louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01577797: A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence
Official title: A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine
Drug Abuse
Substance Abuse
Amphetamine
Dependence
Addiction
Craving
Cognitive Behavioral Therapy
Text Messaging
Lead sponsor: New Leaf Treatment Center
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.

Detailed description: Psychosocial therapies for methamphetamine (MA) addiction all have limited effectiveness, and patients treated for MA dependence have a high rate of relapse. Additionally, there are no currently approved medications for MA dependence. Thus, a significant need exists for add-on therapy for treatment of MA addiction. CBT-based text messaging could serve as a real-time intervention when craving and risk of MA use are high and patients are not in the clinic. It could further serve to reinforce CBT group therapy. If found efficacious, fully-automated CBT-based text messaging would be a relatively inexpensive adjunctive therapy that could be readily scaled up for use in a large number of patients. Additionally, this type of text messaging intervention also could be tailored to individual users, which may enhance its efficacy. This Phase I randomized crossover study will evaluate the feasibility and preliminary efficacy of CBT-based text messages in conjunction with CBT group therapy delivered over a 22-day period in MA users in the San Francisco Bay Area.

Eligibility criteria: Main inclusion criterion:

* English-speaking adults who are currently seeking treatment for methamphetamine addiction

Primary outcomes:
measure: Feasibility of the intervention in methamphetamine users
timeFrame: 22 days
Secondary outcomes:
measure: Acceptability of the intervention in methamphetamine users
timeFrame: 22 days
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: New Leaf Treatment Center
state: California
Study officials:
affiliation: New Leaf Treatment Center
name: S. Alex Stalcup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496597: Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.
Official title: Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Patients
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes Type 1 patients followed in the Endocrinology Department of the CHU Dijon Bourgogne or in a diabetology surgery, and non-diabetic controls will be recruited in the Ophthalmology Department of the CHU Dijon Bourgogne

Brief summary: The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.


Eligibility criteria: Inclusion Criteria:

For the patient group

* Patient who has given consent

  * Type 1 diabetic patient, no retinopathy For the healthy control group
* Patient who has given consent
* Non-diabetic patient

For dyslipidemic control group:

* Person who has given consent
* Person with familial dyslipidemia

Exclusion Criteria:

For the patient group

* Presence of diabetic retinopathy
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a health insurance scheme

For the healthy control group

* Ophthalmological history (vascular and degenerative macular conditions)
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a social security scheme

For dyslipidemic control group:

* Ophthalmological history (vascular and degenerative macular conditions)
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a social security scheme

Primary outcomes:
measure: surface of the central retinal avascular zone
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06626997: Effect of a Symbiotic Drink on the Microbiota
Official title: Nutritional Intervention Study to Evaluate the Effect of a Symbiotic Drink on the Microbiota and Different Nutritional Markers in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Kombucha
Microbiota
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, randomized 6-week nutritional intervention study.
Primary purpose: PREVENTION

Brief summary: This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group (which will consume the fermented drink) and a control group, which will consume a drink with similar characteristics, but without the presence of bioactive components.

Detailed description: At the beginning of the trial, you will have an interview (screening visit) with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it. If it is confirmed that you meet the criteria to participate in the study, after your assent and informed consent have been obtained, you will be able to do so. At the first visit, you will be assigned a code by a random method (computerized) and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control.

Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Caucasian ethnicity
* Adequate level of culture and understanding of the clinical study.
* Agree to voluntarily participate in the study and give written informed consent.

Exclusion Criteria:

* Subjects with dementia, mental illness or decreased cognitive function that prevents the study from being carried out.
* Subjects with serious diseases (liver, kidney, immunosuppressed, etc.).
* BMI ≥ 30 kg/m2, pregnant or breastfeeding women.
* Presence of immunological pathologies, gallstones, gastric ulcer or coagulation problems.
* Presence of any other specific pathology that contraindicates the intake of dietary supplements, specifically inulin and probiotics (diverticulitis, etc.).
* Subjects who are undergoing antibiotic treatment or consuming probiotic supplements.
* Subjects who are undergoing pharmacological treatment for weight loss.
* Subjects who refuse to follow the guidelines for healthy eating or the consumption of the study drink in the indicated guidelines.
* Any other exclusion criteria that the principal investigator of the study considers relevant.
* Non-Caucasian ethnicity

Primary outcomes:
measure: Relative abundance of the gut microbial species
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Imdea Food
Study officials:
References:
Clinical trial NCT01116297: Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
Official title: Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast reconstruction
breast cancer
near infrared imaging
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 4
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.

Detailed description: This pilot study will enroll three patients who have chosen to proceed with deep inferior epigastric perforator (DIEP) flap breast reconstruction. This type of reconstruction uses skin and fat from the abdomen to reconstruct a new breast shape. The construct is vascularized through perforating arteries and veins that provide a blood supply to this tissue.

Current techniques to evaluate vessel selection rely on a handheld Doppler used for confirmation of blood flow and perfusion; however, this modality is limited as it only assesses a specific point within the flap.

The S-FLARE imaging system will be used to visualize vascularization in the DIEP flaps, and this study will compare measurements by the S-FLARE imaging system and the standard-of-care ViOptix point probe.

Eligibility criteria: Inclusion Criteria:

* Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
* Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.

Exclusion Criteria:

* BMI \> 30.

Primary outcomes:
measure: Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery
timeFrame: 10 minute imaging procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: John V. Frangioni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613297: HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
Official title: HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: HLA-G
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.

Detailed description: Single-center, prospective, open-ended, interventional study with minimal risks and constraints. Patients will be divided into 3 groups: patients not infected with COVID-19, patients infected with COVID-19 not hospitalized, patients infected with COVID-19 hospitalized.

Eligibility criteria: Inclusion Criteria:

* Patient with possible or confirmed infection by COVID-19

Exclusion Criteria:

* Patient without liberty or guardianship

Primary outcomes:
measure: Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients.
timeFrame: 1 month
measure: Comparison of the expression of circulating soluble HLA-G, between the groups of patients.
timeFrame: 1 day
Secondary outcomes:
measure: 1 month survival
timeFrame: 1 month
measure: Assessment of the severity of the disease according to the isoform of HLA-G
timeFrame: 1 month
measure: Comparison of the expression of one of the cell receptors of the SARS-CoV-2 virus, called BSG (Basigin), whose expression is modified by the interaction between HLA-G.
timeFrame: 1 day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch hospital
Study officials:
affiliation: Hopital Foch
name: Olivier BRUGIERE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04546997: Study of Retinal Vascular Changes After Ocular Blunt Trauma
Official title: Retinal Vascular Features in Ocular Blunt Trauma by Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Injury
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 40 years with diagnosis of previous ocular blunt trauma. They did not present other ophthalmological diseases.

Brief summary: This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.

Detailed description: To investigate, using optical coherence tomography angiography, early retinal vascular features 48 hours after ocular trauma and to detect their changes during 6 months' follow up.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Eligibility criteria: Inclusion Criteria:

* age older than 40 years
* diagnosis of previous ocular blunt trauma
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria:

* age younger than 40 years
* absence of previous ocular blunt trauma
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.

Primary outcomes:
measure: The measurements of retinal vessel density in patients after ocular blunt trauma during 6 months's follow up
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781597: Efficacy of Tranexamic Acid in Hemoptysis
Official title: Efficacy of Tranexamic Acid in Controlling Hemoptysis, A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemoptysis
Keywords: Hemoptysis
Tranexamic acid
VAS score
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-05-24
Enrollment: 66
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 purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding in patients of hemoptysis and also to evaluate the safety of tranexamic acid.

Detailed description: Hemoptysis is a common problem in India due to high incidence of tuberculosis and also due to post tubercular sequale. Hemoptysis is usually managed conservatively in mild to moderate cases and cases of massive hemoptysis are managed with more definitive treatment options like vessel embolization (bronchial/pulmonary artery) and surgery as a last option. Tranexamic acid is a antifibrinolytic used in many surgeries and trauma patients to control bleeding and it has been shown effective and safe. The purpose of the study is to evaluate the efficacy of tranexamic acid in patients with hemoptysis in controlling bleeding.

Eligibility criteria: Inclusion Criteria:

1. Acute ongoing hemoptysis
2. Age: 18 years and above

Exclusion Criteria:

1. Pregnant females
2. Females on oral contraceptives
3. Patients on antifibrinolytics
4. Patients with known drug allergy
5. Patients with renal failure
6. Patients requiring intubation during study period
7. Patients with Massive hemoptysis (\>600 ml/24 hrs)

Primary outcomes:
measure: Change in severity of hemoptysis
timeFrame: day1 and day2
Secondary outcomes:
measure: Intervention needed
timeFrame: 2 days
measure: Blood transfusion needed
timeFrame: 2 days
measure: Hospital stay
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post graduate institute of medical education and research
state: UT
Study officials:
References:
Clinical trial NCT04485897: Self-monitoring of the Intraocular Pressure Versus Hospital-based Diurnal Monitoring
Official title: Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraocular Pressure
Keywords: Glaucoma
self-monitoring
intraocular pressure
icare HOME
rebound tonometry
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.

Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.

Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.

The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Subjects aged 18 and older
* Glaucoma patients and healthy controls
* Best corrected visual acuity \>0.1
* Astigmatism ≤ 3dpt.
* Good compliance
* Central corneal thickness (400-650μm)
* Passed certification procedure (detailed description under: Measurements and procedures)
* Therapeutic regimen unchanged throughout the past 30 days

Exclusion Criteria:

* History of ocular trauma
* Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity \<0.1
* Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
* Dry eye disease
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
timeFrame: 4 years
Secondary outcomes:
measure: variance of diurnal intraocular pressure
timeFrame: 4 years
measure: Influence of daily activities
timeFrame: 4 years
measure: Change of treatment
timeFrame: 4 years
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Cantonal Hospital of Lucerne
Study officials:
References:
Clinical trial NCT04380597: Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
Official title: Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nail Psoriasis
Lead sponsor: Complejo Hospitalario Universitario de Pontevedra
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed of nail psoriasis for whom are prescribed, according to clinical practice, a topical treatment. Will be included the first 60 patients that consecutively attend the participating centers and meet all the eligibility criteria.

Brief summary: Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the Nail Psoriasis Severity Index (NAPSI) at 12 weeks of treatment with respect to the initial score.


Eligibility criteria: Inclusion Criteria:

* Patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam
* Patients who authorize their participation in the study by signing written informed consent.

Exclusion Criteria:

* Patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. However, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later.
* Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.

Primary outcomes:
measure: Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline
measure: Nail Psoriasis Severity Index (NAPSI)
timeFrame: Week 12 of treatment
measure: Nail Psoriasis Severity Index (NAPSI)
timeFrame: Week 24 of treatment
Secondary outcomes:
measure: Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)
timeFrame: Baseline, Week 12 of treatment and Week 24 of treatment
Other outcomes:
measure: Hands Photographs
timeFrame: Baseline, Week 12 of treatment and Week 24 of treatment
Locations:
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra
Study officials:
References: