louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06428136: Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function
Official title: Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tibial Muscular Dystrophy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.

Detailed description: There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.

Eligibility criteria: Inclusion Criteria:

* Adults aged 45-65 years old (Jeong et al., 2019)
* Both genders will be included (Jeong et al., 2019)
* Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
* Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)

Exclusion Criteria:

* Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
* Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
* Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
* Neurological conditions affecting leg function (Peterson et al., 2022)
* Pregnancy (Jeong et al., 2019)

Primary outcomes:
measure: Measured using a numeric pain rating scale (NPRS)
timeFrame: 12 Months
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 12 months
measure: ITBT length
timeFrame: 12 months
measure: Range of motion (ROM):
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03687736: Subject Satisfaction With AbobutulinumtoxinA Treatment
Official title: A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Detailed description: Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.

Eligibility criteria: Inclusion Criteria:

* Moderate to Severe Glabellar Lines at Maximum Frown
* Understands study requirements and signs an informed consent

Exclusion Criteria:

* Known allergy to any component of study product
* Pregnant or breast feeding or intending to get pregnant during the study
* Botulinum toxin treatment in the face within 9 months

Primary outcomes:
measure: Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
timeFrame: 12 months
Secondary outcomes:
measure: Subject Satisfaction With Aesthetic Outcome in Treated Area
timeFrame: Months 1,3,6,7,9 and 12
measure: Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
timeFrame: Months 1,3,6,7,9 and 12
measure: Evaluate the Impact of Treatment; Psychological Function
timeFrame: Months 1,3,6,7,9 and 12
measure: Subject Self-Assessment Using a 4-point Categorical Scale
timeFrame: Months 1,3,6,7,9 and 12
measure: Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
timeFrame: Months 1,3,6,7,9 and 12
measure: Onset of Treatment Response
timeFrame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Galderma Study Site
state: California
city: San Francisco
country: United States
facility: Galderma Study Site
state: California
city: Santa Monica
country: United States
facility: Galderma Study Site
state: California
city: Greenwood Village
country: United States
facility: Galderma Study Site
state: Colorado
city: Chicago
country: United States
facility: Galderma Study Site
state: Illinois
city: Omaha
country: United States
facility: Galderma Study Site
state: Nebraska
Study officials:
References:
Clinical trial NCT02849236: PECS I Block for Breast Subpectoral Implant Surgery
Official title: Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: PECS block,
pectoral block,
breast augmentation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.


Eligibility criteria: Inclusion Criteria:

* Every female who will benefit of a bilateral subpectoral breast augmentation
* Age more than 18 years
* Social insured

Exclusion Criteria:

* refusal of the patient
* Age less than 18 years
* Inability to consent
* History of thoracic surgery or breast implants
* Pregnancy
* Inability to use a patient controlled analgesia
* Contraindication of the use of opioids or local anesthetics
* Pathology of hemostasis, infection
* Can not use a PCA
* Patients under long-term opioids (WHO pain ladder 2 and 3)
* Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)

Primary outcomes:
measure: Morphine consumption
timeFrame: During the first 24 postoperative hours
Secondary outcomes:
measure: First administration of morphine
timeFrame: During the first 24 postoperative hours
measure: Post-operative nausea and/or vomiting
timeFrame: During the first 24 postoperative hours
measure: Intra-operative opioids consumption
timeFrame: During procedure execution
measure: Post-operative anti-emetic consumption
timeFrame: During the first 24 postoperative hours
measure: Post-operative pain
timeFrame: During the first 24 postoperative hours
measure: 4-point sedation scale
timeFrame: During the first two postoperative hours
measure: Aldrete score
timeFrame: During the first two postoperative hours
measure: Time physiological function recovery
timeFrame: During the first six postoperative hours after tracheal extubation
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Benoit Tavernier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165836: Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy
Official title: Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopy
Erector Spinae Plane Block
Analgesia
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 60
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: The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.

Detailed description: Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .

ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years
* Both genders and BMI \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* Patients who are posted for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* Allergy to all opioid medications
* Diagnostic shoulder arthroscopic procedures,
* Patients with chronic opioid use and coagulopathy

Primary outcomes:
measure: The total rescue morphine (mg) consumption in the first 24 post-operative hours.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Post-operative pain score
timeFrame: 24 hours Postoperative
measure: Time to first request of rescue analgesia
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Kafr ElSheikh
country: Egypt
facility: Kafr El-Sheikh University Hospitals
Study officials:
References:
Clinical trial NCT06806436: Patients' Satisfaction in Thoracic Surgery Inpatients
Official title: Patients' Satisfaction in Thoracic Surgery Inpatients At the Manmohan Cardio-Thoracic Vascular and Transplant Centre: a Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Diseases
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to the study site during the study period

Brief summary: Patient satisfaction is considered a subjective indicator of the quality of care provided during a hospital course. Identifying the factors that affect patient satisfaction across remains essential. Recognizing the growing importance of this metric in assessing medical performance, this study aimed to evaluate the satisfaction and associated factors among inpatients of the thoracic surgery unit of a tertiary care government hospital in Nepal.

Detailed description: A cross-sectional analysis of satisfaction levels was conducted among 122 patients consecutively admitted to the Thoracic Surgery unit. Data were collected by interview using a questionnaire of 23 domains scored on a 4-point Likert scale, adapted from the Health Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Descriptive and inferential statistics (independent t-test and Chi-square test) were used for data analysis.

Eligibility criteria: Inclusion Criteria:

* all patients (or the guardian if the patient was less than 18 years, or could not consent for some reason) admitted to the study site during the study period

Exclusion Criteria:

* refusing to participate, who were hospital staff or their close family members, and those who could not be contacted for interview

Primary outcomes:
measure: Scores of different domains of care received from nurses, doctors and hospital environment
timeFrame: upto 48 hours after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine
Study officials:
affiliation: Institute of Medicine
name: Ranjan Sapkota, MBBS, MS, Mch
role: STUDY_DIRECTOR
References:
Clinical trial NCT05918536: Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality
Official title: Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Muscle Neoplasm
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Azienda Policlinico Umberto I
name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
First posted: 2023-06-26
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments

Brief summary: Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT


Eligibility criteria: Inclusion Criteria:

* Age: no limit
* Patients with musculoskeletal neoplasms predominantly in complex sites
* Patients who will have to undergo surgical resection/amputation for the management of their clinical case
* Preparation of preoperative planning discussed at DMT
* Surgery performed with the aid of Intraoperative CT Navigated
* Written informed consent

Exclusion Criteria:

- Inability to perform pre-post treatment assessment

Primary outcomes:
measure: Quality of life
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT06155136: RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan
Official title: Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer Metastatic
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 163
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 still alive one year after the initiation of NAliri

Brief summary: The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

Detailed description: The objectives on patients still alive one year after the first cycle of nal-IRI :

* Characterize mPDAC patient population according to their demographics
* Identify PDAC treatment by line of treatment from diagnosis to last treatment
* Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years (≥ 19 years in South Korea)
* Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
* All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
* Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
* At least one cycle of nal-IRI-containing regimen should have been administered
* A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
* Availability of data related to survival outcomes in the patient medical record
* Patients deceased or not at the time of enrollment will be eligible for inclusion in the study

Exclusion Criteria:

* No documentation of systemic therapy outcomes or prior treatments in patient medical records
* Patients with second concomitant metastatic malignancy

Primary outcomes:
measure: Disease characteristic according to age
timeFrame: Through study completion (approximatively 5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum der Universität München, - Anstalt des öffentlichen Rechts -
Study officials:
References:
Clinical trial NCT06149936: Excimer Light(308) Therapy for Resistant Alopecia Areata
Official title: Efficacy of Excimer Light(308) Therapy for Resistant Alopecia Areata
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alopecia Areata
Keywords: excimer light
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients take 24 sessions with excimer light for 3 months

Brief summary: This study aimed to evaluate the efficacy and safety of the 308-nm excimer lamp in resistant AA treated with topical minoxidil .

Detailed description: Alopecia areata (AA) is a chronic, nonscarring, T-cell mediated autoimmune disease, presenting with localized or diffuse hair fall in hair-bearing areas. Approximately 1.7% of the population experience an episode of AA during their lifetime. Both sexes are equally affected, and most new cases are recorded below the age of 30 years . Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as IL-4, IL-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid. Benefits have only been seen with localized patches of AA, and regrowth of hair occurs only in treated areas .

Eligibility criteria: Inclusion Criteria:

* ● Having multiple patches of AA.

  * Duration of alopecia \>1 year
  * No topical or systemic treatment for the last 4 months
  * Agreement to regular visits for treatment and follow-up.

Exclusion Criteria:

* ● A single form of AA.

  * Alopecia for \<1 year.
  * Being on other modalities of treatment.
  * Treatment within the last 4 months.
  * Photosensitive disorders.
  * Pregnancy or breastfeeding.

Primary outcomes:
measure: alopecia areata with ecimer light
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03297736: Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Official title: Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Middle Ear Disease
Lead sponsor: Nitinetics LLC
Sponsor class: INDUSTRY
First posted: 2017-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.

Detailed description: Conventional middle ear prosthetic prosthetics, including total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive, require large inventories for otologic surgery services, and carry the risk of extrusion or rejection. Autologous bone and cartilage can be used for many of these applications, but it requires expensive operating room time for carving to the appropriate shape and size.

The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted design/computer assisted manufacture) to produce accurate bone and cartilage autografts on demand in the operating room. Such a technology is hypothesized to save money by reducing operating room time, and reducing the need for expensive inventories of various shapes, sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be less likely to extrude or cause other problems such as infection, this could also reduce costs.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction

Exclusion Criteria:

* congenital anomalies

Primary outcomes:
measure: Cost savings
timeFrame: perioperative
Secondary outcomes:
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
measure: ABG
timeFrame: preoperative; 6weeks, 3 months, and 6 months postoperatively.
measure: Number of participants that experience device rejection
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida-Jacksonville
state: Florida
Study officials:
affiliation: Nitinetics LLC
name: Glenn Knox, M.D., J.D.
role: PRINCIPAL_INVESTIGATOR
References: