitivity to docetaxel or polysorbate 80
* Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
* Uncontrolled hypertension
* History of brain metastases
* Ascites requiring drainage
* Pregnancy or breastfeeding
* Patients who have previously been treated with aflibercept.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
timeFrame: first 3-week cycle
Secondary outcomes:
measure: safety: physical examination, laboratory safety tests, adverse events
timeFrame: up to 60 days after last treatment
measure: pharmacokinetic values
timeFrame: every 3-week cycle
measure: objective response rate
timeFrame: every 3-week cycle
Other outcomes:
Locations:
city: Iruma-gun
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392002
city: Sunto-Gun
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Sunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30.
Clinical trial NCT01743846: CNAP Accuracy Dependent on Hemodynamic Variables
Official title: Accuracy of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Measurements Dependent on Cardiac Function, Vascular Resistance and Volume Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy and Precision of Noninvasive Measurement
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major surgery under general anaesthesia

Brief summary: Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP.

Detailed description: Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP. Body mass index and age may have impact on the accuracy of PPV measured non-invasively on the basis of volume-clamp technique.

Eligibility criteria: Inclusion Criteria:

* need for invasive blood pressure measurement

Exclusion Criteria:

* age under 18
* emergencies
* cardiac dysrhythmia

Primary outcomes:
measure: arterial pressure
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
Study officials:
affiliation: University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
name: Jochen Renner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
name: Robert Hanss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01661946: Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye
Official title: Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: vascular endothelial growth factor
macular edema
diabetic retinopathy
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2012-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).

In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema
* able to return for extra clinic visits according to study schedule

Exclusion Criteria:

* active malignancy
* previous retinal laser treatment
* previous anti-VEGF therapy
* previous vitrectomy

Primary outcomes:
measure: Maximum Concentration (Cmax) of Anti-VEGF Antibody
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Department of Ophthalmology, Queen's University
name: Sanjay Sharma, MD MBA MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: