louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03930927: Effect of Self Assembling Peptide on White Spot Lesion
Official title: Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: White Spot Lesion of Tooth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?

Detailed description: Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.

Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.

Eligibility criteria: Inclusion Criteria:

* Patients with post orthodontic white spot lesion.
* Patients with good oral hygiene.
* Patients with good general health.
* Cooperative patients.
* Subjects who signed the informed consent.

Exclusion Criteria:

* Patients with tetracycline pigmentation and dental fluorosis.
* Enamel cavitation.
* Disable patient.
* patient with any systemic disease or severe medical complications.

Primary outcomes:
measure: Remineralizing process
timeFrame: 6 months
Secondary outcomes:
measure: Visual assessment
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04067427: Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training
Official title: To Reduce Recurrence of Symptomatic Atrial Fibrillation and Improve Quality of Life After Catheter Ablation for Atrial Fibrillation by App-based Mental Training (Mental AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Meditation
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2019-08-26
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.

Detailed description: To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV)
* Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions
* Capability to use mobile phone applications
* Internet access
* Consent to study participation

Exclusion Criteria:

* Patients \< 18 years of age
* Unavailability of smart phone running at least Android 5 or iOS 9
* Pregnancy

Primary outcomes:
measure: Atrial Fibrillation (AF) 6 questionnaire score
timeFrame: 12 weeks, assessed weekly
Secondary outcomes:
measure: Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
timeFrame: Follow up (3 months)
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score
timeFrame: Follow up (3 months)
measure: Atrial fibrillation burden
timeFrame: Follow up (3 months)
measure: Heart Rate
timeFrame: Follow up (3 months)
measure: Blood pressure
timeFrame: Follow up (3 months)
measure: Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
timeFrame: Follow up at 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig Heart Institute
state: Saxony
Study officials:
affiliation: Herzzentrum Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany
name: Julia A Lurz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877227: Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns
Official title: Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Hyperhomocysteinemia
Keywords: CVA
stroke
newborns
homocysteine
folinic acid
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 37
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.

Detailed description: The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.

We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.

Eligibility criteria: Inclusion Criteria:

* admitted at our NICU

Exclusion Criteria:

* midline defects
* Extracorporeal membrane oxygenation (ECMO) treatment
* blood transfusion
* overt renal failure

Primary outcomes:
measure: lowering total homocysteine concentrations
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical center Nijmegen
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Henk Blom, Dr
role: STUDY_CHAIR
affiliation: Radboud University Medical Center Nijmegen
name: Marije Hogeveen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902327: N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women
Official title: Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Obesity
Carbohydrate Metabolism Disorder
Keywords: N - acetylocysteine
Obesity
Insulin resistance
Nutrition intervention
Carbohydrate Metabolism
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trails
Primary purpose: TREATMENT

Brief summary: The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.


Eligibility criteria: Inclusion criteria:

* women diagnosed with carbohydrate metabolism disorder,
* obesity (BMI \>29,9 kg/m2)
* patients not participating in other similar research programs at the same time,
* written agreement to take part in the research.

Exclusion criteria:

* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* pregnancy and breast feeding.

Primary outcomes:
measure: Insulin Resistance
timeFrame: 12 weeks
measure: Oral glucose toletance test OGTT
timeFrame: 12 weeks
Secondary outcomes:
measure: Homocysteine concentrations mg/dL
timeFrame: 12 weeks
measure: Glutathione level uM/L
timeFrame: 12 weeks
measure: Body weight kg
timeFrame: 12 weeks
measure: Body height kg
timeFrame: baseline
measure: Body mass index kg/m2
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: MTHFR polymorphism
timeFrame: baseline
measure: Blood lipoproteins measured.
timeFrame: 12 weeks
measure: Cytokine measured
timeFrame: 12 weeks
measure: C-Reactive Protein measured
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Life Sciences
Study officials:
References:
Clinical trial NCT02715427: Enhanced Recovery After Hepatic Surgery (MultiPAS).
Official title: Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-03-22
Enrollment: 80
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: SUPPORTIVE_CARE

Brief summary: Enhanced rehabilitation programs are based on new therapies and treatment combinations to reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but also the overall cost of care. The operating stress and hypercatabolic conditions surrounding the surgery are sources of complications. In this enhanced rehabilitation approach, the principle is to fight through a series of actions against this surgical stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is not until now French data concerning the assessment of enhanced rehabilitation in liver surgery. The main objective of the study is to compare the effectiveness of the implementation of a multimodal management program after liver surgery in a French university center compared to conventional care. Secondary objectives of the study are to compare an enhanced rehabilitation program in liver surgery versus conventional treatment in terms of morbidity and mortality in the immediate postoperative period and until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program in both groups will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patient to be operated on for hepatectomy in Universitary Hospital of Angers
* No emergency surgery
* No bilio-digestive anastomosis
* Body Mass Index between 18 and 40 kg/m2
* Preoperative morbidity status graded with the American Society of Anesthesiologists (ASA) between I to III
* Affiliated to the national health insurance

Exclusion Criteria:

* Pregnant woman
* Patient who doesn't speack french
* Colorectal surgery combined
* Postoperative stay predictable in critical care unit
* Patient under law protection

Primary outcomes:
measure: Day number to functional recovery
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
state: Maine et Loire
Study officials:
References:
Clinical trial NCT03037827: The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation
Official title: Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: endovenous laser ablation
radial fiber
linear endovenous energy density
1470 nm
occlusion rate
Lead sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Sponsor class: OTHER
Collaborators: name: Medalp Private Surgery Clinic
name: Garantclinic
First posted: 2017-01-31
Enrollment: 203
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: A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.


Eligibility criteria: Inclusion Criteria:

Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec No prior treatment of the insufficient GSV Informed consent

Exclusion Criteria:

Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency

Primary outcomes:
measure: The number of participants with a fully obliterated target vein
timeFrame: 3 month
Secondary outcomes:
measure: Pain score
timeFrame: day 1
measure: Pain score
timeFrame: day 7
Other outcomes:
measure: Number of patients with adverse events
timeFrame: 3 month
measure: Paresthesia
timeFrame: 3 month
measure: Deep venous thrombosis
timeFrame: day 7
measure: Superficial venous thrombosis
timeFrame: day 7
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Clinic of Phlebology and Laser Surgery
city: Moscow
country: Russian Federation
facility: GarantClinic
Study officials:
References:
Clinical trial NCT02820727: Perioperative Three Dimensional Right Ventricular Function
Official title: Perioperative Three Dimensional Right Ventricular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cardiac surgical patients

Brief summary: This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.


Eligibility criteria: Inclusion Criteria:

* informed consent given
* cardiac surgical procedure
* left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation

Exclusion Criteria:

* pregnant patients
* contraindication for transesophageal echocardiography

Primary outcomes:
measure: Time on Intensive Care Unit (ICU)
timeFrame: up to 60 days
Secondary outcomes:
measure: Time to hospital discharge
timeFrame: up to 120 days
measure: Catecholamine dosages
timeFrame: up to 24 hours
measure: Catecholamine free days
timeFrame: up to 60 days
measure: Hours on mechanical ventilation
timeFrame: up to 1440 hours
measure: Organ failure during ICU stay
timeFrame: up to 60 days
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: University Hospital Tubingen
state: BW
Study officials:
affiliation: University Hospital Tuebingen
name: Harry Magunia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magunia H, Jordanow A, Keller M, Rosenberger P, Nowak-Machen M. The effects of anesthesia induction and positive pressure ventilation on right-ventricular function: an echocardiography-based prospective observational study. BMC Anesthesiol. 2019 Nov 4;19(1):199. doi: 10.1186/s12871-019-0870-z.
Clinical trial NCT03322527: Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery
Official title: Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery Grade II or III of Goligher
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with a haemorroid proloapse surgery programmed in GHPSJ

Brief summary: Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery.

The aim is to evaluate the efficacy of this technic and note the post surgery pain and events


Eligibility criteria: Inclusion Criteria:

* age \> 18
* hemorrhoid prolapse grade 2 and 3
* accepting participation

Exclusion Criteria:

* hemorrhoid prolapse grade 1 and 4
* other proctological pathology
* previous surgery of prolapsus
* with anti coagulant treatment
* Intestinal chronic inflammatory disease
* age \< 18
* pregnancy

Primary outcomes:
measure: Goligher score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: DE PARADES Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03147027: Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Official title: Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Tachycardia
Ischemic Cardiomyopathy
Reduced LVEF
Keywords: ischemic cardiomyopathy
prophylactic ablation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF

Brief summary: Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.


Eligibility criteria: Inclusion Criteria:

* left ventricular ejection fraction (TTE or MRI) ≤40%
* diagnosed ischemic heart disease
* nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring
* ICD implantation with primary preventive indication

Exclusion Criteria:

* ICD implantation within 2 months
* previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
* no written informed consent

Primary outcomes:
measure: occurrence of sustained VT/VF or ICD therapy
timeFrame: time from randomization to occurrence of any sustained VT/VF within 24 months
Secondary outcomes:
measure: survival free from clinical events
timeFrame: time from randomization to 24 months
measure: number of appropriate ICD therapies
timeFrame: time from randomization to 24 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT04142827: The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
Official title: The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis Adult
Lung Infection
Quality of Life
Humidifier Lung
COPD Exacerbation
COPD Asthma
Keywords: Bronchiectasis
High Flow Therapy
Humidifcation
Lung Infection
Quality of life
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Bronchiectasis on HRCT
* Optimization of Therapy for at least 15 days before enrollment
* Autonomous patients with possibilities of practicing rehabilitations cycles

Exclusion Criteria:

* OSAS (ODI\>10/h)
* HOME NIV
* PH\<7,35 - paO2\< 60mmHg, paCo2\> 55 mmHg
* Lung cancer
* Contraindication to high-flow nasal cannula (hfnc)

Primary outcomes:
measure: Improvment Daily Life
timeFrame: 1 year
measure: measurement of Sputum production
timeFrame: 1 year
measure: measurement Exercise tolerance
timeFrame: 1 year
measure: Number of missed working or school day
timeFrame: 1 year
measure: time from first exacerbations
timeFrame: 1 year
measure: number of exacerbations including their durations and severity
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of Arterial Blood Glass
timeFrame: 1 year
measure: Unit of Nitric Oxide
timeFrame: 1 year
measure: Evaluation of Reactive C-Protein
timeFrame: 1 year
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Rosa Cauteruccio
Study officials:
References: