louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06999369: Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes
Official title: Heart Failure Food Intervention Trial (HF-FIT): Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
nutrition app
evidence-based nutrition recommendations
guideline-based nutrition app
app-based dietary intervention
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Measuring the impact of a guideline-based nutrition digital tool in heart failure patients

Detailed description: The goal of this research clinical trial is to learn understand or learn whether a guideline-based nutrition application (app) called MedChefs can help heart failure patients adopt and sustain an evidence-based dietary patterns.

Eligibility criteria: Inclusion Criteria:

* 18-89 years old at time of enrollment
* Any type of Heart failure diagnosis (e.g., I50.x) between 1/1/2023-present
* Recent hospital admission (within a year)
* Race/ethnicity: All race/ethnic groups
* Location: patients have been treated in the Greater East Bay division and Greater Silicon Valley division areas.
* Patients with have at least 1 office/outpatient visit with a primary care physician or cardiologist visit before index date

Exclusion Criteria:

* • Patients with certain patient history (cognitive disabilities) and end stage renal or metastatic cancer diagnosis

  * Patients with active drug/substance use. Patients with heart failure who have active substance use are excluded from the study. HF patients with substance use require additional monitoring and follow up due to potential severe withdrawal symptoms, acute HF exacerbation and drug overdose or medication errors. Standard protocol includes additional monitor vital signs (e.g., blood pressure, heart rate) and HF symptoms (e.g., edema, dyspnea), and performing regular laboratory tests (e.g., renal function, electrolytes) which is beyond the clinical and logistical capabilities of this study.

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Weight
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: 2121 N. California Blvd., Suite 310
state: California
Study officials:
References:
Clinical trial NCT00568269: Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Official title: Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Recurrence rate after inguinal hernia repair on primary inguinal herina.
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Stig and Ragna Gorthon Foundation
name: Tyco Healthcare Group
First posted: 2007-12-06
Enrollment: 1513
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.


Eligibility criteria: Inclusion Criteria:

* Male
* Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

* Recurrent hernia
* Scrotal or bilateral hernia
* Previous lower abdominal surgery
* Unable to participate in follow up
* ASA more than 3
* Bleeding diathesis.

Primary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Secondary outcomes:
measure: Operative complications, postoperative recovery and chronic pain at 5 years.
timeFrame: 5 years
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Centre for Clinical Research, Central hospital, entrance 29
Study officials:
affiliation: Centre for Clinical Research
name: Arne S Eklund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
citation: Eklund A, Montgomery A, Bergkvist L, Rudberg C; Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy (SMIL) study group. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg. 2010 Apr;97(4):600-8. doi: 10.1002/bjs.6904.
Clinical trial NCT01241669: Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Multiple Doses of E5555 on the Pharmacokinetics of Metformin (a Substrate for OCT2 Transporter) and on Renal Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.


Eligibility criteria: Inclusion Criteria:

- Healthy male or female subjects aged greater than or equal to 18 years to 55 years

Exclusion Criteria:

* History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc.
* Creatinine clearance \< 90 mL/min as estimated using Cockcroft-Gault formula at screening or baseline
* History of any renal disorders, proteinuria, hepato-biliary disease.

Primary outcomes:
measure: To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.
timeFrame: 15 days
Secondary outcomes:
measure: To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.
timeFrame: Days 7 and 14
measure: To assess the effects of multiple doses of E5555 on the effective renal plasma flow estimated using para-aminohippuric acid (PAH).
timeFrame: Days 7 and 14
measure: To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.
timeFrame: Days 12-18
measure: To assess the safety and tolerability of multiple doses of E5555 and a single dose of metformin either given alone or concomitantly
timeFrame: Day 1 - Day 18
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles Phase I Services
state: Kansas
Study officials:
affiliation: Eisai Inc.
name: Dr. Bhaskar Rege
role: STUDY_DIRECTOR
References:
Clinical trial NCT04021069: Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Official title: Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Lobular Breast Carcinoma
Keywords: radiomics
pathomics
breast cancer
machine learning
biomarkers
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer of any stage, according to the AJCC v7 criteria.

Brief summary: This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

Detailed description: The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.

Eligibility criteria: Inclusion Criteria:

* Participants must be men and women age 18+
* Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
* Any state of disease as described by AJCC v7 criteria
* Participants must have received and completed neoadjuvant chemotherapy

Exclusion Criteria:

* Participants who had other primary cancers prior to breast cancer

Primary outcomes:
measure: Pathologic complete response (pCR)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Time to local breast recurrence
timeFrame: Up to 60 months
measure: Time to distant metastasis (months)
timeFrame: Up to 60 months
measure: Time to death
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: William T. Tran, MRT(T), PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Kasia Jerzak, M.Sc., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Fang-I Lu, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04881669: The Effect of Obturator Thickness on the Function
Official title: The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxilla--Cancer
Keywords: obturator, bulb
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 71
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the effect of obturator bulb thickness on masticatory function has been verified.


Eligibility criteria: Inclusion Criteria:

* having maxillectomy operation

Exclusion Criteria:

* having radiation therapy before the study

Primary outcomes:
measure: the effect of bulb thickness
timeFrame: 3 weeks
measure: the effect of weight reduction
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Istanbul university,Faculty of Dentistry
Study officials:
affiliation: Istanbul University
name: merve benli, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01214369: Anesthetic Efficacy of X-tip Intraosseous Injection
Official title: Anesthetic Efficacy of X-tip Intraosseous Injection Following Mandibular Nerve Block in Molars With Acute Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: intraosseous injection
X-tip
PDL injection
Supplementary Injection
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: * Hypothesis:

  * X-tip intraosseous is an effective supplementary injection in mandibular hot teeth as well as Periodontal Ligament (PDL) injection
* Purposes:

  * Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar Nerve Block
* Methods and Materials:

  * forty patients with mandibular hot molar or second premolar which had not been anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected for this study

Detailed description: * Randomization:

  * All patients will be randomly divided into two groups as follows:

    1. X-tip intraosseous injection will be used as supplementary
    2. PDL injection will be used as supplementary
* Anesthetic evaluation:

  * For anesthetic evaluation we will use Visual Analog Scale (VAS)

Eligibility criteria: Inclusion Criteria:

* Mandibular Molars and second premolars with Acute Irreversible Pulpitis
* None of the teeth selected should have been anesthetized following 3.6 ml Lidocaine block injection

Exclusion Criteria:

* Unhealthy patients
* Teeth which were anesthetized following 3.6 ml nerve block injection
* Patients who did not have any signs of lip anesthesia following 3.6 ml injection

Primary outcomes:
measure: Number of participant who will have the pain following X-tip or PDL as a supplementary injection
timeFrame: 6 months
Secondary outcomes:
measure: Heart rate monitoring
timeFrame: before block injection and after supplementary injection
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Faculty of Dentistry
state: Khorasan Razavi
Study officials:
affiliation: Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran
name: Jamileh Ghoddusi, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01239069: Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
Official title: A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 140
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: Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of dry eye
* Not wear contact lenses during study
* 18 years or older
* Understand and provide written consent
* Negative pregnancy test and use acceptable method of contraception

Exclusion Criteria:

* Use of any topical ocular medication
* Any type of ocular surgery
* Diagnosis of on-going ocular infection and/or allergic conjunctivitis
* Uncontrolled systemic conditions/lid abnormalities
* Corneal transplants
* Females who are pregnant, nursing or planning a pregnancy
* Participation in another drug trial concurrently or within 30 days prior to study

Primary outcomes:
measure: Efficacy of DE-110
timeFrame: 12 weeks
Secondary outcomes:
measure: Individual Response Rate
timeFrame: 12 weeks
measure: Individual Efficacy
timeFrame: 12 weeks
measure: Individual Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Inglewood
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Petaluma
country: United States
state: California
city: Torrance
country: United States
state: California
city: Bloomfield
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Rosewell
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Bangor
country: United States
state: Maine
city: Cleveland
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT00704769: Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
Official title: Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 591
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, ages 2-11, with a history of perennial allergic rhinitis

Brief summary: Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Detailed description: Children, ages 2-11, with a history of perennial allergic rhinitis

Eligibility criteria: Inclusion Criteria:

* Children patients of both sexes aged between 2-11 years, of either gender and any race
* Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
* Minimum score for inclusion: 10
* Capable of complying with the dosing regimen
* Free of any clinically significant disease (other than allergic rhinitis)
* Antihistamine must be justified by investigating doctor

Exclusion Criteria:

* Patients with asthma who require chronic use of inhaled or systemic corticosteroids
* History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
* Patients with rhinitis medicamentosa
* History of hypersensitivity to desloratadine or any of its excipients
* Doctor deems unsuitable

Primary outcomes:
measure: Adverse Events
timeFrame: Minimum of 7 days after initiation of desloratadine
measure: General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
timeFrame: Minimum of 7 days after initiation of desloratadine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04513769: Nutritious Eating With Soul at Rare Variety Cafe
Official title: Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To date, few dissemination and implementation (D\&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:

Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.

Aim 2: Assess resource use and cost associated with a train-the-trainer D\&I approach in a restaurant setting.

Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).

Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.


Eligibility criteria: Inclusion Criteria:

* self-identify as African American
* between 18-65 years old
* be free on meeting night (Tuesday at 6PM)
* be free of eating disorder
* be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
* willing to travel weekly to Rare Variety Café

Exclusion Criteria:

* currently following a plant-based/vegan diet
* have a body mass index of under 25 or over 49.9 kg/m2
* currently on medication for diabetes
* women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* currently participating in a weight loss program or taking weight loss medications
* recent weight loss (\>10lbs in the last 6 months)
* living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
* currently in the NEW Soul study

Primary outcomes:
measure: body weight
timeFrame: 0, 3, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT06088069: Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
Official title: Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Total Hip Arthroplasty
Anxiety
Stress
Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate Virtual reality (VR) on perioperative anxiety, pain, hemodynamics, and stress hormones in patients undergoing Total hip arthroplasty (THA).

Detailed description: VR is a computer technology that provides the feeling of being immersed in a simulated three-dimensional (3D) world where the user may interact with the virtual environment. Clinical studies have shown that VR technology is effective in reducing pain perception and anxiety. It has also been proposed as an effective non-pharmacological alternative for reducing acute procedural pain and providing anxiety relief.

Eligibility criteria: Inclusion Criteria:

* Age 21 years or above.
* Both sexes.
* The American Society of Anesthesiologists (ASA) physical status I-III.
* Scheduled for elective THA under spinal anesthesia.

Exclusion Criteria:

* Cerebrovascular disease.
* Psychiatric-cognitive dysfunction.
* Claustrophobia.
* Deaf and blind patients.
* Uncooperative.
* Adrenal insufficiency.
* Chronic alcohol and substance addiction.
* Chronic sedative and narcotic use.

Primary outcomes:
measure: Anxiety
timeFrame: 15 min before operation till immediately postoperative.
Secondary outcomes:
measure: Total intraoperative haloperidol consumption
timeFrame: Intraoperatively.
measure: Stress measured by Cohen Perceived Stress Scale
timeFrame: 15 min before operation till immediately postoperative.
measure: Stress measured by blood serum level of cortisol
timeFrame: 6 hours postoperative.
measure: The degree of postoperative pain
timeFrame: 24 hours postoperatively.
measure: Amount of opioid consumption
timeFrame: 24 hours after surgery.
measure: Heart rate changes
timeFrame: Till the end of surgery.
measure: Mean arterial blood pressure changes
timeFrame: Till the end of surgery.
measure: Patient satisfaction
timeFrame: 24 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: