louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04834817: Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
Official title: The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: BioPhotas
First posted: 2021-04-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a split-person study design where each participant has one arm with the intervention and the other arm that is control.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.

Detailed description: This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.

Eligibility criteria: Inclusion Criteria:

Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla.

Subjects shall have given written informed consent for both the LED therapy and for clinical photography.

Exclusion Criteria:

Patients will be excluded if any of the exclusion criteria applies

* Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
* Subjects have previous photosensitivity problems (solar urticaria, etc.).
* Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
* Subjects taking any systemic drug with known immunosuppressant properties.
* Subjects applying any medications to the research site (inner biceps, close to the axilla).
* Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance.
* Subjects are smokers or have smoked within the last 30 days prior to the trial.
* Subjects have epilepsy or a history of seizures
* Subjects currently taking cortisone injections or any other kind of steroid injections(s)
* Subjects with known cancer tumor in the treatment area or metastasis

Primary outcomes:
measure: Days to Healing
timeFrame: Assessed from Day 0 to Day 55, up to 56 days
Secondary outcomes:
measure: Pain Level
timeFrame: Assessed from Day 0 to Day 13, up to 14 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: University of California, Irvine
name: Kristen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452617: Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
Official title: Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: hydroxychloroquine
ADRS
azithromycine
torsade de pointe
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ):

* HCQ administered at a daily dosage of 600mg in 3 doses for 10 days.
* AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6 days.

Brief summary: Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.

Many raised concerns regarding the potential cardiac toxicity of this association.

The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.

The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.


Eligibility criteria: Inclusion Criteria:

* critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.

Exclusion Criteria:

* cardiac conduction disorders
* continuous anti-arrhythmic therapy
* heart failure
* chronic renal failure

Primary outcomes:
measure: occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
timeFrame: 30 days after admission in ICU
Secondary outcomes:
measure: assessment of QTc interval prolongation during the treatment period compared to baseline ECG
timeFrame: daily
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Lyes KNANI, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308017: Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP
Official title: Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hypertrophy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 152
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized to one of two different types of scopes.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).


Eligibility criteria: Inclusion Criteria:

* Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms

Exclusion Criteria:

* Patients who lack decisional capacity

Primary outcomes:
measure: Surgery Time difference between the 24F laser scope and the 28F laser scope
timeFrame: Day 0
Secondary outcomes:
measure: Surgeon evaluation of Laser scopes flow rate
timeFrame: Day 0
measure: Surgeon evaluation of Laser scope visualization
timeFrame: Day 0
measure: Surgeon evaluation of Laser scope bladder injury
timeFrame: Day 0
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT00257517: Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
Official title: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: Congenital heart disease
Single ventricle
Infant feeding
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-11-23
Enrollment: 20
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypoplastic left heart syndrome

Brief summary: This study will assess 75-100 patients for feeding issues following surgery for single ventricle.

Detailed description: We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.

If subjects take part in this study, the following will happen:

1. Prior to discharge, the parent/guardian will be given a home feeding log and
2. Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
3. The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
4. The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:

   * First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
   * Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
   * Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.

It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.

The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.

Eligibility criteria: Inclusion Criteria:

* Single ventricle patients who have received the Norwood Stage I operation.

Exclusion Criteria:

* Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis \[NEC\] or other gastrointestinal \[GI\] anomalies)
* Prematurity less than 37 weeks
* Infants greater than 30 days of age at Stage I palliation
* Parents who cannot read or understand questionnaires administered as a part of the study.

Primary outcomes:
measure: weight gain
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Martha Clabby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947817: Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism
Official title: Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Endocarditis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.


Eligibility criteria: Inclusion Criteria:

* All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke

Exclusion Criteria:

* Age \< 18 years
* Pregnancy and feeding
* Health not allowing to give the assent
* Innate abnormalities of the haemostasis
* More than a week before the inclu antibiothérapie adapted begun

Primary outcomes:
measure: Embolic events occurring during the antimicrobial treatment a
timeFrame: 30 months
Secondary outcomes:
measure: Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.
timeFrame: 30months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,
state: Paca
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: franck thuny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04138017: ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
Official title: Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankle Deformity
Ankle Arthritis
Keywords: Arthrodesis
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2019-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.


Eligibility criteria: Inclusion Criteria:

* Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
* Age 18-80
* Willing to complete all follow up evaluations

Exclusion Criteria:

* Prior infection at site of planned arthrodesis
* Prior arthrodesis procedure
* Inability to maintain non-weight bearing status
* Bone defect requiring more than 10 cc of bone graft material
* Known Vitamin D deficiency with a Vitamin D level of \<30ng/ml 1 week prior to surgery
* Inadequate bone stock to allow for rigid internal fixation
* Hemoglobin A1C greater than 8.0%
* Tobacco or Nicotine use 6 weeks prior to surgery
* BMI greater than 40

Primary outcomes:
measure: Fusion
timeFrame: 12 months
Secondary outcomes:
measure: Failure of hardware or obvious non-union
timeFrame: 12 months
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 12 months
measure: Vitamin D levels
timeFrame: 6 months
measure: Visual Analog Pain Scale
timeFrame: 12 months
measure: American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
timeFrame: 12 months
measure: VR-12 (Veterans RAND 12)
timeFrame: 12 months
measure: Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b)
timeFrame: 12 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Joseph Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04622917: Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.
Official title: Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Hay Fever
Pollen Allergy
Allergic Rhinitis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.

Detailed description: The study was an interventional single center double-blinded human randomized trial with two groups treated parallel.The first group received an intramuscular injection of Methylprednisolone 40 mg/ml 2ml x 1 as a single dose. The second group received an intramuscular injection of NaCl 0,9 mg/ml 2ml x 1 as a single dose. Symptom score and the use of medication was registered daily during the pollen peak of the season, using an electronic diary. The study was conducted during the spring of 2019.

Eligibility criteria: Inclusion Criteria:

* Severe birch pollen induced allergic rhinitis.
* Signed informed consent according to International Council of Harmonisation/Good Clinical Practice, and national/local regulations.
* Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.

Exclusion Criteria:

* Pregnancy or nursing.
* Autoimmune or collagen disease.
* Cardiovascular disease.
* Hepatic disease.
* Renal disease.
* Cancer.
* Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive- and restrictive lung disease).
* Medication with a possible side-effect of interfering with the immune response.
* Previous immuno- or chemotherapy.
* Chronic disease.
* Major metabolic disease.
* Alcohol or drug abuse.
* Mental incapability of coping with the study.
* Known or suspected allergy to the study product.
* Suspicion of or confirmed bacterial infection.
* Known allergy to the study drugs, "rescue medication".

Primary outcomes:
measure: Mean Combined Medical- and Symptom score (CSMS)
timeFrame: 3 weeks
measure: Mean symptom score
timeFrame: 3 weeks
Secondary outcomes:
measure: Effects on Quality of Life (QoL), SNOT
timeFrame: 3 weeks
measure: Effects on Quality of Life (QoL), RQLQ
timeFrame: 3 weeks
measure: Effects on Quality of Life (QoL), ACQ
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Lung-and Allergy Research
state: Skane
Study officials:
affiliation: Karolinska Institutet
name: Lars Olaf Cardell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04704817: Prospective Database for Colonic or Rectal Resection Surgery Patients
Official title: Prospective Database for Colonic or Rectal Resection Surgery Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Disorders
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 1000
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: adults treated ot to be treated for colonic and or rectal resection

Brief summary: Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).

Detailed description: Colorectal cancer is the second leading cause of cancer death in France. It accounts for nearly 12% of all cancer deaths, especially among those 65 and over. However, mortality has declined steadily since 1980.

Access to screening for colorectal cancer and resection of precancerous lesions partly explains this decline. All sexes combined, it is estimated that about one in five colorectal cancer is diagnosed at a limited local stage. The treatment is then less heavy and gives better results.

With the development of Enhanced Recovery After Surgery (ERAS) protocols and their extension to rectal excision, it becomes imperative to be able to collect operative data from these patients on a perennial basis for the purpose of evaluating our results. Finally, the evaluations resulting from this database could have prognostic value and ultimately allow us to adapt the surgical management of the patient according to the results.

Eligibility criteria: Inclusion Criteria:

1. Patients treated for colonic and / or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,
2. Patients over 18 years old,
3. Affiliation to a social security scheme, or beneficiary of such a scheme.

Primary outcomes:
measure: clinical events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00405717: Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel
Official title: Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Acute Coronary Syndromes
Keywords: ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
statin
clopidogrel
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).

In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ACS.
* Between ages of 18 Years and 85 years.
* Presence of one or several stenosis in native coronary arteries requiring PCI.
* Willing and able to sign informed consent.

Exclusion Criteria:

* A history of bleeding diathesis.
* New York Heart Association functional class IV.
* Prior PCI or coronary bypass grafting \< 3 months.
* Contraindications to statins, clopidogrel and aspirin (White blood cells counts \< 4×109/L or platelet counts \<100 g/l; creatinine clearance \<25 ml/ min; active liver disease).
* Use of glycoprotein IIb/IIIa inhibitors before PCI.
* Use of statins before PCI.

Primary outcomes:
measure: major adverse cardiac and cerebral events at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: hemorrhage events and subacute thrombosis events at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Northern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References: