louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06352606: Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy
Official title: Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Anesthesia
General Anesthesia
Neonates
Inguinal Herniorrhaphy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.

Detailed description: Spinal anesthesia (SA) is a fast, simple and cost-effective method that has been used for the performance of inguinal hernias since the beginning of the 20th century in adults.

One large observational study documented a low risk of post operative events with spinal anesthesia for inguinal hernia repair in infants . In addition, a randomized trial comparing reginal and general anesthesia in this population have not shown any significant differences in outcome. Spinal anesthesia reduces postoperative oxygen desaturation and respiratory morbidity when compared to general anesthesia (GA) in infants who underwent inguinal herniorrhaphy

Eligibility criteria: Inclusion Criteria:

* Neonates either full term or preterm.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-II
* Undergoing unilateral or bilateral inguinal herniorrhaphy.

Exclusion Criteria:

* Obstructed hernia.
* Neonates with significant chronic lung disease (e.g., disease associated with hypoxemia in room air or chronic hypercapnia).
* Symptomatic congenital heart disease (e.g., cyanosis or congestive heart failure).
* Symptomatic central nervous system disease (e.g., seizures).

Primary outcomes:
measure: Heart rate
timeFrame: Immediately postoperatively at post-anesthesia care unit
Secondary outcomes:
measure: Heart rate
timeFrame: Till two hours postoperatively
measure: Mean arterial blood pressure
timeFrame: Till two hours postoperatively
measure: Incidence of bradycardia
timeFrame: 24 hours postoperative
measure: Incidence of hypotension
timeFrame: 24 hours postoperative
measure: Incidence of postoperative apnea
timeFrame: 24 hour postoperatively
measure: The duration of surgery
timeFrame: Till the end of surgery
measure: Need for postoperative O2 supplementation
timeFrame: Till two hours postoperatively
measure: Hospital stays
timeFrame: 28 days postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbia
Study officials:
References:
Clinical trial NCT05752006: Chronic Adaptations to Spinal Flexion Exposure
Official title: Chronic Adaptations to Spinal Flexion Exposure in Crane Operators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Exposure
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 30
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional study
Primary purpose: BASIC_SCIENCE

Brief summary: An experimental study, which will aim to compare changes of trunk mechanical properties and neuromuscular control following spinal flexion exposure in crane operators and control subjects.

Detailed description: Our experimental study will include 40 participants, more specifically 15 crane operators and 15 control subjects. All participants will complete a 60-min protocol of intermittent trunk flexion. Measurements of trunk mechanical properties and neuromuscular control will be performed prior to and following the 60-min protocol.

Eligibility criteria: Inclusion Criteria:

* Crane operators: employed as crane operators for more than 3 years
* Occupational workers with a predominantly non static job (e.g. combination of sitting and standing)

Exclusion Criteria:

* History of chronic low back pain
* Episode of acute low back pain
* Hip injury in the past six months
* Previous spine, pelvis or hip surgery
* Hypermobility, diagnosed with the Beighton score
* High intensity resistance training (\> 75 % of 1 repetition maximum) more than two times a week
* Control group: sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).

Primary outcomes:
measure: Change in muscle stiffness
timeFrame: 90 minutes
Secondary outcomes:
measure: Change in range of motion
timeFrame: 90 minutes
measure: Change in length of the spine
timeFrame: 90 minutes
measure: Change in muscle activity
timeFrame: 90 minutes
measure: Change in lumbar lordosis angle
timeFrame: 90 minutes
measure: Change in trunk extension maximal strength
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
state: Primorska
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Matej Voglar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01354106: Adhesive Tape Trauma Evaluation of Two Gentle Tapes
Official title: Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Tape Trauma
Keywords: Skin condition after wear
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2011-05-16
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Detailed description: The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Eligibility criteria: Inclusion Criteria:

1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
2. Who are between the ages of 6 months - 4 years of age
3. Who has a Fitzpatrick Skin Type of I, II or III
4. Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
5. Whose parent is willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Who are known to be developmentally delayed
2. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
3. Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study.
4. Who have had a strep infection within the past 2 weeks
5. Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
6. Who have allergies to isocyanates, or acrylate adhesive products
7. Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).

Primary outcomes:
measure: Skin Trauma
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Broomall
country: United States
facility: cyberDERM
state: Pennsylvania
Study officials:
affiliation: cyberDERM
name: Gary L Grove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00034606: Comparing 3 Schedules of Alimta Plus Gemzar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms
Keywords: Lung cancer
cancer
neoplasm
non-small
chemotherapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-small lung cancer
* No prior chemotherapy
* Able to care for self

Exclusion Criteria:

* An ongoing infection
* Pregnancy or breast feeding
* Other serious medical condition
* Cancer that has spread to the brain
* Inability to take folic acid

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT04505306: Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema
Official title: Comparison of Short-pulse Subthreshold (532 nm) and Infrared Micropulse (810 nm) Macular Laser for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: micropulse laser
Lead sponsor: Moorfields Eye Hospital Centre Abu Dhabi
Sponsor class: OTHER
Collaborators: name: King Khaled Eye Specialist Hospital
name: University of Nebraska
First posted: 2020-08-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When applied according to manufacturer recommendations, short-pulse system may yield more temporary reduction in edema while infrared micropulse system may yield slightly better functional outcomes.

Detailed description: Purpose: To assess both anatomic and functional outcomes between short-pulse continuous wavelength and infrared micropulse lasers in the treatment of DME.

Materials and Methods: A prospective interventional study from tertiary care eye hospital - King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving diabetic macular edema were treated with subthreshold laser therapy. Patients in the micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the entire area of the macular edema. Patients in the short-pulse group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last follow-up visit.

Eligibility criteria: Inclusion Criteria:

* center-involving clinically significant macular edema due to diabetic retinopathy (\>300 microns)
* clear ocular media
* ETDRS visual acuity \>29 letters (Snellen equivalent of 20/150) or better
* treatment naïve eyes or previously treated with antiangiogenic intravitreal agent(s) more than 6 months ago to allow for long wash-out period

Exclusion Criteria:

* non-center involving diabetic macular edema
* previous retinal laser or surgery
* intravitreal steroid use
* any condition that may be associated with a risk of macular edema such as age-related macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal membrane and others.

Primary outcomes:
measure: Central foveal thickness
timeFrame: 6 months
measure: Best corrected visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Moorfields Eye Hospital Centre
Study officials:
References:
Clinical trial NCT02931006: Influence of Bovine Milk Consumption on Hormonal Profile in Males
Official title: Influence of Bovine Milk Consumption on Hormonal Profile in Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gonadotrophin and Sex Hormone Changes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
First posted: 2016-10-12
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 50 men will be recruited to this study. Participants will be asked to ingest commercially available bovine milk. Hormonal profile will be analyzed before and after consumption.


Eligibility criteria: Inclusion Criteria:

* healthy, non infertile males

Exclusion Criteria:

* lactose intolerance

Primary outcomes:
measure: sex hormone profile
timeFrame: 4 hours after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02764606: CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer
Official title: CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Lung Cancer
Biomarkers
Bone
Metastases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early-stage non-small cell lung cancer

Brief summary: CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies


Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis or suspected for a diagnosis of lung cancer, non-small cell lung cancer
* age over 18 years
* patient naïve of any oncology treatment (excluding surgery alone) within the past 5 years
* patient who signed the informed consent by the study protocol

Exclusion criteria were:

* any ongoing treatment for cancer
* any history of cancer within 5 years before the diagnosis of lung cancer
* any psychological, sociological or geographical conditions that would not allow the study follow-up

Primary outcomes:
measure: The Serum levels of osteoprotegerin
timeFrame: At the time of initial surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon / Hôpital Neurologique Pierre Wertheimer
Study officials:
References:
Clinical trial NCT02238249: Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria
Official title: Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urticaria
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with urticaria and without experience in treatment with epinastine are selected by physicians at medical institutions

Brief summary: Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria


Eligibility criteria: Inclusion Criteria:

* All the patients who:

  * haven't treatment experience of epinastine product entered the survey;
  * have urticaria

Exclusion Criteria:

* Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: up to 2 years
measure: Incidence of adverse drug reactions classified by patient's background/treatment factors
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall assessment of efficacy by investigator on a 3-point scale
timeFrame: after 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06935149: Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools
Official title: Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Liver Metastasis Colon Cancer
Keywords: Liver metastasis
PSMA
PET
Lead sponsor: Primo Biotechnology Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kaohsiung Chang Gung Memorial Hospital,Taiwan
First posted: 2025-04-20
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.


Eligibility criteria: Main inclusion criteria:

1. The participants can voluntarily sign informed consent forms
2. The participants are male/female over 20 years old.
3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer
4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT.
5. WHO performance status ≦ 2 points
6. The participants can lie on table for two hours during PSMA-PET/CT scanning.

Main exclusion criteria: To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria.

1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.
2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.
3. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.
4. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months.
5. The participants suffered acute kidney injury within 6 months.
6. The participants suffered trauma or fracture.
7. The participants are allergic to any radiopharmaceutical or imaging agent.
8. The participants are history of claustrophobia or are inability to remain quiet during the examination.

Primary outcomes:
measure: PSMA positive detection rate is defined as the rate that is detected positive lesion at the same location/region between [18F]FPSMA-1007 PET/CT (60- minute images) and reference standard.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01892449: Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia Using Endotracheal Intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure
* BMI \> 30 kg/m 2

Primary outcomes:
measure: The peak inspiratory pressure
timeFrame: before 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Study officials:
References:
citation: Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
citation: Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.