louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06226675: 'The Effect of Adding LFCN Block to PENG
Official title: The Effect of Adding Lateral Femoral Cutaneous Nerve Block to PENG Block on Postoperative Opioid Consumption in Hip Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Nerve Block
Opioid Consumption
Keywords: lateral femoral cutaneous nerve block
PENG block
Pain management
Opioid consumption
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of femoral neck fracture in Europe is 330/10000 per year. It is increasing every year due to the aging of the population. In patients 55 years and older, hip fracture-related mortality is estimated to be between 4% and 16% at one month and between 11% and 43% at one year after surgery. The reduced risk of postoperative complications associated with the use of regional anesthesia, shorter mobilization times, and reduced morphine consumption in hip fractures have been reported, and have been incorporated into postoperative pain control as part of multimodal strategies. PENG has been described for postoperative pain control for surgery on the hip joint or for the treatment of post-traumatic pain associated with proximal femur/femoral head fractures. Lateral femoral cutaneous nerve block is used in combination with other peripheral block methods to provide analgesia in the lateral thigh.

The investigators aimed to evaluate the effect of adding lateral femoral cutaneous nerve block to PENG block on pain scores and opioid consumption in femoral fracture procedures under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old,
* ASA I-II-III risk group
* patients undergoing hip fracture surgery under spinal anesthesia
* Patients whose informed consent was read and consent was obtained from them and their representatives.

Exclusion Criteria:

* Those who do not want to participate in the study,
* ASA IV-V patients
* Those with coagulation disorders
* Allergic to local anesthetics

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: up to 24 hour after surgery
Secondary outcomes:
measure: pain scores
timeFrame: up to 24 hour after surgery
measure: first analgesic time
timeFrame: up to 24 hour after surgery
measure: postoperative complications
timeFrame: up to 24 hour after surgery
measure: mobilization time
timeFrame: up to 24 hour after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT06084975: Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy
Official title: Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy: With a Specific Focus on Perioperative Patient Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Pancreatectomy
Spleen Preservation
Postpancreatectomy Hemorrhage
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent SP-MIDP at our institution between July 2018 and December 2022 were enrolled consecutively.

Brief summary: Spleen-persevering distal pancreatectomy (SP-DP) has been widely advocated as a routine procedure for benign or low-grade malignant tumors in the pancreatic body and tail, especially with a minimally invasive approach. Spleen preservation can be accomplished with Kimura technique (KT) or Warshaw technique (WT) Both of the two techniques were proved to be feasible and efficient. However, the perioperative outcomes and long-term benefits between patients with KT and WT in spleen-persevering minimally invasive distal pancreatectomy (SP-MIDP) remains controversial.

Several small series have reported a slightly higher prevalence of postpancreatectomy hemorrhage (PPH) in patients who undergo KT than those undergo WT. The exposure of splenic vessels to erosive pancreatic juice and the preservation of splenic vessels itself may explain the higher chance of PPH in KT. Larger volume studies are warranted to confirm this finding and to clarify the clinical significance. This study compared the perioperative outcomes between the two spleen-preserving techniques, with a focus on parameters relating to perioperative patient safety. Especially, the incidence and clinical relevance of PPH in SP-MIDP were evaluated.


Eligibility criteria: Inclusion Criteria:

* pathological diagnosis of benign or low-grade malignant pancreas tumors.

Exclusion Criteria:

* incomplete medical records,
* history of previous splenectomy,
* high-grade malignant pancreas tumors,
* conversion to open DP (ODP).

Primary outcomes:
measure: major complications
timeFrame: Within 30 days of SP-MIDP
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Liang Tingbo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04300075: The CUSA Clarity Bone Tip Study
Official title: Clinical Performance Investigation of the CUSA Clarity Bone Tip for Cranial Skull Base Bone Removal Procedures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cranial Skull Base Bone Removal
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-03-09
Enrollment: 0
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: Subject requiring a cranial skull base procedure involving removal of bone with a ultrasonic aspirator

Brief summary: The aim of the Study is to investigate the clinical performance and surgeon preferences of the CUSA Clarity Bone Tip during skull base surgery with removal of bony, and other cranial calcified tissue.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject requires a cranial skull base procedure involving removal of bone with ultrasonic aspirator
* Subject is an appropriate candidate to receive use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery, per the study surgeon
* Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures

Exclusion Criteria:

* Subject is currently pregnant or plans to become pregnant prior to the study index surgery
* Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
* Subject's surgical plan includes utilizing CUSA Clarity Bone Tip for bone removal anywhere besides the cranial skull base in an open craniotomy (e.g. transsphenoidal approach or spinal procedures).
* Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.

Intra-operative exclusion criteria :

* Surgeon does not utilize CUSA Clarity Bone Tip for cranial skull base bone removal during surgery or utilizes CUSA Clarity Bone Tip anywhere else besides the cranial skull base

Primary outcomes:
measure: Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale
timeFrame: Surgery time
Secondary outcomes:
Other outcomes:
Locations:
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm-Heessen Klinik für Neurochirurgie
city: Münster
country: Germany
facility: Universitätsklinikum Münster Klinik und Poliklinik für Neurochirurgie
city: Athens
country: Greece
facility: General Hospital of Athens "Georgios Gennimatas"
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico
city: Treviso
country: Italy
facility: Ospedale di Treviso
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
Study officials:
affiliation: Integra LifeSciences
name: Jason Marzuola
role: STUDY_DIRECTOR
References:
Clinical trial NCT06660875: Comparison of Postoperative Analgesic Efficacy of SPSIPB and Combination of IBPB and SCPB
Official title: Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superıor Intercostal Plane Block and Combination of Interscalene Brachial Plexus Block and Superfisial Plexus Block in Shoulder Arthroscopies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroscopy
İnterscalene Brachial Plexus Block
Superficial Cervical Plexus Block
Serratus Posterior Superior Intercostal Plane Block
Keywords: Remifantanile conception
Acute pain
Postoperatif pain
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-28
Enrollment: 80
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: Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Nerve blocks provide better pain control, opioid consumption in the postoperative period, and consequently have advantages such as fewer side effects and lower risks of pulmonary and cardiac complications. Multimodal analgesia approach is preferred for patients undergoing shoulder arthroscopy. Along with intravenous analgesic agents, peripheral nerve blocks (applied to every suitable and consenting patient) are performed based on patient preference. This study aims to compare the analgesic efficacy in the postoperative period of patients undergoing shoulder arthroscopy with a combination of interscalene brachial plexus block and superficial cervical plexus block with serratus posterior superior intercostal plane block.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* Body mass index 18 to 30 kg/m2
* Elective shoulder arthroscopy surgery

Exclusion Criteria:

* Under 18 and over 65
* ASA score IV and above
* Advanced co-morbidity
* History of bleeding diathesis
* BMI under 18 kg/m2 and over 30 kg/m2
* Patient refusing the procedure
* Patients who have previously undergone shoulder surgery
* Chronic opioid or analgesic use
* Patients who will operate under emergency conditions
* Patients who will not undergo shoulder surgery

Primary outcomes:
measure: Intraoperative remifentanil consumption
timeFrame: During The intraoperatif period
Secondary outcomes:
measure: Pain scores
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT05753475: HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANTATION?
Official title: DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANT?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant Failure and Rejection
Hypotension
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing renal transplantation

Brief summary: The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.


Eligibility criteria: Inclusion Criteria:

* patients undergoing renal transplantation

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: baseline
measure: Mean Arterial Pressure
timeFrame: baseline
measure: Systolic Blood Pressure
timeFrame: during the surgery
measure: Mean Arterial Pressure
timeFrame: during the surgery
measure: graft function
timeFrame: immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT02894775: Factors Influencing Inclusion in Digestive Cancer Clinical Trials
Official title: Factors Influencing Inclusion in Digestive Cancer Clinical Trials: A Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with invasive digestive cancer

Brief summary: Since the early 1990s, evidence-based medicine has played an increasingly important role in decision-making for the treatment of patients with cancer. The highest level of evidence is attributed to the results of randomized comparative studies, and the public health authorities require proof from randomized therapeutic trials before authorizing the use of new treatments. Patients included in therapeutic trials benefit either from the best current treatment (control group) or from a treatment supposed to present a better or similar efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize the fight against cancer, French public health policies have led to the progressive implementation of successive nationwide "Cancer Plans" since 2003. One of the objectives is to increase the proportion of patients included in clinical research trials. Thus, the fraction enrolled in France has progressively increased but remained low at around 8% in 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a context of socio-economic inequalities that concern resources, residence and access to services, identifying factors that determine inclusion in trials will in turn highlight the reasons for non-inclusion.

The aim of this study was to determine, at a population level, the influence of demographic characteristics and socio-economic status of patients with digestive cancer on inclusion in a clinical trial.

Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.


Eligibility criteria: Inclusion Criteria:

* patient with digestive cancer residing in Burgundy, France

Exclusion Criteria:

* associated cancer

Primary outcomes:
measure: Number of participants included in a clinical trial
timeFrame: within a year after cancer diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00241475: Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy
Official title: An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Cancer of the Prostate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure


Eligibility criteria: Inclusion Criteria:

* Relapsed prostate cancer after prostatectomy or radiotherapy
* PSA levels below 10 ng/mL
* Lymph node negative
* Metastasis negative
* Withdrawal of hormone therapy at least 6 months before entry into the study
* Written informed consent

Exclusion Criteria:

* Metastatic disease
* Hormonal treatment 6 months before study entry
* Concomitant radiotherapy, surgery and/or chemotherapy
* ILD

Primary outcomes:
measure: PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
Secondary outcomes:
measure: TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
measure: Duration of PSA response
measure: PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Research Site
Study officials:
affiliation: AstraZeneca Finland
name: AstraZeneca Finland Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06798675: Phase 2a Study for PK/PD of nC-001
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING CLINICAL TRIAL TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF nC-001 IN PATIENTS WITH CHRONIC EUVOLEMIC HYPONATREMIA
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: CHRONIC HYPONATREMIA
Lead sponsor: nephCentric
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CHRONIC EUVOLEMIC HYPONATREMIA


Eligibility criteria: Inclusion Criteria:

1. Men or women ≥18 and ≤85 years of age
2. Diagnosis of chronic euvolemic hyponatremia

Exclusion Criteria:

* 1. Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia

Primary outcomes:
measure: Serum Urea and Sodium (Na)
timeFrame: 24 hrs
Secondary outcomes:
measure: Safety
timeFrame: 15 days
measure: Tolerability
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04080375: Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
Official title: the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.


Eligibility criteria: Inclusion Criteria:

* • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

  * Age ≥ 18 years and ≤ 50 years
  * Pre-operative hemoglobin \>8 g/dl
  * Ability to understand and the willingness to sign a written informed consent.
  * Admissible medical/surgical history
  * Five or less symptomatic uterine myomas
  * All myomas are subserous or intramural.
  * Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* • Patients who have had a prior abdominal myomectomy

  * Post-menopausal women
  * Patients with known bleeding/clotting disorders
  * Patients with a history of gynecologic malignancy
  * Hypertension.
  * Cardiac and Pulmonary diseases.
  * Obesity (body mass index \> 30 kg/m2).
  * History of allergic reactions attributed to misoprostol
  * Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Primary outcomes:
measure: Mean amount of intraoperative blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: Change of hemoglobin after surgery
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938375: Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study
Official title: Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Arrythmia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 25
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: Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Brief summary: The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Exclusion Criteria:

* Patient's opposition

Primary outcomes:
measure: To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker
timeFrame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment
Secondary outcomes:
measure: Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality
timeFrame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker
Other outcomes:
Locations:
Study officials:
References: