louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03727074: Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream, With Efudex® (5-FU) Cream, and Both Active Treatments to a Vehicle Control, in the Treatment of Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis (AK)
Keywords: Actinic Keratosis ,AK
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 462
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 relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.

Detailed description: To compare the safety and efficacy profiles of 5-FU Cream with Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.

Eligibility criteria: Inclusion Criteria:

1. Male and female 18 years of age and older.
2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study.
3. Subject must be generally healthy, based on medical records, and free from any clinically significant disease, other than AK, that in the opinion of the investigator might interfere with the study evaluations.
4. At least five (5) and no more than ten (10) clinically typical, visible or palpable, discrete AK lesions, each at least 4 mm in diameter on the face (excluding ears), forehead or bald scalp.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning a pregnancy within the period of study participation.
2. Subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements.
3. Presence of Atopic Dermatitis, Basal Cell Carcinoma, Eczema, Psoriasis, Rosacea, Squamous Cell Carcinoma or other possible confounding skin conditions on the

Primary outcomes:
measure: treatment success
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
Study officials:
References:
Clinical trial NCT00434174: Safety of Everolimus and Pemetrexed in Lung Cancer Patients
Official title: A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: Lung cancer
Non small cell lung cancer
NSCLC
RAD001
Everolimus
Afinitor
Pemetrexed
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.


Eligibility criteria: Inclusion criteria:

* Lung cancer
* Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Negative serum pregnancy test

Exclusion criteria:

* History of another primary malignancy in the last 5 years
* Having recently received an investigational drug
* Having recently received major surgery of wide field radiotherapy
* Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
* Severe or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
timeFrame: Over 18 weeks of combination treatment
Secondary outcomes:
measure: Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
timeFrame: Over 18 weeks of combination treatment
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT01546974: Ventilator-associated Pneumonia (VAP) and Humidification System
Official title: Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ventilator-associated Pneumonia
Keywords: Mechanical Ventilation
Humidification system
Patients submitted to mechanical ventilation for at least 48 hours
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification.


Eligibility criteria: Inclusion Criteria:

* Patients expected to require mechanical ventilation for at least 48 hours

Exclusion Criteria:

* Patients \< 18 yo and pregnant

Primary outcomes:
measure: VAP incidence
Secondary outcomes:
measure: Duration of mechanical ventilation
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: MA
Study officials:
affiliation: Director ICU
name: JOSE R AZEVEDO, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05010174: Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
Official title: Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Immune Tolerance
Keywords: Long-term follow-up
Lead sponsor: Medeor Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 5
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: Kidney transplant recipients who received Medeor's cellular immunotherapy in previous Medeor studies

Brief summary: At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.

Detailed description: Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up.

Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.

Eligibility criteria: Inclusion Criteria:

1. Able and willing to fully comply with all study procedures and restrictions.
2. Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.
3. Have previously completed a Medeor study and received a Medeor cellular immunotherapy product

Exclusion Criteria:

1. Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.
2. Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
3. Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.

Primary outcomes:
measure: Safety Endpoints
timeFrame: Through study completion, up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Medeor Therapeutics
name: Lenuta Micsa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03087474: Treatment of Venous Thromboembolism in Real-Life Patients
Official title: Treatment of Venous Thromboembolism in Real-Life Patients: A Nationwide, Population-Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 89383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Danish National Patient Registry (DNPR), covering all Danish hospitals, will be used to identify first-time and recurrent VTE cases diagnosed from 01-Jan-2006 through 31-Dec-2015.

Brief summary: In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC


Eligibility criteria: Inclusion Criteria:

1. All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
2. First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date

Exclusion Criteria:

1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.

Primary outcomes:
measure: Hospitalization rate in VKA patients for VTE
timeFrame: Approximately 180 months
measure: VTE hospitalization rate in VKA patients by sex
timeFrame: Approximately 180 months
measure: VTE hospitalization rate in VKA patients by age
timeFrame: Approximately 180 months
measure: Hospitalization rate in NOAC patients for VTE
timeFrame: Approximately 180 months
measure: VTE hospitalization rate in NOAC patients by sex
timeFrame: Approximately 180 months
measure: VTE hospitalization rate in NOAC patients by age
timeFrame: Approximately 180 months
measure: Duration of Treatment in NOAC patients
timeFrame: Approximately 180 months
measure: Duration of treatment in VKA patients
timeFrame: Approximately 180 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00149474: Peak Flow Monitoring in Older Adults With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-09-08
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults \>= 50 years with moderate-severe asthma.

Detailed description: BACKGROUND:

We propose a five-year Demonstration and Education project to assess the incremental value of peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma control in adults greater than or equal to 50 years with moderate-severe asthma. We will develop three parallel asthma education programs for older adults using as our base an existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated efficacy for adults ,50 years of age.

DESIGN NARRATIVE:

Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific quality of life

Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: Inclusions: Doctor-diagnosed asthma; \>=50 years; using asthma medications; \>12% increase in FEV1 after two puffs of inhaled beta-agonist; willing to participate in asthma meducation program and two-year follow up; likely to stay in Portland area; KPNW member for two years.

Exclusions: Unable to read, speak or understand English; no telephone; failure to keep two pre-randomization appointments; inability to reproducible FEV 1 maneuver; participation in pilot phase of study; concurrent participation in any other medical research study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04962074: Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
Official title: Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduced Sperm Motility
IVF
ICSI
Astheno Teratozoospermia
Keywords: Sperm
IVF
ICSI
Abnormal morphology of sperm
Astheno Teratozoospermia
Microfluidic chip
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 22
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia.

Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.


Eligibility criteria: Inclusion Criteria:

* Infertile men with astheno-teratozoospermia
* Women were aged from 18 to 39
* Women had at least two mature oocytes.

Exclusion Criteria:

* MI oocytes

Primary outcomes:
measure: Semen parameters after sperm preparation with either method: semen volume
timeFrame: up to 7 months
measure: Semen parameters after sperm preparation with either method: sperm concentration
timeFrame: up to 7 months
measure: Semen parameters after sperm preparation with either method: total motility
timeFrame: up to 7 months
measure: Semen parameters after sperm preparation with either method: progressive motility
timeFrame: up to 7 months
measure: Embryo development after sperm preparation with either method
timeFrame: up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: MaltepeU
Study officials:
References:
Clinical trial NCT02693574: Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori
Official title: Comparison Efficacy of 14-day Triple Therapy Between Clarithromycin and Levofloxacin on the Eradication of Helicobacter Pylori in Syrian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Gastrointestinal Tract Infection
Keywords: Helicobacter pylori
Helicobacter Infections
Proton Pump Inhibitors
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
Collaborators: name: UNIPHARMA. Universal Pharmaceutical Industries
name: Ibn Alhaytham Pharma. Industries Co
First posted: 2016-02-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the Eradication of Helicobacter Pylori in Syrian population


Eligibility criteria: Inclusion Criteria:

1-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

1. Children and teenagers aged less than 18 years.
2. Previous eradication treatment for H. pylori.
3. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
4. History of gastrectomy.
5. Gastric malignancy, including adenocarcinoma and lymphoma,
6. Previous allergic reaction to antibiotics (Amoxicillin, Clarithromycin, Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
7. Contraindication to treatment drugs.
8. Pregnant or lactating women.
9. Severe concurrent disease.
10. Liver cirrhosis.
11. Chronic kidney disease.
12. Patients who cannot give informed consent by himself or herself.

Primary outcomes:
measure: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
timeFrame: 6 weeks after eradication therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus Hospital
Study officials:
References:
Clinical trial NCT02878174: The Site of Puncture in Prelocation Technique of the Internal Jugular Venous Catheterization
Official title: The Site of Puncture in Ultrasound-guided Prelocation Technique of the Internal Jugular Venous Catheterization: Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Jugular Veins
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.

Detailed description: The investigator's own developed screen-rotating program is used. An accelerometer is attached on the front surface of the ultrasound (US) probe. The angle of rotation of the probe is delivered to the laptop and becomes the information to adjust the rotating angle of screen. Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees. In the US group, the investigators obtain a sonographic view and try a cannulation of the internal jugular vein (IJV). In the prelocation group, a skin marker is made on the anticipated skin puncture site where a perpendicular line that passes over the center of the IJV meets the skin on the rotated US screen. It is recorded "success" when the internal jugular vein is successfully punctured without complications. It is recorded "failure" if the internal jugular vein is not punctured during repeated needle passes. The number of tries and tile to success are recorded. The success and complication rates between two groups are compared.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for general anesthesia

Exclusion Criteria:

* Refusal of consent
* Patients with cervical spine injuries
* Patients with atlanto-axial instability
* Patients at risk of increased intracranial pressure

Primary outcomes:
measure: Success rate of internal jugular vein cannulation
timeFrame: intraoperative
Secondary outcomes:
measure: Degree of rotation of ultrasound (US) probe
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02759874: Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
Official title: Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholism
Pregnancy
Lead sponsor: Institute of Health Economics, Canada
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: SoberLink, LLC
name: Alberta Innovates Health Solutions
name: Alberta Health services
First posted: 2016-05-03
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues.

IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD.

The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, with the potential of decreasing healthcare utilization by prevention of FASD. Breathalyzer device usage plus secure document sobriety should improve patient monitoring convenience and demonstrate reductions in alcohol use outside of traditional office visits and patient self-reports.


Eligibility criteria: Inclusion Criteria:

* Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria:

* Not pregnant, not in treatment/therapy for addiction

Primary outcomes:
measure: Change in FASD Birthrate Levels
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry, University of Alberta
name: Andy Greenshaw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Health Economics Executive Director and CEO
name: Egon Jonsson, PhD
role: STUDY_DIRECTOR
References: