louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03774004: Plaque Burden Pre- Myocardial Revascularisation
Official title: Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 252
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.

Brief summary: The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).

Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.

Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.


Eligibility criteria: Inclusion Criteria:

* pre CABG

Exclusion Criteria:

* no consent, prior carotid intervention

Primary outcomes:
measure: Association of MACE rates with peripheral atherosclerotic volume
timeFrame: 5 years
measure: Association of morbidity with peripheral atherosclerotic volume
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
timeFrame: 1 year
measure: Association of the duration of the operation with peripheral atherosclerotic volume
timeFrame: 30 days
measure: Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
timeFrame: 5 years
measure: Association of the aortic clamp time with peripheral atherosclerotic volume
timeFrame: 30 days
measure: Association of the ICU stay with peripheral atherosclerotic volume
timeFrame: 30 days
measure: Association of the hospitalization duration with peripheral atherosclerotic volume
timeFrame: 30 days
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Peter Marschang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03887104: Data Collection of OCT and OCTA-based Ocular Measurements
Official title: Data Collection of OCT and OCTA-based Ocular Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eyes Without Ocular Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 482
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons having eyes without ocular pathology

Brief summary: Data Collection of OCT and OCTA-based Ocular Measurements

Detailed description: The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.

Eligibility criteria: Inclusion Criteria:

* No glaucoma
* No retinal pathology
* No systemic disorders impacting the eye
* No ocular surgery or medical treatment of ocular condition

Exclusion Criteria:

* High IOP
* Poor vision
* Clinical findings consistent with pathology
* Unable to complete the study

Primary outcomes:
measure: Retinal thickness
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Eye Care Center
state: California
city: Fort Lauderdale
country: United States
facility: Eye Care Institute
state: Florida
city: Newark
country: United States
facility: IOVS
state: New Jersey
city: Marysville
country: United States
facility: AMA Eye Physicians & Surgeons
state: Ohio
city: Tahlequah
country: United States
facility: College of Optometry
state: Oklahoma
Study officials:
References:
Clinical trial NCT00820404: Study Evaluating Single Doses of BLI-489 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.


Eligibility criteria: Inclusion Criteria:

1. Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.

Primary outcomes:
measure: Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.
timeFrame: 15 days
Secondary outcomes:
measure: Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
timeFrame: 4 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01527604: Effects of Avenanthramide-enriched Oats on Inflammation
Official title: Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2012-02-07
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese adults.


Eligibility criteria: Inclusion Criteria:

* Men \& postmenopausal women, age 50 years and over
* BMI 30-36 kg/m2
* waist:hip ratio \> 0.8 for women, \> 0.9 for men

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter \[OTC\])
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Strict vegetarians
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Primary outcomes:
measure: Change in biomarkers of inflammation compared with placebo
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Diane L. McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508804: Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion
Official title: Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Keywords: surgical abortion
cervical anesthesia
pain control
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.

Detailed description: This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.

Eligibility criteria: Inclusion Criteria:

* surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
* English or Spanish speaking;
* ability to give informed consent

Exclusion Criteria:

* pre-operative use of misoprostol;
* allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
* known uterine anomaly;
* prior cervical surgery

Primary outcomes:
measure: Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
timeFrame: Intraoperative; Immediately following cervical dilation
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470104: Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Official title: A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplant - Autologous or Allogeneic
Keywords: children
bone marrow transplant
autologous
allogeneic
breastmilk
hematopoietic stem cell transplantation (HSCT)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Prolacta Bioscience
First posted: 2015-06-12
Enrollment: 42
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.

Detailed description: The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.

Eligibility criteria: Inclusion Criteria:

* Children less than 5 years old receiving transplant (autologous or allogeneic)
* Parents must give informed consent

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: Percentage of lactobacillales
timeFrame: 21 days after transplant
Secondary outcomes:
measure: Pro-inflammatory cytokine level
timeFrame: weekly during study course; up to approximately one year
measure: Incidence of bacteremia
timeFrame: though day 14 post transplant
measure: Incidence of graft versus host disease (GVHD)
timeFrame: through study course; approximately one year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stella Davies, MB.BS, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302504: Nature-based Mindfulness Intervention Program for Family Carers
Official title: Nature-based Mindfulness Intervention Program for Family Caregivers with High Levels of Caring Related Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: caregiver
mindfulness-based program
nature
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 95
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: PREVENTION

Brief summary: The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.


Eligibility criteria: Inclusion Criteria:

* parents with children experiencing divorce or separation
* parents of children with special needs
* family caregivers who are the primary caregivers of an older adult with dementia

Exclusion Criteria:

* parents or caregivers who cannot understand Cantonese version of Chinese
* parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program

Primary outcomes:
measure: depression
timeFrame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measure: anxiety
timeFrame: Change from 1-month before intervention, pre-intervention, to 1 month follow-up, to 3-month after intervention
measure: stress
timeFrame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measure: family functioning
timeFrame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measure: family conflict
timeFrame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measure: well-being
timeFrame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT01864304: Fat Distribution and Glucose Metabolism in Williams Syndrome
Official title: Characterization of Fat Distribution and Glucose Metabolism in Individuals With and Without Williams Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Williams Syndrome
Keywords: Williams Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults with Williams Syndrome (WS), and "control" individuals without WS.

Brief summary: Williams Syndrome (WS) is a genetic syndrome with features that may include vascular stenoses, neuro-developmental changes, and a variety of endocrine and metabolic abnormalities, including impaired glucose metabolism and abnormal body composition. Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data suggest increased overall body fat in these individuals, as well as a relative increase in fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain incompletely characterized. The purpose of the current study is to carefully describe glucose metabolism and lipid parameters in people with WS.


Eligibility criteria: Inclusion Criteria

1. M or F age 14-70yo
2. Diagnosis of WS confirmed by FISH or chromosomal microarray (WS only)
3. Availability of a parent or guardian to participate in the consent process (all WS, and controls \<18yo)

Exclusion Criteria

1. History of weight loss surgery or liposuction
2. Use of weight-lowering drugs
3. Positive urine pregnancy test (females only)
4. Obesity or abnormal fat distribution due to a known secondary cause (except WS) such as Cushing syndrome, HIV-infection, etc.
5. Known diabetes will preclude administration of the OGTT but not participation in other aspects of the study.

Primary outcomes:
measure: 2-hour glucose
timeFrame: Baseline
Secondary outcomes:
measure: Percent body fat
timeFrame: Baseline
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Takara Stanley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051804: Evaluation of the Repeated Usage of Systane Ultra Eyedrop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry eye
Visual Performance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 57
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: Comparison of two contact lens solutions.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or more.
* Non contact lens wearer.
* Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

  * Score ≥13 for OSDI Questionnaire total score; AND
  * Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
* Best visual acuity of 6/9 or better in each eye.
* Willingness to adhere to the instructions set in the clinical protocol.
* Signature of the subject informed consent form.

Exclusion Criteria:

* Use of systemic medication which might produce dry eye side effects.
* Systemic disease which might produce dry eye side effects.
* Active ocular infection.
* Use of ocular medication.
* Significant ocular anomaly.
* Previous ocular surgery
* Previous use of Restasis
* Any medical condition that might be prejudicial to the study.
* The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
* The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
* The subject, based on their knowledge, must NOT have diabetes.

Primary outcomes:
measure: Improvement in objective vision
timeFrame: 4 weeks
Secondary outcomes:
measure: Measurement of tear film evaporation
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05594004: A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health
Official title: A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Dental Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 2929
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This meta-analysis includes healthy adult male and females.

Brief summary: The aim of this analysis was to compare gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes


Eligibility criteria: Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.

Primary outcomes:
measure: Number of Bleeding Sites
timeFrame: Up to 6 months (26 weeks)
measure: Dental Plaque Scores
timeFrame: Up to 6 months (26 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Multiple Study Locations
state: Ohio
Study officials:
References: