louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06326333: Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery
Official title: The Effects of Combination of PSB and SAPB on Postoperative Analgesia in Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parasternal Block
Serratus Anterior Plane Block
Acute Pain
Postoperative Analgesia
Cardiac Surgery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.

With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used

Primary outcomes:
measure: Pain Scores
timeFrame: 0th hour of the extubation
measure: Pain Scores
timeFrame: 2nd hour of the extubation
measure: Pain Scores
timeFrame: 4th hour of the extubation
measure: Pain Scores
timeFrame: 8th hour of the extubation
measure: Pain Scores
timeFrame: 12th hour of the extubation
Secondary outcomes:
measure: Remifentanyl Consumption
timeFrame: intraoperative period
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT05521633: Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes and Ultrasound Changes in Non-Diabetic Non-Alcoholic Fatty Liver
Official title: Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NAFLD
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of hepatic disease ranging from fat accumulation in liver to fibrosis and cirrhosis. It affects 25% of the world population on average. Objective of this study is to compare the effect of metformin (1000 milligrams daily) versus pioglitazone (30 milligrams daily) in improving liver transaminases and ultrasound changes in non-diabetic patients of NAFLD when given for six months.

METHODS: A Quasi-experimental study was conducted in Mayo Hospital Lahore from October 2019 to November 2020.Out of 96 half Patients were assigned randomly to Group-A (metformin) or Group-B (pioglitazone). Demographic history, abdominal ultrasound \& liver enzymes were recorded on Proforma monthly till 6 months. Data was put into and analyzed by SPSS version 26; t-test was used to compare the mean liver transaminases between the two groups. Ultrasound findings were compared by Chi square. The P value of less than 0.05 was counted as significant.


Eligibility criteria: Inclusion Criteria:

1. Gender: Both male and female
2. Age: 18-80 Years
3. Ultrasound evidence of fatty liver as per operational definition
4. Liver enzymes as per operational definition

Exclusion Criteria:

1. Pregnancy
2. Cirrhotic patients as per operational definition
3. Chronic Hepatitis B or chronic hepatitis C
4. Patients taking long term steroids, highly active antiretroviral therapy, diltiazem, irinotecan, oxaliplatin and amiodarone
5. Patients taking alcohol (based on history and AST to ALT ratio)
6. Patients with heart failure (NYHA Classification class III or IV status: patients comfortable at rest but less than ordinary physical activity causes undue fatigue, dyspnea or palpitations)
7. Patients with renal failure (serum creatinine ≥ 1.4 mg% or eGFR \< 45 ml/min/1.73 m2)

Primary outcomes:
measure: Liver transaminase levels
timeFrame: The comparison is done after 6 months of drug treatment
Secondary outcomes:
measure: Fatty Liver Grade
timeFrame: The comparison is done after 6 months of drug treatment
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University/Mayo Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Dr. Mohammad Ibrahim, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06737133: Early Management of Fracture Nose in Pediatric Patients
Official title: Early Management of Fracture Nose in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fracture Nose
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction:

Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2).

Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. The incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).The management of nasal injuries since Maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) .

The functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. Due to constraints of resources and the range of services provided, these injuries are typically managed . Most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). A 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . In children, nasal fractures are most commonly due to falls. In a study of 100 children with traumatic nasal deformity, Liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . The possibility of child abuse should be considered in every child presenting with a nasal fracture The prognosis of nasal bone fracture is depend on: If NBFs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. Communication between the surgeon, ENT physician, and primary care physician or emergency physician is crucial to the treatment plan (6). The greatest complications from reduction are malunion and cosmetic concerns. Incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).


Eligibility criteria: Inclusion Criteria:

* Age ranged from since birth to 12 years old
* Isolated nasal fracture
* Presented from time of trauma up to 5 days

Exclusion Criteria:

* Multiple facial fractures
* Age more than 12 years old
* Systemic diseases
* Any hematological disorders

Primary outcomes:
measure: Measure of the outer framework of the nose after trauma
timeFrame: One year and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01050933: Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers
Official title: Safety and Tolerability of Inhaled Carbon Monoxide in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2010-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.

This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation.

We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.


Eligibility criteria: Inclusion Criteria:

* Men and women, age \> 18 years.
* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
* No prior smoking history.
* BMI between 16 and 30 inclusive.
* In good health as per medical history, physical exam, vital signs \& ECG.

Exclusion Criteria:

* Exposure to carbon monoxide during the 48 hours prior to the study day.
* Occupational exposure to CO.
* Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
* Baseline blood level of COHb \>2%.
* Patients with underlying lung disease such as asthma or COPD.
* Baseline oxygen saturation \<92% on room air.
* Planned pregnancy, already pregnant or breastfeeding.
* Participation in another clinical trial within 2 months prior to study.

Primary outcomes:
measure: Adverse Event Rate
timeFrame: Before and after carbon monoxide exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Paul Belliveau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741233: The Genetics Behind Vitamin D Status (VitDgen)
Official title: The Genetics Behind Vitamin D Status (VitDgen)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: SNPs
vitamin D
Vitamin D status
UVB irradiation
genetics
Lead sponsor: Technical University of Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2012-12-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall purpose of the study is to investigate whether there is a relationship between 26 different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B (UV-B) irradiation of the skin and vitamin D status.

The hypothesis is that vitamin D status are influated by different genetic genotypes in the vitamin D pathway.

Detailed description: In this study approximately 80 participants (over 18 years) are included. All the participants has previously participated in the VitmaD intervention study (NCT01184716) .

Participants will in total receive 4 times UV-B irradiation (3 SED) with two day apart each time, to stimulate vitamin D production in the skin. The participants skintype will be measured. The study starts in January 2013 and runs to the end of Marts 2013. During this winter period, it is in Denmark not possible to produce vitamin D in the skin through sunlight exposure.

Eligibility criteria: Inclusion Criteria:

* Health participants over 18 years, that previously participated in VitmaD intervention study

Exclusion Criteria:

* skindiseases
* intake of medicin that causes photosensitive skin
* pregnant or nursing
* sun vacation 3 month before the intervention
* intake of vitamin D supplement 3 month before the intervention

Primary outcomes:
measure: serum 25-hydroxyvitamin D
timeFrame: 10 days
Secondary outcomes:
measure: Skintest
timeFrame: 10 days
Other outcomes:
Locations:
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
city: Morkhoj
country: Denmark
facility: DTU / National Food Institute
state: Søborg
Study officials:
affiliation: DTU, Denmark
name: Lone Rasmussen, M.Sc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexo BA, Andersen R, Mejborn H, Bjerrum PJ, Rasmussen LB, Wulf HC. Common variants in CYP2R1 and GC genes are both determinants of serum 25-hydroxyvitamin D concentrations after UVB irradiation and after consumption of vitamin D(3)-fortified bread and milk during winter in Denmark. Am J Clin Nutr. 2015 Jan;101(1):218-27. doi: 10.3945/ajcn.114.092148. Epub 2014 Nov 5.
Clinical trial NCT03723733: Compensatory Brain Mechanisms for Amygdala-associated Cognitive Dysfunction: Potential Role of the Cortical Mirror Neuron System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: amygdala
mirror neuron system
brain network
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 350
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: sutduents from University of Electronic Science and Technology of China

Brief summary: Identify if the mirror neuron system, or other networks, can compensate for amygdala dysfunction, using behavior and structural/functional MRI.

Detailed description: In the present study, investigators aim to investigate amygdala dysfunction \& potential compensation in individuals with high and low traits (e.g. Autism, Anxiety, Depression traits, Alexithymia), high and low stress or protective factors in the environment (social network, early life stress) and different molecular genetic make-up. On the neural level, functional and structural connectivity as well as task-related BOLD activation will be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* history of head injury
* claustrophobia;
* medical or psychiatric illness
* female subjects were pregnant or taking oral contraceptives.
* taking any form of medication and drunk any caffeine-containing beverages on the day of the experiment.

Primary outcomes:
measure: brain activity and connectivity during social and cognitive tasks
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: China, Sichuan
state: Sichuan
Study officials:
References:
Clinical trial NCT01452633: Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
Official title: Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Keywords: pain
laparoscopy
reduction
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.

Detailed description: The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic surgery

Exclusion Criteria:

* Cardiovascular instability
* malignancies
* pulmonary conditions incompatible with laparoscopic surgery

Primary outcomes:
measure: Reduction in post-operative pain at large lateral port sites
timeFrame: 4 and 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: James N Droesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497833: Retinoic Acid Supplementation and Subjects With Hypercholesterolemia
Official title: Effect of Retinoic Acid Supplementation on the HDL-Associated Paraoxonase 1 Activity in Subjects With Hypercholesterolemia: A Randomized, Double-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 130
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.

Detailed description: Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the ameliorating atherosclerosis effects in many reports.There maybe some correlations between retinoic acid and PON1 activity and the study aim to prove it.

Eligibility criteria: Inclusion Criteria:

* subject has a fasting total cholesterol concentration between 200 and 310mg/dl.
* subject is between 25 and 65 years of age, inclusive.
* subjects' BMI is between 18.5 kg/m2 and 35 kg/m2.

Exclusion Criteria:

* subject that is pregnant.
* subject that has coronafy artery desease, diabetes mellitus, thyroid disorders, mental disorder, cancer, cirrhosis, renal disease and hepatic desease.
* subject that has had operation less than six months prior to screening visit.
* subject that is smoking.
* subject uses any drugs that could influence the measurement of lipid paramerters or inflammatiory makers.

Primary outcomes:
measure: PON1 activity
timeFrame: changes from baseline in PON1 activity at 12 weeks
Secondary outcomes:
measure: Lp-PLA2 activity
timeFrame: changes from baseline in Lp-PLA2 activity at 12 weeks
Other outcomes:
measure: cholesterol efflux capacity
timeFrame: changes from baseline in cholesterol efflux capacity at 12 weeks
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: STUDY_DIRECTOR
References: