louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04066296: Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
Official title: A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lumbar Spinal Stenosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized
Primary purpose: TREATMENT

Brief summary: Evaluate the benefit of using liposomal bupivicaine in lumbar laminectomies in terms of length of stay, IV narcotic use, 30-day narcotic use, visual analog score (VAS) and 30-day readmissions

Detailed description: Recent evidence suggests the use of liposomal bupivicaine (LB) in lumbar spine surgery shortens length of hospital stay and overall post-operative narcotic use. Studies have shown its utility in single level microdiscectomies and lumbar fusions, but there have been no publications regarding lumbar laminectomies and associated outcomes with LB. The investigators' hypothesis is that LB will significantly shorten inpatient stays as well as overall narcotic usage in single, double or multi-level lumbar laminectomies.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Adult (≥18 yo)
3. Lumbar stenosis

Exclusion Criteria:

1. Co-morbidities precluding surgery
2. ≤18 yo
3. Pregnant
4. Breastfeeding
5. Need for instrumented fusion
6. Prisoners
7. Intra-operative CSF leak (identified by gush of CSF)
8. Daily pre-operative opioid use of \> 25 morphine Eq/day
9. Previous lumbar surgery at indicated level

Primary outcomes:
measure: Overall length of hospital stay from hospital admission to hospital discharge
timeFrame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Secondary outcomes:
measure: IV narcotic usage
timeFrame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
measure: 30-day narcotic usage
timeFrame: 30-day post surgery
measure: Change in Visual Analog Pain scale scores
timeFrame: Screening, Day of Procedure, Prior to Hospital Discharge (Post-op, Up to 2 weeks), Up to 30-days post-surgery (Follow-Up#1) and up to 12-months post-op follow up
measure: 30-day readmission rates
timeFrame: Day 30
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References:
Clinical trial NCT02668796: To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
Official title: A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvar and Vaginal Atrophy
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 522
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.


Eligibility criteria: Inclusion Criteria:

1. Female postmenopausal subjects aged \>30 to \<75 years
2. At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her

   * vaginal dryness
   * vaginal and/or vulvar irritation/ itching
   * dysuria
   * vaginal pain associated with sexual activity
   * presence of vaginal bleeding associated with sexual activity
3. Have \<5% superficial cells on vaginal smear cytology and vaginal pH \>5.0 at Visit 1
4. Systolic blood pressure \<150mm Hg and diastolic blood pressure \<90mm Hg at Visit 1

Exclusion Criteria:

1. Known hypersensitivity to Estradiol vaginal tablet
2. Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
3. History of undiagnosed vaginal bleeding.
4. History of significant risk factors for endometrial cancer
5. For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.

Primary outcomes:
measure: The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5
timeFrame: Day 15]
Secondary outcomes:
measure: The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS
timeFrame: Day 15]
Other outcomes:
Locations:
city: Mahwah
country: United States
facility: Glenmark Pharmaceuticals Inc.
state: New Jersey
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd.
name: Dr. Nikhil Sawant
role: STUDY_DIRECTOR
References:
Clinical trial NCT00738296: Vytorin on Carotid Intima-media Thickness and Overall Rigidity
Official title: Vytorin on Carotid Intima-media Thickness and Overall Rigidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lead sponsor: Hospital Regional 1o de Octubre
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level \> 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.


Eligibility criteria: Inclusion Criteria:

* Ldl-C Levels \>100 Mg/Dl
* Patients Who Have Signed The Consent
* Patients Of ages between 30 and 75 Years Old
* Patients Of Both Genders
* Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease
* Patients Without Previous Treatment With Ezetimibe

Primary outcomes:
measure: The annual progression of the slope of the maximum average GIM and the arterial rigidity.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Regional 1o de Octubre, ISSSTE
name: Alejandra Meaney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04527796: Influence of a Residential Rehabilitation Program on Body Composition in Patients with Cystic Fibrosis
Official title: Influence of a Residential Rehabilitation Program on Body Composition in Patients with Cystic Fibrosis (children and Adults)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystic Fibrosis
Keywords: body composition
rehabilitation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients With Cystic Fibrosis

Brief summary: The aim is to evaluate the impact of a 3-week lasting residential rehabilitation program for patients with cystic fibrosis on their nutritional status measured as BMI and body composition and pulmonary function.

Detailed description: Cystic fibrosis Patients following a residential rehabilitation program consisting of dietary adaptation, physical therapy for airway drainage and supervised inhalation therapy and physical activity for at least 3 weeks are asked to participate. Weight, height, body composition and pulmonary function will be measured at start and end of the program. Dietary intake during the program is calculated based on a 2 day weighed intake diary and physical activity will be measured with the "SenseWear pro 3" armband.

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis
* stay at the rehabilitation center for at least 3 consecutive weeks

Exclusion Criteria:

* steroid use
* absence from the program for more than 2 consecutive days

Primary outcomes:
measure: body composition change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
measure: body composition change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
measure: Body mass index change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
measure: Weight change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
measure: pulmonary function change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
measure: pulmonary function change
timeFrame: day 0 and day 21 (start and end of the rehabilitation program)
Secondary outcomes:
measure: Physical activity
timeFrame: Week 1
measure: dietary intake
timeFrame: 2 days/week for 3 consecutive weeks
Other outcomes:
Locations:
city: De Haan
country: Belgium
facility: Zeepreventorium de Haan
Study officials:
affiliation: Gent university hospital
name: Stephanie Van Biervliet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02689596: Oxytocin and Resting State fMRI
Official title: Intranasal Oxytocin and Resting State fMRI in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2016-02-24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males.

Detailed description: Although several fMRI studies investigated the neural correlates of OT administration, only few have focused on the underlying modulatory effects of OT on baseline brain function. While functional MRI examines the neural activity during a certain task, it might be especially interesting to assess the main effect of OT on the basic activity of the human brain in rest. This resting state activity becomes typically evident in the default mode network (DMN), compromising midline structures such as medial frontal cortex, cingulate and precuneus, as well as specific resting state networks .

In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent studies were able to show an increased functional connectivity at rest of amygdala to the medial prefrontal cortex (PFC) in a small sample of 15 subjects.

However, distinct subregions of the amygdala seem to be involved in different OT effects. To goal of the present study is to decipher the modulatory effects of OT to subregions of the amygdala in a larger sample using improved anatomical mapping of the seed regions and relate these alterations to individual traits of healthy volunteers. We expected to add evidence to the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping of this networks.

Eligibility criteria: Inclusion Criteria:

* Health

Exclusion Criteria:

* Chronic physical or mental illness, regular smoking or alcohol consumption and medication intake

Primary outcomes:
measure: Resting state brain activity using fMRI
timeFrame: 30min
Secondary outcomes:
measure: Subject personality using questionnaires
timeFrame: 30min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04590196: Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients
Official title: Effect of Oral Curcumin Supplementation on Choriocapillaris and Drusen Characteristics Measured by Multimodal Retinal Imaging in Dry Age-related Macular Degeneration (AMD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Age Related Macular Degeneration
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: VitreoRetinal Surgery Foundation
name: Illinois Society for the Prevention of Blindness
First posted: 2020-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nutrition plays an important role in preventing progression of dry age related macular degeneration (AMD), a disease of aging that leads to drusen deposits in the macula causing significant decrease in vision. Drusen contains amyloid protein which is inhibited by curcumin, a natural plant based antioxidant. Oral Longvida curcumin has been shown to accumulate in the retina of human subjects within 10 days of supplementation. This study aims to investigate the duration of oral curcumin supplementation needed to see clinical impact in reducing volume and number of drusen and decreasing choriocapillaris density loss or flow impairment in dry AMD patients. Patients will be given a 12-month course of oral Longvida curcumin and clinical impact will be measured by multimodal retinal imaging (fundus photos, OCT and OCT-A) at day 0, month 3, month 6, and month 12 of supplementation. Previous small studies have shown change in drusen size within 4 6months of curcumin supplementation, given that drusen can naturally fluctuate in size, we want to have a longer study period with a control group to better understand the effects of curcumin on drusen characteristics.


Eligibility criteria: Inclusion Criteria:

* Age \> 50 years old BCVA 20/20 to 20/400 Dry AMD with many large (\>300 μm in diameter and more than 100 μm in height) soft drusenoid PEDs

Exclusion Criteria:

* presence (or history) of significant geographic atrophy or choroidal neovascularization in either eye; history of eye surgery (other than cataract extraction) within 90 days, history of BRVO/CRVO, Macular hole, pathologic myopia, uveitis, pseudovitelliform maculopathy will be excluded.

Primary outcomes:
measure: Drusen volume
timeFrame: baseline, 3month, 6month, 12 month timepoints
Secondary outcomes:
measure: Drusen size
timeFrame: baseline, 3month, 6month, 12 month timepoints
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois eye and ear infirmary
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Yekaterina Joltikov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02833116: Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia
Official title: Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Pain
Keywords: radiculalgia
chronic pain
quality of life
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.


Eligibility criteria: Inclusion Criteria:

* Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc.
* Age between 18 and 80 years.
* Moderate to severe pain (NVS\>4).
* Right proficient oral and written language.

Exclusion Criteria:

* Patients with high intracranial pressure.
* Patients with Multiple Sclerosis.
* Patients with Guillain-Barré syndrome radiculopathy of vascular origin.
* Patients with previous lumbar surgery.
* Patients pregnant or lactating.
* Patients with allergy or intolerance to any of the drugs used.
* Patients with severe cognitive impairment.
* Patients with intrathecal injectio radiculalgia.
* Patients with poorly controlled major psychiatric pathology.
* Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac\>8.5).
* Patients with glaucoma.
* Patients with caudal equine syndrome.
* Patients with pre-treatment with steroid injections/or local anesthetics.
* Patients with central canal stenosis.
* patients with chronic treatment with oral corticosteroids without stabilized pattern.

Primary outcomes:
measure: Pain.
timeFrame: 3 months.
Secondary outcomes:
measure: Quality of life.
timeFrame: 7 days, 1, 3 and 6 months.
measure: Pain.
timeFrame: 7 days, 1, 3 and 6 months.
measure: Adverse events.
timeFrame: 7 days, 1, 3 and 6 months.
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Enrique Barez
state: Álava
Study officials:
affiliation: Basque Health Service: Araba University Hospital
name: Enrique Barez
role: PRINCIPAL_INVESTIGATOR
affiliation: Basque Health Service: Donosti University Hospital
name: Borja Mugabure
role: STUDY_DIRECTOR
affiliation: Basque Health Service: Galdakao University Hospital
name: Fernando Torre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00578916: Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects
Official title: Pharmacokinetics and Metabolism of [14C] BMS-690514 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Body mass index (BMS) of 18 - 30 kg/m², inclusive

Exclusion Criteria:

* Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years

Primary outcomes:
measure: Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine
timeFrame: measured for 10 days post-dose
Secondary outcomes:
measure: Determination of biotransformation profiles and recorded adverse events
timeFrame: for 10 days post-dose
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02193516: Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nephropathy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women 14-24 gestational age

Brief summary: Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can indicate possible nephropathy. The evolution of CMD across gestation had not been well established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20 weeks. In our study we would like to determine the exact timing of it's sonographic visualisation. This is a prospective study recruiting women between 14-24 week gestation during routine ultrasound screening. A midsagittal image of each kidney will be taken by a single sonographer and examined for the presence of the CMD by two other sonographers blinded to gestational age.


Eligibility criteria: Inclusion Criteria:

* pregnant women 14-24 weeks
* singleton pregnancy
* Appropriate for gestational age fetuses
* well dated pregnancy

Exclusion Criteria:

* family history of renal disease
* small /large for gestational age fetuses
* known structural anomalies
* unknown dating

Primary outcomes:
measure: CMD presence
timeFrame: A single exam for each participent. The photos will be reviewed within up to 6 month from examination date
Secondary outcomes:
Other outcomes:
Locations:
city: kfar Sava
country: Israel
facility: Meir Hospital
Study officials:
References: