louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01909765: Two Different Surgical Techniques on Postoperative Circumcision Pain
Official title: Comparison of Two Different Circumcision Surgical Technique on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Circumcision
postoperative pain
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-07-29
Enrollment: 30
Sex: MALE
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.

Detailed description: Two different circumcision techniques result in different kinds of pain.This research aims determine which is more beneficial to the patient.

Eligibility criteria: Inclusion Criteria:

* Children

Exclusion Criteria:

* Patients with any bleeding

Primary outcomes:
measure: To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS)
timeFrame: Postoperative first two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Education and Research Hospital
Study officials:
affiliation: Yildirim Beyazit Education and Research Hospital
name: Reyhan Polat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karakoyunlu N, Polat R, Aydin GB, Ergil J, Akkaya T, Ersoy H. Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study. J Pediatr Urol. 2015 Jun;11(3):124.e1-5. doi: 10.1016/j.jpurol.2015.01.002. Epub 2015 Mar 3.
Clinical trial NCT03916965: Stent Implantation for Patients With SIDSMA
Official title: Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dissection of the Superior Mesenteric Artery
Keywords: dissection of the superior mesenteric artery
patency of stents
remodeling
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 102
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: Patients who have been diagnosed as spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) and treated with stents are potential candidates for the study. All participants must meet all inclusion criteria and none of the exclusion criteria.

Brief summary: This study aims to evaluate the prognosis in patients with spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) who have been treated with stents.

Detailed description: This study is a prospective, observational study. Patients who have been diagnosed as spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) and treated with stents are enrolled in the study. We will evaluate the patency of stent, remodeling of the dissection and the relief of the symptoms in the next 1 years after patients have received stents.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female over 18 years of age
2. Diagnosed as spontaneous isolated dissection of the superior mesenteric artery
3. Patients have been successfully treated with stents
4. Patients are willing to participate in this study

Exclusion Criteria:

1. Life expectancy of \< 5 years;
2. Other surgeries or endovascular treatments have been taken concurrently.
3. Elevated serum level

Primary outcomes:
measure: Patency of stents deployed in the superior mesenteric artery
timeFrame: 12 months post-procedure
measure: Remodeling of the superior mesenteric artery
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Relief of symptoms
timeFrame: 12 months post-procedure
measure: Recurrence
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Ziheng Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qiu C, Wu Z, He Y, Tian L, Zhu Q, Shang T, Zhang H, Li D. Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery. Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD014703. doi: 10.1002/14651858.CD014703.pub2.
Clinical trial NCT01193465: Temperature and Humidity Among Different Anesthesia Work-station
Official title: Comparison of Heat and Humidity Conservation Among Different Anesthesia Workstation and Different Flow Rate.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Humidity
Temperature
Keywords: Humidity
Temperature
Low Flow Anesthesia
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation.

Detailed description: The fresh gas flow(FGF) is dry and cold in old fashioned anesthesia machine, especially at high folw (above 1 L/min). To the contrary, it has been assumed that the heat and humidity of FGF may be preserved using low FGF (below 1 L/min) during anesthesia or new anesthesia work station. However, it has not been proved yet. We hypothesized that the heat and moisture of FGF may be different in various FGF rate during anesthesia. In addition, it may be different in accordance to anesthesia work station. Therefore, we planed prospective observational study that will demonstrate that the difference of heat and moisture of FGF in different anesthesia work station (Excel; 1st generation anesthesia machine of Datex-Ohmeda Corp., Avance; 2nd generation anesthesia work station of Datex-Ohmeda Corp., Cato; 2nd generation generation anesthesia work station of Drager, Primus; 3rd generation generation anesthesia work station of Drager) and different FGF (0.5, 1, 4 L/min)

Eligibility criteria: Inclusion Criteria:

* patients who planned more than 2 hour operation under general anesthesia
* ASA class 1,2
* blood loss less than 500ml

Exclusion Criteria:

* acute/chronic cardiac or respiratory disease

Primary outcomes:
measure: absolute humidity at both limb of breathing circuit just distal portion of Y-piece
timeFrame: time point 1-11
Secondary outcomes:
measure: patient body temperature(BT)
timeFrame: time point 1 -11
measure: temperature at both limb of breathing circuit just distal portion of Y-piece
timeFrame: time point 1- 11
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Seung Zhoo Yoon, Assist. P.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164565: The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
Official title: The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Femur Surgery
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.


Eligibility criteria: Inclusion Criteria:

* Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
* Sound judgment

Exclusion Criteria:

* Known hypersensitivity to Tranexamic Acid or component solution provided
* Subarachnoid hemorrhage
* Acquired color blindness
* Myocardial infarction in 12 months before admission
* Unstable angina
* Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
* Kidney or liver failure
* Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
* Oncology patients
* Patients on anticoagulation
* Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy

Primary outcomes:
measure: Evaluation of blood loss in ml.
timeFrame: up to 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Orthopedic Department, HaEmek Medical Center
Study officials:
affiliation: Division of Orthopedic & Rehabilitatio, HaEmek Medical Center
name: Nimrod Rozen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887665: Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use
Official title: Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: substance use disorders
substance abuse
substance abuse treatment
contingency management
Lead sponsor: Brandeis University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The clinical trial portion of this study tests the hypothesis that contingency management-based incentives for primary care patients with substance use disorders to attend treatment services will increase treatment initiation and engagement. The investigators are investigating whether this approach that has been found effective in specialty treatment settings will work in the primary care context, in conjunction with screening.


Eligibility criteria: Inclusion Criteria:

* Positive self-report alcohol or drug use screen in primary care
* Diagnosis of substance use disorder
* age 18 or older

Exclusion Criteria:

* SUD treatment in past 60 days
* cognitive impairment

Primary outcomes:
measure: Initiation
timeFrame: 90 days
measure: Engagement
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse VA Medical Center (Bedford VA)
state: Massachusetts
Study officials:
affiliation: Brandeis University
name: Elizabeth L. Merrick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03157674: Real-World Evidence and Treatment Patterns: Head and Neck Cancer
Official title: Real-World Evidence and Treatment Patterns: Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head & Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-05-17
Enrollment: 43994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Medical Data Vision (MDV) database with a HNC diagnosis will be used to identify eligible subjects by applying the patient inclusion and exclusion criteria.

Brief summary: This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.


Eligibility criteria: Inclusion Criteria:

* HNC or undefined histology (not otherwise specified \[NOS\]) HNC diagnosis from 01-Jan-2013 to 30-Sep-2016 using Japanese disease code
* Age 18 years or older at initial diagnosis of HNC regardless of staging

Exclusion Criteria:

* Diagnosis of another malignancy on or before the initial diagnosis of HNC with the exception of non-melanoma skin cancer and metastatic cancer
* Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016

Primary outcomes:
measure: Proportion of patients receiving radiotherapy as anti-cancer treatment
timeFrame: Approximately 45 months
measure: Proportion of patients receiving surgery as anti-cancer treatment
timeFrame: Approximately 45 months
measure: Proportion of patients receiving chemotherapy as anti-cancer treatment
timeFrame: Approximately 45 months
measure: Proportion of patients receiving targeted therapy as anti-cancer treatment
timeFrame: Approximately 45 months
measure: Proportion of patients receiving supportive care as anti-cancer treatment
timeFrame: Approximately 45 months
measure: Distribution of Treatment History in Head and Neck Cancer (HNC) patients
timeFrame: Approximately 45 months
Secondary outcomes:
measure: Distribution of overall survival (OS) by age
timeFrame: Approximately 45 months
measure: Distribution of overall survival (OS) by gender
timeFrame: Approximately 45 months
measure: Distribution of overall survival (OS) by stage
timeFrame: Approximately 45 months
measure: Distribution of overall survival (OS) by tumor site
timeFrame: Approximately 45 months
measure: Distribution of overall survival (OS) by treatment regimen
timeFrame: Approximately 45 months
measure: Number of treatment-limiting adverse events (AEs)
timeFrame: Approximately 45 months
measure: Number of withdrawals due to AEs
timeFrame: Approximately 45 months
measure: Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC
timeFrame: At Baseline
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution
state: Shibuya-ku
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00449774: Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Official title: An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mental Disorders
Keywords: Food effect
Safety
Tolerability
Water effect
Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects aged 19 to 55 years inclusive
* BMI within the range 19 to 32 kg/m2 inclusive.

Exclusion Criteria:

* Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
* Female subject is pregnant or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
* Female subjects using hormonal replacement therapy.
* History of regular alcohol consumption \> 7 drinks week for women and 14 drinks week for men
* Current smokers of 10 or more cigarettes per day

Primary outcomes:
measure: Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
timeFrame: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary outcomes:
measure: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.
timeFrame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
Other outcomes:
Locations:
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT06984874: Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy
Official title: Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy: A Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Children
Thoracoscopic Sympathectomy
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy.

Detailed description: Pain may occur after pediatric thoracic surgery in cases such as skin incision creation, rib traction, and drain placement, and in other cases, such as rib nerve injury. Such pain is highly unfavorable to pediatric patients' recovery as it may lead to reduced cough strength for clearing secretions, decreased functional residual capacity, and pulmonary complications such as atelectasis and pneumonia.

Erector spinae plane block (ESPB) is a novel trunk block to relieve chronic neuropathic pain. Since then, it has gained prominence as a regional anesthesia technique with the potential to revolutionize postoperative pain management, and it has been effectively administered not only for the management of perioperative pain for a wide variety of surgeries but also for the management of acute post-traumatic pain and chronic pain.

Eligibility criteria: Inclusion Criteria:

* Age from 6 to 16 years.
* Either sexes (male or female).
* American Society of Anesthesiologists (ASA) physical status I-II.
* Scheduled for bilateral thoracoscopic sympathectomy under general anesthesia.

Exclusion Criteria:

* History of allergy to local anesthetics.
* Abnormal liver/kidney function.
* Severe spinal deformities.
* Bleeding or coagulation disorders.
* Skin damage or infection at the proposed puncture site.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: 24 hours postoperatively
measure: Anesthetic consumption: minimum alveolar concentration
timeFrame: Intraoperatively
measure: Diaphragmatic excursion
timeFrame: 24 hours postoperatively
measure: Time to the first request for the rescue analgesia
timeFrame: 24 hours postoperatively
measure: Incidence of complications
timeFrame: 24 hours postoperatively
measure: Recovery profile
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University
state: Menoufia
Study officials:
References:
Clinical trial NCT02633774: Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation
Official title: Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent Atrial fibrillation (20\~80 years old)
* LA diameter \< 55mm
* patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

* Structural cardiac disease
* Contraindication to brain perfusion CT
* Catheter ablation history for AF, Cardiac surgery
* active internal bleeding
* Impossible to anticoagulation or antiarrhythmic drug
* valvular AF ((MA\> GII, Mechanical valve, Mitral valve replacement)
* LVEF \< 30%
* With severe medical disease
* Expected survival \< 1 year
* Severe alcoholics, drug addiction

Primary outcomes:
measure: K-MOCA(Korean version of Montreal Cognitive Assessment)
timeFrame: 12 months after the enrollment
measure: Brain perfusion CT
timeFrame: 12 months after the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References: