louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06066671: The Effect of an Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity
Official title: Evaluation of the Effect of na Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching Pain
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into 3 different groups - GC (placebo); GN (potassium nitrate and sodium fluoride); GCO (copaiba oil resin). The dental elements of the GCO received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GC and GN groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).


Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never undergone bleaching therapy
* not present dental hypersensitivity
* don't be a smoker
* don´t be pregnant
* present at least 28 teeth in the oral cavity

Exclusion Criteria:

* volunteers undergoing orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.

Primary outcomes:
measure: Assessment of post-bleaching sensitivity
timeFrame: 21 days
Secondary outcomes:
measure: Color evaluation
timeFrame: Baseline (Ti) and one week after the 3rd bleaching session (Tf)
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Para
state: PA
Study officials:
References:
Clinical trial NCT03870971: User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Official title: User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Sciema UG
Sponsor class: OTHER
Collaborators: name: Cnoga Medical Ltd.
First posted: 2019-03-12
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.


Eligibility criteria: Inclusion Criteria:

* patients with type 1 or type 2 diabetes or healthy
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;

Exclusion Criteria:

* Does not meet inclusion criteria;
* Subjects with any other severe disease in the discretion of the investigator
* Not capable to read English user instructions at the discretion of the patient
* Pregnancy or Nursing mothers
* Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)
* Illiteracy

Primary outcomes:
measure: measurement performance
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
Study officials:
References:
Clinical trial NCT01822171: Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients
Official title: Multi-Disciplinary Discharge Counseling and MTM Services After Discharge for Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Medication Therapy Management
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Readmission to a hospital shortly after discharge is a common and costly problem. In the United States patients with a diagnosis of heart failure currently experience an elevated 30 day readmission rate of approximately 20%. By providing patients with medication related counseling at discharge by a pharmacist, home medications at discharge, and seeing the patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after discharge, the study anticipates achieving its primary goal of showing a reduction in the readmission rate. Secondary goals are: 1) to determine patients understanding of the medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge counseling service, and 3) determine the number of interventions made and benefit of the MTM clinic.

Detailed description: The active arm of this study (medication related hospital discharge counseling by a pharmacist, home medications, and 7 day follow-up visit at a pharmacist run MTM clinic) is available to all subjects. To study the primary goal of reducing the 30 day readmission rate the data obtained from the active arm subjects will be compared to a match group of hospitalized patients that were previously discharged with a diagnosis of heart failure. The data for all secondary study goals will be obtained directly from the active arm subjects.

Eligibility criteria: Inclusion Criteria:

* Heart Failure with high risk for readmission.
* Enroll in study prior to hospital discharge.

Exclusion Criteria:

-

Primary outcomes:
measure: Reduction in hospital readmissions
timeFrame: 30 day
Secondary outcomes:
measure: Patient assessment of home medications knowledge at time of hospital discharge
timeFrame: 3 days
measure: Patient satisfaction with comprehensive discharge counseling service.
timeFrame: 7 Days
measure: Number of interventions made at the MTM clinic.
timeFrame: 7 Days.
measure: Types of interventions made at the MTM clinic.
timeFrame: 7 days
Other outcomes:
Locations:
city: Centralia
country: United States
facility: Providence Centralia Hospital
state: Washington
city: Olympia
country: United States
facility: Providence St. Peter Hospital
state: Washington
Study officials:
affiliation: Providence St. Peter Hospital
name: Laura Hoekstra, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943371: A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Divided Rising-Dose, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6349 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 28
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: A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.


Eligibility criteria: Inclusion Criteria:

* Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age
* Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs

Exclusion Criteria:

* Subject is on insulin or a PPAR agonist medication
* Subject has Type 1 diabetes

Primary outcomes:
measure: Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences
timeFrame: Through 30 days after the last dose of study drug
measure: 15-Hour weighted mean plasma glucose (WMG) concentration
timeFrame: 15 hours postdose
Secondary outcomes:
measure: 4-Hour weighted mean plasma glucose (WMG) concentration
timeFrame: 4 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04858971: Survey of Diet and Health Beliefs
Official title: Effect of Dietary Advice Source on Perceptions of Information Accuracy and Intended Compliance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Guidelines
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2021-04-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 include American adults aged 18 and over. Minors, i.e., those under 18, will be excluded. To participate, people must have access to internet. Therefore, by default, those who do not have internet access will be excluded from this study. Due to the nature of this study, participants from all over the country will be eligible to participate.

Brief summary: The purpose of this research is to better understand people's health and diet knowledge, beliefs, attitudes, and practices. The researchers will use this information to implement better strategies to help Americans maintain more nutritious diets.

Detailed description: The overall goal of this study is to determine whether there are differences in perceptions of healthy nutrition messages depending on from whom the message is coming. More specifically, the researchers aim to examine whether there are differences in how people perceive and intend to follow nutrition information that is coming from a variety of sources.

Eligibility criteria: Inclusion Criteria:

* US citizen
* have access to internet
* have an Amazon Mechanical Turk (MTurk) account

Exclusion Criteria:

* under 18 years of age
* no access to internet

Primary outcomes:
measure: Perception of health information
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Alese Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00129571: Study of XL820 in Adults With Solid Tumors
Official title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of XL820 Administered Orally to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2005-08-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of XL820 when given orally to adults with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor
* Cancer for which standard therapies do not exist or are no longer effective
* Life expectancy of \> 3 months
* Adequate bone marrow, liver, and kidney function
* Willing to use accepted method of contraception during the course of the study
* Negative pregnancy test (females)
* Written informed consent

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
* Radiotherapy to more than 25% of bone marrow within 4 weeks of the start of treatment
* Investigational drug within 30 days of the start of treatment
* Subjects with known brain metastasis
* Uncontrolled medical disorder such as infection or cardiovascular disease
* Subjects known to be HIV positive
* Pregnant or breastfeeding women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
Study officials:
References:
Clinical trial NCT00410371: Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
Official title: An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mental Disorders
Keywords: tolerability
safety
Pharmacokinetic characteristics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility criteria: Inclusion Criteria:

* Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.

Exclusion Criteria:

* Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
* Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
* Female subjects using hormonal replacement therapy.
* History of regular alcohol consumption
* Current smokers of 10 or more cigarettes per day

Primary outcomes:
measure: Lamotrigine AUC(0-inf) and Cmax
timeFrame: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary outcomes:
measure: tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points
timeFrame: throughout study
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02121171: Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma
Official title: Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Congenital Glaucoma
Lead sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Sponsor class: OTHER_GOV
Collaborators: name: Aeon Astron Europe B.V.
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital glaucoma cases, the efficacy being the primary objective and the safety being the secondary. The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen matrix implant implantation in congenital glaucoma is a safer procedure and may yield better results than combined trabeculotomy-trabeculectomy approach.

Detailed description: "Ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in filtration surgery, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects.

Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 7,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.

Eligibility criteria: Inclusion Criteria:

* Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Haab's stria with or without optic disc cupping.

Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.

Within the age of (0 - 12).

Exclusion Criteria:

* Cases of congenital glaucoma with previous intervention. Age above 12 Yrs. Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma

Primary outcomes:
measure: Intraocular pressure(IOP) reduction
timeFrame: At postoperative up to 24 months
Secondary outcomes:
measure: Postoperative complications and appearances.
timeFrame: At postoperative up to 24 months.
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: National Centre of Ophthalmology
Study officials:
affiliation: Ophthalmologist at National Centre of Ophthalmology
name: Nigar Makhmudova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00492271: First Time in Man Trial for Friulimicin B
Official title: A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Community Acquired Pneumonia
Staphylococcal Skin Infections
Keywords: Friulimicin B
Lipopeptide Antibiotic
First in Man
Lead sponsor: MerLion Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Detailed description: Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.

This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Eligibility criteria: Inclusion Criteria:

* Male or female healthy subjects
* 18-55 years of age
* In good health

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis.
timeFrame: 5 days
Secondary outcomes:
measure: To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects
timeFrame: 5 days
measure: To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B
timeFrame: 5 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Swiss Pharma Contract Ltd
Study officials:
affiliation: Swiss Pharma Contract
name: Michael Sieberling, MD
role: PRINCIPAL_INVESTIGATOR
References: