louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03882736: Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
Official title: Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Keywords: plastic and reconstructive surgery
gluteal ptosis
platipygia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects

Brief summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


Eligibility criteria: Inclusion criteria:

* 12 months minimum delay with bariatric surgery
* female, BMI\<30kg/m2
* Age greater than or equal to 18 years
* Stable weight for more than 6 months
* lack of volume in gluteal region
* agree with clinical trial

Exclusion criteria:

* Patient under tutorship or curatorship
* Pregnancy or breastfeeding
* hemoglobinemia\< 12g/dL
* Albuminemia\<3,5g/dL
* active smoking more than 1 month before surgery

Primary outcomes:
measure: Volumetric increase by para-sacral flap
timeFrame: day before the operation
measure: Volumetric increase by para-sacral flap
timeFrame: then at the 3th month post surgery
measure: Volumetric increase by para-sacral flap
timeFrame: then at the 6th month post surgery
Secondary outcomes:
measure: Clinical evolution
timeFrame: During hospitalization (Day 0 to Day 5)
measure: Results of clinical evolution
timeFrame: Day 15
measure: Results of clinical evolution
timeFrame: 2nd week after surgery
measure: Results of clinical evolution
timeFrame: 3rd week after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Farid BEKARA, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03256149: High Dose Steroids for Dysphagia
Official title: Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphagia
Cervical Spine Disease
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.


Eligibility criteria: Inclusion Criteria:

* Anterior cervical spine surgery
* Elective surgery

Exclusion Criteria:

* Takes steroids for any reason
* Pre-existing condition leading to dysphagia

Primary outcomes:
measure: Voice evaluation
timeFrame: First day post-operatively
measure: Dysphagia evaluation: MBSimp
timeFrame: First day post-operatively
measure: Soft tissue edema
timeFrame: First day post-operatively
measure: Airway evaluation
timeFrame: First day post-operatively
measure: Dysphagia evaluation: Rosenbeck
timeFrame: First day post-operatively
Secondary outcomes:
measure: Hyperreflexia
timeFrame: 3 months post-operatively
measure: Fusion rate
timeFrame: 6 months after surgery
measure: Pain
timeFrame: 3 months after surgery
measure: Strenght
timeFrame: 3 months after surgery
measure: Crude touch sensation
timeFrame: 3 months after surgery
measure: Surgical site infection
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
References:
Clinical trial NCT02300649: Transesophageal Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia on the Cardiac Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular effect through activation of receptors in central and peripheral nervous system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.


Eligibility criteria: Inclusion Criteria:

1. Above 20 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. general anesthesia

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. arrhythmia or received treatment with antiarrythmic drug .
4. severe bradycardia (HR \< 45 bpm) and AV block
5. pathologic esophageal lesion (esophageal stricture or varix )
6. pregnancy

Primary outcomes:
measure: systolic function by TEE (fractional area change and ejection fraction)
timeFrame: The participants will be followed for 1 hour after study drug is administered.
Secondary outcomes:
measure: diastolic function by TEE (ratio between early transmitral flow (E) and mitral annular tissue velocity (E')
timeFrame: The participants will be followed for 1 hour after study drug is administered.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06000449: Center M: Digital Health Innovation Pilot
Official title: Center M: Digital Health Innovation Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Keywords: Maternal Mental Health
Telehealth
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).


Eligibility criteria: Inclusion Criteria:

* Currently pregnant
* Age 18-50 years
* Fluent in English
* Available and able to attend online group scheduled meetings

Exclusion Criteria:

* Current or past enrollment in a mindfulness-based intervention group

Primary outcomes:
measure: Screening Rate
timeFrame: 6 weeks postpartum
measure: PD Symptoms at baseline
timeFrame: Initial screening pre-intervention
measure: PD Symptoms post intervention
timeFrame: Two weeks post intervention
measure: PD Symptoms post intervention
timeFrame: Four weeks post intervention
measure: PD Symptoms postpartum
timeFrame: Six weeks postpartum
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: Six weeks postpartum
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ellen Tilden, PhD, CNM, FACNM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597449: Surgical Patient Education in Pediatric Urology
Official title: Impact of YouTube Videos and Health Literacy on Postoperative Healthcare Utilization Following Pediatric Urologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 400
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families randomized by urologic surgery type to receive access to YouTube video link
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized study to assess the impact of supplemental educational YouTube videos on postoperative healthcare utilization following ambulatory pediatric urologic surgery


Eligibility criteria: Inclusion Criteria:

* Caregivers of patients age \<18 years old undergoing ambulatory pediatric urologic surgery

Exclusion Criteria:

* Caregivers that decline participation

Primary outcomes:
measure: Total number of episodes (Postoperative healthcare utilization)
timeFrame: 30 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT06741449: The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease
Official title: The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease ( Two Times of Recurrence or More): One Year Experience Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pilonidal Sinus Treatment
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.


Eligibility criteria: Inclusion Criteria:

* re-recurrent pilonidal disease

Exclusion Criteria:

* patients with proved anal or perineal malignancy or autoimmune disease
* patient with pilonidal disease for the first time or for the first time of recurrence

Primary outcomes:
measure: operative time
timeFrame: operative time is measured in minutes from incision to wound dressing
measure: bleeding amount
timeFrame: amount of blood lost is measured from incision for 2 days post operative
measure: healing time
timeFrame: healing time is measured for 3 months post-operatively
measure: wound infection
timeFrame: wound infection is evaluated for 3 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharqia
Study officials:
References:
Clinical trial NCT03000049: Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study
Official title: Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis Septic Shock
Keywords: sepsis
septic shock
blood cultures
anti-infective therapy
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 500
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 with sepsis or septic shock with planned blood culture drawing

Brief summary: With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.

Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
* informed written consent

Exclusion Criteria:

* Pediatric patients (\< 18 Years)
* DNR-order

Primary outcomes:
measure: Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock
timeFrame: Nov. 2016 - Nov. 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Study officials:
References:
Clinical trial NCT04766749: Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
Official title: Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 430
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: OTHER

Brief summary: Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.

But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.

RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.

Detailed description: Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.

At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.

The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.

Eligibility criteria: Inclusion Criteria:

* Diameter stenosis\>=50% by visual estimation intend to undergo drug-coated balloon implantation
* Target vessel diameter\> 2.5mm

Exclusion Criteria:

* Chronic Total Obstructive lesion
* Diagnose patients with acute myocardial infarction \<24 hours
* Can't tolerate or not suitable for RIPC
* Severe hepatic and renal insufficiency
* Expected survival \<1 year
* Severe calcification needing rotational atherectomy
* Intolerable to dual antiplatelet therapy

Primary outcomes:
measure: TLF
timeFrame: 12 months
Secondary outcomes:
measure: Late lumen loss of target vessel（mm）
timeFrame: 6 months
measure: DCB expansion time
timeFrame: less than 120 seconds (On the 1 day of PCI)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular Hospital
state: Henan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Muwei Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03924349: ICG-coated Endoscopic Clip for Tumor Localization
Official title: The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2019-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single center open label early phase clinical trial
Primary purpose: OTHER

Brief summary: The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery.

The purpose of this study is to evaluate the efficacy of the localization of colonic lesions using ICG coated endoscopic clip in laparoscopic colon surgery.


Eligibility criteria: Inclusion Criteria:

* Cases which are deemed necessary to mark the location of the colon lesion before surgery

Exclusion Criteria:

* Preoperative colonoscopy is not possible due to intestinal obstruction
* If the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam
* disagreement with the study

Primary outcomes:
measure: Success rate of localization
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: loss rate of clips
timeFrame: through study completion, an average of 1 year
measure: Number of Participants with Complication
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: DAE KYUNG SOHN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hyun JH, Kim SK, Kim KG, Kim HR, Lee HM, Park S, Kim SC, Choi Y, Sohn DK. A novel endoscopic fluorescent band ligation method for tumor localization. Surg Endosc. 2016 Oct;30(10):4659-63. doi: 10.1007/s00464-016-4785-1. Epub 2016 Feb 19.
citation: Choi Y, Kim KG, Kim JK, Nam KW, Kim HH, Sohn DK. A novel endoscopic fluorescent clip for the localization of gastrointestinal tumors. Surg Endosc. 2011 Jul;25(7):2372-7. doi: 10.1007/s00464-010-1557-1. Epub 2011 Feb 7.
citation: Hyun JH, Han KS, Kim BC, Hong CW, Oh JH, Park SC, Kim MJ, Sohn DK. Preoperative endoscopic clipping for rectal tumor localization in laparoscopic anterior resection. Minim Invasive Ther Allied Technol. 2019 Dec;28(6):326-331. doi: 10.1080/13645706.2018.1547765. Epub 2018 Dec 4.
citation: Lee SJ, Sohn DK, Han KS, Kim BC, Hong CW, Park SC, Kim MJ, Park BK, Oh JH. Preoperative Tattooing Using Indocyanine Green in Laparoscopic Colorectal Surgery. Ann Coloproctol. 2018 Aug;34(4):206-211. doi: 10.3393/ac.2017.09.25. Epub 2018 Jul 26.
Clinical trial NCT06016049: Cerebral Changes Following CTS Treated With Guided Plasticity
Official title: Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Magnetic Resonance Imaging
Somatosensory Cortex
Anesthesia
Hand
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.


Eligibility criteria: Inclusion Criteria:

* symptoms of CTS for more than 3 months
* classic or probable CTS according to Katz' hand diagram (2, 27)
* clinical signs of unilateral CTS with a positive Tinel's and Phalen's test
* age between 18 and 70 years
* nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side
* no contraindications for MR examinations.

Exclusion Criteria:

* bilateral symptoms
* having been operated for CTS previously
* prior wrist or carpal fracture
* diabetes
* thyroid disease
* rheumatoid arthritis
* neurological disease
* drug abuse
* complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Symptom Severity Score
timeFrame: 8 weeks
measure: functional MRI activation affected vs healthy side (more activation voxels means more active brain area)
timeFrame: 8 weeks
Secondary outcomes:
measure: quick-DASH upper extremity symptom score
timeFrame: 8 weeks
measure: 2 Point Discrimination (2PD)
timeFrame: 8 weeks
measure: Sensory conduction velocity
timeFrame: 8 weeks
measure: Sensory conduction amplitude
timeFrame: 8 weeks
measure: functional MRI dig 1+2
timeFrame: 8 weeks
measure: functional MRI dig 5
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Translational Sciences Malmö, Lund University
name: Magnus Flondell, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University
name: Anders Björkman, MD, Prof.
role: STUDY_CHAIR
References: