louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00860795: Immunologic Effects of Echinacea
Official title: Study of the Immunologic Effects of Echinacea Purpurea in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Keywords: Echinacea
prevention
immune modulation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 21-65 years old
* If female of child-bearing potential, willing to use contraception to prevent pregnancy
* Speaks and reads English
* No use of any medication (other than multivitamins, essential fatty acids or probiotics)
* Willing to abstain from ingesting edible mushrooms throughout study
* Willing to eat less than 2 garlic cloves per day throughout study

Exclusion Criteria:

* Positive pregnancy test or currently breastfeeding
* History of autoimmune disease
* History of allergic rhinitis
* History of physician diagnosed eczema
* Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)
* Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A

Primary outcomes:
measure: Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
timeFrame: 10 days
Secondary outcomes:
measure: Maximal Levels of Interferon Alpha (pg/ml)
timeFrame: 10 days
measure: Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
timeFrame: 10 days
measure: Adverse Effects
timeFrame: 30 days
measure: Maximal Levels of Interleukin 2 (pg/ml)
timeFrame: 10 days
measure: Maximal Levels of Interleukin 6 (pg/ml)
timeFrame: 10 days
measure: Maximal Levels of Interleukin 12 (pg/ml)
timeFrame: 10 days
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689281: Increasing PrEP With Trans Women in the Deep South
Official title: T'Cher, Take Charge: Increasing PrEP Awareness, Uptake and Adherence Through Health Care Empowerment and Addressing Social Determinants of Health Among Racially Diverse Trans Women in the Deep South
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: CrescentCare
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Primary purpose: PREVENTION

Brief summary: The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.

Detailed description: The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Declaration of willingness to comply with all study procedures and availability during the study
* Age 18 years old or older
* Male sex designated at birth
* Identify as trans woman, woman or another gender identity not associated with being a man
* Desire to use or re-start PrEP
* HIV uninfected
* Speaks English or Spanish
* Live in the New Orleans metropolitan statistical area (which includes 8 parishes)

Exclusion Criteria:

* Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
* Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
* Concurrent or planned enrollment in a research study that provides PrEP
* Unwilling to attend quarterly follow-up visits, which will include survey participation
* Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives

Primary outcomes:
measure: PrEP uptake
timeFrame: 24 months
measure: Social determinant stressors
timeFrame: 24 months
measure: Health care empowerment
timeFrame: 24 months
Secondary outcomes:
measure: Patterns and correlates of PrEP adherence
timeFrame: 24 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: NO/AIDS Task Force d.b.a. CrescentCare
state: Louisiana
Study officials:
References:
Clinical trial NCT01179581: First-in-Human Single Ascending and Multiple Dose of GLPG0634
Official title: Double-blind Placebo-controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG0634 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 48
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 40-60 years
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* any condition that might interfere with the procedures or tests in the study
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single and multiple dosing
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of single and repeated doses, including effect of food.
timeFrame: up to 10 days postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Eva Vets, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.
Clinical trial NCT01278381: Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
Official title: A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasm
Keywords: pancreas, pancreaticoduodenectomy, major complications
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010

Brief summary: Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.

Detailed description: The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

Eligibility criteria: Inclusion Criteria:

- Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion Criteria:

* Metastatic disease
* Patient not suitable for surgery

Primary outcomes:
measure: Major Complication rate
timeFrame: Postoperative. Until 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: Università Vita-Salute San Raffaele
name: Marco Braga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02644681: Neurophysiological Intraoperative Monitoring During Aortic Surgery
Official title: Neurophysiological Intraoperative Monitoring During Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Thoracic
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 100
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: The study population will consist of all consecutive patients with thoracoabdominal aortic aneurysms who will be subjected to neuromonitoring-guided open repair of the aortic aneurysm at the Department of Vascular Surgery of San Raffaele Hospital.

Brief summary: The primary objective of this study is to evaluate if the motor-evoked potentials/motor action potential amplitude ratio and motor action potential amplitude measurement are useful in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.

The secondary objective is to evaluate the presence of a correlation between neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and physiologic changes) in order to find which factor is the most important in determining spinal cord ischemia.

This study is an observational, single-center, prospective study on patients with thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked potentials and somatosensory evoked potentials monitoring.


Eligibility criteria: Inclusion Criteria:

* satisfied criteria for Intraoperative neurophysiological monitoring;
* sign a written informed consent to participate in the study.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Evaluation of the motor-evoked potentials/motor action potential amplitude ratio
timeFrame: During thoracoabdominal aortic aneurysms surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT05555381: Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Official title: Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Onset Dementia
Young Onset Dementia
Stress
Distress, Emotional
Anxiety
Sleep Problem
Sleep
Insomnia
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Odisee University college for applied sciences
First posted: 2022-09-26
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to

* detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep
* implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia

Detailed description: 1. needs detection by means of survey and interviews
2. implementation of a 6 week program in day care facilities

Eligibility criteria: Inclusion Criteria:

* diagnosed with early onset dementia before age of 65Y

Exclusion Criteria:

* severe dementia

Primary outcomes:
measure: anxiety (GAD7 validated questionnaire)
timeFrame: 6 weeks
measure: stress (perceived stress scale, PSS, validated questionnaire)
timeFrame: 6 weeks
measure: sleep (Insomnia severity index, ISI, validated questionnaire)
timeFrame: 6 weeks
measure: sleep (actigraph)
timeFrame: 6 weeks
Secondary outcomes:
measure: emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)
timeFrame: 6 weeks
measure: quality of life (QoL) (quality of life in dementia, QUALIDEM)
timeFrame: 6 weeks
measure: heart rate variance (HRV)
timeFrame: 6 weeks
measure: Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Odisee University of Applied Sciences
state: Flanders
city: Gent
country: Belgium
facility: Familiezorg Oost Vlaanderen
state: Oost-Vlaanderen
Study officials:
affiliation: Odisee University of Applied Sciences
name: Julie Vanderlinden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538781: AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
Official title: AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Cardiva Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-04
Enrollment: 497
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: All subjects 1) treated for A-Fib with or without another arrythmia via catheter ablation 2) who received VASCADE MVP with no other vascular closure device and 3) were discharged the same calendar day during the retrospective date range.

Brief summary: A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age;
2. Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia.
3. VASCADE MVP was the only closure device utilized.
4. Were discharged the same calendar day as the index procedure.
5. Completed a SOC follow-up \> 7 days post-procedure.

Exclusion Criteria:

1. Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)

Primary outcomes:
measure: Freedom from next day access site closure-related complications requiring hospital intervention
timeFrame: 1 day
measure: rate of major venous access site closure-related complications
timeFrame: ≥7 days
Secondary outcomes:
measure: Freedom from next day procedure-related complications requiring hospital intervention
timeFrame: 1 day
measure: Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact
timeFrame: ≥7 days
measure: minor venous access site closure-related complications
timeFrame: ≥7 days
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Coastal Cardiology
state: California
city: Washington
country: United States
facility: MedStar Washington
state: District of Columbia
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT03575481: Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Official title: Differences in Muscle Activity and Fatigue of the Upper Limb Between Task-Specific Training and Robot Assisted Training Among Individuals Post Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2018-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stroke survivors

Brief summary: The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.

Detailed description: Twenty sub-acute post stroke subjects received one TST and one RAT. They marked the pain level in their paretic extremity before and after each session. Muscle activity levels and fatigue and number of repetitions were monitored during each session. The subjective assessment questionnaire of treatment and the Borg scale were administered post-session.

Eligibility criteria: Inclusion Criteria:

* 18 to 85 year old individuals up to three months following stroke
* National Institutes of Health Stroke Scale (NIHSS) score 3-15
* Intact cognitive function
* mild to moderate weakness of the affected hand
* normal or corrected eyesight

Exclusion Criteria:

* neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
* a pace-maker

Primary outcomes:
measure: Muscle activity
timeFrame: 30 minutes
measure: Muscle fatigue
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT06685081: Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery
Official title: Optimal-dose of Dexmedetomidine as Adjuvant to Epidural Local Anesthetic/Steroid Injectate to Improve Pain and Quality of Waking in Patients With Chronic Low Back Pain: A Randomized Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.

Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
* Patients who were free of exclusion criteria were enrolled in the study.

Exclusion Criteria:

* The presence of osteolytic vertebral lesions;
* The Presence of previous surgical intervention;
* The presence of allergy to the studied drugs;
* Patients of ASA grade \>II.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University
state: El Menoufia
Study officials:
References:
Clinical trial NCT00703781: Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract extraction with intraocular lens implantation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery


Eligibility criteria: Inclusion Criteria:

* Scheduled for cataract surgery

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates

Primary outcomes:
measure: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants That Are Pain Free
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
References: