louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06486246: Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
Official title: Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Tear
Pain, Postoperative
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: UNIcenter Non-randomized trial
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results.

Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement.

The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.

Detailed description: Participants scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be allocated to two groups: Adductor canal block or Genicular nerve block- The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2%. The genicular nerve block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2% in total.

Postoperative analgesia will include analgesia (Dexketoprofen 75 mg during first 24 hours), acetomiophen 1 gr every 8 hours and tramadol for rescue pain.

Eligibility criteria: Inclusion Criteria:

* Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

Exclusion Criteria:

* peripheral neuropathy
* pre-existing femoral neuropathy
* diabetes mellitus
* alcoholism
* drug addiction
* cancer with chemotherapy
* chronic pain state
* Negative of the patient to participate in the study.

Primary outcomes:
measure: Pain assessed by NRS at PACU
timeFrame: up to 6 hours postoperative
measure: Opioid consumption at PACU
timeFrame: up to 6 hours postoperative
Secondary outcomes:
measure: Pain score at home
timeFrame: up to 24 hours
measure: Quality of rest
timeFrame: First night
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
Clinical trial NCT06854146: The Effect of Environmental Factors on Gastric Cancer Based on Macrogenome
Official title: Study on the Development and Prognosis of Gastric Cancer Based on Environmental Factors and Macrogenome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancers
Air Pollution
Keywords: Gastric Cancer
Macrogenome
Environmental Pollution
Air Pollution
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy and 1:1 participants with no history of malignancy were included in the study.

Brief summary: The objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and macrogenomic data.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy;
* no chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
* willing to participate in the study and sign the informed consent form;
* complete clinical data.

Exclusion Criteria:

* concurrent primary malignant tumor other than gastric cancer;
* patients with systemic diseases, such as severe cardiopulmonary;
* insufficiency, that affect the choice of treatment plan;
* not suitable for enrollment as assessed by the investigator;
* incomplete clinical data.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months
Secondary outcomes:
measure: Gut microbiome composition differences assessed by shotgun metagenomic sequencing
timeFrame: Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT02790346: Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot
Official title: Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Equine Varus Deformity
Keywords: hemiparesis
deformity of the foot and ankle
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.


Eligibility criteria: Inclusion Criteria:

* Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
* Orthopedic equine-varus deformity of the foot and ankle requiring surgery
* Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability

Exclusion Criteria:

* History of foot surgery the side to be operated
* Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
* Bilateral surgery
* Progressive neurological disease
* Dystonic movements or movement disorders
* Realization of a botulinum toxin injection in the 6 months preceding gesture
* Important cognitive impairment

Primary outcomes:
measure: walking speed at one year
timeFrame: 12 months after surgery intervention
Secondary outcomes:
measure: walking speed at 3 and 6 months
timeFrame: 3 months and 6 months after surgery intervention
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Lapeyronie
state: Herault
Study officials:
References:
Clinical trial NCT04973046: Tissue Oxygen Saturation for Esophagectomy
Official title: Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis for Esophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Esophagostomy Complication
Anastomotic Leak
Oxygen Deficiency
Keywords: Esophagectomy, Tissue oxygen saturation, Gastric tube, Anastomotic leakage
Lead sponsor: Shizuoka Cancer Center
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective study performed at the Shizuoka Cancer Center between November 2020 and March 2021. All 18 patients who underwent esophagectomy with gastric tube reconstruction were enrolled in the study

Brief summary: Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.

Detailed description: One cause of anastomotic leakage after radical esophagectomy is blood flow insufficiency at the cervical anastomosis site. .

Eighteen patients, who underwent radical esophagectomy with gastric tube reconstruction, were studied. The regional tissue oxygen saturation (rSO2) was measured at the tip (point pre 0) and 2, 4, and 6 cm on the anal side of the tip (point pre 1, pre 2, and pre 3, respectively) before the gastric tube was raised to the cervical site through the retrosternal route. After that, rSO2 was measured at the tip, 2 and 4 cm on the anal side of the tip (points post 0, post 1, and post 2), the actual anastomotic site (point AN), and the chest skin as an indicator of whole-body oxygenation . The relationship between rSO2 scores and the rate of anastomotic leakage was determined.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent esophagectomy with gastric tube reconstruction from November 2020 to March 2021.

Exclusion Criteria:

* Patients who underwent esophagectomy with jejunum or colon reconstruction. patients who underwent two-stage operation.

Primary outcomes:
measure: The tissue oxygen saturation score of gastric tube during esophagectomy
timeFrame: During surgery
Secondary outcomes:
measure: The rate of anastomotic leakage
timeFrame: 1month after surgery
Other outcomes:
Locations:
city: Nagaizumicho
country: Japan
facility: Shizuoka cancer center
state: Suntogun
Study officials:
References:
Clinical trial NCT03020446: Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
Official title: Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Wound Ulcers
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.

Detailed description: Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.

Eligibility criteria: Inclusion Criteria:

* venous leg ulcer

Exclusion Criteria:

* pregnant females

Primary outcomes:
measure: Wound Size
timeFrame: 4 weeks
Secondary outcomes:
measure: Wound Maceration
timeFrame: 4 weeks
measure: Wound Necrosis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT04454346: Double Foley Catheter For Cervical Ripening
Official title: Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labour
Keywords: Double Foley Catheter, Cook balloon, Foley catheter
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.

Detailed description: This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects.

Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.

Eligibility criteria: Inclusion Criteria:

* Women with term pregnancy,

Exclusion Criteria:

* Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500

Primary outcomes:
measure: vaginal delivery within 24 hours
timeFrame: 24 hours
measure: ripening success
timeFrame: 12 hours
measure: pain score
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital
Study officials:
affiliation: Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital
name: Mehmet Obut, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04206046: The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
Official title: The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Chronic Pain Post-Proceduraal
Keywords: arthroplasty, knee
chronic pain
Lead sponsor: Sciberras, Stephen M.D.
Sponsor class: INDIV
First posted: 2019-12-20
Enrollment: 200
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: The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.

It will also focus on genetic factors and their influence on chronic pain.


Eligibility criteria: Inclusion Criteria:

* patients able to undergo a total knee arthroplasty

Exclusion Criteria:

* age more than 75 years
* known case of chronic pain syndromes
* arthroplasty not due to osteoarthritis
* sensitivity to any drugs used in protocol

Primary outcomes:
measure: Pain Numerical Rating Scale on physiotherapy
timeFrame: 24 hours
measure: WOMAC Score at 3 and at 6 months
timeFrame: 6 months
measure: WOMAC Pain Score at 3 and at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hours
measure: Pain Numerical Rating Scale after 6 months
timeFrame: 6 months
measure: Incidence of Chronic Post-surgical Pain
timeFrame: 6 months
measure: Change in WOMAC Score at 3 and at 6 months
timeFrame: 6 months
measure: Change in WOMAC Pain Score at 3 and at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Mater Dei Hospital
Study officials:
References:
citation: Sciberras SC, Vella AP, Vella B, Spiteri J, Mizzi C, Borg-Xuereb K, LaFerla G, Grech G, Sammut F. A randomized, controlled trial on the effect of anesthesia on chronic pain after total knee arthroplasty. Pain Manag. 2022 Sep;12(6):711-723. doi: 10.2217/pmt-2021-0081. Epub 2022 Mar 30.
Clinical trial NCT04706546: Hemodynamic Effects During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: hypoxia
exercise
hemodynamics
Vasodilative drug
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To study hemodynamic effects of Sildenafil during exercise in patients with pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: mean pulmonary artery pressure (mPAP) / cardiac output (CO)
timeFrame: 4 hours
Secondary outcomes:
measure: Differences in pulmonary arterial pressure
timeFrame: 4 hours
measure: Differences in cardiac output
timeFrame: 4 hours
measure: Differences in pulmonary vascular resistance
timeFrame: 4 hours
measure: Differences in pulmonary artery wedge pressure
timeFrame: 4 hours
measure: Differences in right atrial pressure
timeFrame: 4 hours
measure: Differences in mixed venous oxygen saturation
timeFrame: 4 hours
measure: Differences in heart rate
timeFrame: 4 hours
measure: Differences in blood pressure (systolic and diastolic)
timeFrame: 4 hours
measure: Differences in oxygen saturation
timeFrame: 4 hours
measure: Differences in arterial blood gases
timeFrame: 4 hours
measure: Differences in mixed venous blood gases
timeFrame: 4 hours
measure: Differences in cerebral tissue oxygenation
timeFrame: 4 hours
measure: Differences in muscle tissue oxygenation
timeFrame: 4 hours
measure: Differences in symptoms (Borg dyspnoea)
timeFrame: 4 hours
measure: Differences in symptoms (leg effort)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
state: Zurich
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich, Department of Pulmonology
Study officials:
affiliation: UniversityHospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05084846: InFLUenza and the HEART An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
Official title: Influenza and the Heart: An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Cardiovascular Complication
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with laboratory confirmed influenza

Brief summary: "Influenza and the Heart: An investigation into the acute and lasting cardiac effects of influenza infection" the investigators aim to assess the mechanisms for cardiovascular disease in patients suffering an acute influenza infection. The project will be carried out by creating a prospective clinical cohort study of consecutive patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory confirmed influenza.


Eligibility criteria: Inclusion Criteria:

* All patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza
* \> 18 years of age

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
* Pregnancy
* Persons simultaneously positive with COVID-19

Primary outcomes:
measure: Number of patients developing cardiovascular complications
timeFrame: 3 years
measure: Number of patients developing in-hospital mortality
timeFrame: 3 years
measure: Rate of cardiac dysfunction
timeFrame: 3 years
measure: Prevalence of elevated biomarkers of infection/inflammation
timeFrame: 3 years
measure: Rate of pulmonary embolisms diagnosed with CT thorax angiography
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev & Gentofte Hospital
city: Hellerup
country: Denmark
facility: Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital
Study officials:
References: