louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704340: DuraSeal Sealant Post Market Study
Official title: DuraSeal Sealant Post Market Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Cranial Procedures With Dural Incision
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Medtronic - MITG
First posted: 2008-06-24
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).


Eligibility criteria: Inclusion Criteria:

* Patient is between 18 and 75 years of age
* Patient is scheduled for an elective cranial procedure that entails a dural incision
* Evidence of intraoperative non-watertight closure

Primary outcomes:
measure: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of Subjects With Post-operative Surgical Site Infections
timeFrame: 30 days
measure: Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak
timeFrame: 30 days
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Confluent Surgical
state: Massachusetts
Study officials:
References:
citation: Osbun JW, Ellenbogen RG, Chesnut RM, Chin LS, Connolly PJ, Cosgrove GR, Delashaw JB Jr, Golfinos JG, Greenlee JD, Haines SJ, Jallo J, Muizelaar JP, Nanda A, Shaffrey M, Shah MV, Tew JM Jr, van Loveren HR, Weinand ME, White JA, Wilberger JE. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. World Neurosurg. 2012 Nov;78(5):498-504. doi: 10.1016/j.wneu.2011.12.011. Epub 2011 Dec 10.
Clinical trial NCT05990140: The Effect of Peppermint Flavored Mouthwash Applied to Patients
Official title: The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Complications
Keywords: nausea-vomiting
anxiety
nurse
Biochemical Parameters
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting of several procedures. One of the most common complications in the early period after bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS), acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium, sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid, iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety after bariatric surgery is also an important problem.

It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling, laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated, the parasympathetic nervous system is activated and cortisol production decreases, reducing stress and anxiety. The peppermint plant, which is widely used in our country, is also used as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse, who is a member of the multidisciplinary team, will be able to properly define the surgical risks and comorbidities associated with the clinical status of obesity in patients who have undergone bariatric surgery and to apply the necessary interventions.


Eligibility criteria: Inclusion Criteria:

1. Be between the ages of 18-65
2. Having had bariatric surgery
3. Absence of communication barriers
4. Volunteering to participate in research
5. Mental well-being

Exclusion Criteria:

1. Presence of major depression or psychosis
2. Having a communication barrier
3. Being transferred to another unit
4. Leaving work voluntarily

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: up to 1 month
measure: Nausea Vomiting Visual Comparison Scale
timeFrame: up to 1 month
measure: Determination of Levels of Biochemical Parameters in Blood
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ataturk University
name: Vesile Eskici İlgin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299140: Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)
Official title: Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Children
Family Focused Therapy
CBT
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 43
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high risk of developping the same disorder and/or a psychopathology. Early intervention focused on emotion and problem solving strategies could improve their prognosis.

The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity. Children emotional dysregulation profile will be compared before and after this CBT intervention.


Eligibility criteria: Inclusion Criteria:

* Children and teenagers from 6 to 16 years-old
* At least one biological parent with bipolar disorder
* T-score CBCL-Total ≥ 60
* Written informed consent

Exclusion Criteria:

* Active severe thymic episode
* Autism spectrum disorders
* Intellectual disability

Primary outcomes:
measure: CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05610540: Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix
Official title: Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IOL
Cataract
Patient Satisfaction
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, aged 40 and older, with bilateral cataracts

Brief summary: The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient.


Eligibility criteria: Inclusion Criteria:

* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Desire to mitigate postoperative presbyopia with implantation of Synergy IOL in one eye and PanOptix Trifocal IOL in the opposite eye

Exclusion Criteria:

* Any vision-limiting problems (e.g., corneal, retinal, infection) which can potentially limit post-operative visual performance
* Any ocular condition or trauma that is not resolved, stable, or would compromise the well-being of the subject

Primary outcomes:
measure: Patient Satisfaction - subjective questionnaire
timeFrame: 3 months to 18 months after cataract surgery
measure: Visual Acuity at Distance
timeFrame: 3 months to 18 months after cataract surgery
measure: Visual Acuity at Intermediate
timeFrame: 3 months to 18 months after cataract surgery
measure: Visual Acuity at Near
timeFrame: 3 months to 18 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01964040: Perineural Dexmedetomidine and Femoral Nerve Block
Official title: Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Onset and Duration of Sensory and Motor Block of Femoral Nerve,
Visual Analogue Pain Scores,
Time to First Request of Rescue Analgesics,
Total Morphine Consumption in 24 Hours
Keywords: femoral nerve block
peri-neural dexmedetomidine
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: anesthesia department
name: faculty of medicine
First posted: 2013-10-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.


Eligibility criteria: Inclusion Criteria:

* all patients with ASA physical status I or II, scheduled for diagnostic knee arthroscopy

Exclusion Criteria:

* Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications

Primary outcomes:
measure: The primary outcome measure of this study will be the change of sensory block over time.
timeFrame: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours
Secondary outcomes:
measure: onset of motor and sensory block
timeFrame: up to 30 minutes after the end of injection
Other outcomes:
measure: duration of motor block
timeFrame: interval between time of injection and complete motor power recover
measure: Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) (
timeFrame: 2hours post operative and for 24hours
measure: time of 1st request of rescue analgesia
timeFrame: over the poatoperative 24hours
Locations:
city: Cairo
country: Egypt
facility: Anesthesia department-faculty of medicine-Cairo University
Study officials:
References:
Clinical trial NCT02243540: Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy
Official title: Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 1828
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who underwent photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment

Brief summary: The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

* patients in whom 12-month follow-up data were available

Exclusion Criteria:

* a previous diagnosis of urethral stricture
* prostate or bladder carcinoma
* neurogenic bladder disease
* a previous history of urological surgery

Primary outcomes:
measure: Change from baseline bladder voiding efficiency at 12 months after surgery
timeFrame: 12-months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Seung Paick, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371640: Sirolimus in COVID-19 Phase 1
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: SARS-CoV-2
Covid-19
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female \>/=18 and \</=65 years of age at the time of consent
* Laboratory confirmed SARS-CoV-2 infection
* Investigator-estimated hospitalization duration of at least 5 days

Exclusion Criteria:

* Need for \>4 liters nasal cannula oxygen to maintain oxygen saturation \>90%
* Hypersensitivity to sirolimus
* Pregnant or breastfeeding
* Anticipated transfer to another study hospital within 72 hours
* Alanine transaminase (ALT) \>3 times the upper limit of normal
* Creatinine clearance \<30mL/min as estimated by Cockcroft-Gault
* Underlying immunosuppression due to daily \>5 mg prednisone equivalent a day, prior solid organ transplant, or other immunosuppression deemed by investigator to be potentially unsafe
* Co-administration with strong inhibitors of CYP3A4 and/or P-glycoprotein (P-gp) (such as ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin and others)
* Co-administration with strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) (such as phenytoin or rifampin)
* Anticipated surgery within 1 month
* Need for healing of a fracture or a significant soft tissue wound

Primary outcomes:
measure: Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment
timeFrame: Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients
Secondary outcomes:
measure: Change in SARS-CoV-2 viral burden at days 1-6
timeFrame: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients
measure: Rate of treatment emergent adverse events
timeFrame: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Walter K Kraft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04054440: Outpatient Office Based Endovascular Procedures
Official title: Outpatient Office Based Endovascular Procedures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Venous Insufficiency
Peripheral Arterial Disease
Dialysis Access Malfunction
Arterio-venous Fistula
Thoracic Outlet Syndrome
Vertebral Artery Insufficiency
Varicose Veins
Keywords: office based angiosuite
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received endovascular procedures performed by board certified vascular surgeons in office-based angiosuites, located in California and Texas.

Brief summary: The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite. Additionally, other studies could compare clinical outcomes between procedures performed in an office based angiosuite and other settings.

Detailed description: Endovascular surgery combined with the demands of patients and physicians for less invasive procedures, have make this type of surgery one of the most innovative fields in medicine. However the endovascular experience in an office-based angiosuite is different from that in a hospital suite, and has been viewed in the past by some physicians as unsafe because it lacks the safety net of immediate hospital resources. In 2005, medicine allowed endovascular procedures to be performed in the office setting. The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of peripheral arterial disease (PAD), chronic venous insufficiency, dialysis access and malfunctioning arteriovenous fistulas, varicose veins, vertebrobasilar insufficiency, and thoracic outlet syndrome.
* Procedures performed as an outpatient in an office based angiosuite.

Exclusion Criteria:

* Age ≤ 18 years

Primary outcomes:
measure: Discharge location
timeFrame: April 2006 to December 2018
measure: postoperative complications
timeFrame: April 2006 to December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: DFW Vascuclar
name: Sam S Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671540: Effects of IPV Assessed With Functional Imaging
Official title: Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
IPV
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Artesis University College, Antwerp
name: FLUIDDA nv
First posted: 2012-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the invetigators seek an answer on the following hypothesis:

* What are the long term effects of an IPV treatment evaluated with classical outcome parameters? (FEV1, Raw)
* Is the possible effect noticeable on the novel technique and is this comparable with the classical outcome parameters?

Detailed description: A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.

Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted to the hospital for an excarebation. The IPV treatment is an additional treatment upon the standard treatment of the patients. The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises. Patients are randomized into either the experimental group or the control group. The control group receives a standard physical therapy treatment without additional IPV treatment.

Eligibility criteria: Inclusion Criteria:

* Patients admitted in the hospital for a acute exacerbation
* Mild to severe COPD

Exclusion Criteria:

* Ischemic / ventricular aritmic
* Tracheotomise
* Pneumothorax
* Facial deformity
* Recent nose, mouth or ear operations
* Recent gastric operations.
* Intubated
* Epilepsy

Primary outcomes:
measure: Lung function testing
timeFrame: baseline and after one week
Secondary outcomes:
measure: functional respiratory imaging
timeFrame: at baseline and after one week
Other outcomes:
measure: questionnaires
timeFrame: 1 week
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: UZA pneumology
name: Wilfried De Backer, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290440: MEdication Counselling Models for Outpatient oRal antIcoaguLation
Official title: Development of Medication Counselling Models for Outpatient Oral Anticoagulant-taking Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder
Keywords: oral anticoagulant
counselling
distance counselling
medication adherence
knowledge
hospitalisation
mortality
venous thromboembolism
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* taking oral anticoagulants
* using smartphones that can access the telepharmacy application
* agreeing to participate

Exclusion Criteria:

* pregnancy or lactation
* having cancer
* having immunodeficiency disorders or using immunosuppressants
* renal impairment (creatinine clearance \<30 mL/min)
* hepatic impairment (Child-Pugh B or C cirrhosis)
* heart failure (class IV, New York Heart Association)
* history of myocardial infarction or stroke within the latest 2 months

Primary outcomes:
measure: Medication adherence
timeFrame: Measured at month 1, 6, and 12 after randomisation
Secondary outcomes:
measure: Knowledge of oral anticoagulants
timeFrame: Measured at month 1, 6, and 12 after randomisation
measure: All-cause hospitalisation
timeFrame: 24 months after randomisation
measure: VTE-related hospitalisation
timeFrame: 24 months after randomisation
measure: Bleeding-related hospitalisation
timeFrame: 24 months after randomisation
measure: All-cause mortality
timeFrame: 24 months after randomisation
measure: VTE-related mortality
timeFrame: 24 months after randomisation
measure: Bleeding-related mortality
timeFrame: 24 months after randomisation
Other outcomes:
Locations:
Study officials:
References: