louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02411955: A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official title: A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 1077
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).

Detailed description: The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
* Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
* Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Primary outcomes:
measure: Change in inflammatory lesion counts
timeFrame: Week 12
measure: Change in non-inflammatory lesion counts
timeFrame: Week 12
Secondary outcomes:
measure: Clinical response of success
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT00181155: Intravenous Allopurinol in Heart Failure
Official title: Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: metabolism
congestive heart failure
allopurinol
Adenosine triphosphate (ATP)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-16
Enrollment: 18
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: This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Detailed description: Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.

The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* The patient is willing and able to provide informed consent
* Clinical diagnosis of chronic heart failure
* Ejection fraction (EF) \< 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
* No significant coronary disease at cardiac catheterization
* New York Heart Association (NYHA) Class I-IV symptoms
* Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.

Exclusion Criteria:

* Metallic implant prohibiting magnetic resonance (MR) evaluation
* Inability to lie flat for MR study
* Administration of additional investigational drugs
* Calculated creatinine clearance \< 50 mL/min
* Allergy to allopurinol
* Current gout flare
* Currently taking oral allopurinol

Primary outcomes:
measure: Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
timeFrame: Onset of imaging acquisition.
measure: Myocardial CK Flux Post Intravenous Allopurinol Infusion.
timeFrame: acute (within 15 minutes of single infusion)
Secondary outcomes:
measure: Cardiac PCr/ATP Pre Intravenous Infusion
timeFrame: Onset of image acquisition.
measure: Cardiac PCr/ATP Post Intravenous Infusion
timeFrame: acute (within 15 minutes of single infusion)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert G Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirsch GA, Bottomley PA, Gerstenblith G, Weiss RG. Allopurinol acutely increases adenosine triphospate energy delivery in failing human hearts. J Am Coll Cardiol. 2012 Feb 28;59(9):802-8. doi: 10.1016/j.jacc.2011.10.895.
Clinical trial NCT01689155: Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
Official title: Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Meningococcal Infection
Keywords: Meningitis
Meningococcal Infection
Menactra®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 116
Sex: ALL
Minimum age (years): 9
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine according to routine clinical practice during the study period.

Brief summary: This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

* To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Detailed description: The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Eligibility criteria: Inclusion Criteria:

* Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Primary outcomes:
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
timeFrame: Day 0 up to Day 75 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.
timeFrame: Day 0 up to Day 75 post-vaccination
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.
timeFrame: Day 0 up to Day 75 post-vaccination
Locations:
city: Oakland
country: United States
state: California
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.
Clinical trial NCT05213455: Booster Effect of mRNA Vaccine on Antibody Response for SARS-CoV-2 After Complete Vaccination With Sinos
Official title: Booster Effect of mRNA Vaccine After Complete Vaccination With Sinos: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccine Reaction
Lead sponsor: Lahore General Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-28
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include participants who have received two doses of sinopharm or sinovac and six months have passed after the second dose.

Brief summary: In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned.

Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2)

Detailed description: In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned.

Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine (BNT162b2, pfizer) as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2).

The antobody IgG RBD levels will be checked before the booster dose and then after 3 weeks of the booster.

Eligibility criteria: Inclusion Criteria:

* people who have received two doses of sinopharm or sinovac and six months have passed after the second dose

Exclusion Criteria:

* people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.

Primary outcomes:
measure: IgG RBD levels
timeFrame: after 3 weeks of booster vaccine dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital
state: Punjab
Study officials:
affiliation: Lahore General Hospital
name: Amina Asif, M.Phil
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahore General Hospital
name: Muhammad Irfan Malik, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594255: CAEB071 Thorough QTc Study in Healthy Volunteers
Official title: A Randomized, Partially Blinded, 4-period, Crossover Study to Assess the Effects of Single-dose AEB071 Administration (300 and 900 mg) on Electrocardiographic QT Intervals Compared to Placebo in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
QT intervals
ECG
QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

Exclusion Criteria:

* Smokers and tobacco product users (in the previous 3 months).
* Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
* A marked baseline prolongation of QT/QTcF interval
* Presence of clinically significant illness
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.
timeFrame: 24 hours
Secondary outcomes:
measure: Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals
timeFrame: 24 hours
measure: Tolerability of 300 and 900 mg of AEB071.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Novartis Investigational Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02865655: Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy
Official title: Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Scar
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings

Brief summary: To apply an existing diagnostic imaging test (saline infusion sonohysterography by Hysteroscopic) to characterize the "filling defect" of a previous cervical cesarean delivery scar in the nonpregnant uterus


Eligibility criteria: Inclusion Criteria:

cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings

Exclusion Criteria:

1) irregular menstrual cycle before cesar¬ean section; 2) previous placement of an intrauterine contracep¬tive device; and 3) presence of another organic uterine pathology responsible for abnormal uterine bleeding examined by hysteroscopy, such as endome-trial hyperplasia, endometrial polyps, malignancy, or submucosal myomas

Primary outcomes:
measure: Cesarean Section Scar Evaluation by TVU and MRI
timeFrame: 2015.12-2016.7
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
state: Shanghai
Study officials:
affiliation: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
name: Xipeng Wang
role: STUDY_CHAIR
References:
Clinical trial NCT02943655: Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Official title: Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Improve Quality of Life
Heavy Menstrual Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.


Eligibility criteria: Inclusion Criteria:

Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.

Exclusion Criteria:

1. Postmenopausal bleeding (over one year since the last menstrual period).
2. Irregular menses or intermenstrual bleeding.
3. Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
4. Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g. non-progestogen-releasing intrauterine contraceptive device, oral contraceptives, other hormonal drug use or anticoagulant agent).
5. Iron deficiency anemia.
6. History of chronic diseases known to interfere with menstrual bleeding or prevent the use of any of the listed drugs e.g previous or current thromboembolic disease.

Primary outcomes:
measure: the amount of menstrual blood loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT01973855: Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
Official title: Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Viral Haemorrhagic Fever
Dengue Fever
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese medicine, Chinese medicine prescriptions mechanism research.

Detailed description: Randomized method: using large sample, central randomized, parallel comparison of Chinese and western medicine and western medicine group.

Eligibility criteria: Inclusion Criteria:

* Viral diseases, such as dengue fever, kidney of hemorrhagic fever, such as xinjiang hemorrhagic fever; Or clinical has fever associated with bleeding as the main performance, and confirmed as the new emergent infectious diseases

Exclusion Criteria:

* Diagnosed with flu, hand, foot and mouth disease, viral hepatitis (except the carrier), liver cirrhosis after hepatitis, AIDS, rabies, encephalitis, polio, measles, German measles, chickenpox, herpes, infectious mononucleosis, infectious atypical pneumonia

Primary outcomes:
measure: Mortality
timeFrame: Anytime of the clinical trail from 2011.1.1 to 2015.12.30
Secondary outcomes:
measure: Safety outcome
timeFrame: From 2012.1 to 2015.12
Other outcomes:
Locations:
city: XiAn
country: China
facility: Xi 'an eighth people's hospital
state: Shanxi
Study officials:
affiliation: Guangzhou 8th hospitol
name: Tan X Hua
role: STUDY_DIRECTOR
References:
Clinical trial NCT05764655: Comparison of Troponin Assay With New POCT Method in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia in Emergency Room (POCT)
Official title: Comparison of Troponin Assay With New POCT Method and in the Automation in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia Entering the Emergency Room (POCT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chest Pain
Myocardial Ischemia
Keywords: chest pain
Myocardial Ischemia
POCT
Troponin
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients accessing at emergency room for acute chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination in the pathway decision-making.

Brief summary: This is a prospective observational study aiming to evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system (by comparison with the results obtained with the Atellica diagnostic system currently in use) and to evaluate the impact of the POCT system on the reduction of decision-making time (particularly of "rule-out"), by evaluating the number of cases in which the conclusion of the decision pathway at 3 h (algorithm currently in use) could have been concluded at 1 h.

Detailed description: Patients accessing the emergency room for chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination for the decision pathway, will be asked to participate at the study. A blood draw will be performed (for determination of Troponin value, with classical method in use and with POCT method) at time:

* Zero (acess at the emergency room)
* 1 h
* 3 h

Eligibility criteria: Inclusion Criteria:

* Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
* Sign of Informed Consent

Exclusion Criteria:

* Diagnostic electrocardiographic picture for Acute Coronary Syndrome-STEMI (ACS-STEMI)
* Absence of symptomatology in the 12 hours prior to admission to the emergency room
* Post-traumatic chest pain

Primary outcomes:
measure: The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The impact of the POCT system on the reduction of decision-making time
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Maria Luisa Biondi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: