louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00554242: Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function
Official title: Chronic Study of the Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: endothelium
antioxidants
flavonoids
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed extract on endothelial function. We then will perform a a randomized, double blind, placebo controlled crossover study designed to investigate the benefit of grape seed extract/vitamin C treatment on endothelial function. Participants (n=40) will take a food supplement containing 450 mg of grape seed extract and 1500 mg of vitamin C or matching placebo for four weeks and then cross over to the alternative treatment (active supplement or placebo) for four weeks. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the vascular effects of these compounds.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Pregnancy
* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
* Treatment with an investigational new drug within the last 30 days.
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Vitamin E, Vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment.

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 1 month
Secondary outcomes:
measure: Fingertip Pulse Amplitude Tonometry
timeFrame: 1 month
measure: Carotid-femoral pulse wave velocity
timeFrame: 1 month
measure: Serum markers of inflammation
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04426942: Sexuality in Medically Assisted Procreation Pregnancies
Official title: Evaluation of the Couple's Sexuality During a Pregnancy Resulting From Medically Assisted Procreation and Comparison With Sexuality During a Spontaneous Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Assisted Reproduction
Keywords: assisted reproduction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting from assisted procreation The literature is poor on thie subject


Eligibility criteria: Inclusion Criteria:

* physiological pregnancy
* pregnancy from assisted reproduction
* age over 18
* to understand french
* patient's agreement

Exclusion Criteria:

* pathological pregnancy

Primary outcomes:
measure: Evaluation of sexual functioning with Female Sexual Function Index (FSFI) test
timeFrame: In the second trimester of the pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Matthieu Dap
Study officials:
References:
Clinical trial NCT00168142: MVCT Imaging Pilot Study Using Helical Tomotherapy
Official title: MVCT Imaging Pilot Study Using Helical Tomotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Carcinoma
Keywords: Helical tomotherapy
Megavoltage imaging
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To compare the two types of scans, the conventional CT planning scan and the tomotherapy planing scan.


Eligibility criteria: Inclusion Criteria:

* Undergoing radiotherapy metallic artifact in radiation field.

Exclusion Criteria:

* Contraindication to radiotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Rufus Scrimger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664742: The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Official title: The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 614
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome


Eligibility criteria: Inclusion Criteria:

* ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
* Triglyceride (TG) \< 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
* Written informed consent for participating in the study

Exclusion Criteria:

* Severe renal disease or renal dysfunction
* Chronic liver disease or liver function impairment
* Inflammatory muscle dysfunction or findings of muscle problems
* Severe cardiac failure

Other protocol defined inclusion exclusion criteria may apply

Primary outcomes:
measure: Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
timeFrame: Baseline,6 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Götzepe Education and Research Hospital
Study officials:
References:
Clinical trial NCT03788642: Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Official title: Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Low Level Laser Therapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomised clinical trial with participants randomised1:1 to either

* Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily
* Laser group : Patients will wear Laser shoe 30 minutes once daily
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and a half to recieve the placebo (LED).

Detailed description: Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to see whether LLLT shoe helps with healing compare with placebo (LED shoe).

Eligibility criteria: Inclusion Criteria:

* Patients with chronic diabetic foot ulcer
* Ankle brachial index ≥ 0.4
* Toe pressure brachial index ≥ 0.3
* Transcutaneous oxygen measurement (TCOM) ≥ 40 mmHg
* Ulcer size less than 25 cm2

Exclusion Criteria:

* Infected ulcer
* Fever
* HbA1C \> 15 %

Primary outcomes:
measure: Ulcer Healing Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to ulcer healing
timeFrame: time from date of randomisation to date of healing within the 12 month study period
measure: Clinical Success - Complications
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Vascular Surgery, Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nuttawut SERMSATHANASAWADI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05490342: Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients
Official title: Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Vaccination
Liver Transplantation
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 61
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: Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)

Brief summary: To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.


Eligibility criteria: Inclusion Criteria:

* Liver transplanted patients \>18 years of age.
* Patients who underwent liver transplantation between 01/2015 to 12/2021.
* Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
* Patients who have had three doses of a vaccine for the prevention of COVID-19.
* Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.

Exclusion Criteria:

* Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
* Patients not vaccinated for prevention of SARS-CoV-2 infection.
* Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.

Primary outcomes:
measure: Rate of positive antibody titer
timeFrame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Secondary outcomes:
measure: Rate of highly protective antibody titer
timeFrame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
measure: Median antibody titer absolute value
timeFrame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Tor Vergata
Study officials:
References:
Clinical trial NCT05624242: Assessment of Right Ventricular Function by Cardiac MRI in Patients With Pulmonary Arterial Hypertension (IRMA)
Official title: Assessment of Right Ventricular Function by Cardiac Magnetic Resonance Imaging in Patients With Pulmonary Arterial Hypertension (IRMA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population concerns patients with pulmonary arterial hypertension followed up in our centre, at diagnosis and when starting vasodilator treatment.

Brief summary: Pulmonary hypertension (PH) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmHg, which encompasses many very dissimilar conditions. Right ventricular function is the major determinant of survival in these patients. Currently, right ventricular function is estimated by trans-thoracic echocardiography via the measurement of standardised parameters. However, cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation. Thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension. This work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.


Eligibility criteria: Inclusion Criteria:

* Patient with pulmonary arterial hypertension (group 1)
* Patient with cardiac MRI, echocardiography and right heart catheterisation within 1 month of each other

Exclusion Criteria:

* Patient with features of venous/capillary involvement
* Pulmonary arterial hypertension associated with with congenital heart disease
* Patient's decline to participate in the study

Primary outcomes:
measure: Transplantation-free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02521142: Non-invasive Optical Angiography in Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age Related Macular Degeneration
Keywords: OCT Angiography
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with CNV due to AMD both, treatment naive and active CNV being treated

Brief summary: Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.


Eligibility criteria: Inclusion Criteria:

- Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion

Exclusion criteria

Any of the following will exclude a patient from the study:

* Previous application of intravitreal drugs except anti-VEGF injections
* Active intraocular inflammation
* Presence of an intraocular disease except AMD and cataract

Primary outcomes:
measure: Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD.
timeFrame: Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Secondary outcomes:
measure: choroidal thickness as assessed with OCT
timeFrame: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
measure: peripapillarly bloodflow as assessed with Doppler OCT
timeFrame: participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00867542: Dental and Oral Finding in Israeli Children With Past Intrauterine Growth Retardation (IUGR)
Official title: Dental and Oral Findings in Israeli Children With Past IUGR - a Comprehensive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Keywords: past IUGR
ECC
oral findings in children with past IUGR
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 children aged 3-4 y old with IUGR in the past, 30 healthy children sex and age matched

Brief summary: oral status and early childhood caries (ecc) in israeli children with past IUGR


Eligibility criteria: Inclusion Criteria:

* children who were born and diagnosed with IUGR

Exclusion Criteria:

* children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy

Primary outcomes:
measure: oral status of children with past IUGR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00044642: Lorazepam-Induced Toxicity in the Aged
Official title: Long-Term Lorazepam Use and Acute Toxicity in the Aged
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety Disorders
Generalized Anxiety Disorder
Keywords: Anxiety
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).

Detailed description: GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls.

Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.

Eligibility criteria: Inclusion Criteria:

* Lorazepam treatment for at least 3 months
* Cognitively intact

Note: Individuals who are unable or unwilling to have an MRI may be included

Exclusion Criteria:

* Major psychiatric disorder other than GAD
* Significant medical illness which may increase the likelihood of adverse reactions to lorazepam
* Severe loss of hearing or vision
* Current or past history of alcohol dependence
* Substance abuse within the past 6 months
* MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease
* Clinical symptoms that suggest neurological disease
* Dementia or other mental syndromes or disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU/Bellevue General Clinical Research Center (8East)
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute
state: New York
Study officials:
affiliation: Nathan S. Kline Institute and New York University School of Medicine
name: Nunzio Pomara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01724242: Vaginal DHEA for Women After Breast Cancer
Official title: Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Vaginal Dryness
Breast Cancer
Urinary Incontinence
Quality of Life
Sexual Satisfaction
Keywords: Vaginal dryness
Breast Cancer
Urinary Incontinence
Quality of Life
Sexual Satisfaction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.


Eligibility criteria: Inclusion Criteria:

* women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.

Exclusion Criteria:

* women using products to alleviate vaginal dryness.
* women taking medication for urinary incontinence
* women not sexually active, for other reasons.

Primary outcomes:
measure: improvement in vaginal dryness
timeFrame: 12 weeks
Secondary outcomes:
measure: improvement in urinary incontinence
timeFrame: 12 weeks
measure: improvement in sexual satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner-Celnikier, MD
role: PRINCIPAL_INVESTIGATOR
References: