louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03040648: Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block
Official title: Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block: a Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Imaging
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat spinal radicular pain. However, inadvertent intravascular injection can lead to severe neurologic complications. Digital subtraction angiography (DSA) during epidural block might increase the detection rate of intravascular penetration, compared to real-time fluoroscopy (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and participants and the high cost of the new and upgraded fluoroscopic equipment. In this study, it was designed to compare DSA and RTF for detection of intravascular penetration in the same participant who underwent cervical TFEB.

The investigators prospectively examined the participants who received cervical TFEB. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under DSA.


Eligibility criteria: Inclusion Criteria:

* participants with radiating pain from spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* pregnancy, allergic to contrast media, participants refusal, and participants with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Primary outcomes:
measure: The incidence of intravascular injection
timeFrame: 4 seconds after injection of contrast media
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Saeyoung Kim, MD
role: STUDY_CHAIR
References:
citation: Jeon Y, Kim S. Detection of Intravascular Injection During Cervical Transforaminal Epidural Injection: A Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy. Pain Physician. 2018 Mar;21(2):E181-E186.
Clinical trial NCT01569048: Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Sinusitis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation.

The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.


Eligibility criteria: Inclusion Criteria:

* ASA Ⅰ-Ⅱ
* Aged between 20 and 70 year
* General anesthesia for endoscopic sinus surgery

Exclusion Criteria:

* Body mass index \>30
* Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension,
* Coagulopathy
* Drug addiction
* Pregnancy
* Allergic fungal infection

Primary outcomes:
measure: surgical satisfaction about visibility of operative field
timeFrame: Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00154648: CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist
Official title: An Open, Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) Study of Arteries Using Gadovist 1.0 in Comparison to Intra-Arterial Digital Subtraction Angiography (IA DSA) Using Ultravist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angiography, Digital Subtraction
Magnetic Resonance Angiography
Keywords: MRA
DSA
gadovist
angiography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

Detailed description: This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.

Eligibility criteria: Inclusion Criteria:

* With suspected or known disease of the arteries
* Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
* Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
* Patient is between 20 and 75 years of age
* Fully informed and has signed consent in advance

Exclusion Criteria:

* Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
* Patient with renal failure
* Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
* Lactating woman
* Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
* Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
* Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.
* Hypersensitivity to gadobutrol products
* Patient has previously entered this study

Primary outcomes:
measure: Rate of agreement
measure: Image quality
measure: Diagnostic confidence
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hon-Man Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213148: Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Official title: A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anovulation
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 271
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.


Eligibility criteria: Inclusion Criteria:

* Aged 18-40 years
* Ovulatory dysfunction characterized by irregular and/or extended cycles
* Non-smoker

Exclusion Criteria:

* No previous gonadotropin treatment
* No more than 6 previous clomiphene treatment cycles

Primary outcomes:
measure: Ovulation Rate in Cycle 1
timeFrame: Up to 1 month
Secondary outcomes:
measure: Number of Subjects With Clinical Pregnancy in Cycle 1
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Rockland
country: United States
facility: Local US Medical Information
state: Massachusetts
Study officials:
affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
Clinical trial NCT06177548: Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions
Official title: Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions: an Investigator-initiated, Single-center, Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Dissection
Aortic Root Aneurysm
Minimally Invasive Surgical Procedures
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Brief summary: This study intends to include patients who had aortic root lesions and were treated with Bentall surgery from January 2019 to July 2023 in the First Affiliated Hospital of Xi'an Jiaotong University. The patients will be divided into the minimally invasive group and control group according to the surgical methods: the former underwent minimally invasive Bentall surgery through a small right intercostal incision; the latter underwent traditional Bentall surgery through a median sternal incision. By comparing the clinical data of patients in two groups, we will investigate the effect and safety of minimally invasive Bentall surgery.


Eligibility criteria: Inclusion Criteria:

- Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Exclusion Criteria:

* Previous sternotomy or aortic root surgery;
* Combined coronary artery disease requiring simultaneous coronary revascularization;
* Combined aortic arch lesions requiring simultaneous aortic arch surgery;
* Preoperative comorbidities with severe single or multiple organ failure;
* Incomplete clinical information;

Primary outcomes:
measure: 30-day mortality rate
timeFrame: 1-month after the operation.
Secondary outcomes:
measure: Mortality rate during hospitalization
timeFrame: About 10 days after the operation.
measure: Blood transfusion volume during hospitalization
timeFrame: About 10 days after the operation.
measure: Postoperative ICU length of stay
timeFrame: About 3 days after the operation.
measure: Postoperative ventilation time
timeFrame: About 1 day after the operation.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683748: Monitoring Cellular Immunity After Kidney and Liver Transplantation
Official title: Monitoring Cellular Immunity After Kidney and Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Terminal Kidney Failure
Terminal Liver Failure
Keywords: Transplantation
Immunological monitoring
Immunological risk
T cell reactivity
Cellular immunity
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2008-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Brief summary: After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Exclusion Criteria:

* Abscence of informed consent

Primary outcomes:
measure: T cell reactivity to viral antigens
timeFrame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Lars Wennberg
Study officials:
affiliation: Karolinska University Hospital
name: Lars Wennberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Gunnar Tyden, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02126748: The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.
Official title: The Effectiveness of Assisted Autogenic Drainage (AAD) and Intrapulmonary Percussive Ventilation (IPV) to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis: a Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: bronchiolitis
Wang score
Sa02
airway clearance techniques
intrapulmonary percussive ventilation
assisted autogenic drainage
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 103
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* first period of wheezing
* Wang score between 3 and 7
* age \< 24 months
* Sa02\> 90%

Exclusion Criteria:

* ICU patients
* mechanical ventilation
* use of antibiotics
* use of corticosteroids
* gestational age \< 34 weeks
* chronic cardiac or pulmonary disease
* no parental consent

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 6 days
Secondary outcomes:
measure: Wang Score
timeFrame: before treatment, immediately after treatment and 1h after treatment
measure: Heartrate
timeFrame: before, after and 1h after intervention
measure: Oxygen Saturation (SaO2)
timeFrame: before, after and 1h after treatment
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Uz Brussel
state: Brussels
Study officials:
References:
Clinical trial NCT05231148: Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics
Official title: Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . \[6\]
* infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. \[6, 7\]
* Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. \[7\]
* This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue


Eligibility criteria: Inclusion Criteria:

* Patient at any age and of any sex with infected non united fracture of long or short bones

Exclusion Criteria:

* Presence of previous vascular injury or pathological fracture
* Refusal to participate
* Inability to provide informed consent
* Allergy or sensitivity to vancomycin or tobramycin
* Patient with impaired renal function
* Patient with hypercalcemia

Primary outcomes:
measure: Non union scoring system
timeFrame: one year
measure: Karlström-Olerud physical function scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Calori GM, Mazza EL, Mazzola S, Colombo A, Giardina F, Romano F, Colombo M. Non-unions. Clin Cases Miner Bone Metab. 2017 May-Aug;14(2):186-188. doi: 10.11138/ccmbm/2017.14.1.186. Epub 2017 Oct 25.
citation: Drosos GI, Ververidis A, Babourda EC, Kakagia D, Verettas DA. Calcium sulfate cement in contained traumatic metaphyseal bone defects. Surg Technol Int. 2012 Dec;22:313-9.
citation: Laycock PA, Cooper JJ, Howlin RP, Delury C, Aiken S, Stoodley P. In Vitro Efficacy of Antibiotics Released from Calcium Sulfate Bone Void Filler Beads. Materials (Basel). 2018 Nov 13;11(11):2265. doi: 10.3390/ma11112265.
Clinical trial NCT04858048: Use of the WALANT Anesthesia Technique for Forefoot Surgery.
Official title: Use of the WALANT Anesthesia Technique for Forefoot Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 85
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: Patients with scheduled forefoot surgery.

Brief summary: To compare the perioperative pain level with WALANT anesthesia versus general anesthesia during forefoot surgery.

Detailed description: Orthopaedic foot and ankle surgery is typically performed while the patient is under general or regional anesthesia. The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is a local anesthesia technique used since 1980s in Canada for hand surgery. WALANT uses a combination of a local anesthetic and vasoconstrictor to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. This practice eliminates the need for the tourniquet due to the hemostatic effect of the vasoconstrictor. The administration of the local anesthetic is done as close as possible to the surgical site, which allows the mobility of the joint to be maintained, while having complete anesthesia. The retention of mobility and the absence of a tourniquet improve patient comfort.

The main objective of this prospective study is to evaluate the perioperative pain level with WALANT anesthesia compared to general anesthesia during forefoot surgery.

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient with scheduled forefoot surgery

Exclusion Criteria:

* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Pain assessment
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Hôpital Privé saint Martin
Study officials:
affiliation: Hôpital Privé Saint Martin
name: François LAVIGNE
role: PRINCIPAL_INVESTIGATOR
References: