louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237925: Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
Official title: Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Gel) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Mild to Moderate Sunburn Related Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sunburn
Keywords: Sunburn
Dexchlorpheniramine
Gel
Cream
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 124
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria: Inclusion Criteria:

* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Signs of severe sunburn (vesicles, bullae or ulceration)
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy to any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility

Primary outcomes:
measure: Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).
timeFrame: 7 days
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda
state: São Paulo
Study officials:
References:
Clinical trial NCT00534625: Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
Official title: Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma, exacerbation, pulmonary function
Lead sponsor: Critical Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients 12 years of age or older
2. Diagnosis of asthma by current ATS guidelines
3. FEV1 of 4-80%.
4. Reversibility of at least 13% after bronchodilator treatment
5. Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.
6. Informed consent

Exclusion Criteria:

1. Females of child bearing potential unless using birth control
2. Uncontrolled systemic disease
3. Known hypersensitivity to zileuton or components of zileuton injection.
4. Upper or lower respiratory tract infection within the last 2 weeks
5. Admission to hospital or ER visit for asthma exacerbation within the last 3 months
6. Course of oral or parenteral steroids within the last 3 months
7. Current smoker or H/O \> 15 pack years
8. Creatinine \> 1.5 x ULN
9. ALT \> 3 x ULN
10. BP \< 100 (systolic)
11. H/O HIV
12. H/O alcohol or drug abuse
13. Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.
14. Pregnant or breast feeding females
15. Current participation or participation in an experimental drug study within 30 days.

Primary outcomes:
measure: Effect on pulmonary function
timeFrame: Within 0-12 hours after single dose
Secondary outcomes:
measure: Safety assessments
timeFrame: Within 0-36 hours after single dose
Other outcomes:
Locations:
Study officials:
affiliation: Critical Therapeutics
name: Dr. Cees Wortel
role: STUDY_DIRECTOR
References:
Clinical trial NCT04416425: Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment
Official title: Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Lead sponsor: Zibo Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 200 eligible coronary atherosclerosis disease patients were anticipated to include in this study.

Brief summary: Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.


Eligibility criteria: Inclusion Criteria:

* 1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
* 2.patients were referred for optimal medical treatment;
* 3.patients agreed to undergo follow-up CCTA at 1-year interval.

Exclusion Criteria:

* 1.patients had previous history of myocardial infarction or coronary revascularization;
* 2.patients were contraindicated to the usage of iodine contrast media;
* 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
* 4.patients withdrew the informed consents during follow-up;
* 5.patients experienced major adverse cardiac events during follow-up;
* 6.patients refused to undergo follow-up CCTA;
* 7.lost follow-up

Primary outcomes:
measure: the change of lesion-specific CT-FFR
timeFrame: June 2020 to December 2021
Secondary outcomes:
Other outcomes:
measure: the change of minimal lumen diameter between baseline and follow-up CCTA
timeFrame: June 2020 to December 2021
measure: the change of total plaque volume (TPV) between baseline and follow-up CCTA
timeFrame: June 2020 to December 2021
measure: the change of lesion length between baseline and follow-up CCTA
timeFrame: June 2020 to December 2021
Locations:
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
Study officials:
affiliation: Zibo Central Hospital
name: Bo Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03593525: SPARK Symptom Screening and Feedback to Providers
Official title: A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Oncology
Quality of Life
Keywords: Pediatric Oncology
Randomized Control Trial
Symptom Screening
Quality of Life
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 345
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care

Detailed description: Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers

Eligibility criteria: Inclusion Criteria:

* 8 to 18 years of age
* Diagnosis of cancer or have received or about to receive HSCT
* Understand English
* Expected to be in hospital or clinic for 5 day

Exclusion Criteria:

* illness severity
* cognitive disability
* visual impairment

Primary outcomes:
measure: SSPedi (Symptom Screening in Pediatrics) Total Scores
timeFrame: Measure will be completed by all participants on day 5±1 day.
Secondary outcomes:
measure: Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom
timeFrame: Measure will be completed by all participants on day 5±1 day
measure: Faces Pain Scale-Revised
timeFrame: Measure will be completed by all participants on day 5±1 day
measure: PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module
timeFrame: Measure will be completed by all participants on day 5±1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lillian Sung
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598725: Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China
Official title: Beijing Children's Hospital, Capital Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemophilia A With Inhibitor
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 55
Sex: MALE
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study start on January 18, 2017. The Severe(FⅧ\<1%) and moderate hemophilia A (FⅧ1%～5%)children with high titer inhibitor(historical peak inhibitor titer≥5BU ) combining with poor ITI risk(s) were enrolled. The low-dose ITI was alone or combined with immunosuppression.

Detailed description: Poor risk(s) includes:①peak historical inhibitor titer≥200BU ②inhibitor titer≥10BU before ITI initiation ③peak inhibitor titer during ITI≥200BU ④time to titer decline to\<10BU before ITI≥24 months ⑤age≥8 years at start of ITI ⑥ITI initiated ≥5 years after inhibitor diagnosis ⑦interruptions in ITI≥2 weeks in duration. The low-dose ITI strategy consist of FⅧ（25-50IU/kg）alone or combining with immunosuppression: prednisone and Rituximab when the inhibitor titer ≥40BU ml/ml before or during ITI.

Eligibility criteria: Inclusion Criteria:

* Males
* from 1 to 14 years old
* severe or moderate hemophilia A;
* inhibitors positive before ITI started.

Exclusion Criteria:

* Females
* \<1 or \>14 years old
* hemophilia B or mild haemophilia A;
* inhibitor negative before ITI started.

Primary outcomes:
measure: Success rate
timeFrame: 2 years
Secondary outcomes:
measure: Annualized Bleeding Rate
timeFrame: 2 year
measure: Annualized Joint Bleeding Rate
timeFrame: 2 year
measure: Success time
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02067325: Effects of Thai Massage on EMG
Official title: Effects of Thai Massage on EMG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of Thai massage on electromyogram in patients with chronic upper back pain associated with myofascial trigger points.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age between 18 - 50 years old
* The participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* A history of the following diseases or disorders:
* Cervical radiculopathy
* Contraindications of traditional Thai massage
* Contagious skin disease
* Injury or inflammation of muscle
* Bone fracture and/or joint dislocation
* Open wound
* Uncontrolled hypertension
* Drug and/or alcohol intoxication

Primary outcomes:
measure: Muscle activity as a Measure of Electromyogram
timeFrame: 1 day
Secondary outcomes:
measure: Pain scores on Visual Analog Scale
timeFrame: 1 day
measure: Muscle tension on Visual Analog Scale
timeFrame: 1 days
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: School of Health Science, Mae Fah Luang University
state: Chiang Rai
Study officials:
References:
citation: Buttagat V, Narktro T, Onsrira K, Pobsamai C. Short-term effects of traditional Thai massage on electromyogram, muscle tension and pain among patients with upper back pain associated with myofascial trigger points. Complement Ther Med. 2016 Oct;28:8-12. doi: 10.1016/j.ctim.2016.07.004. Epub 2016 Jul 19.
Clinical trial NCT00563225: 20 Week Bridging Study in Type II DM
Official title: A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type II
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus diagnosed at least 3 years ago
* Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
* Treated with OHA monotherapy over at least 1 year
* HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
* BMI \< 40 kg/m2
* No history of ketonemia
* Women of childbearing potential using the medically approved contraceptive method
* Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
Secondary outcomes:
measure: To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Choe Seong Choon
role: STUDY_DIRECTOR
References:
Clinical trial NCT00610025: Minimally Invasive Trocar Placement in Obesity Surgery
Official title: Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: NOTES
transgastric endoscopy
obesity surgery
Roux-en-Y surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Stryker SA
name: Natural Orifice Surgery Consortium for Assessment and Research
First posted: 2008-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.

Detailed description: Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery

Exclusion Criteria:

* Lack of consent
* History of previous gastric surgery
* Contraindication to upper endoscopy

Primary outcomes:
measure: The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient.
timeFrame: At surgery
Secondary outcomes:
measure: Bacterial contamination analysis; results compared to previous study.
timeFrame: Surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center/Center for Minimally Invasive Surgery
state: Ohio
Study officials:
affiliation: The Ohio State University Medical Center/Center for Minimally Invasive Surgery
name: Jeffrey W Hazey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270425: Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis
Official title: Sonographic Characterization of the Thyroid Gland in Patients With Systemic Sclerosis With and Without Hashimoto Thyroiditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Hashimoto Thyroiditis
Thyroid Nodules
Keywords: systemic sclerosis
hashimoto thyroiditis
thyroid nodules
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 60
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 with SSc according to the current international classification

Brief summary: Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.

The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease

Detailed description: The study protocol Fifty patients with SSc according to the current international classification will be included in the study. The patients, followed-up regularly in an out-patient clinic, will be tested for their thyroid function tests as well as the presence of thyroid auto antibodies. Clinical data will be collected from their medical records. Ultrasonographic examination of the thyroid gland will be performed by a single examiner. The gland will be characterized in detail with regards to its size and echotexture and cervical lymph nodes will be detected. The number and size of its nodules will be described as well as their echoic pattern (iso, hyperechoic or hypoechoic) calcifications (micro and macro), and borders status. Large nodules (≥ 1 cm in diameter) or with malignancy- associated characteristics will be aspirated according to current clinical practice. Treatment will be given according to the cytology diagnosis. Thyroid hormone supplementation will be recommended when thyrotropin level \>8 mIU/L or according to clinical judgment of the investigators.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

* non

Primary outcomes:
measure: There are no spesific outcome measures from trail
timeFrame: Nnone
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Israel
name: Pnina Rotman-Pikielny, MD
role: PRINCIPAL_INVESTIGATOR
References: