louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00436540: A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
Official title: A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved

Exclusion Criteria:

* Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® spray or more than 50 grams per week of Olux® foam
* Subjects whose psoriasis involves the scalp, face or groin
* Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Primary outcomes:
measure: Efficacy - Body Surface Area, Investigator Global Severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety - Tolerability assessments, adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Saint Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
Study officials:
affiliation: Galderma Laboratories, LP
name: Ronald W. Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00591240: A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
Official title: A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Bladder, Neurogenic
Keywords: RNA, ribosomal, 16S
Biosensing techniques
Microchip analytical procedures
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-01-11
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at risk for urinary tract infections.

Brief summary: The purpose of this proposal is clinical validation of an electrochemical biochip for rapid pathogen identification and antibiotic susceptibility determination.

Detailed description: Point-of-care identification of pathogens and determination of antibiotic susceptibility will significantly improve the clinical management of urinary tract infection. We have previously developed a biochip based on microfabrication technology capable of rapid detection of pathogens. The specific objectives of the current proposal are: 1) Determination of microbial constituents in spinal cord injury (SCI) patients and development of additional species-specific probes against these pathogens; 2) Development of a rapid antibiotic susceptibility and molecular pyuria assay using the electrochemical biochip; and 3) Clinical validation of the biochip as a diagnostic test for urinary tract infection.

Within a single protocol, two non-interventional studies were conducted at different time points to achieve the aforementioned objectives. Sensitivity and specificity of the electrochemical biosensor based assay was demonstrated in each study.

Eligibility criteria: Inclusion Criteria:

* Patients suspected or at risk for complicated urinary tract infections

Exclusion Criteria:

* Gross contamination of urine samples at the time of collection

Primary outcomes:
measure: Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.
timeFrame: Up to 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Joseph C. Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen CH, Lu Y, Sin ML, Mach KE, Zhang DD, Gau V, Liao JC, Wong PK. Antimicrobial susceptibility testing using high surface-to-volume ratio microchannels. Anal Chem. 2010 Feb 1;82(3):1012-9. doi: 10.1021/ac9022764.
citation: Mach KE, Du CB, Phull H, Haake DA, Shih MC, Baron EJ, Liao JC. Multiplex pathogen identification for polymicrobial urinary tract infections using biosensor technology: a prospective clinical study. J Urol. 2009 Dec;182(6):2735-41. doi: 10.1016/j.juro.2009.08.028. Epub 2009 Oct 17.
Clinical trial NCT01979640: Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preventing Blood Leakage of Bronchial Cuff
Keywords: bronchial cuff
double lumen tube
blood tight seal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
* patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube

Exclusion Criteria:

* dislocation or great movement of double lumen tube depth

Primary outcomes:
measure: leakage of autologus blood through bronchial cuff
timeFrame: 10, 20, 30 minutes after dripping of blood around bronchial cuff
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00998140: Optimizing Resuscitation After Cardiac Arrest in the Community
Official title: Optimizing Resuscitation After Cardiac Arrest in the Community: Increasing the Probability of Survival While Reducing Costs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiopulmonary Arrest Outcome
Keywords: resuscitation
sudden death
cardiopulmonary resuscitation
emergency medical services
termination of resuscitation
ventricular fibrillation
out-of-hospital cardiac arrest
asystole
medical futility
withdrawing treatment
transportation of patients
health expenditures
healthcare costs
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.

Brief summary: Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with asystole; this seems primarily to be the result of long collapse-to-arrival times. Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with a futile prognosis, leading to excessive costs.

Study hypotheses:

1. Subpopulations for whom intervention is futile/counter-productive are identifiable
2. Substantial waste of resources can be avoided
3. Optimization of emergency medical services (EMS) reorganization without adding resources is an achievable goal


Eligibility criteria: Inclusion Criteria:

* All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.

Exclusion Criteria:

* Patients with do-not-resuscitate orders or an advance directive to that effect.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Sharon Einav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pachys G, Kaufman N, Bdolah-Abram T, Kark JD, Einav S. Predictors of long-term survival after out-of-hospital cardiac arrest: the impact of Activities of Daily Living and Cerebral Performance Category scores. Resuscitation. 2014 Aug;85(8):1052-8. doi: 10.1016/j.resuscitation.2014.03.312. Epub 2014 Apr 12.
Clinical trial NCT00329940: Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
Official title: Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Letrozole
breast cancer
critical musculoskeletal
postmenopausal
rheumatologic tolerance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
* Polymorphonuclear neutrophils (PNN) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (Hb) ≥ 10 g/dL
* Bilirubin ≤ 30 μmol, SGOT/SGPT \< 3N
* Fully signed informed consent

Exclusion Criteria:

* Pain due to bone fracture
* Metastatic disease
* Hormone therapy other than anastrozole
* Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
* Hypersensitivity to letrozole or its components

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day
timeFrame: at 1, 3 and 6 months of letrozole treatment
Secondary outcomes:
measure: To determine the causes of discontinuation
timeFrame: at 1, 3 and 6 months of letrozole treatment
measure: To determine how long letrozole treatment is maintained
timeFrame: at 1, 3 and 6 months of letrozole treatment
Other outcomes:
Locations:
city: Saint Cloud
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01213940: Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)
Official title: Vascular Endothelium Changes After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: American Society for Metabolic and Bariatric Surgery
First posted: 2010-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.

Detailed description: Same as above

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes, Glucose \> 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.

Exclusion Criteria:

* Type 1 Diabetes

Primary outcomes:
measure: Change in Late Outgrowth Endothelial Progenitor Colonies
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: University of South Alabama, Department of Surgery
name: William O Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03911440: Treatment and Vaccine Development of Mycoplasma Pneumoniae
Official title: Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atypical Pneumonia
Keywords: Mycoplasma pneumoniae, Macrolide-resistance, Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

Detailed description: Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae.

Eligibility criteria: Inclusion Criteria:

* Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
* The diagnosis is made within 72 hours after fever onset.
* The patient and his/her guardians are willing to participate the study and able to follow the instruction.

Exclusion Criteria:

* None

Primary outcomes:
measure: Defervescence
timeFrame: Up to 10 days
Secondary outcomes:
measure: Hospital stay
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02143440: The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
Official title: The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes.
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.


Eligibility criteria: Inclusion Criteria:

All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital.

Exclusion Criteria:

Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.

Primary outcomes:
measure: When the glucose level decreased to about 10 mmol/L
timeFrame: 72-96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04856540: Adult Outcomes of Children With CAPS
Official title: Clinical Characteristic and Quality of Life Assessment in Adulthood of Patients With Cryopyrin Associated Periodic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryopyrin Associated Periodic Syndrome
Keywords: CAPS Cryopyrin associated periodic syndromes
MWS Muckle-Wells syndrome
CINCA Chronic infantile neurological cutaneous and articular syndrome ;
FCAS Familial cold auto-inflammatory syndrome
Phenotype ; Quality of life
Quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients follow-up in a CEREMAIA reference or competence center.

Brief summary: The patients included in this study were followed up in the Internal Medicine and Paediatrics Departments of the Lille CHU, the Paediatric Rheumatology and Immunology Department of the Necker Enfant Malade Hospital in Paris and the Paediatric Rheumatology Department and Internal Medicine of the Bicêtre Hospital in Paris. All patients selected presented one of the 3 CAPS clinical phenotypes (CINCA/NOMID, Muckle-Wells or Cold Urticaria). The mutation and the determination of the variant had to be confirmed by genetic analysis.

Patient data were collected from their medical records, retrospectively. Data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. In addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the SF36 questionnaire.

The study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. We also wanted to compare the clinical phenotypes of patients according to their genetic variant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of FCAS, Muckle-Wells or NOMID/CINCA;
* age \< 16 years at the apparition of the first symptoms of the disease;
* age ≥ 16 years old at inclusion
* follow-up in a CEREMAIA reference or competence center.

Exclusion Criteria:

* Age \< 16 years at inclusion;
* non-consenting patient

Primary outcomes:
measure: Clinical characteristics of patients with CAPS in adulthood
timeFrame: Baseline
Secondary outcomes:
measure: Assessment of the quality of life of patients with CAPS in adulthood
timeFrame: Baseline
measure: Compare the clinical status between childhood and adulthood
timeFrame: Baseline
measure: Compare the clinical status of patients according to their genetic variant.
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Eric Hachulla, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504240: Role of Famotidine in the Clinical Improvement of COVID-19 Patients.
Official title: Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: COVID 19
Famotidine
Bangladesh
Lead sponsor: Chattogram General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: M Abdur Rahim Medical College and Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
First posted: 2020-08-07
Enrollment: 208
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to investigate the effect of Famotidine in the clinical recovery of COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Like other countries of the world, Besides antiviral drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail history of each participant with comorbidity will be taken and will be examined carefully. The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study. Critically ill patients who require ventilator support will not be included in this study. The outcome of the Famotidine treatment will be evaluated and compared with a control group.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
* Severe COVID-19 patients require hospitalization under HDU/ICU.

Exclusion Criteria:

* Patients with severe and/or uncontrolled medical conditions with significantly compromised organ function.
* Patients who were hospitalized from the before due to other reasons.
* Contraindication / possible drug interaction with Famotidine with existing therapy.
* Immunocompromised patients.
* Pregnancy, Pulmonary Tuberculosis, AIDS

Primary outcomes:
measure: Time to Clinical Improvement (TTCI)
timeFrame: Following randomization 30days.
measure: Time to symptomatic recovery.
timeFrame: Following randomization 30 days.
Secondary outcomes:
measure: Mortality Rate
timeFrame: Following randomization 30 days.
measure: Duration of ICU Stay.
timeFrame: Following randomization 30 days.
measure: Total hospital stay.
timeFrame: Following randomization 30 days.
measure: Time to clinical failure or death.
timeFrame: Following randomization 30 days.
measure: Time to Viral clearance / COVID-19 recovery.
timeFrame: Following randomization 60 days.
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chattogram General Hospital
city: Dinājpur
country: Bangladesh
facility: M. Abdur Rahim Medical College Hospital
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: STUDY_CHAIR
References: