louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03232970: Full Plate Diet Study
Official title: Full Plate Diet Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Ardmore Institute of Health
First posted: 2017-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

Brief summary: Comparison between two groups, experimental and control. Experimental will undergo lectures on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done before and after the 3-months long program. Comparisons will be made pre and post and with groups.

Detailed description: The Full Plate Diet Clinical Trial is a study that will verify if the three months course is sufficient to change diet behavior of the participants. Forty participants will be recruited and then randomly assigned to one of two groups (20 in each group): The Experimental group will attend one weekly session with instructions on how to increase fiber intake; Control group will not have the intervention. The goal of the study is to see if the Full Plate Diet program will improve blood measures of metabolic diseases and weight.

Eligibility criteria: Inclusion Criteria:

* Any gender and age between 21-65 years

Exclusion Criteria:

* BMI between 25 to 35,
* no debilitating disease,
* no previous participation in the FPD program,
* no allergies to beans

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3 months
Secondary outcomes:
measure: Body Fat
timeFrame: 3 months
measure: Lipids
timeFrame: 3 months
measure: HbA1C
timeFrame: 3 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
References:
citation: Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.
Clinical trial NCT04943575: Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Official title: Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: PPC Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2021-06-29
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC Pak \& EZC Pak+D for the treatment of the common cold and/or a URI.

Detailed description: This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the efficacy of PPC Pharmaceuticals EZC Pak (\& EZC Pak+D) to improve the severity and duration of the common cold or a URI in individuals. It is hypothesized that study participants will experience a positive impact on the duration and severity of their cold/URI while using EZC Pak (\&EZC Pak+D). The second study objective is to examine if patients are accepting the test product as an alternative to antibiotics.

Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years old
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Seeking OTC remedies to reduce the severity and duration of their common cold symptoms, when they arise
* Must have a thermometer at home
* Must have a blood pressure monitor at home
* Ideally, uses one of the following devices: Apple Watch, Oura Ring, FitBit, other fitness trackers

Exclusion Criteria:

* Unwilling to try the test product for their cold
* Has any of the following medical conditions:

  * ragweed or daisy allergy
  * chronic seasonal allergies
  * liver disease
  * autoimmune or connective tissue disorder (e.g., rheumatoid arthritis, lupus, multiples sclerosis, HIV)
  * alcohol consumption more than 7 drinks per week, or more than 3 drinks per occasion
  * IV drug use
  * renal disease
  * females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Primary outcomes:
measure: Primary Objective: Reduction in severity of common cold symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03777475: the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Official title: the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* unresectable;
* the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
* sign up consent

Exclusion Criteria:

* cannot tolerate TAI or surgery;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy

Primary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: ORR
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: PFS
timeFrame: From date of randomization until the date of progress from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05580575: Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses
Official title: Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism Bilateral
Keywords: contact lenses
astigmatism
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.


Eligibility criteria: Inclusion Criteria:

* Subjects must be current soft lens wearers in both eyes.
* Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
* Either gender
* Any racial or ethnic origin

Exclusion Criteria:

* Participants cannot be pregnant or lactating.
* Participants cannot be current wearers of the study lenses
* No current ocular inflammation or infection as assessed by the study investigator

Primary outcomes:
measure: Visual Analog Scale Survey of Overall Comfort
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
Study officials:
References:
Clinical trial NCT06354075: Evaluation of Patient Information in Interventional Radiology
Official title: Evaluation of Patient Information in Interventional Radiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Keywords: Patient information
pediatrics
consultation
information sheet
questionnaire
interventional radiology
video
cementoplasty
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 50
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: All patients receiving a consultation prior to a cementoplasty procedure and children receiving a consultation prior to any interventional radiology procedure.

Brief summary: Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos.

Detailed description: The aim of our work is therefore the evaluation of patient information in interventional radiology.

Eligibility criteria: Inclusion Criteria:

* All patients receiving a consultation prior to a cementoplasty procedure and children receiving a consultation prior to any interventional radiology procedure.

Exclusion Criteria:

* None

Primary outcomes:
measure: to evaluate satisfaction of patient of explanatory videos in interventional radiology
timeFrame: Year : 2
measure: To evaluate satisfaction of patient of comic book in interventional radiology
timeFrame: Year : 2
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04157075: Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy
Official title: The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Opioid Use
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 years old
* undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
* Patients must be English speaking.

Exclusion Criteria:

* Pregnancy
* allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
* pre-operative daily opioid consumption
* peri-operative transverse abdominis plane block
* recent history of drug or alcohol abuse (in last year)
* severe cardiovascular, hepatic or renal disease.

Primary outcomes:
measure: Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
timeFrame: 7 days post-op
Secondary outcomes:
measure: Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection
timeFrame: 7 days post-op
measure: Time to first bowel movement following uterosacral ligament bupivicaine injection
timeFrame: 7 days post-op
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Karen Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510375: Cocoa Supplementation, Inflammaging, and Epigenetic Aging
Official title: Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aging
Inflammation
Cardiovascular Diseases
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2022-08-22
Enrollment: 21442
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of CVD risk factors and outcomes.


Eligibility criteria: Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

Inclusion Criteria:

* Provided blood samples at baseline, Year 1, and Year 2 of follow-up.
* Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured.

Exclusion Criteria:

• Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.

Primary outcomes:
measure: Epigenetic age acceleration
timeFrame: 2 years
measure: Inflammaging
timeFrame: 2 years
Secondary outcomes:
measure: Blood pressure
timeFrame: 2 years
measure: Body mass index
timeFrame: 2 years
measure: Pulse wave velocity
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04006275: Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC
Official title: Comparing SonoVue With Sonazoid in the Performance of Contrast Enhanced Ultrasound The Liver Imaging Reporting and Data System (CEUS-LIRADS) in Diagosing HCC: a Prospective Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Cirrhosis
Keywords: Hepatocellular Carcinoma
cirhossi
Contrast-enhanced ultrasound
LI-RADS
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: included patients receive both SonoVue and Sonazoid with a randomized crossover design. The wash out period is at least 30min to make sure the fore-inject contrast agent is clear in blood.
Primary purpose: DIAGNOSTIC

Brief summary: The new version of CEUS LI-RADS published at 2018(version 2017). In this study, the investigators aim to investigate the diagnosing performance of CEUS LI-RADS by administrating different contrast agents (SonoVue/ Sonazoid).

Detailed description: Independent radiologists from department of ultrasound will report their diagnosing results according to CEUS LI-RADS version 2017 without getting any information about patients. The researcher of this subject will collect all results and evaluated the sensitivity and specificity of CEUS LI-RADS and the diagnosing performance with different contrast agents.

Eligibility criteria: Inclusion Criteria:

* Patients at risk for HCC with focal liver lesion on conventional ultrasound.
* history of cirrhosis.
* historty of HBV infection.

Exclusion Criteria:

* systemic therapy with sorafenib
* pretreat lesion
* patients don't sign the informed consent.

Primary outcomes:
measure: CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients.
timeFrame: 6 months
Secondary outcomes:
measure: The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies.
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01228175: Effectiveness of Varenicline: Testing Individual Differences
Official title: Effectiveness of Varenicline: Testing Individual Differences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Addiction
Lead sponsor: The Mind Research Network
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-10-26
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 yrs to 55 yrs
* smoker

Exclusion Criteria:

* Medical Contraindications

Primary outcomes:
measure: Cigarettes Per Smoking Day
timeFrame: up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network
state: New Mexico
Study officials:
affiliation: Director, Neurogenetics Core, The Mind Research Network
name: Kent Hutchison, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891475: Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients
Official title: Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: metastatic renal cell carcinoma
radiofrequency ablation
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.

Detailed description: Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.

Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (\<5 cm) will be evaluated in this Phase I/II study.

Eligibility criteria: Inclusion Criteria:

* Histologically proven renal cell carcinoma before RFA;
* Primary tumor no grater than 5 cm;
* CT-confirmed metastatic measurable sites;
* Good prognosis by adapted MSKCC criteria;
* No treatment for RCC;

Primary outcomes:
measure: Progression-free survival
timeFrame: 11 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: rate of complications
timeFrame: 1 year
measure: time from the end of ablation to start of medical treatment
timeFrame: 3 months
measure: Progression-free survival
timeFrame: 6 months
measure: Quality of life (QOL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Ilya Tsimafeyeu
Study officials:
affiliation: KCRB
name: Ilya V. Tsimafeyeu, MD
role: STUDY_DIRECTOR
affiliation: Beijing Hospital
name: Bin Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: