louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05589649: Erector Spinae Versus Paravertebral in Pediatric PCNL
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Percutaneous
Nephrolithotomy
Keywords: paravertebral block
Erector spinae plane block
Percutaneous nephrolithotomy
pediatric
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy

Detailed description: Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Erector spinae plane (ESP) block is an interfascial block that was first described by Forero et al. in 2016. It can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle to provide both visceral and somatic analgesia with a sensory level from T2-4 to L1-2.

. Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

* Coagulation disorders
* Infection at the site of injection
* Allergy to the local anesthetics used
* Spinal cord abnormalities or neurological deficits

Primary outcomes:
measure: Total consumption of nalbuphine
timeFrame: The first 24 hours postoperatively
measure: Time to first rescue analgesia
timeFrame: The first 24 hours postoperatively
Secondary outcomes:
measure: The concentration of sevoflurane in percent
timeFrame: Through the surgery, an average of 2 hours
measure: Systolic, diastolic, and mean blood pressure during surgery in mmHg
timeFrame: Through the surgery, an average of 2 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT05657249: Alternative Surveillance Program for Patients With High Risk Group of HCC
Official title: Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: US
MRI
HCC
surveillance
risk estimation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: The Catholic University of Korea
name: Korea University Guro Hospital
First posted: 2022-12-20
Enrollment: 199
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared


Eligibility criteria: Inclusion Criteria:

* chronic hepatitis B or C
* Child-Pugh classification A
* HCC risk score \>= -2.04
* have not diagnosed with HCC
* on surveillance program using US and negative on previous US within 6-8 months of enrollment
* sign informed consent

Exclusion Criteria:

* younger than 40 years or older than 70 years old
* history of HCC
* severe GFR or on HD/PD due to renal failure
* contra-indication of MRI
* congestive hepatopathy
* iron deposition
* pregnancy or nursing mother
* non-viral hepatitis or liver cirrhosis

Primary outcomes:
measure: Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
timeFrame: up to one year
Secondary outcomes:
measure: Comparison of annual focused MRI and biannual US for HCC detection
timeFrame: up to one year
measure: diagnostic yield for HCC
timeFrame: up to one year
measure: scan time of focused MRI
timeFrame: up to one month
measure: comparison between false referral rates of biannual US and annual focused MRI
timeFrame: up to one year
Other outcomes:
measure: comparison between incidental findings between biannual US and annual focused MRI
timeFrame: up to one year
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Hee Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06321549: New Era of DIEP With Minimally Invasive Mastectomy
Official title: Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Mastectomy; Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 278
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022 from a single experienced reconstructive surgeon's practice at a medical institution.

Brief summary: The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.

Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
* Patients who have a minimum follow-up duration of six months post-reconstruction.

Exclusion Criteria:

* Patients who did not meet the six-month follow-up duration was excluded from the study.

Primary outcomes:
measure: Endoscopy mastectomy
timeFrame: Post-operative day 0
measure: Robotic mastectomy
timeFrame: Post-operative day 0
measure: Incision
timeFrame: Post-operative day 0
measure: Usage of SIEV
timeFrame: Post-operative day 0
measure: Inclusion of bipedicle
timeFrame: Post-operative day 0
measure: Location of recipient artery/vein
timeFrame: Post-operative day 0
measure: Recipient artery/vein selection
timeFrame: Post-operative day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jung-Ju Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02763449: Appetite and Adiposity Across a Continuum of Activity
Official title: Appetite and Adiposity Across a Continuum of Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity and Sedentary Behavior
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand what happens when someone either becomes more active or more inactive. This study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive.


Eligibility criteria: Inclusion Criteria:

* Men and women

  * Age 25-35 yrs
  * BMI ≥25.0 to \<35.0 kg/m2
  * Subjective physical activity (pre run-in): Sedentary for the previous 3 months (\< 20min, 3 times/week of structured exercise)
  * Objective physical activity (run-in): daily steps/day \>4500 yet \<7,000 during 7 day run-in period
  * Weight-stable (± 5%) within the previous 3 months
  * Non-smoking for last year
  * Able to provide own transportation to study visits and intervention
  * Not currently involved in any other research study
  * Willing and able to participate in all aspects of the trial including research testing
  * Willing to give informed consent to participate
  * Able to participate in a moderate physical exercise program

Exclusion Criteria:

* Self-reported significant cardiovascular disease including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, myocardial infarction, stroke

  * Other self-reported medical conditions including but not limited to metabolic disorders such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease interfering with exercise, or any serious medical condition that may affect adherence to the protocol or exercising safely, or be aggravated by exercise
  * Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
  * Excess caffeine use (\> 500mg/day)
  * Restrained eater (\>13) on the restraint section of the three-factor eating questionnaire
  * Current or past diagnosis of an eating disorder
  * Any self-reported contraindications to exercise according to the American College of Sports Medicine criteria
  * Pregnant or actively trying to become pregnant
  * Gave birth in the past 12 months or \<6 months post-lactation
  * Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
  * Known allergy to the metal nickel
  * Known allergies to pasta or tomato sauce

Primary outcomes:
measure: Appetite- subjective
timeFrame: 14 days
Secondary outcomes:
measure: Appetite- objective
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01811849: Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
Official title: A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: diabetes
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2013-03-15
Enrollment: 12
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: A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Detailed description: The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 to ≤70 years
* Body Mass Index: ≥18 and ≤35 kg/m2
* Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

* Type 2 diabetes mellitus
* Serum C-peptide \>1.0 ng/mL
* HbA1c \>10.0%
* History of hypersensitivity to any of the components in the study medication
* Treatment with any other investigational drug in the last 30 days before dosing.
* Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Primary outcomes:
measure: Time to 1/2 maximal insulin concentration
timeFrame: 480 minutes
Secondary outcomes:
measure: Time to maximal insulin concentration
timeFrame: 480 minutes
measure: Time to 1/2 maximal insulin concentration after peak
timeFrame: 480 minutes
measure: Visual analog scale
timeFrame: 30 minutes
measure: AUC 0-30 and AUC 0-60
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00692549: Ultrasound Guidance for Intravenous Cannulation in Emergency Department Patients.
Official title: Ultrasound-Guided Peripheral Intravenous Cannulation in Emergency Department Patients With Difficult IV Access: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult IV Access
Keywords: ultrasound
iv access
Patients with difficult iv access in emergency departments.
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A randomized trial of the use of ultrasound by emergency physicians in the placement of intravenous catheters in emergency patients who are found to have difficult intravenous access (defined as two failed attempts by nursing staff).


Eligibility criteria: Inclusion Criteria:

* patients requiring an IV in the emergency department and who have two failed attempts by nursing staff

Exclusion Criteria:

* emergent need for IV access

Primary outcomes:
measure: Number of IV Attempts
Secondary outcomes:
measure: Time to placement of IV catheter
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
References:
Clinical trial NCT00988949: Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
Official title: Phase I, Randomized, Placebo Controlled Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release In Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Depression
Keywords: Proof of mechanism study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will be a Proof of Mechanism (POM) study to establish evidence of central pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Change from baseline area under the serum PRL concentration time curve from 0 to 120 minutes after intramuscular administration of PF 00345768 (spiradoline).
timeFrame: 1 week
Secondary outcomes:
measure: Change from baseline to peak of serum PRL concentration.
timeFrame: 1 week
measure: Change from baseline to peak of plasma ACTH concentration.
timeFrame: 1 week
measure: Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline).
timeFrame: 1 week
measure: Plasma concentrations of PF 04455242.
timeFrame: 1 week
measure: Clinical monitoring of safety and tolerability will include physical exam and neurological assessment, clinical safety laboratory results, 12 lead ECGs, vital signs, suicidality assessment, and adverse event monitoring
timeFrame: 1 week
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02048449: Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists
Official title: Inter-rater Reliability of the Reflux Finding Score Based on Endoscopic Laryngeal Findings in the Diagnosis of Laryngopharyngeal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngitis
Reflux
Keywords: Reflux finding score, interrater reliability
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: not appliable

Brief summary: Title:

Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in the diagnosis of laryngopharyngeal reflux disease

Participants:

Voluntary participants after invitation among members (a total of about 40 gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and an otorhinolaryngologist

Primary endpoint:

Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7 points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off value for the diagnosis of laryngopharyngeal reflux disease)

Secondary endpoint:

Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among gastroenterologists

Detailed description: Study Design

1. Recruitment of doctor participants: introduction by e-mail
2. Education on reflux finding score - standardized materials (instructional video)
3. PRETEST (15 pictures) / feedback (at-a-glance assessment format)
4. TEST 1 (50 pictures) - Acess format including 8 items at each pictures
5. Feedback education (individualized intruction of an otorhinolaryngologist)
6. TEST 2 (50 pictures) - Acess format including 8 items at each pictures
7. Test-Retest reliability - repeat Test 2 with 1 week interval (Participants should take retest of TEST 2 with the concealment of the answer)
8. Analysis

Eligibility criteria: Inclusion Criteria:

* Participants: Gastroenterologists (GI specialists) or trainees /
* Pictures: Endoscopic laryngeal pictures with good quality

Exclusion Criteria:

* Participants: Major other than gastroenterology /
* Pictures: Endoscopic laryngeal pictures without good quality

Primary outcomes:
measure: Cohen's kappa coefficient
timeFrame: 5 months
Secondary outcomes:
measure: Agreement (%) at each item out of 8 items of reflux finding score
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistant professor, ENT department, Chuncheon Sacred Heart Hospital
name: Dong Kyu Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04907149: Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970
Official title: A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.


Eligibility criteria: Inclusion Criteria:

* Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
* Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Participant has participated in a \[14C\]radiolabeled study within the past 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.

This list only contains the key exclusion criteria.

Primary outcomes:
measure: Absolute oral bioavailability (F [%]) of GLPG3970
timeFrame: From Day 1 pre-dose until Day 4 in Period 1
measure: Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
timeFrame: From Day 1 pre-dose until Day 8 in Period 2
measure: Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
timeFrame: From Day 1 pre-dose until Day 8 in Period 2
Secondary outcomes:
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
timeFrame: From Day 1 through study completion, an average of 1 month
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Ltd
Study officials:
affiliation: Galapagos NV
name: Ekaterina Tankisheva
role: STUDY_DIRECTOR
References: