louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04806542: Two-year Follow-up of a Mindfulness-based Intervention in Children.
Official title: A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 34
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study.
Primary purpose: OTHER

Brief summary: The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.

Methods

The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.


Eligibility criteria: Inclusion Criteria:

* F32.0 Mild depressive episode
* F32.1 Moderate depressive episode
* F41 Anxiety disorders
* F43 Reactions to stress
* F51 Nonorganic sleep disorders
* F93 Emotional disorders with onset specific to childhood
* F94.8 Other childhood disorders of social functioning
* F94.9 Other childhood disorder of social functioning, unspecified

Exclusion Criteria:

* Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
* Cognitive disorders
* Difficulties in understanding Swedish
* Neuropsychiatric considerations and diagnosis
* Learning disabilities with difficulties in verbal understanding
* Ongoing parental conflict in conjunction with separation/divorce.
* Attending less than 5 of the 8 sessions of the TMR program.

Primary outcomes:
measure: Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
timeFrame: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
measure: Resilience.
timeFrame: Change from Baseline Resilience at 2 years.
measure: Stress.
timeFrame: Change from Baseline stress at 2 years.
measure: Mindfulness.
timeFrame: Change from Baseline mindfulness at 2 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01735942: Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions
Official title: A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Actinic Keratosis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between 18 and 89 years old.
* Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp
* The subjects are in good health
* The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator

Exclusion Criteria:

* Subjects under 18 years of age and over the age of 89
* Subjects who are pregnant or lactating
* Subjects with sensitivity to cold
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects who received previous treatment of target AKs
* Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
* Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
* Subjects who are unable to understand the protocol or to give informed consent

Primary outcomes:
measure: Change from baseline in visual assessment scores at 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794442: Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins
Official title: Correlation Between Retinal Metabolism and the Observation of a Visible Retinal Spontaneous Venous Pulse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Open Angle Glaucoma
Normal Tension Glaucoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism.

However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues.

The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein

Detailed description: 1. Visual field examen will be performed.
2. Structural examination of the optic disc (confocal microscopy) will be performed.
3. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
4. Oximetry reading in the non-contact retinal oximetry of the first 3 order retinal vessels

Eligibility criteria: Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply with the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for cataract surgery)
* eye disease (except glaucoma)
* systemic diseases with ocular involvement like diabetes

Primary outcomes:
measure: Retinal Oxygen saturation in retinal veins with absent pulsation
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Ingeborg Stalmans, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01849042: Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease
Official title: A Multicenter, Randomized, Open-label, Prospective Study to Estimate the add-on Effects of Memantine as Ebixa Oral Pump on Language in Moderate to Severe Alzheimer's Disease Patients Already Receiving Donepezil.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer's Disease
Dementia
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 188
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.


Eligibility criteria: Inclusion Criteria:

* probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria
* MMSE score equal to or less than 20
* Brain CT or MRI scan performed within the past 12 months
* living or having regular visit at least three times a week from caregiver
* able to visit outpatient clinic and to perform cognitive function test
* already taking stable dose of donepezil for 3 months prior to screening
* subject and caregiver who signed informed consent

Exclusion Criteria:

* involved in another clinical trial within 4 weeks prior to screening
* severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure
* bradycardia (pulse rate less than 50bpm), sick sinus syndrome
* any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)
* severe auditory or visual disturbance
* other degenerative disease or psychosis
* taken any drug used for the treatment of Alzheimer's disease or dementia

Primary outcomes:
measure: AQ-WAB(Western aphasia battery)
timeFrame: Six months
Secondary outcomes:
measure: ROSA (Relevant Outcome Scale for Alzheimer's Disease)
timeFrame: six months
Other outcomes:
measure: SIB-short form
timeFrame: six months
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk university medical center
Study officials:
References:
Clinical trial NCT04554342: Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity
Official title: Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Dryness of Mouth
Keywords: salivary flow rate
salivary flow stimulation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: doppel- blind testing of 5 different variations of a candy in each participant by (unstimulated and stimulated) salivary flow rate; each participant is testing each variation of candy once in a randomized order at 5 consecutive days
Primary purpose: TREATMENT

Brief summary: This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

Detailed description: A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Eligibility criteria: Inclusion Criteria:

* non- smoker
* no allergies
* no drug- use (except for contraception)
* healthy volunteers (no disease/infection 4 weeks before study participation)

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: dryness of mouth- sensation
timeFrame: one point assessment following consumption of candy (approx 5 minutes)
measure: Change in salivary flow rate (ml/min)
timeFrame: before and after consumption of candy (approx 5 minutes for each salivary flow measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäres Zentrum für Zahnmedizin Basel
Study officials:
affiliation: Universitäres Zentrum für Zahnmedizin Basel
name: Andreas Filippi, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917642: Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
Official title: Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Nonvital
Keywords: bacterial infection
endotoxin
passive ultrasonic irrigation
root canal treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide \[LPS\]) from root canals.

Detailed description: Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.

Eligibility criteria: Inclusion Criteria:

* Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion Criteria:

* patients who had received antibiotics during the previous 3 months or had any general disease,
* teeth that could not be properly isolated with rubber dam,
* non-restored teeth,
* periodontal pockets depths greater than 4 mm,
* previous endodontic treatment,
* open apex,
* crown/root fracture
* root resorption or calcifications.

Primary outcomes:
measure: Bacterial Levels
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Endotoxin Levels
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dentistry, School of Dentistry, University of São Paulo.
name: Giulio Gavini, DDS, Ms, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05690542: Nanoparticles in Blood: Understanding and Controlling Protein Corona for Optimized Nanomedicine
Official title: Nanoparticles in Blood: Understanding and Controlling Protein Corona for Optimized Nanomedicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulation Tests
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Leftover plasma sample from controls and patients hospitalized in CHU Dijon

Brief summary: The main objective is to study the effect of engineered nanoparticles SPIONs (superparamagnetic iron oxide) on hemostasis. Nanoparticles will be incubated in blood and platelet aggregation will be measured. In parallel, nanoparticles will also be incubated in blood and then plasma proteins adsorbed on them will be separated and analyzed. The proteins found on the nanoparticles will be linked to the platelet aggregation observed to help developing innovative protein functionalized nanoprobes for optimized nanomedicine.


Eligibility criteria: Inclusion Criteria:

* all people

Exclusion Criteria:

* patient under 18 years old, legal protection measure, pregnancy

Primary outcomes:
measure: impact of nanoparticles on coagulation tests ou platelet functions
timeFrame: at the baseline
Secondary outcomes:
measure: Difference of behaviour of the nanoparticles (N=10 preparations) on coagulation cascade and platelet functions
timeFrame: at the baseline
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU DIJON BOURGOGNE - laboratoire mixte
Study officials:
References:
Clinical trial NCT04840342: MR Antagonist and LSD1
Official title: Role of LSD1 in Hypertension in Blacks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertension
Mineralocorticoid Excess
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lysine specific demethylase-1 (LSD1) is an epigenetic regulator of gene transcription involved in the pathophysiology of elevated blood pressure and likely renal damage in Blacks. This project investigates whether a genetically driven anti-hypertensive approach proves superior in controlling blood pressure and mitigating renal injury in Blacks who carry the risk allele for LSD1 (rs587168). The findings of these investigations may lead to a new approach in treating a subset (\~30%) of the essential hypertension population (Black LSD1 risk allele hypertensives).

Detailed description: This proof-of-principle physiologic study in hypertensive Black LSD1 risk allele carriers testing the hypothesis that reductions in blood pressure will be greater with a genetically-driven anti-hypertensive approach (mineralocorticoid receptor antagonist, eplerenone) compared to a non-specific approach (amlodipine). 56 participants will be enrolled in a 12-week randomized, double-blind, active controlled, outpatient study to assess whether eplerenone (LSD1 specific treatment) proves superior in 24-hr ambulatory systolic blood pressure reduction than amlodipine (non-specific treatment). Participants will be randomized to either eplerenone 50mg or amlodipine 2.5mg with escalations in dose of study drug every 4 weeks if the participant's blood pressure is \> 140/90.

Eligibility criteria: Inclusion Criteria:

* untreated as well as currently treated hypertensives
* rs587168 allele carriers
* not on more than two anti-hypertensives
* normal renal, metabolic, electrolyte, and CBC laboratory tests
* self-identified Black race
* age \>17 yrs.

Exclusion Criteria:

* known cardiac disease other than HTN
* renal, circulatory or neurologic diseases
* diabetes
* smoking
* secondary HTN as indicated by history, physical examination or screening blood and urine tests
* smoking
* any drug therapy, except for anti-hypertensives and stable thyroid medication replacement

Primary outcomes:
measure: 24-hour systolic ambulatory blood pressure
timeFrame: Change in systolic blood pressure between baseline and 4 weeks on study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's
state: Massachusetts
Study officials:
affiliation: Brigham and Women's
name: Andrea Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02644642: Utility of Disconnection Technique for One Lung Ventilation
Official title: Utility of Disconnection Technique for One Lung Ventilation: a Comparison of a Double Lumen Endobronchial Tube With a Bronchial Blocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. However, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. Therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated


Eligibility criteria: Inclusion Criteria:

* patients scheduled for wedge resection for pneumothorax, unilateral
* ASA class I, II

Exclusion Criteria:

* know lung disease
* any kind of lung abnormality on preoperative chest x-ray
* coronary artery occlusive disease
* cerebrovascular disease
* pregnancy
* unable to understand the informed consent form

Primary outcomes:
measure: Lung deflation score
timeFrame: 10 min after inflation of balloon
Secondary outcomes:
measure: time for initial placement
timeFrame: from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
measure: time for lung deflation
timeFrame: from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University School of Medicine
name: Go Un Roh, MD
role: PRINCIPAL_INVESTIGATOR
References: