louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05055778: Establishing the Effectiveness of Publicly Available Smoking Cessation Resource
Official title: Establishing the Effectiveness of Publicly Available Smoking Cessation Resources: Does Rurality Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of SmokefreeTXT, a smoking cessation text messaging program currently available to anyone in the United States through www.smokefree.gov, and to compare cessation outcomes for smokers living in different regions of Virginia while participants use the program. Participants will be asked to complete assessments at Baseline, 7 weeks, 3 months, and 6 months and will be asked to use a research version of SmokefreeTXT.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Current cigarette smoker (has smoked at least 100 cigarettes in their lifetime and currently smokes)
* Ability to read and speak English
* Resident of Virginia
* Owns a cell phone

Exclusion Criteria:

* Not a current smoker (e.g., started a quit attempt between providing interest information and starting the study)
* Identity not able to be verified from information provided on interest form
* Does not own a cell phone
* Pregnant smoker or may become pregnant in the next 6 months
* Lives in an area that has met recruitment criteria (after recruitment has begun)

Primary outcomes:
measure: Self-reported Smoking Cessation
timeFrame: 7 weeks after study start
measure: Self-reported Smoking Cessation
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported Continuous Abstinence
timeFrame: 7 weeks after study start
measure: Self-reported Continuous Abstinence
timeFrame: 3 months
measure: Self-reported Smoking Cessation
timeFrame: 6 months
measure: Self-reported Continuous Abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT02168478: Neo-Synalar Modified 48 Hour Patch Test
Official title: A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergy
Keywords: Neo-Synalar
Patch Test
Sodium lauryl sulfate
Saline
Presensitization
Lead sponsor: Medimetriks Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2014-06-20
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline).

The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.

Detailed description: Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale).

The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 to 79 years inclusive.
* Subjects must be able to understand and execute informed consent.
* Female subjects must produce a negative pregnancy test.
* Subjects must be capable of following directions.
* Subjects must be considered reliable .

Exclusion Criteria:

* Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial.
* Female subjects who are pregnant.
* Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products.
* Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial.
* Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin.
* Subjects with known allergy to corticosteroid.
* Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).

Primary outcomes:
measure: Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
timeFrame: 48, 96 and 168 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Michael Caswell PhD., CCRC,CCRA
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Corporation
name: Michael Caswell, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02988778: Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
Official title: Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Persistent Rhinitis Moderate to Severe
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Detailed description: Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.

This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 12
2. History of allergic persistent rhinitis moderate to severe at least 2 years
3. Proved allergic using PRICK or RAST test
4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1
5. Indication of nasal corticosteroids use
6. Washout of nasal corticosteroids for 14 days
7. ICF

Exclusion Criteria:

1. Other types of rhinitis
2. Asthma non controlled
3. Use of oral/injectable corticoids 30 days before screening
4. patients not eligible to complete diaries
5. patients with allergy to any substance of medicines
6. non controlled disease

Primary outcomes:
measure: Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Alexandra Dumont
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: Mauro Acir Crippa Junior, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714778: Toxins and Delivery in e-Cigarette Users
Official title: Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smokers from the community who wish to stop smoking.

Brief summary: Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects.

To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time.

To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting.

This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.


Eligibility criteria: Inclusion Criteria:

* Smokers who want help in quitting
* Aged 18 or over

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* People with any current serious illness

Primary outcomes:
measure: Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)
timeFrame: 4 weeks
measure: Electronic cigarette acceptability
timeFrame: 6 months
measure: Use of electronic cigarettes
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
Study officials:
References:
Clinical trial NCT03004378: Interventions for Adolescent Obesity
Official title: The Role of Activity Tracking on Weight Loss in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Obesity
Keywords: obesity
adolescent
tracking device
fitbit
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

Detailed description: This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.

Eligibility criteria: Inclusion Criteria:

Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition

Exclusion Criteria:

Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English

Primary outcomes:
measure: Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.
timeFrame: 18 weeks
Secondary outcomes:
measure: Body mass index (BMI) (kg/m2)
timeFrame: Change from 0 to 18 weeks
measure: Weight (kg)
timeFrame: Change from 0 to 18 weeks
measure: Change in obesity related biomarkers
timeFrame: Change from 0 to 18 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Kanika K Bowen-Jallow, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowen-Jallow K, Nunez-Lopez O, Wright A, Fuchs E, Ahn M, Lyons E, Jupiter D, Berry L, Suman O, Radhakrishnan RS, Glaser AM, Thompson DI. Wearable Activity Tracking Device Use in an Adolescent Weight Management Clinic: A Randomized Controlled Pilot Trial. J Obes. 2021 Jan 7;2021:7625034. doi: 10.1155/2021/7625034. eCollection 2021.
Clinical trial NCT03546478: 99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
Official title: 99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: SPECT/CT
HER2 imaging
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 32
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed description: 99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-ABH2 SPECT/CT in stratifying breast cancer.

Eligibility criteria: Inclusion Criteria:

Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

Exclusion Criteria:

Pregnancy Breastfeeding Renal function: serum creatinine \> 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Primary outcomes:
measure: T/B
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical Colleg
name: Fang Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01905878: Biological Half Life of DLBS1033 in Healthy Volunteers
Official title: Biological Half Life of DLBS1033 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Condition
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dexa Medica Group
First posted: 2013-07-23
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was open label-single arm trial, which was done at Pharmacology and Therapeutic Department and Clinical Pathologic Department of Faculty Medicine of University of Indonesia Cipto Mangunkusumo Hospital. The study drug was enteric coated DLBS1033 tablet, which contained 490 mg bioactive protein fraction; and produced by PT Dexa Medica, Tangerang, Indonesia.
Primary purpose: BASIC_SCIENCE

Brief summary: DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a drug that consists of serin protease enzyme, suspected that the mechanism of action of lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic of this drug. As a pilot study, the aim of this study is to evaluate biological half life of DLBS1033.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-55 years old
* Body mass index between 18-25 kg/m2
* Normal physical examination
* Patient still have the ability to undergo examinations and give written informed consent
* Plasmin-antiplasmin complex (PAP complex) level between 0-514 ng/ml

Exclusion Criteria:

* Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia
* Creatinin serum more than 1,5 x ULN
* SGOT and SGPT more than 3 x ULN
* Blood pressure ≥ 140/90 mmHg
* Fasting blood glucose \> 126 mg/dL
* Alcohol patients
* Took any medications (including traditional medicine, supplement and vitamin) in 1 week before the study)
* Patient has bleeding history which unclear etiology
* Hemoglobin \< 10 g/dL
* Thrombocyte count \< 100.000/microliter
* Heavy smoker (Bringman Index \> 600)

Primary outcomes:
measure: Serial Plasmin-antiplasmin complex (PAP complex)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia
Study officials:
affiliation: Indonesia University
name: Anggi Gayatri, MD, SpFK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00661778: A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Official title: An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Stage IIIb or IV non-small cell lung cancer.
* Chemotherapy-naive.

Exclusion Criteria:

* Previous treatment for non-small cell lung cancer.
* Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
* Recent or current chronic treatment with aspirin (\> 325 mg/day).

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 4 years)
Secondary outcomes:
measure: Percentage of Participants With an Objective Response
timeFrame: Baseline to the end of the study (up to 4 years)
measure: Duration of the Objective Response
timeFrame: Baseline to the end of the study (up to 4 years)
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 4 years)
measure: 1-year Survival
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Cádiz
country: Spain
state: Cadiz
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Alcala de Henares
country: Spain
state: Madrid
city: Sagunto
country: Spain
state: Valencia
city: Castellon
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Palencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Valladolid
country: Spain
city: Zamora
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: