louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01671891: Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
Official title: Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: rectal cancer
circulating tumor cells
predict responses
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rectal cancer diagnosed with stage II-IV

Brief summary: Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically verified rectal carcinoma
* Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
* the distance from anal verge \<= 12cm
* with or without metastasis
* Age 18-75 years old
* ECOG PS 0-2
* No previous chemotherapy or radiotherapy for rectal carcinoma
* Written informed consent

Exclusion Criteria:

* no histologically verified rectal carcinoma
* rectal cancer with stage I
* distance from verge \>12cm
* age \<=18 or \>=75 years old
* performed previously chemotherapy or radiotherapy
* infection diseases within three months
* serious other diseases
* no written informed consent

Primary outcomes:
measure: circulating tumor cells level changes after radiotherapy
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: disease-free survival
timeFrame: 3 years
measure: serum carcinoembryonic antigen (CEA) level
timeFrame: 3 years
measure: pathological response (tumor regression grade)if surgery
timeFrame: 3 years
measure: RECIST-based tumor response at 10 week after radiotherapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT00938691: Optimal Suture Choice for Improved Scar Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix
Keywords: Scar
Appearance
Spread
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2009-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.


Eligibility criteria: Inclusion Criteria:

Patients requiring excision of a lesion on chest, back, or shoulders

Exclusion Criteria:

* History of ionizing radiation
* History of keloid or hypertrophic scarring
* History of or current internal malignancy
* History of bleeding disorder
* History of collagen or elastin disorder
* Current use of immunosuppressive medications

Primary outcomes:
measure: Scar spread
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: Scar appearance
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Dermatology, UT-Southwestern
name: Kevin F Kia, MD
role: STUDY_DIRECTOR
References:
citation: Kia KF, Burns MV, Vandergriff T, Weitzul S. Prevention of scar spread on trunk excisions: a rater-blinded randomized controlled trial. JAMA Dermatol. 2013 Jun;149(6):687-91. doi: 10.1001/jamadermatol.2013.3004.
Clinical trial NCT00534391: Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage
Official title: Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hordeolum
Keywords: Antibiotics
hordeolum
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage

Detailed description: Hordeolum is a common eyelid disease. In case of mass, I\&C is required but role of antibiotic after I\&C is not clear. It may not need in post drainage period.

Eligibility criteria: Inclusion Criteria:

* at least 5-millimeters hordeolum
* the onset within 7 days

Exclusion Criteria:

* previous incision and curettage of the same site within 1 month or more than 3 times
* lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
* The patients with immunodeficiency, history of bleeding tendency
* allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine

Primary outcomes:
measure: Pain scale
timeFrame: 1,3,7 days after treatment
Secondary outcomes:
measure: Mass size and duration of cure
timeFrame: 1, 3, 7, 30 days after treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Ophthalmology, Chulalongkorn University
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
name: Parima Hirunwiwatkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirunwiwatkul P, Wachirasereechai K. Effectiveness of combined antibiotic ophthalmic solution in the treatment of hordeolum after incision and curettage: a randomized, placebo-controlled trial: a pilot study. J Med Assoc Thai. 2005 May;88(5):647-50.
Clinical trial NCT02159391: The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs.
Official title: The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AODD and AODR Disorder
Keywords: Accident Prevention
Alcohol Drinking
Substance-Related Disorders
Motivational Interviewing
Adult
Humans
Intervention Studies
Recurrence
Risk Factors
Trauma Centers
Wounds and Injuries/epidemiology
Wounds and Injuries/etiology*
Wounds and Injuries/prevention & control*
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
name: Andaluz Health Service
First posted: 2014-06-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism.

Detailed description: Objectives:

1. To determine the efficacy of Brief Motivational Interview against an usual hospital treatment (no psychological treatment) in patients who have suffered an accident under the influence of drugs (1) to reduce risk behaviors and drug consumption and (2) to increase motivation to change behavior and risk perception.
2. To investigate the mediating role of impulsive personality and decision making in the impact of Brief Motivational Interview on reduction of risk driving.
3. To assess the economic viability of the results of Brief Motivational Interview through a cost-utility analysis.

Eligibility criteria: Inclusion Criteria:

* Trauma patients who have had: 1) A road crash, 2) A sport injury, 3) Occupational accident.
* Tested positive on alcohol and/or other abuse drugs tests.

Exclusion Criteria:

* Cognitive or brain-damage that prevent assessment and Brief Motivational Interview
* Psychopathological disorders
* Residence status that prevents follow-up (residence outside of Spain, homeless).

Primary outcomes:
measure: Risk behavior
timeFrame: Baseline, month 3.
Secondary outcomes:
measure: Alcohol and Other Drug consumption
timeFrame: Baseline, month 3.
measure: Motivation to change
timeFrame: Baseline, post-intervention, month 3
measure: Risk perception
timeFrame: Baseline, post-intervention, month 3.
measure: General Health
timeFrame: Baseline, month 3.
Other outcomes:
measure: Risk Taking and Impulsive Behavior
timeFrame: Baseline, month 3.
measure: Real-life decision making
timeFrame: Baseline, month 3.
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
state: Andalucia
Study officials:
affiliation: Universidad de Granada
name: Raquel Vilar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05987891: Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test
Official title: The Influence of Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test in Asymptomatically Subjects: a Clinical Perspective (ERGO-RISC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cardiovascular Abnormalities
Healthy
Keywords: treadmill exercise test
asymptomatic subjects
Cardiovascular risk factor
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and assymptomatically subjects who are visiting cardiologyst for routine.

Brief summary: The goal of this observational cross-sectional study is to analyze the effect of cardiovascular risk factors in healthy and asymptomatic populations. The main questions it aims to answer are:

* Does the combination of the presence of different risk factors increase the risk for abnormalities appearing on electrocardiograms, such as ischemia, arrhythmia, and hemodynamics effects during and at the peak of effort of treadmill exercise test?
* What are the main differences observed in the recovery period? Participants will answer an anamnesis of risk factors such as sex, race, age, familiar history of coronary artery disease, overweight or obesity, smoking, stress, and physical activity practice and perform treadmill exercise test on Ellestad protocol. If there a comparison groups: Researchers will compare individuals with most risk factors with those without, to see the cardiovascular responses.

Detailed description: The main outcomes broad the effect of simples and easy doccumented cardiovascular risk factors such as sex, race, age, familiar history of coronary artery disease, overweight or obesity, smoking, stress, and physical inactivity on electrocardiogram and hemodinamics abnormalities during and after exercise treadmill exercise test.

Eligibility criteria: Inclusion Criteria:

* Subjects that can complete the treadmill exercise test with the Ellestad protocol with 6 minutes of recovery.

Exclusion Criteria:

* Use of remedies for blood pressure, glycemia, cholesterol, and serum lipids;
* Symptomatically subjects;
* Electrocardiogram that are not able to be interpreted;
* Blood pressure in rest state ≥180 mmHg and ≥110 mmHg, for systolic and diastolic, respectively.

Primary outcomes:
measure: ECG abnormalities and risk factors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Pró-Coração
state: SP
Study officials:
References:
Clinical trial NCT00553891: Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
Official title: Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nasal Obstruction
Adenoids Hypertrophy
Adenoidectomy
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.

This study was terminated - Please see "P04367 - Lebanon"


Eligibility criteria: Inclusion Criteria:

* Should be between 2 and 11 years.
* Should have nasal obstruction for at least 3 months.
* Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause \>50% obstruction of the posterior choanae.
* May have concomitant allergic rhinitis, by history, \& and specific blood studies; however, the symptoms should be under control during the study period.

Exclusion Criteria:

* Patients with less than 50% obstruction of the post choanae.
* Patients with history of recurrent epistaxis or immunodeficiency.
* Patients with severe septal deviation.
* Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
* Known allergy to the drug.
* Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded).
* Cystic fibrosis \& other causes responsible for nasal obstruction.
* Infection (ie; sinusitis).
* History of recent surgery or trauma to nose, unless all wounds have healed.

Primary outcomes:
measure: To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.
timeFrame: The total duration of therapy is 3 months the follow up period is for 12 months.
Secondary outcomes:
measure: To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.
timeFrame: The total duration of therapy is 3 months the follow up period is for 12 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02869191: Blood Cultures's Profitability in Intensive Care Unit
Official title: Blood Cultures's Profitability in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All admitted patients in intensive care unit

Brief summary: The purpose of this study is to assess the blood cultures' profitability in intensive care unit and create a validated prediction rule for extractioning in critical patients.

Detailed description: Implementing a predictive rule blood cultures to determine the probability of positive or negative result, improving the profitability of the diagnostic test.

Eligibility criteria: Inclusion Criteria:

* Patients who have been extracted blood culture sample

Exclusion Criteria:

* Under-aged, pregnants, Major burns.

Primary outcomes:
measure: Percentage of positive, negative and contaminated blood cultures
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of positive, negative and contaminated blood cultures after training program
timeFrame: 9 months
Other outcomes:
measure: Contamination rates of blood cultures
timeFrame: 1 year
Locations:
city: Getafe
country: Spain
facility: Hopsital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe
name: Susana Arias, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514291: Sleep Intervention for Pediatric Epilepsy
Official title: Evaluation of a Clinic-based Sleep Intervention for Pediatric Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to develop and evaluate a sleep intervention program for improving sleep and health in youth with epilepsy and their parents.

Detailed description: Sleep problems are more prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Inadequate sleep has long been recognized as a trigger for seizure and poor sleep habits have been associated with unfavorable outcomes in children with epilepsy. Attention to sleep in children with epilepsy as a result is critically important for seizure control and health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations.

Exclusion Criteria:

* Children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.

Primary outcomes:
measure: Objective sleep
timeFrame: 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shao-Yu Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai SY, Lee WT, Lee CC, Jeng SF, Weng WC. Behavioral-educational sleep interventions for pediatric epilepsy: a randomized controlled trial. Sleep. 2020 Jan 13;43(1):zsz211. doi: 10.1093/sleep/zsz211.
citation: Tsai SY, Lee WT, Lee CC, Jeng SF, Weng WC. Sleep in children with epilepsy: the role of maternal knowledge of childhood sleep. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy157.
Clinical trial NCT00486291: Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Official title: A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, Obese diabetics
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
First posted: 2007-06-14
Enrollment: 210
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Type 2 Diabetes
* BMI 27-42
* Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

* BP \> 150/95
* Stroke/MI/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic, or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* History of glaucoma
* Pregnancy or breastfeeding
* Alcohol abuse
* Eating disorder
* Excluded medications

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 28.
timeFrame: Baseline to 28 weeks
Secondary outcomes:
measure: Absolute Weight Change (kg) From Baseline to Week 28
timeFrame: Baseline to 28 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: VIVUS LLC
name: Barbara Troupin, MD, MBA
role: STUDY_DIRECTOR
References: