louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00186420: Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Official title: Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Taxotere
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-16
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:

  * Node positive disease post-operatively
  * Capsule involvement
  * Seminal Vesicles involvement
  * Gleason score ≥ 8
  * \>50% of core biopsies that are positive
  * Clinical Stage T2c and T3
  * Pre-op PSA \> 15 plus Gleason score of 7

    * Age greater than 18
    * ECOG Performance Status 0-1
    * Serum creatinine \<= 1.5 mg/dl
    * Granulocyte count \>= 1500/m3, Hemoglobin \> 8.0 g/dl, and platelet count \>= 100,000/m3
    * Total bilirubin \<= ULN
    * AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
    * Signed patient informed consent.
    * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion Criteria:

* Peripheral neuropathy \> grade 1
* History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
* Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
* Active infection within 14 days of beginning treatment
* Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
* Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.

Primary outcomes:
measure: To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
timeFrame: Following treatment
Secondary outcomes:
measure: To evaluate the toxicity of taxotere and hormones given adjuvantly.
timeFrame: Following treatment
measure: To measure Quality of Life on this therapy.
timeFrame: Following treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Sandy Srinivas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896674: Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)
Official title: Value of Knowledge-based Iterative Model Reconstruction at Low-kilovoltage Cardiac 256-slice CT: A Comparison of Filtered Back Projection-, Hybrid-, and Iterative Model Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Computed tomography
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enroll consecutive patients.

Brief summary: The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.


Eligibility criteria: Inclusion Criteria:

* A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units.

Exclusion Criteria:

* BMI exceeded 27 kg/m2
* renal dysfunction (serum creatinine level \> 1.5 mg/dl)
* atrial fibrillation
* prior coronary artery bypass grafting
* heart failure (New York Heart Association class III-IV)

Primary outcomes:
measure: Contrast to noise ratio of coronary arteries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yuki H, Utsunomiya D, Funama Y, Tokuyasu S, Namimoto T, Hirai T, Itatani R, Katahira K, Oshima S, Yamashita Y. Value of knowledge-based iterative model reconstruction in low-kV 256-slice coronary CT angiography. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):115-23. doi: 10.1016/j.jcct.2013.12.010. Epub 2014 Jan 12.
Clinical trial NCT01504074: Morphological and Functional Evaluation of Irvine-Gass Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irvine Gass Syndrome
Keywords: Irvine Gass syndrome
multimodal imaging
SD-OCT
CME secondary to cataract surgery
in vivo correlation of morphology and function
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients suffering on CME secondary to cataract surgery

Brief summary: Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome

Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance, contrast sensitivity and microperimetry in a fixed time schedule


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* St.p Cataract surgery
* able to read
* informed consent
* with fluorescein angiography and SD-OCT diagnosed Irvine Gass syndrome

Exclusion Criteria:

* \< 18 years
* CME of other origin
* diabetic macular edema

Primary outcomes:
measure: Reduction of central retinal thickness
timeFrame: 3 months
Secondary outcomes:
measure: Increase of Best corrected visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology Medical University of Vienna
Study officials:
References:
Clinical trial NCT03667274: Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
Official title: Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Double Valve Replacement
Keywords: aortic valve replacement
mitral valve reconstruction
mitral valve replacement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009

Brief summary: To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction

Detailed description: To compare patient outcome data ( death, re-surgery, change in transvalvular gradient) after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction in patients with cardiac surgery at University Hospital Basel/ Switzerland since 2009.

Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009

Exclusion Criteria:

* denial of consent

Primary outcomes:
measure: death
timeFrame: time from hospitalisation for cardiac valve surgery and following 12 months
measure: re-surgery
timeFrame: time from hospitalisation for cardiac valve surgery and following 12 months
measure: change in transvalvular gradient
timeFrame: time from hospitalisation for cardiac valve surgery and following 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Martin Grapow, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egger ML, Gahl B, Koechlin L, Schomig L, Matt P, Reuthebuch O, Eckstein FS, Grapow MTR. Outcome of patients with double valve surgery between 2009 and 2018 at University Hospital Basel, Switzerland. J Cardiothorac Surg. 2022 Jun 13;17(1):152. doi: 10.1186/s13019-022-01904-9.
Clinical trial NCT05202574: Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section
Official title: Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post-Dural Puncture Headache
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting


Eligibility criteria: Inclusion Criteria:

* A total of one hundred and fifty parturients in child bearing period (20-40 years), with BMI of 23-27, and ASA physical status II, who were candidate for elective caesarean section, were enrolled in this prospective randomized study.

Exclusion criteria

Exclusion Criteria:

1 - Lady refusal to participate. 2. All pregnant women candidate for emergency caesarean section elligible for general anaesthesia (GA).

3.presence of any contraindications of dexamethasone (as DM and uncontrolled infection ) or any contraindication of ondansetron (as prolonged QT interval 6. Presence of cardiac, respiratory, hepatic, renal and mental diseases. 7. Coagulopathy, or any contraindication to spinal anaesthesia. 8. Presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).

Primary outcomes:
measure: incidence of post-dural puncture hedache
timeFrame: 24 hours post-partum
Secondary outcomes:
measure: incidence of post-partum nausea and vomiting
timeFrame: 24 hours post-partum
Other outcomes:
Locations:
city: ALMinya
country: Egypt
facility: Mina Raouf
state: Minia
Study officials:
References:
Clinical trial NCT05660174: Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery
Official title: Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Vascular Surgical Procedures
Digestive surgery
Vascular surgery
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 2626
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: Adult patients with a digestive or vascular surgery procedure between 01/01/2019 and 01/06/2021 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective), at the University Hospital of Besançon

Brief summary: The study aims to identify the preoperative parameters associated with the risk of postoperative acute kidney injury (in particular the parameters of the SPARK score) in patients of the Besançon University Hospital who have undergone digestive or vascular surgery.


Eligibility criteria: Inclusion Criteria:

* Digestive surgery or vascular surgery at Besancon University Hospital between 01/01/2019 and 31/12/2019 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective)

Exclusion Criteria:

* No preoperative creatinine value
* Outpatient surgery
* Surgery other than digestive or vascular (organ procurement surgery/nephrectomy surgery/renal transplantation)
* Kidney/urinary tract surgery
* Arteriovenous fistula surgery
* End-stage renal disease or renal replacement therapy, except for renal transplant patients
* Acute kidney injury KDIGO≥1 within 2 weeks before surgery
* Patients in need of emergency surgery for ongoing haemorrhage
* Legal incapacity or limited legal capacity
* Subjects with no social security coverage.

Primary outcomes:
measure: Occurrence of acute kidney injury
timeFrame: 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Cécile Courivaud, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00361374: Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Official title: Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Omega-3
Boston
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2006-08-08
Enrollment: 196
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: This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.

Detailed description: The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 18-80 years old.
* Must meet criteria for current Major Depressive Disorder.

Exclusion Criteria:

* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
* History of seizure disorder.
* Substance use disorders, including alcohol, active within the last six months (past history is OK).
* History of multiple adverse drug reactions or allergy to the study drugs.

Primary outcomes:
measure: Score on a Depression Severity Rating Scale Over Eight Weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical Research Program, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Depression Clinical and Research Program, Massachusetts General Hospital
name: David Mischoulon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Clinical trial NCT00397774: Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Official title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Palliative care
Physical exercise
Physical function
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Eligibility criteria: Inclusion Criteria:

* Palliative cancer patients,
* life expectancy between 3 and 12 months,
* Karnofsky status equally or above 60,
* pain score equal or below 3 on numerical rating scale (0-10),
* cognitive function intact

Primary outcomes:
measure: Fatigue
timeFrame: immediately before and after the intervention
Secondary outcomes:
measure: Health related quality of life and physical functioning
timeFrame: immediately before and after the intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Sunniva Clinic for Palliative Care
city: Oslo
country: Norway
facility: Hospice Lovisenberg
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Skien
country: Norway
facility: Telemark Hospital
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Department of Cancer Reserach and Molecular Medicine
name: Line M Oldervoll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oldervoll LM, Loge JH, Lydersen S, Paltiel H, Asp MB, Nygaard UV, Oredalen E, Frantzen TL, Lesteberg I, Amundsen L, Hjermstad MJ, Haugen DF, Paulsen O, Kaasa S. Physical exercise for cancer patients with advanced disease: a randomized controlled trial. Oncologist. 2011;16(11):1649-57. doi: 10.1634/theoncologist.2011-0133. Epub 2011 Sep 26.
Clinical trial NCT01271374: Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
Official title: Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: African American
Hypertension
Cardiometabolic Syndrome
Lead sponsor: InVasc Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.

Detailed description: Participants must be 18-75 years of age, African American, and have a combination of high blood pressure, insulin resistance (Type 2 Diabetes), low HDL cholesterol levels or obesity.

Eligibility criteria: Inclusion Criteria:

* African American
* Hypertension and one of the following:
* Fasting glucose \> 100 mg/dl
* HgA1C\> 6.0 %
* Plasma triglycerides \>150
* HDL cholesterol \< 40 mg/dl in men or \< 50 mg/dl in women

Exclusion Criteria:

* History of Heart failure
* use of insulin
* non-dominant arm circ \> 50 cm.

Primary outcomes:
measure: Change in Central Aortic Pressure (CAP)
timeFrame: 14 weeks
Secondary outcomes:
measure: Blood pressure control
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Tucker
country: United States
facility: Atlanta Clinical Research Center
state: Georgia
Study officials:
affiliation: Director, Atlanta Clinical Research Centers
name: Bobby V Khan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Clinical Research Centers
name: Keith C Ferdinand, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01371474: Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Official title: Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Panic Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 1483
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information

Brief summary: The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.


Eligibility criteria: Inclusion Criteria:

* Patients with depression or in a depressed state
* Patients who start taking paroxetine at 20mg a day

Exclusion Criteria:

* Patients who have been treated with paroxetine prior to this investigation
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 12 weeks
measure: Efficacy evaluation based on overall improvement
timeFrame: 12 weeks
measure: Efficacy evaluation based on severity by symptoms
timeFrame: 12 weeks
measure: Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: