louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02096484: A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy
Official title: Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Metacognitive therapy
mindfulness meditation therapy
group therapy
generalized anxiety disorder
Group Based Metacognitive Therapy
Group Based Mindfulness Meditation Therapy
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.


Eligibility criteria: Inclusion Criteria:

* individual's score on the GAD-7 \& PHQ-9
* individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder

Exclusion Criteria:

* Individuals with major depressive disorder
* Individuals who report suicidality
* Individuals with a brain injury or neurological insult
* Individual who currently engage in substance abuse
* Individuals with bipolar disorder
* Individuals with psychotic symptoms
* Individuals who cannot converse or read English

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
Secondary outcomes:
measure: CAS-I
timeFrame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
measure: GAD-7
timeFrame: Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of anxiety.
measure: PHQ-9
timeFrame: Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of depression.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Rawnsley Building, Manchester Royal Infirmary, Oxford Road
state: Lancashire
Study officials:
affiliation: University of Manchester
name: Lora Capobianco
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: James Thompson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864884: A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
Official title: A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Post Operative Pain
Third Molar Extraction Surgery
Keywords: wisdom teeth surgery
Lead sponsor: Arcato Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are:

1. How much of the investigational product is absorbed in the blood?
2. Are there side effects?


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* In generally good health
* BMI 18 to 38kg/m²
* Scheduled to undergo wisdom teeth extraction

Exclusion Criteria:

* Serious medical condition
* Clinically significant abnormal lab values
* Blood donation in the last 60 days, or plasma donation in the last 7 days.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: CenExel JBR
state: Utah
Study officials:
References:
Clinical trial NCT03228784: The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
Official title: The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incidence and Severity of Dry Eye After Myopic LASIK
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients


Eligibility criteria: Inclusion Criteria:

* Patients with age ≥ 21 years
* Normal Pentacam maps
* Myopia with spherical equation less than 12 D
* Corneal thickness ≥ 500 Microns
* Calculated residual stromal bed ≥ 280 microns
* No signs or symptoms of dry eye.

Exclusion Criteria :

* Keratoconus and forme fruste keratoconus
* Auto-immune diseases
* History of dry eye or previous use of tear substitutes
* Previous ocular surgery
* Pregnant or lactating women.

Primary outcomes:
measure: Incidence of dry eye
timeFrame: 6 months
measure: Degree of dryness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06743984: Evaluate the Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors Using Universal , Layering & One Shade Composite In-vivo on Patients
Official title: Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class IV Dental Caries
Keywords: Universal resin composite
Monoshade resin composite
Polychromatic composite
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class IV carious lesions

Detailed description: Shade matching cabability of different resin composite materials and different techniques for restoration application, layering versus conventional incremental

Eligibility criteria: Inclusion Criteria:

1- Fractured class IV upper central incisors.

Exclusion Criteria:

1- cracked teeth

Primary outcomes:
measure: shade matching evaluation
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University in Cairo
Study officials:
affiliation: BADR UNIVERSITY IN CAIRO
name: AHMED A ABDELAZIZ, ASS. PROFESSOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT03607084: School-based Health Programs on Children's Wellbeing in Lusaka, Zambia
Official title: Evaluating the Impact of School-based Health Programs on Children's Well-being and Academic Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Disease
Morbidity
Keywords: school-aged children
school-based health program
Zambia
child and adolescent health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Healthy Kids/Brighter Future
First posted: 2018-07-31
Enrollment: 614
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia.

Detailed description: While school-aged children in low- and middle-income countries remain highly exposed to acute infections, programs targeting this age group remain limited in scale and scope. In this study, we evaluate the impact of a new and comprehensive primary school-based health intervention program on student health outcomes and academic performance in Lusaka, Zambia. The intervention involved the training of teachers to become school health workers and the provision of vitamin A supplementation and deworming medication on a bi-annual basis. Teachers in intervention schools were trained to deliver health lessons and to refer sick students to care. This study is designed as a prospective matched control study. Students from the seven intervention schools are matched with students from control schools.

Eligibility criteria: Inclusion Criteria:

* Children attending one of the 14 schools in the study.

Exclusion Criteria:

* Children not attending one of the 14 schools in the study.

Primary outcomes:
measure: Change in prevalence of acute disease
timeFrame: Baseline, 6 months, and one-year follow-up
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 6 months, and one-year follow-up
measure: Change in height
timeFrame: Baseline, 6 months, and one-year follow-up
measure: Change in health knowledge
timeFrame: Baseline, 6 months, and one-year follow-up
measure: Change in school attendance
timeFrame: Baseline, 6 months, and one-year follow-up
measure: Change in academic performance
timeFrame: Baseline, 6 months, and one-year follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: Wei D, Brigell R, Khadka A, Perales N, Fink G. Comprehensive school-based health programs to improve child and adolescent health: Evidence from Zambia. PLoS One. 2019 May 31;14(5):e0217893. doi: 10.1371/journal.pone.0217893. eCollection 2019.
Clinical trial NCT00464984: Lifestyle Intervention in Morbidly Obese Patients
Official title: Lifestyle Intervention in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Weight loss
Physical fitness
Quality of life
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2007-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

Detailed description: Due to limited recruitment from GP, the study design has been changed into an observational long term study following the participants in the intensive lifestyle intervention group

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patients not planned for bariatric surgery

Exclusion Criteria:

* Participation in other weight loss programs during the last 12 mths
* Serious psychiatric conditions

Primary outcomes:
measure: Weight loss, physical fitness and quality of life
timeFrame: 1 and 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stavern
country: Norway
facility: Spesialsykehuset for Rehabilitering i Stavern
state: Vestfold
Study officials:
affiliation: Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY
name: Jøran Hjelmesæth, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04402684: Influenza Vaccination in Patients Living With HIV in the Northern Region
Official title: Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 124
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: Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020

Brief summary: Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza is a viral infection that has a significant impact on the health care system. However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country. Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.

Detailed description: Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for a scheduled consultation as part of their HIV follow-up in the spring of 2020. Non-opposition letter given to the patient. Collection of data a posteriori from the medical file recorded in the eNadis patient file.

Eligibility criteria: Inclusion Criteria:

* Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020
* People who do not read French may participate if they wish with the help of a medical or paramedical staff member.
* Patient did not object

Exclusion Criteria:

* Minor patients
* Major under guardianship, curatorship, protected person

Primary outcomes:
measure: questionnaire influenza vaccine coverage
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: modalities of influenza vaccination
timeFrame: through study completion, an average of 1 year
measure: the drivers and disincentives to influenza vaccination
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: CH TOURCOING
name: Macha TETART, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515684: Corneal Thinning During Topical Bevacizumab Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Corneal Neovascularization
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether topical bevacizumab is safe or not when used in corneal neovascularization for long term period.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of corneal neovascularization
* must be able to apply eyedrop

Exclusion Criteria:

* have active keratitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Severance hospital, Seoul , Korea
name: Sang Woo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543684: Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
Official title: Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: glycemic response
diabetes
insulinemic response
mixed meals
glycemic index
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).

Detailed description: The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements.

The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.

Eligibility criteria: Inclusion Criteria:

* Subjects are eligible if they are 45-75 years of age
* non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
* Body Mass Index (BMI) value higher than 20 kg/m2
* HbA1c levels of 6.5 to 11%

Exclusion Criteria:

* insulin-dependent T2DM
* cardiovascular (i.e. coronary heart disease, stroke etc.)
* liver and/or renal disease

Primary outcomes:
measure: serum glucose changes over time
timeFrame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
measure: serum insulin changes over time
timeFrame: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial
Secondary outcomes:
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University of Athens
state: Attica
Study officials:
affiliation: Harokopio University, Athens
name: Yannis Manios, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05935384: SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Official title: SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Colorectal Cancer
Breast Cancer
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 440
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: The primary study population will include participants with Non-small cell lung cancer (stage III-IV), Colorectal adenocarcinoma (stage III-IV), and Breast Cancer (stage III-IV), as per inclusion/exclusion criteria. Approximately 440 total patients will be enrolled into the study.

Brief summary: The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.


Eligibility criteria: * Will be treated with a first- or second-line systemic and/or oral standard of care regimen at the enrolling site
* Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed a prior line of SOC therapy and will commence subsequent line of SOC therapy
* Provide written informed consent to participate in the study
* Diagnosed with an unresectable advanced solid malignancy and have a histologically confirmed cancer that qualifies for inclusion, defined as:

  * Non-small cell lung cancer (stage III-IV)
  * Colorectal adenocarcinoma (stage III-IV)
  * Breast Cancer (stage III-IV)

Exclusion Criteria:

* History of a prior solid or hematological malignancy within 5 years of enrollment
* Life expectancy \< 12 weeks
* Unable to collect baseline blood sample prior to starting SOC regimen
* Is participating in an interventional clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

Primary outcomes:
measure: Sensitivity of ctDNA to Detect Disease Progression
timeFrame: 6 years
Secondary outcomes:
measure: RECIST Response
timeFrame: 6 years
measure: Progression-Free Survival (PFS)
timeFrame: 6 years
measure: Lead Time
timeFrame: 6 years
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
Study officials:
References: