louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01955330: Long Term Follow-up Hybrid Revascularization
Official title: Long Term Follow-up of Robotic Hybrid Surgical Revascularization With CT Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: CABG, Hybrid, Robotic surgery
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2013-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii.

Brief summary: OBJECTIVES:

The objectives of the year study are two-fold:

1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft and stent of patients who have already had robotically-assisted Hybrid CABG surgery using CTA and MPS-MIBI.
2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG surgery

Detailed description: New techniques such as robotically-assisted Hybrid CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft and the stented graft in patients that have already undergone robotically assisted Hybrid CABG.

Eligibility criteria: Inclusion Criteria:

- Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii.

Exclusion Criteria:

- Patients not described above

Primary outcomes:
measure: Graft patency
timeFrame: 5-7 years post Hybrid surgery
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University & Victoria Hospitals
state: Ontario
Study officials:
References:
Clinical trial NCT01435330: Safety and Tolerability of BVS857 in Subjects With Insulin Resistance
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Parenterally Administered BVS857 in Healthy Subjects Without and With Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Keywords: Safety
BVS857
insulin resistance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects with insulin resistance
* Subjects with controlled hypertension and hyperlipidemia

Exclusion Criteria:

* Smokers
* History of drug or alcohol use
* Autonomic dysfunction
* Significant illness or cardiovascular disease
* Immunodeficiency disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Blood glucose
timeFrame: Continuously up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novartis Investigative Site
state: California
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03325530: Providing Healthy Food Access and Physical Activity Opportunities at Boy Scouts of America Summer Camp
Official title: A Collaborative Approach to Providing Healthy Food Access and Sustainable Physical Activity Opportunities at Boy Scouts of America Summer Camp
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Keywords: Adolescent
Nutrition
Physical Activity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Boy Scouts of America
First posted: 2017-10-30
Enrollment: 1158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Boy Scout staff, troop leader or parent of Boy Scout camper

Brief summary: To measure impact of improved healthy food access and physical activity opportunities at summer Boy Scout camp, a four-week intervention to address nutrition and physical activity with youth (n=911) and adults (n=247) was conducted at Bashore Scout Reservation in Jonestown, Pennsylvania between June and July of 2016. Intervention components included dining hall menu modifications, healthy messaging, introduction of nutritious snacks available for purchase, and a physical activity challenge.

Menu modifications resulted in improved satisfaction scores related to portion sizes (+28%) and variety (+14%), decreased plate waste, and consistent food costs. Introduction of nutritious snacks at Trading Post resulted in increased satisfaction (+13%) and increased sales per person (+20%). Physical activity increased (+22%) as a result of a step competition between troops. Small changes towards a healthier camp were widely accepted and successful, indicating potential for translation to other camps within the organization.


Eligibility criteria: Inclusion Criteria:

1. Age: ≥18 years
2. Sex: Male or female
3. Fluent in written and spoken English
4. Boy Scout staff, troop leader or parent of Boy Scout camper

Exclusion Criteria:

1. Not Fluent in written and spoken English
2. Non Boy Scout stafftroop leader or not a parent of a Boy Scout camper
3. Decisional impairment

Primary outcomes:
measure: Efficacy of intervention as assessed through focus groups and evaluation surveys
timeFrame: June 2016- August 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00010530: Basic Mechanisms of Meditation and Cardiovascular Disease in Older Blacks
Official title: Basic Mechanisms of Meditation and Cardiovascular Disease in Older Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: CVD
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of meditation on older African Americans with documented cardiovascular disease (CVD).

Detailed description: Cardiovascular disease (CVD) is the leading cause of death and disability in older African Americans, and accounts for 40% of the disproportionate risk for mortality observed in African Americans compared to white Americans. The majority of CVD patients experience acute cardiac events, many sudden and unexpected, despite conventional treatment of their disease and associated traditional risk factors. The pathophysiologic basis of these cardiac events is not fully established, but substantial evidence indicates that psychosocial stress and the sympathetic nervous system have adverse effects on both vasomotor function and long-term autonomic balance. Recent advances in the understanding of the pathophysiology of acute cardiac events-specifically, the roles that arterial vasomotor dysfunction and sympathetic nervous system imbalance play in the pathophysiology of such acute events-provide a platform for a new mechanistic investigation of the interplay of psychosocial and environmental stress and CVD. Preliminary evidence demonstrating elevated peripheral vasoconstriction due to stress-mediated sympathetic nervous system response in African Americans further suggests that these mechanisms are particularly relevant in this group.

Eligibility criteria: Inclusion Criteria:

* African-American (self-identified)
* Local residence
* Able to participate
* Coronary artery disease by MI, CABG, PTCA (\>3 months prior), or angiography
* Consent and referring MD approval

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science
state: California
city: Fairfield
country: United States
facility: Maharishi University of Management Center for Health and Aging Studies
state: Iowa
Study officials:
affiliation: Center for Health and Aging Studies
name: Robert H. Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02979730: Impact of Rapid Flu Testing in BMC ED
Official title: Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza-Like Illness
Influenza
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 233
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing


Eligibility criteria: Inclusion Criteria:

* Adult patients 21 years of age or older
* Presenting to the BMC main ED or Urgent Care area with influenza-like illness
* Physician ordered an influenza A/B diagnostic test

Exclusion Criteria:

* Previously enrolled in the study
* Any Influenza test result already available at the time approached by the ED RA
* Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
* Unable to give informed consent

Primary outcomes:
measure: Time to Disposition
timeFrame: By the End of the ED visit (an average time of 4 hours)
Secondary outcomes:
measure: Delivery of prescription or administration of antibiotics
timeFrame: by the end of ED visit (an average time of 4 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Elissa Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981330: Pilot Study of Stem Cell Treatment of Patients With Vocal Fold Scarring
Official title: Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Improved Healing of Scarred Vocal Folds
Improved Vocal Fold Status
Improved Vocal Fold Function
Keywords: vocal fold scarring
mesenchymal stem cells
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Laryngfonden
name: Karolinska Institutet
First posted: 2013-11-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma cells, aMSC (which were previously harvested from each patients´s bone marrow, purified, expanded and characterized according to standard procedure at the Center of Hematology and Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska Institute. The laryngeal status, vocal fold function, and voice function will be followed individually with an advanced battery of examinations performed before and up to 1 year postoperatively. Side effects and complications are noted and reported during surgery and following surgery at regular intervals during at least 1 year Since spring 2015 no new patients have been recruited and no treatments are given during 2016 or 2017. The monitoring authority was changed from Swedish National Board of Health to Swedish Medical Product Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission is granted from MPA to continue the study.


Eligibility criteria: Inclusion Criteria:

* severe hoarseness
* vocal fold scarring
* no active other treatment
* age above 18 years

Exclusion Criteria:

* active treatment of laryngeal disorder
* active inflammatory condition of the larynx
* diagnosed or suspicions of local malignancy

Primary outcomes:
measure: Improved healing of scarred vocal folds
timeFrame: 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: Hertegard S, Nagubothu SR, Malmstrom E, LeBlanc K. Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells-first phase I/II human clinical study. Stem Cell Res Ther. 2020 Mar 20;11(1):128. doi: 10.1186/s13287-020-01632-8.
Clinical trial NCT02022930: Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
Official title: A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Lead sponsor: Carbylan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 510
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.


Eligibility criteria: Inclusion Criteria:

* Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
* Symptoms in the index knee for at least 12 months.
* Fully ambulatory Subject (ability to perform a 15 meters walk test).
* Male and female Subjects 40 through 85 years of age.

Exclusion Criteria:

* BMI \>40 kg
* Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
* Intra articular steroid therapy in last 3 months
* Intra articular viscosupplementation in last 6 months

Primary outcomes:
measure: Change from baseline in the WOMAC A subscale score for the treatment knee.
timeFrame: 2 weeks and 26 weeks
Secondary outcomes:
measure: Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
timeFrame: 26 weeks
Other outcomes:
Locations:
city: St.Leonards
country: Australia
state: New South Wales
city: London
country: Canada
state: Ontario
city: Oshawa
country: Canada
city: Quebec City
country: Canada
city: Willemstad
country: Netherlands Antilles
state: Curacao
Study officials:
References:
Clinical trial NCT01916330: Development of Pharmacokinetics Model in Pregnancy Women and Fetus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Preterm Premature Rupture of Membrane (PPROM)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 96
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm labor, PPROM in pregnant women from tertiary university hospital

Brief summary: Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus


Eligibility criteria: Inclusion Criteria:

* 20 \<= age \< 50
* pregnant women who were administered intramuscular dexamethasone (ex) preterm labor)
* pregnant women who were administered PO clarithromycin (ex) PPROM/intrauterine infection or inflammation)

Exclusion Criteria:

* who deny the study entrance
* who administered study drug before transfer to tertiary hospital

Primary outcomes:
measure: Analysis of drug concentration
timeFrame: Day 1 after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joong Shin Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01153230: Frequencies of Histo-pathological Findings in Patients With Paraquat Toxicity
Official title: Study of Frequencies of Histo-pathological Findings in Paraquat Poisoned Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraquat Toxicity
Keywords: PQ
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: forty two poisoned patients

Brief summary: The purpose of this study is to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

Detailed description: Acute poisoning of paraquat which is taken either to commit suicide or by mistake has become a social problem in world. The present study was conducted to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

Eligibility criteria: Inclusion Criteria:

* every patients who dithionate test were positive

Exclusion Criteria:

* nothing

Primary outcomes:
measure: histo-pathological findings
timeFrame: 1 day after patient died
Secondary outcomes:
measure: age
timeFrame: 5 min after admission time
measure: gender
timeFrame: 5 min after admission time
measure: dosage of poisoning
timeFrame: 5 min after admission time
Other outcomes:
Locations:
city: Isfahan,
country: Iran, Islamic Republic of
facility: Noor university hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04197830: Evaluation of Acute Post-thrombectomy Complications for Stroke
Official title: Evaluation of Acute Post-thrombectomy Complications for Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Complication
Stroke, Acute
Stroke Hemorrhagic
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 361
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: Retrospective cohort based on a computer medical record.

Brief summary: Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.

Detailed description: Research in the computerized medical file of patients admitted to intensive care unit (ICU) in the last 5 years for a stroke.

Searching for acute complications during the ICU stay. Looking for hemorrhagic, acute renal failure, hemodynamic support, neurologic degradation.

Eligibility criteria: Inclusion Criteria:

* \>18 year old
* ICU admitted patient for stroke and received thrombectomy

Exclusion Criteria:

* missing data

Primary outcomes:
measure: Survival
timeFrame: day 0 to day 5
measure: hemorrhagic complication
timeFrame: day 1
measure: Neurological evaluation
timeFrame: day 0 to day 5
measure: Evolution of renal function
timeFrame: day 0 to day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: MontLegia Hospital
Study officials:
affiliation: MontLegia Hospital, Groupe Santé CHC, Liège, Belgium
name: Pierre Goffin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: