louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01335022: African American Community Health Project on Cardiovascular Disease
Official title: African American Community Health Project on Cardiovascular Disease (AACP-CVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).

Detailed description: Cardiovascular disease causes significant morbidity and mortality in the African American community. Among African Americans adults almost 1/3 have hypertension, 1/10 have heart disease, 1/20 have coronary heart disease, and 1/30 have had a stroke. Compared to their Caucasian American counterparts, African Americans are 3 times more times as likely to die from cardiovascular diseases than Caucasians, 1.5 times more likely to die from heart failure, and 1.8 times more likely to die from stroke. In addition, both lower socioeconomic position and minority race/ethnicity are associated with poorer health and shortened survival. These alarming statistics highlight the health disparities in the African American community. In our study, the investigators propose that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of CVD in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* African American adults \> 18 years old

Primary outcomes:
measure: Blood pressure
timeFrame: 2 months
measure: Weight
timeFrame: 2 months
measure: Body mass index
timeFrame: 2 months
measure: Waist Circumference
timeFrame: 2 months
measure: Multiple choice test on cardiovascular disease
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Heritage International Christian Church
state: Illinois
Study officials:
affiliation: Northwestern University
name: Donald M Lloyd-Jones, MD, ScM
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: William J Mosley II, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04080622: Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
Official title: A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mucositis Oral
Stem Cell Transplant Complications
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.


Eligibility criteria: Inclusion Criteria:

* Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
* Signed informed consent.

Exclusion Criteria:

* Autologous stem cell transplantation for another medical condition than lymphoma or myéloma.
* Intolerance to selenium.
* High selenium levels before study.
* Pregnancy or patients breast-feeding.

Primary outcomes:
measure: Incidence of severe oral mucositis (grade 3-4)
timeFrame: 31 months
Secondary outcomes:
measure: Incidence of any grade oral mucositis
timeFrame: 31 months
measure: Number of days with severe oral mucositis
timeFrame: 31 months
measure: Incidence of infectious complications
timeFrame: 31 months
measure: Number of days with artifical nutrition
timeFrame: 31 months
measure: Number of days with opioids
timeFrame: 31 months
measure: Duration of hospitalization
timeFrame: 31 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
state: Maine et Loire
Study officials:
References:
Clinical trial NCT01294722: A Study to Determine the Number of Participants With Rheumatoid Arthritis (RA) Who Meet the Requirements for Treatment With Anti-Tumor Necrosis Factor α (TNFα) in a General Hospital Setting in Korea
Official title: The Prevalence of Out-patients With Rheumatoid Arthritis Fulfilling the Indication for Anti-tumor Necrosis Factor(TNFa) Therapy in General Hospital Setting in Korea: a Multi-center, Non-interventional, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
anti-TNF α
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 1700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosis of RA visiting an internist as an outpatient

Brief summary: This is an observational study to estimate the proportion of patients diagnosed with RA visiting a medical internist in a general hospital in Korea who are candidates for anti-TNF α therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with RA
* Visiting a medical internist in a study site during the study period on out patient basis
* Able to give written informed consent voluntarily Exclusion Criteria: None

Primary outcomes:
measure: Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA
timeFrame: Baseline
measure: Number of anti-TNF α agent candidates based on the clinical judgement in total out- patients with RA
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00582322: Genetic Studies in Breast Cancer
Official title: Genetic Studies in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ovarian Cancer
Keywords: Breast Cancer
Ovarian Cancer
Family History
Genetic Studies
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 483
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer seen at MSKCC and healthy family members.

Brief summary: The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.

Detailed description: It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

Eligibility criteria: Inclusion Criteria:

* patient with breast cancer under age 41
* patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50
* patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60
* patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50
* relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample

Exclusion Criteria:

N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Teresa Gilewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419822: Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients
Official title: A Randomized, Intent to Treat, Controlled Study of the Efficacy of Verum Acupuncture Compared to Sham Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Subjects That Have Undergone Axillary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Acupuncture
Range of Motion
Quality of Life
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2007-01-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).


Eligibility criteria: Inclusion Criteria:

* Female subjects
* Expected survival at least 6 months or greater
* Has had surgery with axillary dissection
* Greater than 6 nodes removed during surgery
* Greater than 21 years of age

Exclusion Criteria:

* Previous mastectomy
* Double mastectomy at the time of current axillary surgery
* Any diagnoses of autoimmune disease
* Pregnant or lactating women
* Unable to provide written informed consent
* Suspected or diagnosed fibromyalgia
* Previous shoulder injuries for the specific arm that will undergo axillary dissection
* Known or suspected drug or alcohol abuse as determined by the investigator
* Decreased range of motion (ROM) as evidenced on standard preoperative exam
* Previous acupuncture (lifetime)

Primary outcomes:
measure: Determine the difference in pain and range of motion
timeFrame: 3 months after surgery
measure: Determine the difference in function
timeFrame: 3 months after surgery
measure: Determine the difference in quality of life
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital and Medical Center
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Nathalie Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00064922: Incentive Programs for Female Substance Abusers Who Smoke - 3
Official title: Incentive Programs for Female Substance Abusers Who Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tobacco Use Disorder
Keywords: nicotine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-07-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.

Detailed description: This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.

Eligibility criteria: Inclusion Criteria:

* Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol
* Nicotine Dependent as confirmed by DSM-IV checklist
* Current cigarette smoker
* Breath CO reading of at least 8 ppm at the time of the initial study screening
* Current client with the Shields for Families (Shields) treatment programs

Exclusion Criteria:

* Non-smoker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Shields for Families, Inc.
state: California
Study officials:
affiliation: Los Angeles Treatment Research Center
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438422: Effect of Pollen Extract on Urinary Incontinence
Official title: Evaluation of the Impact of 3 Pollen Extracts in the Control of Urinary Incontinence in Women. Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence


Eligibility criteria: Inclusion Criteria:

* Moderate, severe or very severe urinary incontinence, according to the severity index Incontinence Severity Index (ISI) \* of Sandvik
* Healthy patients from 18 to 75 years of age
* Normal cytology in the last year and normal urological culture at inclusión
* Negative result in urine culture and normal vaginal canal (no evidence of dysplasia and / or infection)
* External vaginal area (vestibule and introitus) free of wounds or bleeding

Exclusion Criteria:

* Surgery for urinary incontinence
* Acute or recurrent infections of the urinary tract or genital infections (herpes or candida) in the last 3 months
* Malignant neoplasm or history of neoplasia in the last 5 years
* Concomitant disease such as a cardiac disorder, uncontrolled type I or II diabetes, lupus porphyria, relevant neurological disorders, any disease that in the opinion of the doctor could interfere with the treatment or resolution of the disease
* Anticoagulant alteration or thromboembolic alteration or taking anticoagulant drugs one week before treatment or during treatment for possible drug interaction (to allow inclusion, temporary cessation of use at the discretion of the doctor)
* History of immunosuppression or immunodeficiency (including HIV infection or AIDS) or use of immunosuppressive medications
* Hormonal imbalance, related to the thyroid, hypophysis or androgen not controlled
* Having a significant alteration in the areas under treatment or inflammatory alterations including but not limited to lacerations, abrasions or ulcers prior to treatment (time of resolution at the discretion of the doctor) or during treatment
* Dysplastic nevus in the treatment área
* Prolapse grade II according to the classification of the "Pelvic Organ Prolapse Quantification (ICS-POP-Q) System"
* Kegel exercises or electrostimulation at least 30 days before the start of treatment are not allowed

Primary outcomes:
measure: Effect of the pollen extract on Urinary Incontinence
timeFrame: Baseline, two and three months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References:
Clinical trial NCT03220139: Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry
Official title: Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Modification
Lead sponsor: North-West University, South Africa
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 18372
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Apparently healthy US adults age\>=30

Brief summary: Background Cancer and cardiovascular diseases combined account for more than 50% of the overall mortality burden in the USA. Accumulating evidence indicates that saturated fat intake is related to an increase, while unsaturated fat intake is related to a decrease in all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to unsaturated fat.

Objective The aim of the present study was to estimate the mortality risk reduction related to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat intake.

Design The American National health and nutrition examination surveys conducted between 1999 and 2010 were linked to the 2011 national US death registry resulting in an observational prospective mortality study. Proportional hazards Cox models were used to evaluate the association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric substitution of 10% of the energy from dietary fat intake applied to the substitution of saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.


Eligibility criteria: Inclusion Criteria:

* Included NHANES 1999-2010
* age \>= 30 years old

Exclusion Criteria:

* Record not reported in the mortality linked file
* Cancer, type-II diabetes, cardiovascular disease at baseline
* Missing data on covariates used in the model

Primary outcomes:
measure: all causes and specific cause mortality
timeFrame: up to 9 years of observatinal time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02444039: Slit Lamp and Digital Camera Attachment
Official title: Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Willing and Able Person for Ocular Imaging
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any Willing and able subjects will be recruited from Topcon Medical Systems.

Brief summary: The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.

Detailed description: The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon and ascertain that the changes and new features incorporated do not interfere with the normal use and application of the device.

Eligibility criteria: Inclusion Criteria:

* Any willing subject

Exclusion Criteria:

* Subjects unwilling to participate

Primary outcomes:
measure: Instrument and Device Evaluation
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Danny Leung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401139: Ketamine Trial for the Treatment of Depression
Official title: Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unipolar Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2015-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.


Eligibility criteria: Individuals will be eligible for enrolment on the basis of:

* major depressive disorder for at least three months duration
* an inadequate response to at least 2 adequate antidepressants
* MADRS ≥ 20

Patients will be excluded on the basis of:

* History of psychosis
* History of bipolar disorder
* Any unstable medical or neurologic condition
* Any Axis I disorder other than MDD judged to be primary presenting problem
* Planned major changes to psychotropic medication
* Significant risk of suicide
* Planned or probable use of ECT
* Age under 16 years, or 16-17 years without parental consent
* Substance abuse or dependence in previous 6 months
* Any history of abuse of ketamine or phencyclidine
* Contraindication to the use of ketamine
* Planned use of ketamine
* Women of childbearing potential not taking reliable contraception
* Likely non-compliance with trial treatment
* Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Brain & Mind Research Institute (BMRI), University of Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Black Dog Institute, University of New South Wales
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Colleen K Loo, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: