louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04430244: Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas
Official title: Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Istituto Internazionale di Ricerca e Formazione in Oftalmologia
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

Detailed description: Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation.

Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored.

The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

Eligibility criteria: Inclusion Criteria:

* Keratoconus
* Surgical candidates for deep anterior lamellar keratoplasty

Exclusion Criteria:

* Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
* Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
* Inability to comply with study protocol or participate in follow-up visits

Primary outcomes:
measure: Change in best spectacle-corrected visual acuity
timeFrame: Preoperatively; and 6 and 12 months postoperatively
Secondary outcomes:
measure: Change in astigmatism
timeFrame: Preoperatively; and 6 and 12 months postoperatively
measure: Change in Thinnest-point pachymetry
timeFrame: Preoperatively; and 6 and 12 months postoperatively
measure: Change in endothelial cell density
timeFrame: Preoperatively; and 6 and 12 months postoperatively
measure: Incidence of graft rejection
timeFrame: 6 and 12 months postoperatively
measure: Incidence of graft failure
timeFrame: 6 and 12 months postoperatively
measure: Corneal donor loss due to preparation
timeFrame: Intraoperative
Other outcomes:
measure: Refraction
timeFrame: 6 and 12 months postoperatively
measure: Adverse Events/Complication
timeFrame: up to 12 months postoperatively
Locations:
city: Forlì
country: Italy
facility: Ospedali Privati Forlì "Villa Igea"
state: Emilia-Romagna
Study officials:
affiliation: Università degli Studi di Ferrara
name: Massimo Busin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06089044: Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
Official title: Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prosthesis-related Infections
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for a prosthetic device infection requiring suppressive antibiotic therapy for more than 6 months.

Brief summary: The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:

What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.

Translated with www.DeepL.com/Translator (free version)


Eligibility criteria: Inclusion Criteria:

* Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
* Patients requiring suppressive antibiotic therapy (\>6 months) with dalbavancin.

Exclusion Criteria:

* Patients who are protected adult;
* Patients who are minors;
* Patients having expressed their opposition

Primary outcomes:
measure: efficacy of suppressive Dalbavancin therapy
timeFrame: two-year follow-up after initiation of suppressive therapy with Dalbavancin
Secondary outcomes:
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
References:
Clinical trial NCT02642744: Improving Coordination and Transitions of Care in Stroke Patients
Official title: Improving Coordination and Transitions of Care for Stroke Patients With an Attending Nurse: a Comparative Effectiveness Single Center Study Comparing Models of Nursing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine if the attending nurse model will enhance critical patient-centered elements of care that will in turn improve patient education and shared decision-making, medication adherence, stroke-related health literacy, and reduce early readmissions to ultimately yield improved patient quality of life. Our primary objective is to determine whether the attending nurse model of care improves stroke patients' health at 7 days, 30 days, and 90 days after hospital discharge as assessed through questionnaires.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Admission to the Hospital of the University of Pennsylvania Vascular Neurology service
* Incident or recurrent:
* Ischemic stroke: focal neurological deficit of likely ischemic vascular origin
* Intracerebral hemorrhage: blood seen on initial head CT
* Transient Ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved

Exclusion Criteria:

* Pregnancy
* Comfort or hospice care
* Severe dementia prior to stroke
* Non-communicative and have no family/social support

Primary outcomes:
measure: Stroke Patient Education Retention Tool
timeFrame: 90 days
measure: Medication Compliance
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott E Kasner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682344: Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
Official title: Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Surgical Pathology of the Leg or the Foot.
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).

Detailed description: The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.

This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.

Eligibility criteria: Inclusion Criteria:

* Surgical pathology of the leg or the foot with garot tyre of thigh
* Age included between 6 months and 12 years
* Status ASA I or II

Exclusion Criteria:

* Bilateral or one-sided surgical gesture realized without garot tyre
* Cutaneous infection in the point of draining
* Clinical confusion of the coagulation
* Allergy informed in the local anesthesics of amino-acid class
* Evolutionary neurological pathology of the operated limb
* Renal, respiratory, cardiac or hepatic insufficiency.

Primary outcomes:
measure: The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.
timeFrame: 24 months
Secondary outcomes:
measure: Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique
Study officials:
affiliation: ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
name: Frédéric LACROIX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801744: Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
Official title: Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Post-stroke Hemiparesis
Foot Drop
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using operant conditioning. We are recruiting 5 individuals with chronic post-stroke hemiparesis with foot drop in the affected leg to participate in the reflex training procedure. The study involves 40 visits with a total study duration of about 4 months.


Eligibility criteria: Inclusion Criteria:

* At least 6 months following a single, unilateral stroke, resulting in hemiparesis.
* Ambulatory with or without assistive device, but must demonstrate a gait deficit which is indicative of foot drop from reduced activation of the tibialis anterior muscle.
* Able to follow verbal directions.
* Able to see icons on computer monitor (with or without corrective lenses) from at least 4 feet away.
* All subjects will be adults at least 18 years old.
* Know history and current medication management for lower limb spasticity, if any.

Exclusion Criteria:

* No history of ear disease or balance problems outside of those caused by the stroke.
* Cerebellar stroke
* No other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking.

Primary outcomes:
measure: Change in magnitude of reciprocal inhibition
timeFrame: Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT03060044: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µg/Inhalation: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects


Eligibility criteria: Inclusion Criteria:

* written informed consent obtained
* good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed
* known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
* pregnant or lactating females

Primary outcomes:
measure: Cmax of plasma salmeterol and fluticasone propionate
timeFrame: 0 hour to 34 hours after study treatment administration
measure: AUCt of plasma salmeterol and fluticasone propionate
timeFrame: 0 hour to 34 hours after study treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma pharmacology Unit
Study officials:
affiliation: Clinical Study director
name: Iissa Kivistö
role: STUDY_DIRECTOR
References:
Clinical trial NCT05233644: Medication Adherence in Heart Failure After Hospitalisation
Official title: Study Title Medikamentenadhärenz Bei Erwachsenen Personen Mit Herzinsuffizienz
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence, Medication
Heart Failure
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 72
Sex: ALL
Minimum age (years): 118
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure

Brief summary: To explore medication adherence in patients who were hospitalised due to heart failure.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Heart failure
* Hospitalisation due to heart failure in the past two years

Exclusion Criteria:

* Not speaking German
* cognitive impairment

Primary outcomes:
measure: Medication Adherence
timeFrame: at one timepoint (cross sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT01383044: Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding
Official title: Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Variceal Bleeding
Keywords: Carvedilol
Banding ligation with Carvedilol
the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Detailed description: Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Eligibility criteria: Inclusion Criteria:

1. Cirrhosis with esophageal varices are larger than F2.
2. No history of variceal bleeding.
3. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.

Exclusion Criteria:

1. Association with HCC or other cancers .
2. Refractory ascites.
3. Jaundice, bilirubin \> 5mg/dl.
4. Encephalopathy.
5. Cr.\>3mg/dL.
6. A-V,block bradycardia (PR \< 60/mim).
7. Hypotension systolic blood pressure\<95/mmHg .
8. Refusal to participate.
9. Carvedilol allergy
10. Second degree-third degree Atrio-ventricular block.
11. Bradycardia.
12. WPWsyndrome
13. Hypotension
14. Psychogenic shock.
15. Asthma. All the patients are randomized based on a random number.

Primary outcomes:
measure: patients with first bleeding
timeFrame: 3 years
Secondary outcomes:
measure: patients with complications and mortality rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Kaogsiung
country: Taiwan
facility: E-DA hospital
Study officials:
References:
Clinical trial NCT03413644: Evaluation of ClearLLab Leukemia and Lymphoma Panels
Official title: Evaluation of ClearLLab Leukemia and Lymphoma Panels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia-Lymphoma
Keywords: Hematological diseases
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 482
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.

Brief summary: Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.

Detailed description: Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. Residual specimens will be tested using the ClearLLab Panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).

Eligibility criteria: Inclusion Criteria:

* Residual samples from patients with hematological abnormalities being evaluated by Flow Cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. All subjects of any ethnicity, age and racial background will be included.

Exclusion Criteria:

* Specimens and/or spent samples that are visibly hemolyzed
* Specimens and/or spent samples that are visibly clotted
* Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours from time of collection
* Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48 hours from time of collection
* Samples with insufficient volume to complete the protocol tests

Primary outcomes:
measure: Hematologically Malignant or Non-Malignant
timeFrame: Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: NeoGenomics Laboratories, Inc.
state: Florida
city: Calgary
country: Canada
facility: Calgary Laboratory Services
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Munich
country: Germany
facility: Munich Leukemia Laboratory
Study officials:
affiliation: NeoGenomics Laboratories, Inc.
name: Adrian Padurean, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Center
name: Mike Keeney
role: PRINCIPAL_INVESTIGATOR
affiliation: Calgary Laboratory Services
name: Joanne Luider
role: PRINCIPAL_INVESTIGATOR
affiliation: Munich Leukemia Laboratory
name: Wolfgang Kern
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04861844: Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
Official title: Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 4
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to administer a brief, phone(voice)-based training program in mindfulness (or control task of active listening to narrated articles) to older adults who receive primary care services at NM. Older adults represent a population that is at risk for depression and anxiety, especially during the current COVID-19 pandemic and the social isolation it entails. Many older adults also possess relatively low access to application-based mindfulness training opportunities. The monitoring aims are:

1. To determine whether the experimental intervention (mindfulness training) performs better than a control task (active listening) in improving mood assessed using the Profile of Mood States (POMS) and/or anxiety assessed using the State-Trait Anxiety Inventory (STAI).
2. To determine whether the experimental and/or control intervention is associated with quantified changes in language use (e.g., frequency of negative word use), which may or may not also be associated with changes in mood and anxiety.


Eligibility criteria: Inclusion Criteria:

1. Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
2. English-speaking; and
3. Able to verbally consent

Exclusion Criteria:

patients with dementia or otherwise not meeting inclusion criteria

Primary outcomes:
measure: Change in mood assessed using the Profile of Mood States (POMS)
timeFrame: 3 days
measure: Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
timeFrame: 3 days
measure: Change in mood assessed using the Profile of Mood States (POMS)
timeFrame: 1 month
measure: Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References: