louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04195971: Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension
Official title: Multiphasic Liver CT Scan Including Dual Arterial Phase Imaging in Patients With Liver Cirrhosis and Suspected Portal Hypertension: Evaluation of Acquisition of Appropriate Late Arterial Phase Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCC
Cirrhosis, Liver
Keywords: CT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. In patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. In this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of LAP acquisition than single arterial phase acquisition.


Eligibility criteria: Inclusion Criteria:

* Older than 20 years
* Liver cirrhosis diagnosed with characteristic imaging feature or histology
* Presence of portal hypertension sign (splenomegaly and varices)
* Scheduled for liver CT
* And signed informed consent

Exclusion Criteria:

* Relative or absolute contra-indication of contrast-enhanced CT

Primary outcomes:
measure: Incidence of optimal late arterial phase acquisition
timeFrame: 1 months after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02460471: Palliative Radiotherapy Protocol in Head and Neck Cancer
Official title: Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Quality of Life
Keywords: Radiotherapy
Palliative Care
IMRT
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2015-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.

Detailed description: Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.

Eligibility criteria: Inclusion Criteria:

* Able to give an informed consent
* Able to complete QOL questionnaires
* Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
* Presence of measurable disease
* Biopsy proven squamous or salivary cancer of the head and neck region
* Expected survival of at least 2 months.

Exclusion Criteria:

* Pregnancy
* No previous RT to the neck and no plan to receive concomitant chemotherapy
* Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
* Unavailable for follow-up

Primary outcomes:
measure: Quality of life
timeFrame: from radiation treatment until 24 months planned follow-up or death
Secondary outcomes:
measure: Toxicity (CTCAE v 4.0 graded)
timeFrame: from radiation treatment until 24 months planned follow-up or death
Other outcomes:
measure: Progression free survival
timeFrame: from radiation treatment until 24 months planned follow-up or progression or death
measure: Overall survival
timeFrame: from radiation treatment until 24 months planned follow-up or death
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Maisonneuve Rosemont Hospital, University of Montreal
name: Bernard Fortin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortin B, Khaouam N, Filion E, Nguyen-Tan PF, Bujold A, Lambert L. Palliative Radiation Therapy for Advanced Head and Neck Carcinomas: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):647-53. doi: 10.1016/j.ijrobp.2016.01.039. Epub 2016 Jan 28.
Clinical trial NCT00817271: To Evaluate the Response to Glucagon During Hypoglycemia
Official title: A Randomised, Open, Two-Way Cross-Over, Phase I Study to Evaluate the Response to Glucagon Versus the Spontaneous Counter-Regulatory Response in T2DM Patients Treated With AZD1656 and Metformin During Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type II Diabetes
Counter-regulatory response
Hypoglycemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin


Eligibility criteria: Inclusion Criteria:

* type II diabetes patients, female with non child-bearing potential
* T2DM diagnosis confirmed by C-peptide \>0.3nmol/L and no glutamic acid decarboxylate (GAD) antibodies at enrolment (screening)
* Treatment with metformin alone with a total daily dose not less than 1 000 mg. Stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment

Exclusion Criteria:

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study
* Participating in another clinical study during the last 30 days prior to enrolment

Primary outcomes:
measure: P-Glucose levels
timeFrame: Repeated sampling during the 24 hour period on day 5 and 8
Secondary outcomes:
measure: Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)
timeFrame: Frequent measurements during the study period
measure: Pharmacokinetic variables (Area under the plasma conc-time curve from time 0 to 24 hours post dose (AUC0-24), maximum plasma conc(Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance
timeFrame: Repeated sampling during the 24 hour period on day 5 and 8
measure: Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)
timeFrame: Repeated sampling during the 24 hour period on day 5 and 8
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: Profil Institut for Clinical Research Inc.
name: Marcus Hompesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250471: PROTECT-TIMI 30 Trial
Official title: A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unstable Angina
Keywords: GP IIb/IIIa inhibitors
eptifibatide
Anti-thrombotic agents
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 900
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 purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

Detailed description: Platelet inhibitor drugs

Eligibility criteria: Inclusion Criteria:

* Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:

  * diabetes
  * elevated cardiac proteins in the blood (indicating acute coronary syndrome)
* Be willing and able to give informed consent

Exclusion Criteria:

* uncontrolled hypertension
* cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
* prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
* any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read

Primary outcomes:
measure: Efficacy: Improved Coronary Flow Reserve
measure: Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
Secondary outcomes:
measure: Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
measure: Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial
Other outcomes:
Locations:
Study officials:
References:
citation: Wilson SR, Sabatine MS, Braunwald E, Sloan S, Murphy SA, Morrow DA. Detection of myocardial injury in patients with unstable angina using a novel nanoparticle cardiac troponin I assay: observations from the PROTECT-TIMI 30 Trial. Am Heart J. 2009 Sep;158(3):386-91. doi: 10.1016/j.ahj.2009.06.011. Epub 2009 Jul 15.
Clinical trial NCT00532571: Effects of Coenzyme Q10 in PSP and CBD
Official title: Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Progressive Supranuclear Palsy
Neurological Disorders
Keywords: CoQ10
PSP
CBD
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2007-09-20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years
* Age \> 40
* Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit.
* Patients agreeable to participate in the study.

Exclusion Criteria:

* Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit.
* Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs.
* History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
* Previous use of coenzyme Q10 within 60 days of the baseline visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Diana Apetauerova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773471: A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
Official title: A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 69
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 overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.


Eligibility criteria: Inclusion criteria:

1. Age ≥ 18 years.
2. Fulfillment of the ACR/EULAR 2010 classification criteria for RA \[9\].
3. Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
4. Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.

Exclusion criteria:

1. Current or previous use of ArthritisPower™ by the patient.
2. Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
3. Inability or unwillingness to participate with using the ArthritisPower™ app for this study

Primary outcomes:
measure: - Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine - Rheumatology
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John M Davis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06174571: Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.
Official title: Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients with breast cancer at different stages of the disease.

Brief summary: This work aims to:

1. Evaluation of the role of pregnancy associated plasma protein A( PAPPA ) in diagnosis \& early detection of breast cancer.
2. Evaluation of the relationship between ( PAPPA ) levels and stages of breast cancer.


Eligibility criteria: Inclusion Criteria:

* female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment.

Exclusion Criteria:

* Patients who received chemotherapy or radiotherapy.
* Patients with known other organ malignancy.

Primary outcomes:
measure: Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02853071: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
Official title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 0
Sex: FEMALE
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 evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

Detailed description: For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist.

Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis.

Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer HER2-/RH+
* Progression after hormonotherapy
* Treated by taxanes, anthracyclines, capecitabine and eribulin
* Treated by everolimus
* ECOG ≤ 2
* Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥ 100 x 109 / L
* Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of the standard) (unless disease of Gilbert), transaminases ≥ 3 x N
* Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL / min
* Estimated Life expectancy ≥ 3 months

Exclusion Criteria:

* Hypersensitivity known about one of the constituents of the estramustine phosphates
* Preliminary Treatment by estramustine phosphates
* Brain Metastases
* Patients not being under effective contraception
* Minor, pregnant or lactating Patients
* Patients not previously treated by everolimus
* Transaminases \> 3xN
* Other concomitant anticancer treatment less than 1 month before the inclusion
* Digestive function: malabsorption
* History of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma)
* Active Thrombo-phlebitis
* Risk thromboembolic known,
* Unchecked cardiovascular Pathology
* Grave hepatic Affection

Primary outcomes:
measure: Proportion of the alive patients without progress of the disease
timeFrame: 3 months
Secondary outcomes:
measure: quality of life
timeFrame: 18 months
measure: progression-free survival
timeFrame: 18 months
measure: overall survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
References:
Clinical trial NCT01824771: Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Injury, Acute
Keywords: Continuous veno-venoous haemofiltration
Plasma lactate
Critical illness
Acute kidney injurytissue perfusion
Multiple organ dysfunction syndrome
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was carried out in Surgical Intensive Care Unit (SICU) of the first affiliated hospital, Sun Yat-sen University.The project has been approved by Ethics Committee of Sun Yat-sen University. All the subjects have signed written informed consent.

Brief summary: Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and replace renal function partly. It is widely used in intensive care units (ICUs), especially for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a molecule smaller than glucose, which can pass through filtration membrane freely in CVVH. Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status in patients with unstable hemodynamic status. However, there is no prospective study evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of different dose of CVVH on lactate elimination is not clear in patients with different level of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate clearance, and then re-estimate the prognostic value of lactate in critically ill patients with CVVH.


Eligibility criteria: Inclusion Criteria:

1. The critical ill patients with acute kidney injury
2. Patients requiring continuous veno-venous hemofiltration
3. APACHE II scores more than 12
4. Arterial lactate is higher than 0.5mmol/L but lower than 15mmol/L (due to the sensitivity and optimal measuring range of the equipment)
5. Continuous veno-venous hemofiltration for at least 12 hrs
6. Hemo-filter age of \<24 hrs

Exclusion Criteria:

1. APACHE II scores lower than 12
2. patients' age are more than 75Y or lower than 18Y

Primary outcomes:
measure: plasma lactate
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Levraut J, Ciebiera JP, Jambou P, Ichai C, Labib Y, Grimaud D. Effect of continuous venovenous hemofiltration with dialysis on lactate clearance in critically ill patients. Crit Care Med. 1997 Jan;25(1):58-62. doi: 10.1097/00003246-199701000-00013.