louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02683382: Effects of a Moisturizing Product on Dry Eye and Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Aromtech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Turun Silmäexpertit Oy, Turku, Finland
name: Tekes - The Finnish Funding Agency for Technology and Innovation
name: Finnsusp Oy, Lieto, Finland
First posted: 2016-02-17
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.


Eligibility criteria: Inclusion Criteria:

* Dry eye symptoms OSDI score 20 or higher
* Dryness, burning or foreign body sensation moderate or higher

Exclusion Criteria:

* Severe eye diseases
* Known allergy to any of the ingredients of the product
* Laser surgery of eyes during the last year

Primary outcomes:
measure: Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
measure: Change in tear film osmolarity (mOsm/L)
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
measure: Change in tear film break-up time (s)
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
measure: Change in tear secretion, Schirmer test (mm/min)
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
measure: Change in signs of irritation of eyes, scoring by an eye specialist
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
measure: Change in transepidermal water loss from skin around the eyes (g/m2h)
timeFrame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Secondary outcomes:
measure: Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3)
timeFrame: Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turun Silmäexpertit Oy
Study officials:
affiliation: Turun Silmäexpertit Oy, Turku, Finland
name: Minna Sandberg-Lall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04569682: Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Official title: Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Organ Preservation
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.


Eligibility criteria: Inclusion Criteria:

1. Adult recipients older than 18 years;
2. Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation;
3. First single kidney transplantation;
4. The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
5. Ethics committee approved.

Exclusion Criteria:

1. Patients less than 18 years old, or more than 65 years old;
2. Patients who receive multiple organ transplants;
3. Diagnosed with malignancy or had a history of malignancy in the past 5 years;
4. non-kidney transplantation history.

Primary outcomes:
measure: Delayed graft function
timeFrame: Within one week posttransplantation
Secondary outcomes:
measure: Graft loss
timeFrame: One year after transplantation
measure: biopsy-confirmed acute rejection
timeFrame: One year after transplantation
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
Study officials:
References:
Clinical trial NCT05317182: Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.
Official title: "Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusal Splints
Keywords: Digital Dentistry
Occlusal records
Intraoral scan
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3).

Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.
Primary purpose: OTHER

Brief summary: To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled.

Detailed description: Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment).

Eligibility criteria: Inclusion Criteria:

* Patients between 18 to 70 years old.
* Patients who maintain until first molar in both arches.
* Patients who need occlusal splints due to bruxism.

Exclusion Criteria:

* Pregnant patients.
* Patients with removable prostheses.
* Patients with fixed prostheses between six to six in both arches.
* Patients with partial edentulism, do not maintain until first molar in both arches.
* Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.

Primary outcomes:
measure: Volumetric changes assessed in Root Mean Square (RMS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Blasi Clinica Dental Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Miguel Roig, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00847782: An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism
Official title: An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels


Eligibility criteria: Inclusion Criteria:

* Hypercholesterolemia
* Statin monotherapy

Exclusion Criteria:

* Significant acute or chronic illness
* Secondary causes of hypercholesterolemia

Primary outcomes:
measure: Serum PCSK9 concentration
timeFrame: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled
Secondary outcomes:
measure: Serum LDL cholesterol concentration
timeFrame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
measure: Serum HDL cholesterol concentration
timeFrame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
measure: Serum TG concentration
timeFrame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
measure: Serum Apo B concentration
timeFrame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00988182: The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
Official title: The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Keywords: Whey protein
Hydrolysate whey protein
Blood glucose
Insulin
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Mondelēz International, Inc.
First posted: 2009-10-02
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults.

Detailed description: A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety, insulin and blood glucose were measured at baseline and selected intervals pre- and post-meal.

Eligibility criteria: Inclusion Criteria:

* normal body weight

Exclusion Criteria:

* breakfast skippers
* smokers
* dieters or individuals with diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases

Primary outcomes:
measure: Blood glucose, Insulin, Subjective appetite
timeFrame: 0-170 min
Secondary outcomes:
measure: Physical comfort
timeFrame: 0-170 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akhavan T, Luhovyy BL, Brown PH, Cho CE, Anderson GH. Effect of premeal consumption of whey protein and its hydrolysate on food intake and postmeal glycemia and insulin responses in young adults. Am J Clin Nutr. 2010 Apr;91(4):966-75. doi: 10.3945/ajcn.2009.28406. Epub 2010 Feb 17.
Clinical trial NCT03928782: Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury
Official title: Study on Dose-effect Relationship Between Radiation Injury Dose and Expression of Associated microRNAs in Human Peripheral Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Injuries, Experimental
Keywords: Radiation Injuries
microRNA
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute leukemic patients after chemotherapy,who will be pretreated by whole-body irradiation

Brief summary: Rapid and accurate assessment of radiation injury dose is the key to success in early treatment and an urgent issue to be solved in clinical medicine.Researches showed that the expression of the microRNAs in human peripheral blood had much correlation with radiation injury resulted from different dosages of radiation.In this study,acute leukemic patients who will be pretreated by whole-body radiation are taked as the object of study,and biochip technology are adopted to detect the expression levels of the microRNAs in subject peripheral blood before-and-after radiation,and different expression is tested and Bioinformatics prediction,to evaluate the correlation between radiation injury dose and expression levels of the microRNAs in human peripheral blood.


Eligibility criteria: Inclusion Criteria:

* subjects who suffer from acute leukemic subjects who accept chemotherapy within one month and will be pretreated by whole-body irradiation peripheral blood cells of subjects are approximate to those of healthy person aged between 18 and 50 years old subjects who are competent to give written informed consent subjects without other systemic diseases

Exclusion Criteria:

* subjects who suffer from serious other systemic diseases subjects who are unwilling or unable to cooperate with this clinical study other serious cases that probably hinder this clinical study

Primary outcomes:
measure: expression levels of the microRNAs
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chiese PLA 307 hospital
state: Beijing
city: Beijing
country: China
facility: Chiese PLA 307 hospital
state: Beijing
Study officials:
affiliation: Chinese PLA 307 Hospital
name: Lu rongjian, doctor
role: STUDY_CHAIR
affiliation: Chinese PLA 307 Hospital
name: Guo biao, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT04667182: A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes
Official title: Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: T1D
T2D
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with T1D and T2D

Brief summary: The main purpose of this study is to determine whether combining meal, glucose and insulin data in a web-based system will improve management of type 1 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.


Eligibility criteria: Inclusion Criteria:

* Individuals with type 1 or type 2 diabetes for \>3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
* Insulin pen use for at least 3 months
* Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
* A1c 6.5-9.5%

Exclusion Criteria:

* Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
* Individuals requiring single insulin boluses of \>40 units
* Individuals planning to follow a specific diet plan for weight loss
* Inability to consume regular, consistent meals
* Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
* Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months

Primary outcomes:
measure: Change from Baseline in Area Under the Curve (AUC) of CGM
timeFrame: Baseline, Week 17
Secondary outcomes:
measure: Qualitative data from study investigators and participants
timeFrame: Baseline through Week 17
measure: Percent Time-in-Range (TIR)
timeFrame: Baseline through Week 17
measure: Postprandial TIR
timeFrame: Baseline through Week 17
measure: Time Above Range (TAR)
timeFrame: Baseline through Week 17
measure: Time Below Range (TBR) <70 mg/dL
timeFrame: Baseline through Week 17
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT07014982: Remote Assessment of Digital Neurologic Testing
Official title: Remote Assessment of Digital Neurologic Testing (RADiaNT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurology
Keywords: Neurology
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will have two cohorts; one intervention cohort and one control cohort.
Primary purpose: TREATMENT

Brief summary: The RADiaNT study investigates whether guided meditation, using the Muse™ headband and biofeedback app, can improve sleep, mood, and cognitive performance, aiming to assess its impact on mental and emotional well-being.


Eligibility criteria: Inclusion Criteria:

* Cognition unimpaired or mild cognitive impairment
* Fluent in English
* United States resident
* Able to tolerate wearing Muse headband
* basic competence in using electronic devices (Smartphone or tablet) to engage with the Muse application and complete digital surveys and assessments

Exclusion Criteria:

* Neurological and Brain Disorders
* Not Fluent in English
* Not a US Resident
* Unable to tolerate wearing Muse Headband

Primary outcomes:
measure: Duration in slow wave sleep
timeFrame: 17 weeks
measure: Proportion in slow wave sleep
timeFrame: 17 weeks
measure: Perceived Stress Scale
timeFrame: 17 weeks
Secondary outcomes:
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: 17 weeks
measure: General Anxiety Disorder 7-item (GAD-7)
timeFrame: 17 weeks
measure: Cognitive Performance
timeFrame: 17 weeks
measure: Cognitive Performance
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03296982: Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
Official title: A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Whole blood clotting time
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2017-09-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.

Detailed description: Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).

Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent form
2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -

Exclusion Criteria:

1. Subjects who cannot communicate reliably with the Investigator
2. History of major bleeding or major trauma within the 6 months prior to signing informed consent
3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
4. Significant infection or known inflammatory process in the 2 weeks prior to screening
5. Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
6. Treatment with any investigation product or therapy within 30 days prior to screening
7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
8. Unwilling to comply with the procedures in the protocol
9. Currently enrolled in any other study -

Primary outcomes:
measure: Distribution and variability of WBCT measurements
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Quintiles Phase 1 Services, LLC Overland Park KS
name: Scott Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: