louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05141955: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official title: A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pain control is a signiﬁcant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.

The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.

The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
* BMI \> 35 kg/ m2

Exclusion Criteria:

* Patients unfit for surgery or refuse to sign the consent of regional block.
* Patients with known coagulation defects.
* Patients with known hypersensitivity to bupivacaine.
* Patients with infection at the site of injection.
* Conversion of laparoscopic surgery to laparotomy

Primary outcomes:
measure: Time to first requested rescue analgesia(Minutes)
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT02894255: Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Teikyo University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.


Eligibility criteria: Inclusion Criteria:

* Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.

  * Patients with multivessel coronary artery disease including significant stenotic lesion\* in the right coronary artery and also including left main stem disease.
  * Patients who will be referred for CABG.
  * Patients with significant stenotic lesion in the right coronary artery amenable to PCI.
  * Patients who can take DAPT medications.
  * Patients who provided written informed consent. \* Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%.

Exclusion Criteria:

* • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.

  * Patients who previously underwent CABG.
  * Patients who are at high risk of receiving CABG.
  * Patients who need simultaneous surgery such as valve surgery other than CABG.
  * Patients with a life expectancy of 1 year or shorter due to co-morbidities.
  * Patients with a history of cerebral infarction within the last 6 months.
  * Patients with congestive cardiac failure of NYHA 3 or higher.
  * Patients with unstable hemodynamics at enrollment.
  * Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23).
  * Patients receiving long-term dialysis.
  * Patients who are allergic to antiplatelet agent.
  * Patients who are critically allergic to contrast media.
  * Patients who are allergic to any DES component.

Primary outcomes:
measure: Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03379155: Internet-based Self-help for Negative Life Events
Official title: ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorders
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2017-12-20
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial design, comparing to a waitling list
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events.

Detailed description: The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events compared to a waiting list, in a randomized controlled trial design. Assessments are at baseline, 4-week and 3 months post-randomization. After 4 weeks, participants in the waiting control group get also access to the intervention.

Eligibility criteria: Inclusion Criteria:

* Negative life event in a period between two weeks and two years before the study
* Internet account
* Sufficient German language skills
* Informed consent

Exclusion Criteria:

* Persons with moderate or severe depressive symptoms
* Acute suicidality
* Psychotic disorder, bipolar disorder
* Severe, acute mental or physical disorder

Primary outcomes:
measure: Adjustment Disorder - New Module 20 (ADNM-20)
timeFrame: 4-week
Secondary outcomes:
measure: Brief Symptom Inventory - Short Version (BSI-18)
timeFrame: 4-week
measure: Beck Depression Inventory (BDI)
timeFrame: 4-week
measure: Short Form 12-Item Survey (SF-12)
timeFrame: 4-week
measure: Sense of Coherence Questionaire Revised (SOC-R)
timeFrame: 4-week
measure: Questionnaire for measuring patient satisfaction (ZUF-8)
timeFrame: 4-week
measure: Credibility/Expectancy Questionaire (CEQ)
timeFrame: 4-week
measure: System Usability Scale (SUS)
timeFrame: 4-week
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
city: Zürich
country: Switzerland
facility: Universität Zürich
Study officials:
affiliation: Universität Zürich
name: Andreas Maercker, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05555355: Prevena Spine for Use in Spine Surgery
Official title: A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgery
Incision, Surgical
Keywords: negative pressure wound therapy
incisional wound therapy
spine surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2022-09-26
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center study
Primary purpose: TREATMENT

Brief summary: A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

Detailed description: The objective of the study is to evaluate the efficacy of the Prevena Plus 125 therapy Unit (KCI USA, Inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. Furthermore, the investigators want to illustrate which patients benefit most significantly from Prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with Prevena intervention.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing spine surgery that requires closure by plastic surgeon
2. Over 18 years old
3. Risk Score Cutoff 80+
4. (Control) Matched to a prospective research participant

Exclusion Criteria:

1. Risk Score Cutoff \<80
2. Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into this study
3. Subjects who are pregnant at the date of surgery (SOC for surgery)

Primary outcomes:
measure: Frequency of Surgical site infections
timeFrame: 1-6 weeks following surgery
measure: Frequency of Wound dehiscence
timeFrame: 1-6 weeks following surgery
measure: Frequency of Seroma
timeFrame: 1-6 weeks following surgery
Secondary outcomes:
measure: Frequency of skin necrosis
timeFrame: 1-6 weeks following surgery
measure: Frequency of readmission
timeFrame: 1-6 weeks following surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT05180955: The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
Official title: The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax and Air Leak
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

Detailed description: Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery.

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

Eligibility criteria: Inclusion Criteria:

* Digital chest tube drainage system
* Pneumothorax (primary, secondary, pulmonary surgery)

Exclusion Criteria:

* Pleural effusion as primary indication for chest tube placement.
* Empyema
* Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
* Intubated during chest tube removal

Primary outcomes:
measure: Recurrent pneumothorax after chest tube removal
timeFrame: 0-24 hours after drain removal
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: Isala
name: Jos Stigt, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02448355: Ocular Effects of Carotid Endarterectomy
Official title: Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choroid
Carotid Stenosis
Carotid Endarterectomy
Keywords: OCT
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate.

Retinal and choroidal structural changes will be assessed using swept-source OCT technology


Eligibility criteria: Inclusion Criteria:

* Carotid stenosis requiring surgical management

Exclusion Criteria:

* Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception
* Ocular surgery within 6 months prior to endarterectomy

Primary outcomes:
measure: Change in choroidal thickness
timeFrame: one year
Secondary outcomes:
measure: Visual acuity
timeFrame: One year
measure: Retinal changes
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05151055: Lactoferrin + Vitamin E + Zinc for Hormonal Acne
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial To Determine The Safety and Efficacy of Lactoferrin With Vitamin E and Zinc as an Oral Therapy for Mild to Moderate Hormonal Acne in Adult Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hormonal Acne
Lead sponsor: United Laboratories
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 136
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We previously showed that twice daily intake of a combination of 100 mg lactoferrin, 11 IU vitamin E, and 5 mg zinc significantly reduced both inflammatory and non-inflammatory acne lesions compared to placebo control. In that study, females showed an overall better response compared to males in terms of total lesions. We speculated that the gender effect may be due to mitigation of the pre- menstrual flare-ups women have that lead to recurring acne, making them have a better response. The objectives of this study are: 1.) to characterize the efficacy and safety of 100 mg lactoferrin + 11 IU vitamin E + 5 mg zinc in the adult female population who suffer from hormonal acne, 2.) to determine whether the anti-acne effect is maintained after treatment stops.


Eligibility criteria: Inclusion Criteria:

1. Females aged 22-50.
2. At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lower face
3. Not responsive to conventional treatment
4. Clinical diagnosis of mild to moderate acne according to Lehmann et. al.

Exclusion Criteria:

1. Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a pregnancy.
2. Post-menopausal women
3. Current or recent (within 3 months) use of any topical or oral anti- acne products,
4. Hormonal contraceptive intake in the preceding six months
5. A cancer diagnosis within the past 5 years
6. History of hypersensitivity to any component of the test product.
7. Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases patients requiring maintenance medications, such as vascular disease,

   * hepatitis, eczema, psoriasis, or acute febrile/infectious illnesses
   * (i.e. Dengue, pneumonia, etc)

Primary outcomes:
measure: Mean percentage change in inflammatory acne lesions at 2, 4, 6, 8, 10, and 12 weeks compared to baseline, in the treatment versus placebo groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage change in inflammatory acne lesion counts at 14, 16, 18, 20, 22, and 24 weeks compared to baseline
timeFrame: 24 weeks
measure: Mean percent change in the AFAST scores at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 weeks compared to baseline, in the treatment versus placebo groups
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: Clinical Trial Management and Testing Associates, Inc.
Study officials:
References:
Clinical trial NCT02752555: Severe Male Factor Infertility Management
Official title: Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oligoasthenoteratozoospermia
Keywords: Oligoasthenoteratozoospermia
Male factor managment
Intacytoplasmic sperm injection
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is the first to evaluate the effect of oral supplementation with antioxidants combined with lifestyle modification for severe male factor partner of couples undergoing ICSI.

Detailed description: Patients underwent a therapy of a three-month period of treatment with either oral L-carnitine only (2g daily) or oral carnitine (2g daily) combined with modifiable lifestyle factors.

Eligibility criteria: Inclusion Criteria:

* Long protocol for ovulation
* Oligoasthenoteratozoospermic male partner ( (count \< 0.5 million/ml, Motility=\< 40% Progressive motility =\<10 %, Abnormal forms \>99%).
* Fresh semen samples.

Exclusion Criteria:

* Day 3 embryo transfer
* Incomplete ICSI cycles
* Endometrial thickness\> 7mm

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: two weeks
measure: Implantation rate
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dar Almaraa fertility and gynacology center
city: Cairo
country: Egypt
facility: Elite fertility care center
city: Cairo
country: Egypt
facility: Nile badrawi Hospital
Study officials:
affiliation: Department of Urology, Benha university, Egypt
name: Salah Elbashir
role: STUDY_DIRECTOR
References:
citation: Tremellen K, Miari G, Froiland D, Thompson J. A randomised control trial examining the effect of an antioxidant (Menevit) on pregnancy outcome during IVF-ICSI treatment. Aust N Z J Obstet Gynaecol. 2007 Jun;47(3):216-21. doi: 10.1111/j.1479-828X.2007.00723.x.
Clinical trial NCT03867955: Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study
Official title: Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurosurgical Intervention
Keywords: photomotor reflex
depth of anesthesia
AlgiScan™
pupil diameter
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 30
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 a neurosurgical intervention will be included.

Brief summary: Pupillary diameter monitoring is currently used routinely for assessment of the nociception / antinociception balance during surgery.

Pupillary diameter decreases reflexively in response to light flash, called photomotor reflex. The photomotor reflex is described by the latency between the light flash and the beginning of the decay expressed in milliseconds, the slope or decay rate expressed in millimeters per second, and the percentage of variation, corresponding to the ratio between the basal pupil diameter and the minimum diameter reached during the light stimulation.

The AlgiScan™ videopupillometer used includes a device for producing a flash light, designed for this purpose.

It has recently been shown that the slope (or rate) of pupillary diameter decrease during a light flash varies during anesthesia, independently of any nociceptive stimulus.

Detailed description: The hypothesis of this study is the variation of the decay slope of the pupil diameter is proportional to the depth of the anesthesia.

Eligibility criteria: Inclusion Criteria:

* Majors patients
* Score American Society of Anesthesiologists (ASA) 1 or 2
* Managed in the operating theater of the University Hospital of Saint-Etienne for a neurosurgical intervention.

Exclusion Criteria:

* Single or bilateral eye surgery modifying the possibilities of variation of the pupillary diameter
* Having been asleep under general anesthesia in the 7 days prior to the current surgery
* History of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomous stage

Primary outcomes:
measure: slope (or rate) of pupil diameter change
timeFrame: Day 0
Secondary outcomes:
measure: latency and the amplitude of pupillary diameter reduction
timeFrame: Day 0
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References: