louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01320514: Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift
Official title: A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant
Lead sponsor: Nguyen, Davis B., M.D.
Sponsor class: INDIV
Collaborators: name: Baxter BioScience
First posted: 2011-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects planned for endoscopic browlift; healthy female or male; age 18-75

Brief summary: The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.


Eligibility criteria: Inclusion Criteria:

* Subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements

Exclusion Criteria:

* Subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.

Primary outcomes:
measure: Comparison of ecchymosis and edema
timeFrame: 30 days
Secondary outcomes:
measure: Resolution of ecchymosis and edema, incidence of hematoma/seroma
timeFrame: 30 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Davis B Nguyen, M.D.
state: California
Study officials:
affiliation: Davis B Nguyen, M.D.
name: Davis B Nguyen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00679614: Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery
Official title: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Arthroplasty
Knee Arthroplasty
Spinal Anesthesia
Keywords: Tramacet
naloxone
morphine
analgesia
elderly
elderly patients
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period.

The primary objective is to determine opioid use during combined use of oral tramacet and naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective knee/ hip arthroplasty under spinal anesthesia.

Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of independent mobilization.

Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction in opioid use and reduced opioid-induced side effects.


Eligibility criteria: Inclusion Criteria:

1. Aged 70 years and older\*
2. Able to give informed consent
3. Able to communicate in English
4. Having elective hip/knee arthroplasty
5. ASA physical status 1-3.

Exclusion Criteria:

1. Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
2. Contraindication to spinal anesthesia
3. Contraindication to use of tramacet or celebrex
4. ASA physical status 4
5. Chronic opioid use
6. Chronic pain syndrome All the above will be included in the letter of information

Primary outcomes:
measure: Morphine use / day
timeFrame: per day
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's Health Care
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ngozi Imasogie, MBBS, FRCA UK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312414: Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype
Official title: Effects of Carnitine on Oxidative Stress and Inflammatory Responses to Intravenous Iron Administration to Patients With CKD: Impact of Haptoglobin Genotype
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Lead sponsor: The Nazareth Hospital, Israel
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Anemia is a common disorder in CKD patients. It is largely attributed to decreased erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in CKD patients.

In this proposed study we wished to examine whether Hp genotype influences intravenous iron administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the response of these patients to L-Carnitine therapy.

Detailed description: This study will include at least 25 anemic CKD patients (stages 3-4) that will be given a weekly IVIR (Sodium ferric gluconate, \[125 mg/100 ml\] for 8 weeks, and during weeks 5-8 also received Carnitine (20mg/kg, IV) prior to IVIR. Weekly blood samples will drawn before and after each IVIR for Hp genotype, C-reactive protein (CRP), advanced oxidative protein products (AOPP), neutrophil gelatinase-associated lipocalin (NGAL), besides complete blood count and biochemical analyses.

Eligibility criteria: Inclusion Criteria:

1. Patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by MDRD.
2. CKD patients with Hb of less than 10 g%.
3. At age ≥18 y.

Exclusion Criteria:

1. Pregnant women.
2. Patient with CKD stage 5 on Dialysis.
3. Patients with severe liver diseases.
4. Patients with severe CHF.
5. Inter-current illness such as fever.
6. Allergic rhinitis.

Primary outcomes:
measure: AOPP (Advanced Oxidation Protein Products)
timeFrame: 1 month
measure: neutrophil gelatinase-associated lipocalin (NGAL),
timeFrame: 1 month
Secondary outcomes:
measure: Haptoglobin
timeFrame: 1 month
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Nazareth hospital (EMMS)
Study officials:
affiliation: Nazareth EMMS Hospital
name: Amir Abd El Qader, Ph.D
role: STUDY_DIRECTOR
References:
citation: Armaly Z, Abd El Qader A, Jabbour A, Hassan K, Ramadan R, Bowirrat A, Bisharat B. Effects of carnitine on oxidative stress response to intravenous iron administration to patients with CKD: impact of haptoglobin phenotype. BMC Nephrol. 2015 Aug 13;16:135. doi: 10.1186/s12882-015-0119-0.
Clinical trial NCT00293514: TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
Official title: An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Diseases
Intraoperative Complications
Keywords: standard surgical treatment for air leakage in pulmonary lobectomy
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2006-02-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.


Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Primary outcomes:
measure: Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)
Secondary outcomes:
measure: Reduction of intra-operative air leakage intensity after first application of trial treatment
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT02477514: A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)
Official title: A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Diseases, Bacterial
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.


Eligibility criteria: Inclusion Criteria:

* healthy, adult males or females (women of non-childbearing potential)
* continuous non-smokers who have not used nicotine-containing products for the previous 3 months

Exclusion Criteria:

* mentally or legally incapacitated or has significant emotional problems
* history or presence of clinically significant medical or psychiatric condition or disease
* history or presence of alcoholism or drug abuse within the past 2 years
* female participants who are pregnant, lactating, or of childbearing potential
* donated blood or had significant blood loss within 56 days prior to first dose of study drug
* plasma donation within 7 days prior to first dose of study drug

Primary outcomes:
measure: Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate
timeFrame: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
measure: AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate
timeFrame: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
measure: Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate
timeFrame: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
measure: AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate
timeFrame: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
measure: Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate
timeFrame: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
measure: Cmax of rosuvastatin alone or in combination with tedizolid phosphate
timeFrame: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04457414: Identifying Cricothyroid Membrane With Ultrasound
Official title: Learning Curve of Inexperienced Trainees for Identifying Cricothyroid Membrane With Ultrasound in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients undergoing general anesthesia

Brief summary: Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an instructional video, 30 trainees performed 5 cricothyroid membrane identification on pediatric patients undergoing general anesthesia. We analysed their learning curves relative to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing general anesthesia

Exclusion Criteria:

* previous history of tracheostomy
* previous history of operation on neck

Primary outcomes:
measure: Performance time for identifying cricothyroid membrane with ultrasound
timeFrame: from immediately after anesthetic induction to end of surgery
Secondary outcomes:
measure: ultrasound anatomy of cricothyroid membrane
timeFrame: from immediately after anesthetic induction to end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT05042414: Acute Effects of Endurance Exercise on Breastmilk Composition
Official title: Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastmilk
Keywords: Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2021-09-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days. At the time of study commencement, the trial (including planned analyses) is not fully funded. Additional milk will be stored for future analyses (not yet specified) when funding is secured.


Eligibility criteria: Inclusion Criteria:

* 6 to 12 weeks postpartum
* Exclusive breastfeeding
* Term birth

Exclusion Criteria:

* Known cardiovascular disease
* Type 1 or 2 diabetes mellitus
* Limited ability to exercise

Primary outcomes:
measure: Breastmilk metabolite composition
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary outcomes:
measure: Adiponectin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
measure: Leptin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
measure: Insulin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
measure: Insulin Growth Factor-1
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
measure: Cytokine profiling (Multiplex 27)
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Other outcomes:
measure: Cardiorespiratory fitness
timeFrame: At baseline
measure: Body mass in kg
timeFrame: At baseline
measure: Height in metres
timeFrame: At baseline
measure: Fat mass in kg
timeFrame: At baseline
measure: Muscle mass in kg
timeFrame: At baseline
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT05748314: Marfan Syndrome and Quality of Life of Pediatric Patients
Official title: Marfan Syndrome: the Impact on the Quality of Life, Phenotypic Manifestations on Self-image and Self-management Skills, As an Index of Adaptation to the Disease in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Pediatric Disorder
Keywords: Quality of Life
Self-identification
Self-care
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with clinical and/or genetic diagnosis od MFS currently in follow up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato

Brief summary: The goal of this observational study is to learn about the impact of Marfan syndrome (MFS) in paediatric affected subjects. the main questions it aims to answer are:

* The assessment of quality of life in MFS Italian patients;
* The impact of phenotypic manifestations on self-image and self-management skills;
* Stratify patients according to the need of psychological support. Participants will take part in the study by completing four self-report questionnaires.

Detailed description: In literature, adolescents with MFS experience difficulty in connecting with peers, and are convinced that they would have been more physically attractive without the disease. Additionally, due to physical activity restrictions and orthopedic limitations, these patients reported having difficulty adjusting and participating in educational events.

Data from present study will be able to support clinicians in identifying patients who need psychological support (through parental counseling interviews) aimed at increasing compliance with treatments and adaptation to the disease.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* MFS diagnosis according to Revised Ghent criteria (2010);

Exclusion Criteria:

* Known cognitive deficits

Primary outcomes:
measure: Psychological counseling
timeFrame: 12 months
measure: Psychological counseling
timeFrame: 12 months
measure: Psychological counseling
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
Study officials:
affiliation: Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
name: Alessandro Pini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04722614: Music and Essential Oil in Agitation
Official title: The Effect of Music and Essential Oil on Agitation in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Keywords: Mechanical ventilation
Music therapy
Essential oil
Bergamot oil
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-group pre-test and repeated post-test study
Primary purpose: PREVENTION

Brief summary: The study aims to assess the effect of using music and essential oil on agitation in mechanically ventilated patients. Listening to classical relaxation music, and inhalation to bergamot oil will be used in this study.

Detailed description: Agitation in critically ill patients is a phenomenon that can compromise patient safety and assistance during intensive care unit (ICU) hospitalizations. This trial will be conducted in five general intensive care unit. One hundred and twenty patients will be enrolled in this study divided into three equal groups (40 patients in each group). Group A is the control group. Group B is music group. Group C is essential oil group. Agitated mechanically ventilated patients will be randomly assigned to one of the three groups. Each group will be subjected to its specific intervention and they will be monitored for seven days. Agitation score and frequency outcome will be assessed at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Agitation with RASS score +2 or more
* Mechanical ventilation
* Patients with GCS 13-15

Exclusion Criteria:

* Psychiatric illness
* Cognitive disorders
* Neurological disorder
* Hearing deficit
* Smelling deficit
* Respiratory asthma
* Allergic rhinitis

Primary outcomes:
measure: Agitation score
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital
city: Alexandria
country: Egypt
facility: Faculty of nursing
Study officials:
affiliation: Alexandria University
name: E A Hassan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01165814: Naproxen Versus Tramadol for Post Cesarean Pain Control
Official title: Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Cesarean Section
Keywords: Pain control after cesarean section
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-20
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.


Eligibility criteria: Inclusion Criteria:

* all patients after cesarean section

Exclusion Criteria:

* emergent CS
* hypersensitivity to drug
* drug abuse

Primary outcomes:
measure: Pain Score
Secondary outcomes:
measure: Side effects
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References: