louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01568437: Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery
Official title: Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric-bypass Surgery
Opioid Consumption
Obesity
Keywords: Laparoscopic gastric-bypass surgery
TAP block
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid obesity, which is performed under general anesthesia. TAP block is an analgesic strategy covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are located. As far as the investigators know, this analgesic technique has never been studied in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass surgery, compared to conventional therapy only.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* 18-70 years of age, inclusive
* scheduled for elective laparoscopic gastric-bypass surgery.

Exclusion Criteria:

* contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* pregnancy
* history of alcohol or drug dependence/abuse
* history of long term opioid intake or chronic pain disorder
* history of significant psychiatric conditions that may affect patient assessment
* inability to understand the informed consent and demands of the study

Primary outcomes:
measure: Opioid consumption over the first 24 hours following LGBS.
timeFrame: 24 hrs
Secondary outcomes:
measure: Pain scores
timeFrame: 48 hours
measure: Opioid consumption at 48 hours
timeFrame: 48 Hours
measure: Duration of block
timeFrame: 48 hours
measure: Block procedure time
timeFrame: 30 minutes
measure: TAP block complications
timeFrame: 48 hours
measure: incidence of nausea and vomiting, and number of antiemetic medication administrations
timeFrame: during hospital stay average of 2 - 3 days
measure: incidence of itching, and number of antipruritic medication administrations
timeFrame: 48 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto. University Health Network. Toronto Western Hospital.
name: Richard Brull, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05920837: Relationship Between Upper Extremity' Viscoelastic Properties and Functionality in Subacute Stroke
Official title: The Relationship Between Upper Extremity Viscoelastic Properties and Functionality in Sub-acute Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Stiffness of Right Hand, Not Elsewhere Classified
Muscle Tone Abnormalities
Functional; Bleeding
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
Collaborators: name: Sanko University
First posted: 2023-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18 and 50 who had an ischemic stroke for the first time will be included in the study. Individuals with impairments that may affect upper extremity performance will be excluded from the study.

Brief summary: In stroke patients, the shoulder-upper extremity complex is affected and reduces independence and quality in activities of daily living. Investigating the relationship between the functions of the upper extremity muscles and viscoelastic properties is important in understanding the rehabilitation of individuals with stroke.

Detailed description: Upper extremity functions of individuals will be measured and correlated with viscoelastic properties of upper extremity muscles. The box and block test will be used for the function test. The viscoelastic properties of the muscles will be measured with the myotonPRO device. Deltoideus, Triceps, Biceps, Brachioradialis and Extansor digitorum longus were evaluated with myotonPRO. The tonus, stiffness and elasticity of muscles were recorded. Assessments will applied bilaterally and average recorded.

Eligibility criteria: Inclusion Criteria:

Patients who had ischemic SVO 3-9 months ago Individuals who have had a stroke for the first time MAS ≤ 2 of spasticity in paretic upper extremity

Exclusion Criteria:

TIA survivors Presence of cognitive deficits ( Mini-Mental State Examination score ≥ 24) Presence of another neurological, neuromuscular or orthopedic disease Presence of diseases that cause pain, such as fibromyalgia or arthritis Comorbidity with depression or psychiatric illness

Primary outcomes:
measure: Stiffness
timeFrame: through study completion, an average of one month
measure: Elasticity
timeFrame: through study completion, an average of one month
measure: Tone
timeFrame: through study completion, an average of one month
measure: Functionality- Box and Block Test
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Tuba Maden
state: Sahinbey
Study officials:
References:
Clinical trial NCT05546437: A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System
Official title: A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 288
Sex: ALL
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: Subjects who underwent an Ion Endoluminal dye marking procedure with a pulmonary nodule, 18 years or older, who subsequently underwent a resection of their pulmonary nodule.

Brief summary: The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

Detailed description: This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older at the time of the procedure.
* Dye marking attempted/performed using the Ion Endoluminal Platform

Exclusion Criteria:

* Resection not performed following dye marking procedure

Primary outcomes:
measure: Successful dye injection
timeFrame: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure
measure: Pneumothorax
timeFrame: Intra-procedure
Secondary outcomes:
measure: Adverse events
timeFrame: Intra-procedure until the start of the resection procedure
measure: Procedure time
timeFrame: Intra-procedure
measure: Operative time
timeFrame: Intra-operative
measure: Type of resection planned and performed
timeFrame: Intra-operative
measure: Conversion to alternate approach or termination of procedure due to localization issues
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
References:
Clinical trial NCT05152537: FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia
Official title: A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Folate
CML
Treatment-free Remission
Keywords: FOLR3
CML
TFR
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. The patient signs the informed consent form
2. Age over 18, male or female
3. The patient was diagnosed as chronic phase of CML.
4. ECoG score 0-2
5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.

Brief summary: For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

Detailed description: Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

Eligibility criteria: Inclusion Criteria:

1. The patient signs the informed consent form
2. Age over 18, male or female
3. The patient was diagnosed as chronic phase of CML.
4. ECoG score 0-2
5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.

Exclusion Criteria:

NA

Primary outcomes:
measure: treatment-free remission or relapse
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affliated Hospital of Nantong University
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Hong Liu, Doctorate
role: STUDY_CHAIR
References:
Clinical trial NCT01697137: Patient and Physician Intervention to Increase Organ Donation
Official title: Patient and Physician Intervention to Increase Organ Donation in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue and Organ Donation
Communication
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 916
Sex: ALL
Minimum age (years): 15
Maximum age (years): 78
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The number of persons on the national solid organ waiting list continues to increase while the number of donated organs has failed to keep pace. In some portions of northeastern Ohio the donation rate is as low as 32%. There is a positive association between discussing organ donation with a primary care physician and signing a donor card. However, such discussions are rare. The investigators propose a blinded randomized controlled trial to evaluate the effectiveness of two interventions: 1) showing a donation video to patients in primary care settings waiting to see their physician and 2) cueing of primary care providers to have donation discussions with their patients. The study will be conducted throughout Cuyahoga County in at least 10 ambulatory clinics associated with a single county medical system. Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that patients exposed to the interventions will be 1) more likely to consent to donate organs, 2) more likely to have donation discussions with their primary care providers, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.


Eligibility criteria: Inclusion Criteria:

* At least 2 visits with their primary care provider in the last 3 years
* Not previously consented to organ donation
* At least 15.5 years of age
* Less than 78 years of age

Exclusion Criteria:

* Visually impaired
* Cognitively impaired
* Non-English speaking

Primary outcomes:
measure: Proportion of participants who consent to donate organs
timeFrame: 1 Day
Secondary outcomes:
measure: Proportion of participants who reported holding donation discussions with their primary care provider
timeFrame: 1 Day
Other outcomes:
measure: Proportion of participants who were satisfied with time spent with their provider on the study date
timeFrame: 1 Day
Locations:
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: John D Thornton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thornton JD, Sullivan C, Albert JM, Cedeno M, Patrick B, Pencak J, Wong KA, Allen MD, Kimble L, Mekesa H, Bowen G, Sehgal AR. Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial. J Gen Intern Med. 2016 Aug;31(8):832-9. doi: 10.1007/s11606-016-3630-5.
Clinical trial NCT00804037: Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate
Official title: Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Apnea
Keywords: Snoring and Mild Apnea
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection snoreplasty arose as a promising alternative in some selected cases.

OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing Ethanol and Ethanolamine Oleate.


Eligibility criteria: Inclusion Criteria:

* Snoring
* RDI \< 15 /h

Exclusion Criteria:

* BMI \> 35

Primary outcomes:
measure: Snoring
timeFrame: 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Fabio TM Lorenzetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Michel B Cahali, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06201637: Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty
Official title: Investigation Of The Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty, knee, Short Physical Performance Battery, validity, reliability
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives: Practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with Total Knee Arthroplasty(TKA) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. Therefore, the aim of this study is to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) among patients with TKA.

Methods: We included patients who underwent TKA surgery. The SPPB, Timed up and go(TUG) test and, Hospital for Special Surgery (HSS) Knee Score were administered to the patients. SPPB was performed twice on the same day with 1 h rest.


Eligibility criteria: Inclusion Criteria:

* patients who had primary TKA surgery at six months ago, were diagnosed with preoperative knee OA, and were willing to participate in the research

Exclusion Criteria:

* a previous orthopedic, neurological, or systemic disease that effected walking or standing, body mass index of 40 kg / m2 and over and having any other surgery on the same limb that effected walking.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: 1 Hour
Secondary outcomes:
measure: TUG
timeFrame: 15 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT03561337: Nutrient Supplementation Influences Mitochondria Adaptation
Official title: Effect of Whey Protein Hydrolysate on Adaptions to Endurance Training in Well-trained Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance
Nutrition
Protein
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: block randomized controlled intervention
Primary purpose: OTHER

Brief summary: Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. The PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6 km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).


Eligibility criteria: Inclusion Criteria:

1. maximal oxygen uptake (VO2max) of \>50ml O2 kg-1 min-1 for women and \>55ml O2 kg-1 min-1 for men,
2. running at least 3 times a week and
3. running being the primarily training form

Exclusion Criteria:

1. use of medicine
2. diagnosed metabolic diseases
3. injuries which hindered running and body mass index (BMI) \< 25 kg m-2

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: Change from week 1 to week 6
Secondary outcomes:
measure: VDAC
timeFrame: Change from week 1 to week 6
measure: CytC
timeFrame: Change from week 1 to week 6
measure: Performance
timeFrame: Change from week 1 to week 6
measure: COX-IV
timeFrame: Change from week 1 to week 6
measure: HSP60
timeFrame: Change from week 1 to week 6
measure: CD36
timeFrame: Change from week 1 to week 6
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
city: Aarhus
country: Denmark
facility: Sport Science, Department of Public Health, Aarhus University
Study officials:
References:
citation: Hansen M, Oxfeldt M, Larsen AE, Thomsen LS, Rokkedal-Lausch T, Christensen B, Rittig N, De Paoli FV, Bangsbo J, Ortenblad N, Madsen K. Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners. J Int Soc Sports Nutr. 2020 Sep 7;17(1):46. doi: 10.1186/s12970-020-00376-3.
Clinical trial NCT06569537: Comparison of Compounded Topical Anesthetics
Official title: Comparison of Compounded Topical Anesthetics for Pain Relief of Intense Pulsed Light, Pulse Dye Laser, and Microneedling Treatments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Procedural Pain
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18, but not more than 75 years of age.
* Patients who have a regularly scheduled dermatology appointment for Intense Pulse Light (IPL), Pulse Dye Laser (PDL), or microneedling.

Exclusion Criteria:

* Any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine.
* Patients with cardiac/respiratory disease, seizure disorder, or neuropathies.
* Patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study.
* Pregnant women and women who are breastfeeding.
* Patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.

Primary outcomes:
measure: Pain as measured by the Numeric Pain Rating Scale (NPRS)
timeFrame: At baseline
measure: Pain as measured by the Wong-Baker Face Pain Rating Scale
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Dermatology Clinic
state: New Hampshire
Study officials:
affiliation: Dartmouth Health
name: Brian J Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References: