louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02969720: Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
Official title: Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome x
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 220
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 objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Informed consent written
* Available subjects to follow-up visits
* Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria
* Subjects with health visits ongoing
* Subjects with arterial hypertension under control.
* Subjects with mellitus diabetes under control.

Exclusion Criteria:

* Subjects with alcoholism history.
* Subjects with history of sitosterolemia.
* Subjects with familiar hypercholesterolemia
* Subjects who are consuming phytosterols
* Pregnancy women
* Breastfeeding period women
* Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation

Primary outcomes:
measure: Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de Los Andes
Study officials:
References:
citation: Palmeiro-Silva YK, Aravena RI, Ossio L, Parro Fluxa J. Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2020 Aug 10;12(8):2392. doi: 10.3390/nu12082392.
Clinical trial NCT02386020: Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus
Official title: Clinical Efficacy of Locally Delivered Aloe Vera Gel as an Adjunct to Non-surgical Periodontal Therapy in Chronic Periodontitis Subjects With Type 2 Diabetes Mellitus: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

Detailed description: BACKGROUND: Advances in the field of alternative medicine have promoted widespread use of herbal agents, like Aloe vera (AV), for both medical and dental therapy. AV has anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune boosting properties. The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

MATERIAL AND METHODS: A total of 60 subjects with probing depth (PD) ≥5mm and clinical attachment level (CAL) ≥3mm were randomly divided into two groups. Group 1 was treated with SRP + placebo gel local drug delivery (LDD) and Group 2 with SRP + AV gel LDD. Clinical parameters including full mouth plaque index (PI), modiﬁed sulcus bleeding index (mSBI), probing depth (PD) and clinical attachment level (CAL) were recorded first at baseline and then at intervals of 3 months and 6 months.

Eligibility criteria: Inclusion Criteria:

* Well-controlled type 2 DM
* Chronic periodontitis with moderate to deep pockets \[probing depth (PD) ≥5mm and clinical attachment loss (CAL) ≥3mm\]
* No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

* Any known disease/condition or on any medication that can affect the periodontal status
* Known or suspected allergy to herbal medications
* Systemic antimicrobial therapy
* Aggressive periodontitis
* Smokers
* Alcoholics
* Immunocompromised patients
* Pregnant or lactating females

Primary outcomes:
measure: Change in Clinical attachment level
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in Plaque index
timeFrame: baseline to 6 months
measure: Change in modified sulcus bleeding index
timeFrame: baseline to 6 months
measure: Change in Probing depth
timeFrame: baseline to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01957020: Stereotactic Directional Vacuum-Assisted Breast Biopsy
Official title: The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Stereotactic Directional Vacuum-assisted Breast Biopsy
Female
Adult Patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 130
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asymptomatic women with mammographic screening, and with suspicious findings on mammography.

Brief summary: Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years \[1-3\], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)\[4,5\]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy \[6,7\]. However, its sensitivity, accuracy has seldom been reported in Asian countries \[8\] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.


Eligibility criteria: Inclusion Criteria:

* The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy

Exclusion Criteria:

-

Primary outcomes:
measure: The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis
timeFrame: up to 5 years ( July 2008 to June 2013)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05016674: Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat
Official title: Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laser Assisted Liposuction
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure


Eligibility criteria: Inclusion Criteria:

1. Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
2. Between 18 and 70 years of age.
3. Estimated fat harvesting of at least 300 milliliters.
4. Provided written Informed Consent.

Exclusion Criteria:

1. Pregnant or intending to become pregnant during the course of study.
2. Current smoker.
3. Presence of known malignancy.
4. Active infection in the treatment area.
5. History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\]).
6. History of connective, metabolic, or atrophic skin disease.
7. History of keloid scarring.
8. Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
9. Subjects with immune system diseases.
10. Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.

Primary outcomes:
measure: Average adipose cell cluster size
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: William Jason Martin, MD
state: Colorado
Study officials:
affiliation: Jason Martin, M.D.
name: William Jason Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507920: The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain
Official title: The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of the Basque Country (UPV/EHU)
First posted: 2018-04-25
Enrollment: 40
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: This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.


Eligibility criteria: Inclusion Criteria:

* Primary complaint of neck pain
* Non-traumatic history of onset
* Pain has a clear mechanical aggravating and easing positions or movements
* Limited range of motion
* Local provocation tests produce recognisable symptoms
* A positive expectation that mobilisations will help

Exclusion Criteria:

* No neurological deficit
* No signs of central hyperexcitability
* Referral to other health professional to exclude red flags not required

Primary outcomes:
measure: Global rating of change scale
timeFrame: Immediately after the intervention
measure: Change in pain reported by the participant during neck movements
timeFrame: Baseline and immediately after the intervention
measure: Change in Sympathetic nervous system activity using skin conductance
timeFrame: Baseline, during the intervention and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: University of the Basque Country, Faculty of Medicine and Infirmary
state: Bizkaia
Study officials:
References:
Clinical trial NCT02727374: Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls
Official title: Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatric Disorder
Keywords: Fear to Fall
Geriatric
Rehabilitation
Psychology
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fear to fall has been proven to be a risk factor affecting those geriatric patients who have previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy and psychological combined intervention, aimed at reducing the fear to fall in the aforementioned patients

Detailed description: One of the main consequences of falling is the fear to fall again. This involves changes in the elderly behaviour which leads to a reduction of the physical activity, higher need of cares, reduction of the quality of life and risk of social isolation. In this framework, this works is aimed at performing a treatment to reduce the fear to fall in those geriatrics patients with previous falls, based on the combination of physical activity, health education and cognitive-behavioural psychological treatment targeted to this effect. The reason is that literature points at combined treatment use to present higher effectiveness

Eligibility criteria: Inclusion Criteria:

* Community-dwelling older people
* Looking for Physiotherapy attendance
* Patients who have suffered at least one fall episode
* Patients with fear of falling

Exclusion Criteria:

* Some cognitive affection that may affect the intervention

Primary outcomes:
measure: Fear Related Psychological Concerns (Falls)
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Fear Related Psychological Concerns (Balance)
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Fear Related Psychological Concerns (Fear)
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
Secondary outcomes:
measure: Risk of Falling
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Center Epidemiological Studies Depression Scale
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Ryff Scale
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Celedonia Igual, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Jose M Blasco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03191474: Linkage of Transgender Individuals to PrEP
Official title: CCTG 602: Linkage of Transgender Individuals to PrEP, A Multicenter Trial of the California Collaborative Treatment Group (CCTG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Seronegativity
Linkage
Keywords: PrEP
Pre-exposure Prophylaxis
Truvada
Client-centered case management
Transgender
Gender non-conforming
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Los Angeles LGBT Center
First posted: 2017-06-19
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).

Detailed description: Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.

Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.

Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Self-identifies as a transgender or gender non-conforming person
* Self-identifies as HIV-negative or unknown status
* Ability to provide informed consent
* English or Spanish speaking

Exclusion Criteria:

* Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent

Primary outcomes:
measure: Facilitated Linkage
timeFrame: Baseline up to Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
state: California
city: San Diego
country: United States
facility: UC San Diego AntiViral Research Center (AVRC)
state: California
Study officials:
affiliation: CCTG, UCSD AVRC
name: Sheldon Morris, MD MPH
role: STUDY_CHAIR
References:
Clinical trial NCT06930274: Stillbirth Risk Identification Using Multiparametric Ultrasound
Official title: Stillbirth Risk Identification Using Multiparametric Ultrasound
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perinatal Hypoxia
Keywords: Quantitative Ultrasound
Placenta
Stillbirth
Fetal Hypoxia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2025-04-16
Enrollment: 282
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants are recruited from the following sources:

1. South Community Birth Program
2. Maternal Fetal Medicine Clinics at BC Women's Hospital (EMMA and Fetal Monitoring)

Brief summary: The goal of this observational study is to identify a novel biomarker for stillbirth.

Specifically the aim is to predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 and 37 weeks gestation.

Detailed description: Funding: Wellcome Leap, In Utero Program

Primary outcome: Perinatal hypoxia

Background: Perinatal hypoxia is an inadequate supply to or utilization of oxygen by the fetus. It is typically diagnosed at delivery and can lead to serious medical complications, including encephalopathy, and ultimately stillbirth. Fetal hypoxia represents 23% of neonatal deaths worldwide.

Aim: To predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 weeks gestation and delivery.

Methods: Raw radio frequency data is collected during ultrasounds between 35 and 37 weeks gestation using ClariusTM (handheld ultrasound). All scans take place at BC Women's Hospital. QUS-P parameters are derived from the raw radio frequency data and analyzed using linear regression.

Impact: The ability to identify perinatal hypoxia as early as 35 weeks gestation will allow for additional monitoring as well as efforts to prepare for immediate intervention if necessary (e.g. c-section, resuscitation, neonatal cooling), prevent progression to encephalopathy, and ultimately stillbirth.

Eligibility criteria: Inclusion Criteria:

1. Pregnant with singleton
2. Age 19 years or older
3. Provision of informed consent
4. Planning to deliver at BC Women's Hospital
5. 38 weeks gestation or less

Exclusion Criteria:

1. Pregnant with multiples
2. Not planning to deliver at BC Women's Hospital
3. Less than 19 years of age
4. Greater than 38 weeks gestation

Primary outcomes:
measure: Presence of Perinatal Hypoxia at 35-37 weeks gestation
timeFrame: 35-37 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: South Community Birth Program
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Robert Rohling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06103474: Clinical Reporting to Alleviate the Nocebo Effect
Official title: Clinical Reporting to Alleviate the Nocebo Effect (CRANE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nocebo Effect
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Roentgen Ray Society
First posted: 2023-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Survey, cross-sectional study of sixty (n=60) participants undergoing MRI for lower back pain will be randomized to receive an anatomic report (standard of care) versus a Clinical Report (CR). Ordering physicians receiving the Clinical Reports will be instructed to avoid terms that may result in cyberchondria or fear (e.g. disc bulge or nerve impingement) when discussing MRI results.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain.


Eligibility criteria: Inclusion Criteria:

* History of lower back pain undergoing MRI
* Greater than 18 years of age
* Able to understand and willing to comply with all study procedures and is available for the duration of the study

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in the study:

  * Acute lower back pain secondary to trauma within 1 months
  * Severe cord compression on MRI
  * Cord signal abnormality on MRI
  * Metastatic cancer
  * Spinal epidural abscess
  * Vertebral osteomyelitis
  * Judgement of the ordering physician (e.g. focal neurologic deficit)
  * Anything that, in the opinion of the investigator or team, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Primary outcomes:
measure: Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
timeFrame: 6 weeks post intervention
measure: Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
timeFrame: within 7 days post intervention
Secondary outcomes:
measure: Improvement in pain interference measured via brief pain inventory
timeFrame: 6 weeks post intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References: