louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00144066: A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Official title: A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: West Japan Thoracic Oncology Group
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.


Eligibility criteria: Inclusion Criteria:

Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent

Exclusion Criteria:

Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Primary outcomes:
measure: Over all survival
Secondary outcomes:
measure: Time to disease progression
Other outcomes:
Locations:
Study officials:
affiliation: West Japan Thoracic Onoclogy Group
name: Toyoaki Hida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469066: Cone Beam CT Scanning in Lung and Bladder Cancer.
Official title: Improving the Accuracy of Radiotherapy Planning and Delivery Using Kilovoltage Cone Beam CT Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasm
Small Cell Carcinoma
Bladder Carcinoma
Keywords: small cell lung cancer
bladder cancer
conformal radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2007-05-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clniic

Brief summary: To study changes in tumor and normal organ size and/or position which occur during a course of radiation treatments.


Eligibility criteria: Inclusion Criteria:

* Patient has biopsy proven limited stage SCLC
* receiving radical concurrent chemoradiotherapy
* no prior chest RT
* no prior surgical resection of lung tumor
* no prior chemotherapy
* patients' lung tumors should be centrally-located to minimize the effect of respiratory motion
* patient has biopsy proven TCC bladder
* receiving radical concurrent chemoradiotherapy or RT alone
* no prior chemotherapy
* patient signs study-specific consent form

Exclusion Criteria:

* mixed small cell and non small cell histology
* patient not being treated with concurrent chemoradiotherapy
* chemoradiotherapy given sequentially
* previous chest RT
* previous chemotherapy
* prior surgical resection of lung mass
* patient ineligible for pelvic RT
* patient does not sign study consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Don Yee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03777566: Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method
Official title: Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cavity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 185
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergo sonohysterography for gynecologic indication without gross uterine pathology.

Brief summary: Measuring of uterine cavity volume using sonohysterography will be done in two groups of patients, Group A included 35 patients for home hysterectomy were indicated and group B includes 150 infertile patients in the childbearing age.

Detailed description: Uterine cavity volume will be measured in group A before and after hysterectomy, and in the group, B will be measured using sonohysterography only using a mathematical method of the sum of a volume of a cone and part of a sphere.

Eligibility criteria: Inclusion Criteria:

1. Patients without any gross pathology within the uterus.
2. Patients admitted for hysterectomy.
3. Patients agreed with written consent to participate in the study.

Exclusion Criteria:

1. Virgins.
2. Pregnancy.
3. Systemic blood disease.
4. Any clinical evidence of cervical, uterine or tubal infection.
5. Refusal to undergo saline infusion sonography.
6. Any gross uterine pathology diagnosed clinically or with sonography.

Primary outcomes:
measure: calculation of uterine cavity volume with an objective method
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AIn Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed I Amer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04159766: A Study With NLY01 in Subjects With Type 2 Diabetes
Official title: A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type2 Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Neuraly, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.


Eligibility criteria: Inclusion Criteria:

* Male or female subject with type 2 diabetes for at least one year
* Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic
* Body Mass Index (BMI) 22.0 to 35.0 kg/m\^2,

Exclusion Criteria:

* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator
* Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)
* History of gastroparesis
* History of severe hypoglycemia in the past 6 months
* If female, pregnant or breastfeeding

Primary outcomes:
measure: Number of participants with Treatment Emergent Adverse Events
timeFrame: 35 days
measure: Number of Incidences of Adverse Events
timeFrame: 35 days
measure: Plasma glucose
timeFrame: 24 hours
measure: Change in serum insulin
timeFrame: 24 hours
measure: Change in plasma glucagon
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institute fur Stoffwechselforschung GmbH
city: Neuss
country: Germany
facility: Profil Institute
Study officials:
affiliation: Neuraly, Inc.
name: Dan Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT03607565: A New Parameter Derived From DSA to Evaluate Cerebral Perfusion
Official title: The Association Between a New Parameter Derived From DSA and Outcomes in Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Ischemia
Lead sponsor: Xi'an No.3 Hospital
Sponsor class: OTHER_GOV
First posted: 2018-07-31
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population is from primary care clinic

Brief summary: This observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography.

Detailed description: Ischemic cerebrovascular disease is an important cause of death and disability in the world. Digital Subtraction Angiography (DSA) is the golden index for evaluating cerebral blood vessels. We introduced a new parameter derived from DSA to evaluate the perfusion to predict the outcomes in acute stroke with large vessel occlusion.

To study the possible relationship between the new parameter of cerebral perfusion derived from DSA and outcomes in cerebral ischemia（modified Rankin Scale）, we intend to retrospectively analyze the images derived from patients who undergone the DSA and follow-up outcomes（modified Rankin Scale）.

Eligibility criteria: Inclusion Criteria:

1. Cerebral ischemia
2. patients undergone DSA

Exclusion Criteria:

1.cerebral hemorrhage

Primary outcomes:
measure: the outcomes between good perfusions and poor perfusions
timeFrame: 3 months to 2 years
Secondary outcomes:
measure: the outcomes between good perfusions and middle perfusions
timeFrame: 3 months to 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shaanxi
Study officials:
affiliation: department of neurology Xi'an No3 Hospital
name: Nannan Han, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00712465: An Interaction Study With Digoxin and AZD1305
Official title: A Phase I, Randomised, Open, Single-centre, Three-period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
interaction
pharmacokinetic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.


Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range

Primary outcomes:
measure: Pharmacokinetic variables
timeFrame: During all dosing visits
Secondary outcomes:
measure: Adverse event, vital signs, ECG, physical examination and laboratory variables.
timeFrame: During the study
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital
name: Marianne Hartford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324465: King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope
Official title: King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope: A Comparative Study in Ambulatory Surgery Center Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.

Detailed description: Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.

Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

* Patients who require rapid sequence induction and intubation or fiberoptic intubation.
* Pregnancy

Primary outcomes:
measure: Time Until Intubation With Each Device
timeFrame: <100 seconds
Secondary outcomes:
measure: Mean Pulse Oximetry Saturation Value Reading During Intubation
timeFrame: <100 seconds
measure: Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)
timeFrame: <100 seconds
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: during and immediately after procedure (approx 180 minutes)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Douglas Hester, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00895765: The Follow up of Chinese Young Children With Melamine-Related-Calculus
Official title: Part 1 The Outcome of Children With Melamine-Related-Calculus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calculus
Keywords: Melamine
Calculus
Kidney
Child
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 250
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young children with melamine-related-calculus

Brief summary: The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.

Detailed description: 1. To investigate the outcome of melamine-related-calculus.

   * The change of calculus.
   * The change of obstruction features,including hydronephrosis and ureterectasia.
   * The change of the urinalysis.
2. To investigate the change of renal function in children with melamine-related-calculus during the follow up.

   * Creatinine, urea and uric acid.
   * α and β2 microglobulin.
3. To analysis the factors might be associated with the outcome.

   * The characteristics of patients: age, gender, and so on.
   * The characteristics of calculus: location, size, and so on.

Eligibility criteria: Inclusion Criteria:

* children with melamine-related-calculus: with a history of melamine contaminated products
* the parents leave the detailed information for contact and willing to be recalled

Exclusion Criteria:

* children with other congenital renal abnormality
* children with hypercalciuria
* children have abnormality of parathyroid gland

Primary outcomes:
measure: The calculus measured by sonography
timeFrame: at 1, 3, 6 and 12 months
Secondary outcomes:
measure: Renal function (e.g., creatinine, microglobulin)
timeFrame: at 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Departemnt of Endocrinology and Children Health care
name: Zou Chao Chun, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01082666: Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Official title: Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critically Ill
Keywords: Cuff pressure
microaspiration
pepsin
VAP
Mechanical ventilation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2010-03-08
Enrollment: 122
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: We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed description: Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.

In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* age \> or = 18 years
* tracheal intubation using a polyvinylchloride tube
* predictible duration of mechanical ventilation \> 48 h
* enteral nutrition

Exclusion Criteria:

* refuse to participate to the study
* no informed consent
* contra-indication for semirecumbment position

Primary outcomes:
measure: Pepsin level in tracheal aspirate
timeFrame: 48 h after randomization
Secondary outcomes:
measure: Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions
timeFrame: day 28 after randomization
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Calmette Hospital, University Hospital of Lille
state: Nord
Study officials:
affiliation: CHRU de Lille
name: Alain Durocher, MD
role: STUDY_DIRECTOR
affiliation: CHU de Lille
name: Malika Balduyck, MD
role: STUDY_DIRECTOR
affiliation: CHU de Lille
name: Farid Zerimech, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02862366: Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
Official title: Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Neoplasm
Keywords: myeloproliferative neoplasms
Circulating Procoagulants Microparticles
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ET, PV or PMF. Healthy volunteers.

Brief summary: Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.

These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.


Eligibility criteria: Inclusion Criteria for MNPs patients:

* Age \> 18
* Establish MNPs Phi- diagnosis (ET, PV, MFP)
* Consent to participate

Inclusion Criteria for healthy volunteers:

* Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count
* No personal thromboembolic history
* No known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (Atrial fibrillation, etc.)
* Not pregnant
* Non smoker
* For women, no hormonal contraceptives

Exclusion Criteria for MNPs patients:

* Pregnancy
* Patient unable to give consent

Primary outcomes:
measure: Comparison of the average number of microparticles detected by flow cytometry in all subgroup
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: EFS
city: Lille
country: France
facility: GHICL
city: Lille
country: France
facility: CHRU Lille
Study officials:
affiliation: GHICL
name: Agnès Charpentier, MD, PhD
role: STUDY_DIRECTOR
References: