louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06815887: Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
Official title: Effect of Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnesium Sulfate
Local Anesthetic
Pectoral Nerve
Stellate Ganglion Block
Postoperative Pain
Modified Radical Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.

Detailed description: Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.

Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.

Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Female gender.
* American Society of Anesthesiologists (ASA) physical status II or III.
* Patients scheduled for elective modified radical mastectomy for breast cancer.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

Exclusion Criteria:

* Bleeding tendency due to coagulopathy,
* Patients with opioid dependence or alcohol or drug abuse,
* Significant liver and renal sufficiency
* Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
* Local infection at the site of the block.
* Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
* Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
* Pregnant or lactating individuals.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Time to first request analgesia
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03697187: Patient Registry to Evaluate the Real-world Safety of Ruconest®
Official title: An Observational Patient Registry to Evaluate the Real-world Safety of Ruconest® (C1 Esterase Inhibitor [Recombinant]) for the Treatment of Hereditary Angioedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema
Keywords: Hereditary Angioedema
HAE
Ruconest
rhC1INH
Registry
Pharming
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
Collaborators: name: US Hereditary Angioedema Association
First posted: 2018-10-05
Enrollment: 152
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients will be 13 years of age and older, have a current diagnosis of HAE for which they have been prescribed and are currently being treated with Ruconest.

Brief summary: This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE.

Detailed description: See below.

Eligibility criteria: Inclusion Criteria:

1. Patient provides informed consent as documented on the Institutional Review Board (IRB) approved informed consent document (ICF). For patients aged between 13 and 17 years old, the method of consent with or without assent will be determined by the IRB.
2. Patient is male or female and at least 13 years of age at the time of providing consent / assent.
3. Patient has been prescribed Ruconest for HAE.

Exclusion Criteria:

1. Patient is receiving HAE therapy as part of a clinical trial.

Primary outcomes:
measure: Safety analysis will consist of AEs reported per patient for up to 30 days after each single or repeated dose of Ruconest.
timeFrame: 3 years
Secondary outcomes:
measure: AEs occurring during pregnancy or lactation and for breastfed infants will be summarized separately using the same methods as described in the primary outcome measure.
timeFrame: 3 years
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: The US Hereditary Angioedema Association
state: Virginia
Study officials:
affiliation: Pharming Technologies BV
name: Anurag Relan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06255587: Relationship Between the Sagittal Lumbopelvic Alignment and Balance Control in Adolescents With Mechanical Low Back Pain
Official title: Relationship Between the Sagittal Lumbopelvic Alignment and Balance Control in Adolescents With Mechanical Low Back Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain, Mechanical
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents with low back pain

Brief summary: To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.

Detailed description: To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.Patients will be recruited from the secondary schools in Benha city be general invitations, and the study will be conducted at outpatient clinic of faculty of physical therapy, Benha University

Eligibility criteria: Inclusion Criteria:

* age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity

Exclusion Criteria:

* Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP

Primary outcomes:
measure: level of back pain
timeFrame: 10 minutes
measure: standardized lateral views radiographs in a neutral standing position for the lumbopelvic region
timeFrame: 15 minutes
measure: Balance control
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06156787: Patterns of Urinary Bladder Cancer in Darfur, Suda
Official title: Patterns of Urinary Bladder Cancer in Darfur, Sudan 2020 - 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Cancer
Lead sponsor: National Center for Gastroentestinal and Liver Disease
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sudanese patients present to the urology department with urinary bladder mass

Brief summary: Background: Bladder cancer (BC) exhibits extreme heterogeneity regarding clinical outcome, etiology, histology, and geographic distribution. Recent clinical observations point to alterations in the BC pattern in the Sudan, possibly as a result of lifestyle changes brought on by the enormous migration from rural to urban locations. This study aimed to identify the pattern of bladder cancer in Darfur.

Patients and Methods: A cross sectional, hospital-based study, it was conducted inNyala specialized hospital, during the period from (2020 to 2022), included one hundred and five patients with bladder mass matching the inclusion criteria were studied over the diversity of demographic data , clinical finding, pathological type and possible risk factors .


Eligibility criteria: Inclusion Criteria:

* All Sudanese pts who lives in Darfur and presented with urinary bladder mass.
* Adult above 18 years

Exclusion Criteria:

* Patient who does not live in Darfur.
* Patients refused to participate in the study.

Primary outcomes:
measure: Patterns of Urinary Bladder Cancer in Darfur, Sudan
timeFrame: The research is a cross-sectional, hospital-based study conducted at Nyala Specialized Hospital in Darfur. The study spans a period from 2020 to 2022.
Secondary outcomes:
Other outcomes:
Locations:
city: Darfur
country: Sudan
facility: Nyala specialized hospital
Study officials:
References:
Clinical trial NCT06770387: Telenursing and Transitional Care
Official title: Telenursing and Transitional Care After Lumbar Disc Herniation Surgery: A New Paradigm for Postoperative Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Disc Surgery
Keywords: mHealth
telenursing
transitional care
lumbar disc surgery
complications
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. The aim of the study is to determine the effects of transitional model-based telenursing and mobile application-based follow-up on fall risk, post-discharge recovery, mobility, anxiety, and complications in patients who underwent lumbar disc surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years of age or older,
* Can speak and understand Turkish,
* Have no hearing, understanding, vision or speech problems,
* Have undergone LDH surgery for the first time,
* Have undergone LDH surgery with the open method,
* Have not been diagnosed with depression or anxiety disorder before surgery and are not taking medication for this purpose,
* Have a smart mobile phone suitable for taking photos or for those close to them,
* Have not developed serious complications that would delay their discharge from the hospital,
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Patients who wish to withdraw from the study at any stage after voluntarily participating in the study.

Primary outcomes:
measure: Complication
timeFrame: From enrollment to the end of treatment at 1 weeks
measure: Rehospitalization
timeFrame: From enrollment to the end of treatment at 1 weeks
measure: Readmission
timeFrame: From enrollment to the end of treatment at 1 weeks
Secondary outcomes:
measure: Measuring recovery status with the Post-Discharge Surgical Recovery Scale
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: mobilization
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Measurement of anxiety status with the hospital anxiety depression scale
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01062087: Pain Perception After Tubal Ligation
Official title: Retrospective Investigation of Postoperative Pain Perception After Laparoscopic Tubal Sterilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: postoperative pain
tubal ligation
local anesthetic
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 62
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Urban clinic population, mix of ethnicities, most are Medicaid patients

Brief summary: The purpose of this study is to attempt to determine retrospectively whether there was a statistically significant difference in patient need for postoperative narcotics between two different groups of women who received a laparoscopic tubal ligation. One group received a local anesthetic injection or gel at the surgical sites, in addition to general anesthesia. The other group did not receive any local anesthetic but did receive general anesthesia. The investigators hypothesize that the group that received the local anesthetic injection or gel had lower average postoperative narcotic requirements and shorter postoperative dismissal to home times than the group that did not receive the auxiliary local anesthetic.


Eligibility criteria: Inclusion Criteria:

* Female, age 21-52,having a laparoscopic tubal ligation by the fallopia ring method at Oklahoma State University Medical Center between January 1, 2005 and December 31, 2009

Exclusion Criteria:

* We will exclude women with the following comorbid conditions, since they may alter the patient's pain level or her perception of pain after the tubal ligation: history of chronic pelvic pain, history of pelvic inflammatory disease, opiate abuse, conversion to open procedure, unsuccessful tubal ligation, laceration of tube, more than one ring placed on single tube, admittance to the hospital, additional procedures performed, endometriosis, allergy to marcaine, lidocaine, or bupivicaine.

Primary outcomes:
measure: Amount of postoperative narcotic required before dismissal from hospital
timeFrame: up to 12 hours
Secondary outcomes:
measure: The amount of time required for postoperative hospitalization before dismissal
timeFrame: 2-12 hours
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Medical Center
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Terry Badzinski, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bordahl PE, Raeder JC, Nordentoft J, Kirste U, Refsdal A. Laparoscopic sterilization under local or general anesthesia? A randomized study. Obstet Gynecol. 1993 Jan;81(1):137-41.
citation: Benhamou D, Narchi P, Mazoit JX, Fernandez H. Postoperative pain after local anesthetics for laparoscopic sterilization. Obstet Gynecol. 1994 Nov;84(5):877-80.
Clinical trial NCT02623387: Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
Official title: A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anaesthesia
Mastectomy
Breast-Conserving Surgery
Keywords: paravertebral block
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.

Detailed description: Adequate pain control is important in breast cancer surgery. In addition to benefits to patients, effective pain management strategies also facilitate day case surgery. Regional anaesthetic techniques, and paravertebral blocks in particular, are valuable in this sphere. The conventional method of administering this block is blind and depends on anatomical landmarks for placement. Performing the block under US guidance provides real time imaging while advancing the needle. This might allow for a more accurate placement and hence a more effective block which would enhance pain relief and minimise complications.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing resectional breast surgery
* Benign or malignant indications for surgery

Exclusion Criteria:

* Previous spinal surgery
* Severe coagulopathy
* Allergies to local anaesthesia
* Localised infection at site of injection

Primary outcomes:
measure: Analgesia requirements in 24 hours post op.
timeFrame: 24hours
Secondary outcomes:
measure: Pain Scores
timeFrame: 1, 2 and 24 hours post operatively and 1 week post operatively
measure: Patient satisfaction
timeFrame: Up to 2 weeks post operatively
measure: Complications
timeFrame: Up to 2 weeks post operatively
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospital Galway
state: Co. Galway
Study officials:
References:
Clinical trial NCT00709787: Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management
Official title: Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Epidemiology, hypertension, risk factors, coronary heart disease, patient management, compliance with medication
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 899
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Hypertensive Patients managed in primary care

Brief summary: To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification.

Detailed description: routine physician visits

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years old
* Patients with hypertension: newly diagnosed and /or already diagnosed and treated , whether at goal or not for the blood pressure level;
* Patients with no history of CHD/CVD

Exclusion Criteria:

* None

Primary outcomes:
measure: Description of hypertensive patients in terms of presence of associated cardiovascular (CV) risk factors (number of additional CV risk factors and frequency)
Secondary outcomes:
measure: Description of pattern of management of HT and CVD prevention, through lifestyle and use of drug therapies,
measure: Estimate adherence to treatment using the Morisky Adherence Scale (MAS)
measure: Estimation of hypertensive patients CV risk stratification based on ESH/ESC Hypertension Guidelines 2007 and to compare it with physicians' estimation of CV risk.
Other outcomes:
Locations:
city: Varazdin
country: Croatia
facility: Pfizer Investigational Site
city: Prague 4
country: Czechia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02070887: Inhibiting COMT in Parkinson's Disease
Official title: Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson's Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary movement disorder clinic

Brief summary: The overall aim of this observational study is to investigate the impact of COMT inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or computer-based.


Eligibility criteria: Inclusion Criteria:

* Age 60 - 75 years,
* Caucasian ethnicity,
* diagnosed PD by UK brain bank criteria,
* Hoehn \& Yahr scale 2 - 3,
* fertile females have to use contraception
* Group 1: medication with Stalevo® (L-DOPA/DDI + Entacapone)
* Group 2: medication with Madopar® or Sinemet® (L-DOPA/DDI)

Exclusion Criteria:

* methotrexate therapy during the last 12 months,
* treatment with Tolcapone
* vitamin B6, B12 and/or folic acid supplementation during last 6 months,
* pregnancy,
* intention to become pregnant during the course of the study,
* breast feeding,
* other clinically relevant concomitant disease states by discretion of the investigator
* known or suspected non-compliance, drug or alcohol abuse,
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
* participation in another study with investigational drug within the 30 days preceding and during the present study,
* enrolment of the investigator, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: Serum level of homocysteine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neurology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurology
name: Christian Baumann, MD
role: PRINCIPAL_INVESTIGATOR
References: