louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05451303: Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Official title: Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
Premalignant Lesion
Keywords: Viome
oral cancer
detection
OSCC
OPMD-B
OPMD-PM
OPMD
OPV
Tobacco
HPV
Lead sponsor: Viome
Sponsor class: INDUSTRY
Collaborators: name: New York Medical College
First posted: 2022-07-11
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.

Brief summary: To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

Detailed description: This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.

A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.

Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Eligibility criteria: Inclusion Criteria

* Signed Informed Consent obtained
* 18 years and older
* At a high risk of developing oral or throat cancer based on clinician's discretion

Exclusion Criteria

* Pregnancy
* Use of fertility enhancing medications

Primary outcomes:
measure: The primary endpoint will be the detection or not of OSCC or OPC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYMC
state: New York
Study officials:
affiliation: Viome
name: Cristina Julian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06310603: Determinants and Outcomes of High vs. Low Ultra-processed Feeding
Official title: Determinants and Outcomes of High vs. Low Ultra-processed Feeding
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Nutrition
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:

• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.

If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.


Eligibility criteria: Inclusion Criteria:

* rural county resident
* not meeting physical activity guidelines for adults
* consuming a typical Western diet (rich in UPF)

Exclusion Criteria:

* chronic diseases
* tobacco, vape, or illicit drug use
* overly active
* already on a restrictive diet (e.g., keto, intermittent fasting)

Primary outcomes:
measure: Body Weight
timeFrame: 1 year
measure: Body Composition
timeFrame: 1 year
measure: Fat Mass Percentage
timeFrame: 1 year
measure: Fat-Free Mass Percentage
timeFrame: 1 year
Secondary outcomes:
measure: Triglyceride Levels
timeFrame: 1 year
measure: Glucose Levels
timeFrame: 1 year
measure: Cholesterol Levels
timeFrame: 1 year
measure: HDL
timeFrame: 1 year
measure: LDL
timeFrame: 1 year
measure: Alanine transaminase (ALT)
timeFrame: 1 year
measure: Aspartate transaminase (AST)
timeFrame: 1 year
Other outcomes:
measure: Energy Intake
timeFrame: 1 year
measure: Energy Expenditure
timeFrame: 1 year
measure: Gut Microbiome Collection
timeFrame: 1 year
Locations:
city: Stillwater
country: United States
facility: Laboratory for Applied Nutrition and Exercise Science (LANES)
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Sam Emerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177903: Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
Official title: Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: hypothermia
surgical site infection
opioid usage
blood loss
pain severity
anxiety
Length of Stay
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2014-06-30
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.

Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

* Increased comfort in the pre-operative period by being warmer
* Decreased incidence of mild hypothermia
* Possible decreased incidence of transfusion with less bleeding
* Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
* Possible shorter stay in the PACU and overall Length of Stay (LOS)
* Possible decreased risk for surgical site infection


Eligibility criteria: Inclusion Criteria:

* Elective or "urgent" surgery under general anesthesia
* ≥19 years but ≤85 years of age
* Able to provide informed consent.

Exclusion Criteria:

* Refusal of Informed consent
* Metabolic derangement/drug therapy already affecting thermal homeostasis
* Preexisting hypothermia (\<35.5 degreeC) or hyperthermia (\>37.5 degreeC) (oral)
* Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
* Emergency (category 1a) Surgery
* Patients undergoing exclusively spinal or epidural anesthesia
* Patients receiving aortic cross-clamping
* Patients receiving transdermal medications

Primary outcomes:
measure: Duration of hypothermia
timeFrame: Up to 12 hours, until PACU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Staff Anesthesiologist
name: Richard Merchant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.
Clinical trial NCT02844803: Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Official title: Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
* Treated with metformin of ≥ 500 mg/day over 3 months on screening
* Fasting glucose level of 110\~180 mg/dl or HbA1c of 7.0\~9.0% on screening

Exclusion Criteria:

* With acute or chronic inflammation
* Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
* With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
* With acute or chronic renal failure or nephrotic syndrome
* With impaired hepatic function.
* Drug or Alcoholic abuser
* Pregnant or nursing woman

Primary outcomes:
measure: Change of serum glucose level after 8 weeks from baseline
timeFrame: Day1 and Day 57 on the 1st and 2nd periods
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi
Study officials:
affiliation: Dongguk University College of Medicine and Ilsan Hospital
name: Han Seok Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034003: Success of Zirconia and Composite Strip Crowns for Primary Incisors
Official title: Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: zirconia crowns, composite strip crowns, dental caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors

Detailed description: Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.

Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Eligibility criteria: Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least two primary maxillary incisor with caries that require crown restoration
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth with no mobility and enough root length
* Patients that have good cooperation to the procedure

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients who are uncooperative
* Teeth that doesn't have opposing primary incisors
* Patients who have bruxism or deep-bite
* Teeth that are close to be erupted
* Teeth that have vital or non-vital pulp therapy

Primary outcomes:
measure: Number of zirconia and composite strip crowns that showed successful retention over two years
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe university , Faculty of dentistry, ankara/Turkey
name: zafer c cehreli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347503: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Official title: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
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: Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.


Eligibility criteria: Inclusion Criteria:

* Healthy Male/Female 21 years of age of older.
* Patient understands and is willing to sign the written informed consent form
* Likely to complete the entire course of the study.
* Patient is scheduled to undergo cataract surgery
* Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
* Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria:

* Patient has been using a topical NSAID within 1 week of study entry
* Patient has a known sensitivity to any of the ingredients in the study medications
* Patient has sight in only one eye
* Patient has a history of previous intraocular surgery
* Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
* Female patients who are pregnant, nursing an infant or planning a pregnancy
* Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
Study officials:
affiliation: Bucci Vision Center
name: Frank Bucci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015703: Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
Official title: A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vaccine
Keywords: Vaccine, hypertension
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.


Eligibility criteria: Inclusion Criteria:

* Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI)
* Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG.
* Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.

Exclusion Criteria:

* History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption.
* Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing
* Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis

Primary outcomes:
measure: Safety Events
timeFrame: Duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Quintiles Drug Research Unit
Study officials:
affiliation: Quintiles, Inc.
name: Darren Wilbraham, MB., BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536703: Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
Official title: LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aortic Valve Stenosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.


Eligibility criteria: Inclusion Criteria:

1. Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of \< 1 cm2, mean AV gradient of \> 40 mmHg, or AV peak systolic velocity of \> 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
4. Patients are technical and anatomical eligible for interventions

Exclusion Criteria:

1. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:

   Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
2. Subject refuses a blood transfusion.
3. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
4. Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging.
5. Life expectancy is less than one year

Primary outcomes:
measure: Combined rate of death from any cause, myocardial infarction, and stroke
timeFrame: 30 days following procedure
Secondary outcomes:
measure: Number of participants with procedural complications
timeFrame: 30 days following procedure
measure: Functional status (NYHA-classification)
timeFrame: 6 months following procedure
measure: Echocardiographic prosthesis status
timeFrame: 6 months following procedure
measure: Quality of Life (SF-12)
timeFrame: 6 months following procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Jian-an Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05544903: Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
Official title: The Use of Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Flosonics Medical
First posted: 2022-09-19
Enrollment: 150
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: Patients presenting to the emergency department who meet sepsis criteria based on presenting vital signs will be eligible for the study.

Brief summary: The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.


Eligibility criteria: Inclusion Criteria:

* Emergency department patient
* 18+ years old
* Systolic blood pressure less than 100mmHg
* Respiratory rate greater than 22 breaths per minutes
* Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius
* Heart rate greater than 90 beats per minute

Exclusion Criteria:

* Already intubated prior to emergency department arrival
* Ventilator-dependent
* Patients transferred from another hospital
* Pregnancy

Primary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: ICU admission
timeFrame: 24 hours
measure: Rapid response team activation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital
name: Allison Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: