louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06407037: Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
Official title: Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Serratus Posterior Superior Intercostal Plane Block
Acute Pain
Postoperative Pain
Breast Neoplasms
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-09
Enrollment: 50
Sex: FEMALE
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: Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.

Detailed description: Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

Eligibility criteria: Inclusion Criteria:

* Those aged 18-65
* Those with ASA scores I-II-III
* Those with a body mass index (BMI) between 18-35
* Patients who will undergo breast surgery

Exclusion Criteria:

* Those under the age of 18 and over the age of 65
* Those with ASA score IV and above
* Those with a history of allergy to the drugs to be blocked
* Those with a history of bleeding diathesis
* Patients with infection in the area to be blocked
* Those with a BMI below 18 and above 35
* Patients who underwent surgery under emergency conditions

Primary outcomes:
measure: Postoperative analgesia
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Postoperative tramadol consumption
timeFrame: Perioperative day 1
measure: Patient satisfaction
timeFrame: Postoperative 24th hour
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT04294537: TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: a Pilot Study
Official title: TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendectomy
Laparoscopy
Anesthesia, Conduction
Child, Preschool
Keywords: TAP Block
Wound Infiltration
Laparoscopic Appendectomy
Levobupivacaine
Pediatric Surgery
Pediatric Anesthesia
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children

Detailed description: Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children.

The available local anesthesia techniques include wound infiltration or "wall" blocks such as the TAP (transversus abdominis plane) block.

The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time.

The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 3 and 16 years, candidates for laparoscopic appendectomy for suspected acute appendicitis.
* ASA physical status Class I and II
* Informed consent signed by parents / legal guardians

Exclusion Criteria:

* severe obesity (BMI\> 95th percentile for age and weight)
* perforated appendicitis
* paralytic ileum
* non-stabilized neuropathies
* allergy to local anesthetics or analgesics used in the study protocol.
* patients on chronic opiate treatment
* need for perioperative hospitalization in intensive care with sedation and / or mechanical ventilation

Primary outcomes:
measure: Postoperative pain at 2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: Postoperative pain at 4-12-24 hours
timeFrame: from 4 to 24 postoperative hours
measure: Total opioid consumption
timeFrame: from 2 to 24 postoperative hours
measure: time to first opioid analgesic rescue
timeFrame: from 2 to 24 postoperative hours
measure: Side effects
timeFrame: from 2 to 24 postoperative hours
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Day Surgery Ospedale di Circolo Varese
state: VA
Study officials:
References:
Clinical trial NCT06691737: Effect of Whole-body Vibration on Postural Stability, Muscle Flexibility and Lower Limb Power in Young Basketball Players with Generalized Joint Hypermobility
Official title: Effect of Whole-body Vibration on Postural Stability, Muscle Flexibility and Lower Limb Power in Young Basketball Players with Generalized Joint Hypermobility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Generalized Joint Hypermobility
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 75
Sex: MALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to assess the effect of whole body vibration (WBV) on postural stability, flexibility of the lumbar-pelvic-hip complex and lower leg muscles, and jumping ability in basketball players aged 9-15 years. The main questions it aims to answer are:

Does WBV affect the level of postural stability in basketball players aged 9-15 years? Does WBV affect the level of postural stability in basketball players aged 9-15 years? Does WBV affect the flexibility of the iliopsoas, rectus femoris, posterior group of hamstrings, soleus and gastrocnemius in basketball players aged 9-15 years? Does WBV affect the jump height, relative peak power, contraction time in basketball players aged 9-15 years?

Participants will take part in 6 vibration sessions at 20Hz over 6 weeks. Vibration will be performed on the Galileo Med35 platform (3x3 min).


Eligibility criteria: Inclusion Criteria:

* Men aged 9-15
* Playing basketball in a sports club at least 2 training sessions a week

Exclusion Criteria:

* Thrombosis (acute narrowing of blood vessels),
* Inflammation of the musculoskeletal system,
* Arthropathy,
* Hernias,
* Discopathies,
* Tendonitis,
* Fresh fractures,
* Scars,
* Surgeries,
* Kidney stones,
* Rheumatoid arthritis,
* Implants in the body,
* Epilepsy,
* Current injuries to the musculoskeletal system,
* Occurrence of chronic pain complaints of the musculoskeletal system.

Primary outcomes:
measure: Changes in Postural Stability
timeFrame: 6 weeks before the intervention, the day before the intervention began, the day after the intervention, and 6 weeks after the intervention.
measure: Range of motion (ROM) of the ankle, knee, and hip joints.
timeFrame: 6 weeks before the intervention, the day before the intervention began, the day after the intervention, and 6 weeks after the intervention.
measure: Countermovement Jump Performance
timeFrame: 6 weeks before the intervention, the day before the intervention began, the day after the intervention, and 6 weeks after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01210937: Early Warning and Optimization Strategy in Carotid Endarterectomy
Official title: Early Warning and Optimization Strategy in Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carotid Stenosis
Carotid Artery Diseases
Stroke
Vascular Diseases
Keywords: Internal Carotid Artery Stenosis
Carotid Endarterectomy
Stroke
Cerebrovascular
Atherosclerosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in patients with severe carotid artery stenosis (symptomatic,\>50%;asymptomatic,60%). But during the surgery, when the carotid artery is clipping, the patient will have the chance to have hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk of death and nonfatal stroke in patients .

Detailed description: AHA guidelines recommend carotid endarterectomy (CEA) for severe carotid stenosis. But during CEA, there is little chance that the patient suffer from severe hypoperfusion or stroke. So we use TCD to monitor the blood flow of brain in the surgery and keep the blood pressure stable. The sudy is designed to find out whether the index which we found in previous work is more sensitive to show the blood flow of middle cerebral artery.

Eligibility criteria: Inclusion Criteria:

* Carotid artery stenosis detectable by duplex ultrasound, and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS.
* Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG)
* Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years)
* Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA .

Exclusion Criteria:

* Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: cardiac and neurological morbidity (TIA and CVA)
timeFrame: 12 months
measure: brain hyperperfusion
timeFrame: 12 months
measure: long term recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
name: Liu Changwei, bachelor
role: STUDY_CHAIR
name: Liu Bao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445637: Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Official title: Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasm
Keywords: Metastatic breast cancer
safety
ibrance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants enrolled should meet the usual prescribing criteria for IBRANCE® as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Brief summary: This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).

Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.


Eligibility criteria: Inclusion Criteria

* Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease).
* Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).
* Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
* Patients must be appropriate candidates for hormone therapy.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE®

Exclusion Criteria

* Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
* Pregnant women

Primary outcomes:
measure: Treatment-related adverse events during first 3 months
timeFrame: 2018 ~ 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Tower
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00679237: Risk Reduction in Coronary Heart Disease
Official title: Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2008-05-16
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death


Eligibility criteria: Inclusion Criteria:

* acute myocardial infarction, CABG or PCI

Exclusion Criteria:

* Age \< 18 and age \> 80
* pregnant
* critical illness
* drug abuse

Primary outcomes:
measure: New cardiovascular events (MACE)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Serena Tonstad, dr.med.
role: STUDY_CHAIR
References:
citation: Kaldal A, Tonstad S, Jortveit J. Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial. BMC Cardiovasc Disord. 2021 Dec 16;21(1):600. doi: 10.1186/s12872-021-02426-3.
Clinical trial NCT01394237: Laparoscopic Sacrocolpopexy: Long Term Follow-up
Official title: Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Vault Prolapse
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007

Brief summary: The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
* consent

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment
timeFrame: 3-6 years after surgery
Secondary outcomes:
measure: Quality of life
timeFrame: 3-6 years after surgery
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Frauenklinik Kantonsspital Aarau
state: Aargau
Study officials:
affiliation: Kantonsspital Aarau
name: Dimitri Sarlos, MD
role: STUDY_DIRECTOR
References:
citation: Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7.
Clinical trial NCT03310437: Cost Effectiveness if Primary PCI Versus Thrombolytic Therapy in Acute STEMI in Assiut University Hospital
Official title: Cost Effectiveness of Primary PCI Versus Thrombolytic Therapy in STEMI in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-10-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presented by ST elevation myocardial infarction

Brief summary: Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients without contraindications

Detailed description: Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients 100 patient each within 90 m for PPCI and 6h for thrombolytic

Eligibility criteria: Inclusion Criteria:

* All PPCI patients within 90 minutes door to ballon.
* All thrombolytic patient without contraindication ,within 6 golden hours of chest pain.

Exclusion Criteria:

* patients don't meet inclusion criteria

Primary outcomes:
measure: Compare between PPCI and thrombolytic therapy regarding over all cost in STEMI patients
timeFrame: one year for collecting 100 patient for each arm with follow up 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut medicine faculty
Study officials:
References:
Clinical trial NCT00748137: Bolus Insulin Card Calculator Randomised Controlled Study
Official title: Bolus Insulin Card Calculator Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Youth
Insulin dose
Lead sponsor: John Hunter Children's Hospital
Sponsor class: OTHER
Collaborators: name: Royal North Shore Hospital
name: Sydney Children's Hospitals Network
name: Royal Children's Hospital
name: Lady Cilento Children's Hospital, Brisbane
name: NovoNordisk Pharmaceuticals
First posted: 2008-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.


Eligibility criteria: Inclusion Criteria:

* Age 11 - 18 years old
* Currently using indvidual subcutaneous injections (not CSII)

Exclusion Criteria:

* HbA1c \> 9.5%
* Serious illness

Primary outcomes:
measure: 24 hours BGL > 8.3mmol/l (CGMS)
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c
timeFrame: 3 months
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: Gosford District Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Children's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Children's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Royal Children's Hospital
state: Queensland
Study officials:
References:
Clinical trial NCT05806437: Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]
Official title: Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia, Iron Deficiency
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance

Detailed description: We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention.

We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained

Eligibility criteria: Inclusion Criteria:

* Candidates for prosthetic surgery
* Patients of both sexes over 40 years of age
* Hemoglobin values \<12 g% for females and 13 g% for males
* % transferrin saturation \< 10%
* Willingness and ability to provide informed consent.

Exclusion Criteria:

* Patients with Mediterranean anemia
* Patients with coagulation disorders
* Patients who do not sign the consent form
* Pregnant or breastfeeding women (self-declaration)
* Minor aged

Primary outcomes:
measure: Reduction in transfusion patients
timeFrame: 7 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro
Study officials:
References: