louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01133730: Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft
Official title: The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Surgery
Iliac Crest Bone Harvest
Keywords: supraclavicular nerve block
regional anesthesia
transversalis fascia plane block
ultrasound guided
opioid consumption
iliac crest bone harvest
hand surgery
wrist surgery
Upper limb surgery combined with iliac crest bone harvest.
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block.


Eligibility criteria: Inclusion Criteria:

1. ASA physical status I-III
2. 18-85 years of age, inclusive
3. Weight 50kg+
4. Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG

Exclusion Criteria:

1. Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
2. Pregnancy
3. History of alcohol or drug dependency/abuse
4. History of long term opioid intake or chronic pain disorder
5. History of significant psychiatric conditions that may affect patient assessment
6. Failure of upper extremity block
7. Previous iliac crest bone grafting
8. History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
9. Inability to understand the informed consent and demands of the study.

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: 7 days
measure: Pain measures
timeFrame: 48 hours
measure: Time of block performance
timeFrame: 6 hours
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01746030: Geriatric Assessments in Senior Adults With Multiple Myeloma
Official title: Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bone Marrow Transplant Clinic at Siteman Cancer Center

Brief summary: This study will evaluate the prevalence of geriatric syndromes in older adults with multiple myeloma, examine relationships between baseline geriatrics syndromes and initial treatment selection, and examine risk of functional decline.

Relationship between baseline geriatric questionnaires and initial treatment selection in older adults with newly diagnosed multiple myeloma.

Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6 months.

Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Patient must have a diagnosis of multiple myeloma by IMWF criteria: diagnosis must have occurred within 3 months of study enrollment.
* Patient must be ≥ 65 years of age.
* Patient's life expectancy must be ≥ 6 months.
* Patient must be willing to complete follow-up assessments.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have a diagnosis of smoldering myeloma.
* Patient must not have concomitant amyloidosis.

Primary outcomes:
measure: The relationship between initial treatment recommendation and baseline questionnaires assessment
timeFrame: At baseline visit
Secondary outcomes:
measure: Changes in questionnaires from baseline to 6 months
timeFrame: Through 6 months of follow-up
measure: Completion of the questionnaires at baseline, 3 months and 6 months.
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tanya Wildes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01141530: Deep Sequencing of the Breast Cancer Transcriptome
Official title: Deep Sequencing of the Breast Cancer Transcriptome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Identify novel genes and predict putative proteins in breast cancer.
Find biomarkers that can be used for early detection, diagnosis, and prognosis.
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled. Tissue was collected during biopsies or mastectomies after pathologist's approval.

Brief summary: This project is a pilot study designed to investigate transcriptional regulation in breast cancer. Although the main focus of the present study will be triple negative breast cancer where all of the clinically relevant receptors - estrogen receptor (ER), progesterone receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside collaborators or purchased from commercial vendors will eventually be investigated. We will use high throughput molecular profiling techniques such as microarrays and next generation sequencing to correlate gene expression and gene expression regulation with clinical parameters such as tumor size, time to relapse and overall survival.


Eligibility criteria: Inclusion Criteria:

* There is no inclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

Exclusion Criteria:

* There is no exclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT06293430: Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Official title: Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Left Atrial Appendage Closure
Atrial Arrhythmia
Lead sponsor: LUMA Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the investigator's general patient population. Subjects considered for participation in this study will be entitled to undergo a standard of care PAF ablation and/or LAAC procedure with the VERAFEYE System.

Brief summary: The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.


Eligibility criteria: Key Inclusion Criteria:

* Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent
* Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;
* Subject is able to understand and willing to provide written informed consent
* Subject is able and willing to complete all study assessments at an approved clinical investigational center

Key Exclusion Criteria:

* Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure
* Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
* Unrecovered/unresolved Adverse Events from any previous invasive procedure
* Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)

Primary outcomes:
measure: Acute procedural success rates during the index procedure
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04999930: Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)
Official title: Comparison of Clinical Efficacy and Patient's Satisfaction of Tiotropium Respimat Administration With and Without Aerochamber in Patient With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: COPD patient on Tiotropium Respimart divided into two group, Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .

Detailed description: 1. COPD patient who is on Tiotropium Respimart and other inhalers continued.
2. Those fullfill inclusion criteria will be randomized into two group.
3. To do Baseline CAT score and SGRQ questionnaires with Lung function test.
4. Assess inhaler technique with and without aerochamber.
5. Teach proper inhaler technique by templates and demonstrate to patients.
6. Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
7. First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
8. Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
9. Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
10. Analysis data

Eligibility criteria: Inclusion Criteria:

1. COPD patients under Respiratory clinic UKM follow up

   * Patients who are with stable COPD (no exacerbation past 2 months)
   * Age same and more than 40-year-old
2. Patient able to perform inhaler medication
3. Patient able to perform technically acceptable pulmonary function test

Exclusion Criteria:

1. Drug hypersensitivity
2. Bronchial Asthma
3. Significant disease that may influence patient's ability to participate in the study.
4. Unable to provide signed informed consent
5. Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.

Primary outcomes:
measure: To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
timeFrame: 18 weeks
Secondary outcomes:
measure: Change of FEV1 (%) between the treatment group
timeFrame: 18 weeks
measure: Types of inhaler technique error between the group
timeFrame: 18 weeks
measure: To assess quality of life (SGRQ questionaire)
timeFrame: 18 weeks
measure: To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: Kuala Lumpur
Study officials:
References:
Clinical trial NCT05162430: Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery
Official title: Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus Vulvae
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 150
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: PREVENTION

Brief summary: OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery.

METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4 and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). The perineal itching, the onset and duration of itching, the visual analogue score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence of adverse reactions were recorded in the five groups.


Eligibility criteria: Inclusion Criteria:

Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2

Exclusion Criteria:

Patients with paresthesia or pruritus Drug and alcohol abuse Allergies to lipid drugs and contraindications; corticosteroids are cautious Patients Hyperlipidemia Patients during pregnancy and lactation Mental diseases, communication disorders Patients who use hormones for a long time

Primary outcomes:
measure: Duration of pruritus
timeFrame: 3-6 minutes
measure: Incidence of pruritus
timeFrame: 3-6 minutes
measure: Severity of pruritus
timeFrame: 3-6 minutes
measure: VAS score
timeFrame: 10-30 seconds
measure: Ramsay score
timeFrame: 10-30 seconds
Secondary outcomes:
measure: Adverse reactions
timeFrame: 3-6 minutes
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Liu meiyu
state: Jiangsu
Study officials:
affiliation: Yangzhou University
name: Liu m yu, Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799730: Expression of CXCR4 in Patients With Systemic Lupus Erythematosus
Official title: Study of CD184 in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: CXCR4,CD184,Flow cytometry ,Systemic lupus erythematosus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be classified into two group:

1. SLE patients group: Confirmed SLE patients diagnosed and fulfilled the SLE classification criteria according to the 2019 ACR/EULAR classification criteria for SLE (Aringer et al., 2019).
2. Control group: Healthy age and sex matched subjects.

Then SLE group I patients will be subdivided according to the disease activity to three subgroups:

I. Group A: SLE cases in remission II. Group B: SLE cases in activity, but no internal organ involvement (i.e. only mucocutaneus and/or musculoskeletal involvement).

III. Group C: SLE cases in activity, and with internal organ involvement (renal, neuropsychiatric, hematological or cardiopulmonary).

Brief summary: The objective of this study is to estimate the possible role of CD184 in the pathogenesis of SLE; comparing its level among SLE cases to healthy controls.

Detailed description: Detection of CXCR4 (CD184) expression on CD19+ B cells by flow cytometry in patients of SLE, comparing its level in the development of lupus activity and pathogenic process of SLE internal organ involvement/ mucocutaneus and/or musculoskeletal involvement. Identify this correlation will be useful for clarifying other accessory factors to improve the diagnosis, better treatment strategy, follow up as well as prognosis for these patients

Eligibility criteria: Inclusion Criteria:

* Confirmed SLE patients diagnosed and fulfilled the SLE classification criteria according to the 2019 ACR/EULAR classification criteria for SLE (Aringer et al., 2019)
* Willing and agreed to be included in the study.

Exclusion Criteria:

* Childhood SLE.
* SLE-patients will refuse to consent to this study.
* Other autoimmune diseases.
* Known or suspected malignancies, especially B cell lymphoma.

Primary outcomes:
measure: changes in the expression of CD184(CXCR4) expression in circulating B cells
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05573230: A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
Official title: A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Participants who regularly use known drugs of abuse
* Women who are lactating and who are of child-bearing potential
* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
timeFrame: Predose up to 96 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 96 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03432130: Injury Occurrence in Hip-hop Dance
Official title: The Effect of Structured Training Program and Body Composition on Injury Occurrence in Hip-hop Dance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Injury
Body Composition
Keywords: hip-hop dance, injuries, body fat
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will investigate the effect of structural training program and body composition on injury occurrence in hip-hop dance. Assuming that training program can significantly lower the number of injuries (experimental group will have less injuries during and at the end of the trial) and that body fat percentage negatively effects injury occurrence (dancers with higher body fat percentage will be more often injured).


Eligibility criteria: Inclusion Criteria:

* hip-hop dancer (active)

Exclusion Criteria:

* injured

Primary outcomes:
measure: Number of injuries
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University of Ljubljana, Faculty of Sport
Study officials:
References: