louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03873935: Vitamin D in Periodontal and Cardiovascular Disease Progression
Official title: Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 179
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will finally enrolled.

Brief summary: Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Detailed description: Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.

Eligibility criteria: Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical Attachment level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956535: Air Optix® Night and Day® Aqua Therapeutic Wear
Official title: Air Optix® Night and Day® Aqua Therapeutic Wear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Keratopathy
Corneal Erosion
Entropion
Corneal Edema
Corneal Dystrophy
Keywords: Bandage lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll charts following a pre-identified process.

Brief summary: The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

Detailed description: In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
* Baseline and Follow-up (up to 1 year from Baseline) charts available.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
* Used systemic or ocular medication that would confound study results during the data collection period.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in corneal pain at the Follow-up Visit - Primary exposure
timeFrame: Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Delray Physician Care Center
state: Florida
city: Saint Louis
country: United States
facility: Koetting Associates
state: Missouri
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05180435: Dietary Approaches for Cardiovascular Health Study
Official title: Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-01-06
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to examine the efficacy of family meal frequency as an intervention target in addressing the primary prevention of CVD.


Eligibility criteria: Inclusion Criteria:

* Parents who have a male or female child aged 6-12 years-old with a BMI-for-sex and age \<95th percentile
* Parent age is ≥18 years-old
* Parent reports at least 2 of the following CVD risk factors: smoking, high cholesterol, high blood pressure, physical inactivity, overweight/obesity, diabetes
* Parent is able to read, speak and understand English

Exclusion Criteria:

* Parents who live with their child \<5 days per week
* Parents who do not have access to the internet and/or are unable to attend intervention sessions
* Parents who report a medical condition that impacts growth or requires a specific eating plan for themselves or their child.

Primary outcomes:
measure: Change from baseline in diet quality.
timeFrame: Baseline and Months 2, 6, 8 and 10
Secondary outcomes:
measure: Change from baseline in body mass index z-scores (zBMI)
timeFrame: Baseline and Months 2, 6, 8 and 10
measure: Change from baseline in blood pressure
timeFrame: Baseline and Month 6
measure: Change from baseline in fasting insulin
timeFrame: Baseline and Month 6
measure: Change from baseline in fasting glucose
timeFrame: Baseline and Month 6
measure: Change from baseline in lipid levels
timeFrame: Baseline and Month 6
measure: Change from baseline in pulse wave analysis.
timeFrame: Baseline and Month 6
measure: Change from baseline in carotid-to-femoral pulse wave velocity (PVW)
timeFrame: Baseline and Month 6
measure: Change in baseline in flow-mediated dilation (FMD)
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware, Energy Balance and Nutrition Laboratory
state: Delaware
Study officials:
References:
Clinical trial NCT03731286: A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults
Official title: A Double-Blind Randomized, Double-dummy, Placebo-controlled, Parallel-Group Study of the Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine Dependence
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.


Eligibility criteria: Inclusion Criteria:

1. History of regular caffeine consumption.
2. Body mass index (BMI) of ≥18.5 and \<25.00 kg/m2.
3. Fasting blood glucose \< 126 mg/dl
4. Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
5. Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit.

Exclusion Criteria:

1. Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit.
2. Known cases of type II Diabetes Mellitus.
3. Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication.
4. Participants suffering from primary or secondary insomnia with/ without active treatment.

Primary outcomes:
measure: Change in ECG from baseline to end of the treatment.
timeFrame: 84 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences Pvt. Ltd
state: Opp Infinity Mall
Study officials:
References:
Clinical trial NCT05535686: Methotrexate Adherence in Rheumatoid Arthritis Patients
Official title: Assessment of Adherence of Rheumatoid Arthritis Patients to Methotrexate and Its Effect on Quality of Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey participants were adults diagnosed as RA patients in accordance to 2010 ACR/EULAR classification criteria.

Brief summary: This study was conducted for assessment of adherence of Rheumatoid Arthritis patients to Methotrexate as a gold standard drug for treatment of R.A. Moreover, evaluating the effect of drug adherence to patient quality of life.

Detailed description: Rheumatoid arthritis one of most common autoimmune diseases. characterized by numerous complications which may affect patient quality of life. Hence, this review aim to search the relation between patient"s drug adherence and clinical health outcome. our review utilizing survey as a tool to collect needed data from rheumatoid patients. survey consisted of number of questions , participants were required to answer these questions. participation to this questionnaire was optional.

Eligibility criteria: Inclusion Criteria:

1. The study was carried out among all RA patients (adults patients ≥ 18 years).
2. Patients not suffering from severe mental disorders.
3. Patients with a disease duration from (1-5) years.
4. Patients on MTX treatment from (1-5) years.
5. Patients taking MTX alone or in combination with other DMARDs.

Exclusion Criteria:

1. Patient who on MTX for more than 5 years
2. Patient who have complications like:-

   * History of liver or kidney disease
   * Diabetic patients
   * Hypertensive patients
   * Bone marrow hypoplasia
   * Leukopenia or significant anemia
   * Peptic ulcer or any GIT problems
   * Hereditary alopecia.

Primary outcomes:
measure: Assessment of Rheumatoid Arthritis patient adherence to Methotrexate and its effect on quality of life
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa
Study officials:
References:
Clinical trial NCT02255786: "ACT" for Parents of Children With Autism Spectrum Disorder
Official title: Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Group Therapy
Parents
Autism
Quality of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Organization for Autism Research
First posted: 2014-10-03
Enrollment: 16
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 investigators will develop and pilot test an intervention called "ACT for Parents" which aims to decrease stress and improve quality of life in parents of children \< 15 years who have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be conducted to gather initial data on the treatment feasibility and acceptability, detect treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine the treatment design for a future clinical trial.

Detailed description: Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents with similar mental health presentations. Using a randomized controlled study design, investigators seek to gather initial data on the treatment feasibility and acceptability, detect treatment effects in a cohort of parents who have a child (under the age of 15) with autism spectrum disorder.

Eligibility criteria: Inclusion Criteria:

* A parent with a child (under the age of 15) with a diagnosis of Pervasive Developmental Disorder-NOS, Asperger's Disorder or Autistic Disorder
* Child with ASD diagnosed by a mental health or medical professional
* Must be comfortable speaking and reading and understanding English

Exclusion Criteria:

* Inability to attend sessions in person on the specified date/time/location of the intervention sessions
* unwillingness to be audio-taped should randomization into the experimental (ACT) group occur.

Primary outcomes:
measure: Change in Acceptance and Action Questionnaire-II Score
timeFrame: From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lurie Center | Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital - Lurie Center
name: Lisa A. Nowinski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital - Lurie Center
name: Kirstin Brown Birtwell, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03620786: HIFU for Focal Ablation of Prostate Tissue: An Observational Study
Official title: High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.

Brief summary: The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

Detailed description: This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.

Eligibility criteria: Inclusion Criteria:

1. Age 40 years to 85 years
2. Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
3. PSA ≤ 20
4. Prostate volume of ≤ 70 cc
5. Ability to complete informed consent form

Exclusion Criteria:

1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
2. Medical contraindication to follow-up mpMRI or prostate biopsy
3. Unable to tolerate general or regional anesthesia
4. Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)

Primary outcomes:
measure: Oncological Response
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Quality-of-Life Symptoms (EPIC-CP)
timeFrame: 6 months
measure: Evaluation of Quality-of-Life Symptoms (EPIC-CP)
timeFrame: 18 months
measure: Decisional Regret Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Leonard Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06212986: Enhancing Psychological Skills and Well-being in Sport Through a Blended Intervention: a Controlled Study With Perform-UP Tennis
Official title: Enhancing Psychological Skills and Well-being in Sport Through a Blended Intervention: a Controlled Study With Perform-UP Tennis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Well-Being
Keywords: mobile app
psychological well-being
sport
tennis players
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 41
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Mental preparation is a fundamental aspect of athletic performance. The investigators present here an experiment aimed at evaluating the effectiveness of a blended intervention to promote mindfulness and self-confidence and a reduction of anxiety among professional athletes. Perform-UP Tennis is an application that provides a weekly mental training program to be integrated into the athlete's daily routine. The intervention included eight weekly modules with variable and progressive training and relaxation exercises. Meetings with the athletes took place every 2 weeks. The study involved 41 tennis players who were randomly assigned to either the intervention or the control group.


Eligibility criteria: Inclusion Criteria:

* being tennis players with a minimum age of 14
* being fluent in Italian
* having a smartphone with an Internet connection

Exclusion Criteria:

* having hearing difficulties
* not playing tennis
* being younger than 14 years old
* not having a good knowledge of Italian

Primary outcomes:
measure: The Psychological Inventory of Sport Performance (IPPS-48) was used to assess athletes' mental abilities. The questionnaire included 48 items, divided into eight subscales each reflecting eight mental abilities.
timeFrame: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
measure: The Mindfulness Inventory for Sport (MIS) was used to evaluate the awareness processes within the athlete's sports performance. The scale consists of 15 items reflecting three distinct components of mindfulness.
timeFrame: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Sacred Heart
Study officials:
References:
Clinical trial NCT05607186: Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian Institute
Official title: Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Oncology
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital

Brief summary: This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.


Eligibility criteria: Inclusion Criteria:

* Rectal cancer
* At least 1 high risk feature on MRI
* Undergo long course neoadjuvant chemoradiotherapy (LCCRT)

Exclusion Criteria:

* metastatic disease
* Patients who undergo short course radiotherapy
* Patients without a repeat MRI after completion of LCCRT

Primary outcomes:
measure: Correlation between mrTRG and pTRG
timeFrame: Between 1 Jan 2011 to 31 Dec 2016
Secondary outcomes:
measure: Prognostic value of mrTRG on survival outcomes of rectal cancer patients
timeFrame: Between 1 Jan 2011 to 31 Dec 2016
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01890486: The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen
Official title: The Prospective Collection, Storage and Reporting of Data on Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Multiple Myeloma
Germ Cell Neoplasms
Myelodysplastic Syndromes
Chronic Lymphocytic Leukemia
Immunodeficiency Diseases
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are not on a specific "treatment research protocol" but who are nevertheless receiving "standard of care" dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Brief summary: To provide the IRB approved mechanism for the prospective collection, analysis and reporting of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed and for which peer reviewed, published data have demonstrated efficacy for this treatment approach.


Eligibility criteria: Inclusion Criteria:

Planned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Exclusion Criteria:

Participation in any other treatment research protocol

Primary outcomes:
measure: Data followup
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Dianna Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: