louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06628583: Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine
Official title: Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lumbar Degenerative Disease
Sarcopenia
Keywords: Lumbar Degenerative disease
PLIF
Sarcopenia
Sagittal bit balance
Machine learning
Lead sponsor: First Affiliated Hospital of Suzhou Medical College
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 936
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data of 936 patients who underwent PLIF for lumbar Degenerative disease from June 2018 to March 2023 were collected retrospectively. The patients were divided into rehabilitation group（N=501） and residual pain group（N=435）according to their postoperative pain

Brief summary: The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors.


Eligibility criteria: Inclusion Criteria:

1. confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
2. lumbar spinal fusion surgical treatment with PLIF;
3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
4. observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion Criteria:

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.

Primary outcomes:
measure: General situation of the patient
timeFrame: Before the operation
Secondary outcomes:
measure: Surgical situation
timeFrame: 1-3 months after surgery
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China
state: Jiangsu
Study officials:
References:
Clinical trial NCT02355483: Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain
Official title: Accuracy of Unenhanced CT in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 423
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.

Detailed description: A systematic unenhanced abdominal CT is performed in elderly patients admitted to the emergency patients with acute abdominal symptoms. Accuracy of unenhanced CT is assessed by comparing diagnosis and therapeutic management recorded before and after unenhanced CT versus gold standard diagnosis and management. Gold standard diagnosis and management are established at 3 month follow up, based on patient's medical records and a systematic telephone interview.

Eligibility criteria: Inclusion Criteria:

* Elderly patients admitted to the emergency department (aged 75 year old and older)
* acute abdominal pain
* informed consent

Exclusion criteria:

* traumatic pain
* symptom duration of more than a week
* unability for the patient to give informed consent

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 3 months
Secondary outcomes:
measure: Therapeutic management accuracy
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Medical Imaging department
Study officials:
affiliation: Montpellier University Hospital
name: Ingrid MILLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00504283: An Analgesia Protocol for Acute Renal Colic in the Emergency Department
Official title: An Analgesia Protocol for Acute Renal Colic in the DHMC Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: Renal colic, pain, protocol, emergency department
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.

Detailed description: A retrospective study was performed that assessed the time to significant analgesia and medications used to achieve analgesia in the DHMC ED. Based upon this a prospective pain management protocol was designed and we will track the difference in time to significant pain relief between the two groups.

Eligibility criteria: Inclusion Criteria:

* Kidney stone on stone protocol CT scan
* Acute pain from a kidney stone

Exclusion Criteria:

* Age \< 18 or \> 65
* Pregnant women
* Contraindications to NSAID's or opiates

Primary outcomes:
measure: Time to significant pain relief
timeFrame: Within emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: DHMC
state: New Hampshire
Study officials:
affiliation: DHMC dept of Urology
name: Peter L Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02476383: Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Official title: Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.


Eligibility criteria: Inclusion Criteria:

* Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
* Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
* Appropriate for conservative treatment for low back pain.

Exclusion Criteria:

* Non-English speaking;
* Systemic medical conditions know to affect sensation (e.g. diabetes);
* History of lumbar surgery or fracture within the past 6 months;
* Received spinal manipulative therapy for treatment of low back pain within past 6 months;
* Current or history of chronic pain condition other than low back pain

Primary outcomes:
measure: numeric pain rating scale
timeFrame: Change in baseline at 2 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Change in baseline at 2 weeks
measure: Back Performance Scale
timeFrame: Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks
measure: Quantitative Sensory Testing
timeFrame: change in baseline immediately following spinal manipulative therapy during day 1
measure: Patient Centered Outcome Questionnaire
timeFrame: change in baseline immediately following spinal manipulative therapy during day 1
measure: Working alliance subscale of the Pain Rehabilitation Expectation Scale
timeFrame: change in baseline immediately following spinal manipulative therapy during day 1
measure: North American Spine Society Lumbar Spine Outcome Assessment
timeFrame: 2 weeks
measure: Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joel E Bialosky, PT, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03149783: Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
Official title: A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain, Postoperative
Delirium
Anesthesia, Local
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Double Blind Trial
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.

This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.


Eligibility criteria: Inclusion Criteria:

* Age \>=50 years.
* Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.

Exclusion Criteria:

* Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
* Patients with an epidural or spinal catheter block.
* Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
* Patients who are abusing alcohol defined by a high AUDIT score (\>8) will be excluded.
* History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
* Patients with a documented allergy to ropivacaine or other sodium channel blockers.

Primary outcomes:
measure: Pain Scores
timeFrame: Days 0-7 following the operation
Secondary outcomes:
measure: Amount of anesthetic
timeFrame: During the operation
measure: Amount of narcotic administered postoperatively
timeFrame: Days 0-7 postop
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Veterans Affairs Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Thomas Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05245383: Skin Irritation Test of Ten Products
Official title: Skin Irritation Test of Ten Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dermatitic Reaction of Face
Keywords: skin
skin health
allergen
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Evaluation of cutaneous tolerance of ten products by primary irritant patch test

Detailed description: The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.

Eligibility criteria: Inclusion Criteria:

* 20 to 70 years old, healthy male and female (sex ratio 1:1)
* No acute or chronic diseases including skin diseases.
* No current medications.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
* Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
* Current dermatology medication which might affect skin condition evaluation.
* Current irritated reaction on test site.
* Participating in other clinical trial(s) within 7 days.

Primary outcomes:
measure: Safety/Adverse Event Outcome Measure
timeFrame: Up to 48 hours
measure: Total Number of Positive Responses Across All Participants
timeFrame: Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: SUNG-JAN LIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505.
citation: Fullerton A, Benfeldt E, Petersen JR, Jensen SB, Serup J. The calcipotriol dose-irritation relationship: 48 hour occlusive testing in healthy volunteers using Finn Chambers. Br J Dermatol. 1998 Feb;138(2):259-65. doi: 10.1046/j.1365-2133.1998.02071.x.
Clinical trial NCT05515783: 68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies
Official title: 68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tumor
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.

Detailed description: Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Integrin αvβ3 is restrictedly expressed on angiogenic blood vessels and tumour cells. It plays a key role in angiogenesis for tumour growth and metastasis. RGD peptide can specifically recognise the integrin αvβ3, which serves as targeted molecular for anti-angiogenesis strategies. 68Ga-FAP-RGD is a novel dual targeting tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-RGD, and performed a head-to-head comparison with 68Ga-FAPI-02 or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility criteria: Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: Human biodistribution
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Human dosimetry
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Standard uptake value (SUV)
timeFrame: Up to 2 weeks
measure: Lesion numbers
timeFrame: Up to 2 weeks
measure: the sensitivity of 68Ga-FAP-RGD PET/CT
timeFrame: Up to 2 weeks
measure: the specificity of 68Ga-FAP-RGD PET/CT
timeFrame: Up to 2 weeks
measure: the accuracy of 68Ga-FAP-RGD PET/CT
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Count of participants with treatment emergent adverse events
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital, Fujian Medical University
name: Weibing Miao, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03338283: Electro-massage in Subjects With Subacromial Pain Syndrome
Official title: Short-term Efficacy of Interferential Current Electro-massage on Self-perceived Pain and Function in Subjects With Subacromial Pain Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Pain Syndrome
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 56
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: Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. To evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention.

Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants Methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. Both groups of patients will undergo six physiotherapy sessions (three times a week). The experimental group will undergo a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes will be used. Session length with electrotherapy will be approximately ten minutes.


Eligibility criteria: Inclusion Criteria:

* patients having undergone acromioplasty surgery in the three months prior to the first day of Physiotherapy treatment

Exclusion Criteria:

* Value equal to or less than 45 in Personal Psychological Apprehension Scale, showing any absolute contraindication for Physiotherapy or Electrotherapy treatment, fear or apprehension for Electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with SCS, having been applied local infiltration with corticoids following surgery and having started Physiotherapy treatment before signing informed consent.

Primary outcomes:
measure: Pain level, assessed by Visual Analogue Scale
timeFrame: Change from Baseline Pain level at 3 weeks
Secondary outcomes:
measure: Functional evaluation, assessed by Constant Scale. Reference: Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4
timeFrame: Change from Baseline Constant Scale at 3 weeks
Other outcomes:
measure: Range of shoulder´s motion (ROM)
timeFrame: Change from Baseline ROM at 3 weeks
Locations:
city: Sevilla
country: Spain
facility: Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry
Study officials:
affiliation: University of Seville
name: Manuel Albornoz-Cabello, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04594083: Two Different Tactile Stimulus Methods
Official title: A Comparison of Two Different Tactile Stimulus Methods on Reducing Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain management
child
nursing practice
Intramuscular Injection
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 159
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, and experimental design
Primary purpose: PREVENTION

Brief summary: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Detailed description: Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (Kahta State Hospital) between February 2019 and July 2019 and who received an IM injection as part of the medical treatment.

Interventions: The study data were collected from the children, who were divided into Palm Stimulator, ShotBlocker, and control groups.

Main outcome measures: The children's pre-procedure fear levels were evaluated using the Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain levels using the Visual Analog Scale (VAS).

Eligibility criteria: Inclusion Criteria: children who

* had no diagnosed physical or mental disability or chronic illness;
* had no communication problems;
* received single injection,
* required Ampicillin + Sulbactam group of antibiotics for standardization; and
* received ventrogluteal muscle injection during the study.

Exclusion Criteria:

* Parents who were unable to collaborate in the fear and pain evaluation,
* overweight or underweight children (under the third or above the 97th percentile),
* children with any incision or scar tissue in the injection area,
* children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history

Primary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: 5 months
measure: Faces Pain Scale-Revised (FPS-R)
timeFrame: 5 months
measure: Visual Analog Scale (VAS)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Kahta State Hospital
Study officials:
affiliation: Adiyaman University
name: Mürşide Zengin
role: PRINCIPAL_INVESTIGATOR
affiliation: İnönü University
name: Emriye Hilal Yayan
role: PRINCIPAL_INVESTIGATOR
References: