louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06168877: Use of Integrated PET/CT as a First Line Staging and Re-staging Technique in Oncologic Patient.
Official title: Use of Integrated PET/CT as a First Line Staging and Re-staging Technique in Oncologic Patient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients suffering from lymphoma or lung cancer undergoing PET/CT and contrast-enhanced CT in a single examination session.

Brief summary: Positron emission tomoscintigraphy (PET) and contrast computed tomography (CTmdc) are diagnostic methods widely used in the staging and restaging of neoplastic diseases. In recent years, PET tomographs have been implemented, integrating a CT scanner into the PET tomograph (PET/CT): these tomographs are able to simultaneously acquire the function/metabolism study (PET) and the morgfostructural study (CT).

Numerous clinical studies have demonstrated the added diagnostic value of PET/CT compared to PET with consequent effect on the choice of treatment type. In addition to the potential clinical value deriving from the simultaneous execution of the two diagnostic methods, it is necessary to consider the possibility of a reduction in indirect costs deriving from the reduction of days of work lost and costs related to transport, both for the patient and for any companions.

The aims of this multicenter observational study are:

1. evaluate the diagnostic accuracy of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer).
2. evaluate any psychological, quality of life and economic benefits deriving from carrying out the two diagnostic procedures in a single examination session.


Eligibility criteria: Inclusion Criteria:

* patients suffering from lung cancer or lymphoma in which the two diagnostic investigations mentioned (PET and contrast-enhanced CT) are part of the routine diagnostic-therapeutic program of the disease in question;
* Patients suffering from lung cancer will be in the stage of primary neoplasm staging;
* Patients suffering from lymphoma will be evaluated both in the disease staging phase at onset and re-evaluation after radio-chemotherapy treatment.

Exclusion Criteria:

* Patients with contraindications to performing investigations with contrast medium.

Primary outcomes:
measure: Use of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02496377: Cross Iron (Comparative Randomized Oral Versus Systemic IRON)
Official title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogenic Transfusion
Perioperative Anaemia
Knee Arthroplasty
Hip Arthroplasty
Keywords: Anaemia
Iron deficiency
Ferric carboxymaltose
Patient blood management
Hip arthroplasty
Knee arthroplasty
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.


Eligibility criteria: Inclusion criteria:

* unilateral prothetic orthopaedic surgery scheduled
* age \> 18
* weight \> 50 kg
* hemoglobin rate: 10 g/dl ≤ Hb \<13 g/dl

Exclusion criteria:

* bilateral arthroplasty
* EPO contraindication
* generalized infection

Primary outcomes:
measure: Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
timeFrame: the day before surgery (day - 1)
Secondary outcomes:
measure: Hb level
timeFrame: before iron treatment, then the day before surgery (day - 1) based on reference iron balance
measure: number of red blood cells
timeFrame: during surgery and 3 days after surgery
measure: the change in iron indices
timeFrame: before iron treatment and after iron treatment the day before surgery (day - 1)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A
Study officials:
affiliation: Montpellier University Hospital
name: Philippe BIBOULET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347477: Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
Official title: Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Arrest
Keywords: cardiac arrest
hypothermia
neurologic outcome
edema
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 23
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: Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.

Detailed description: After the patients are admitted to our hospital we randomise them to either std. fluid therapy (NaCl/RA) or HyperHAES. After PCI we state the rate of cerebral edema by carrying out a cerebral MRI before the cooling starts. We treat the patients with the different fluids for 24 hours. We then evaluate the edema after 24 and 72 hours by the same method. In addition we state the rate of peripheral capillary leak by Wick'S method. The capillary leak is calculated every 8.th hour for the 1. day the patients are treated in our ICU. AFter 1 year, those who survive are invited to a follow-up where we test the patient using Mini MEntal Status, SF-36, in addition to neurophysiological tests as EEG and the P300-test. We then relate the results to the fluid given initially after the cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* Witnessed cardiac arrest,
* ALS started within 15 min.
* ROSC within 60 min.
* Still unconscious,
* Age 18-80

Exclusion Criteria:

* Other malignancies,
* Persons who wake up,
* Pregnancy

Primary outcomes:
measure: Mortality
measure: Quality of Life
Secondary outcomes:
measure: Days in the ICU
measure: Neurological test as described
measure: Grade of Edema
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: AKuttmedisin/KSK/ Haukeland University Hosp.
name: Jon k Heltne, Dr.med
role: STUDY_CHAIR
References:
citation: Heradstveit BE, Guttormsen AB, Langorgen J, Hammersborg SM, Wentzel-Larsen T, Fanebust R, Larsson EM, Heltne JK. Capillary leakage in post-cardiac arrest survivors during therapeutic hypothermia - a prospective, randomised study. Scand J Trauma Resusc Emerg Med. 2010 May 25;18:29. doi: 10.1186/1757-7241-18-29.
Clinical trial NCT02029547: Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians
Official title: Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.


Eligibility criteria: Inclusion Criteria:

* Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician
* Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans
* Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans

Exclusion Criteria:

* Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans

Primary outcomes:
measure: Inter Rater Reliability
timeFrame: Scan acquired 50-60 minutes post injection
measure: Percent Agreement with Expert Panel
timeFrame: Scan acquired 50-60 minutes post-injection
Secondary outcomes:
measure: Change in inter reader reliability after application of quantitation software
timeFrame: Scan acquired 50-60 minutes post injection
measure: Change in agreement with expert panel
timeFrame: Scan acquired 50-60 minutes post-injection
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Research Site
Study officials:
References:
Clinical trial NCT01837147: Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)
Official title: Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: primary prevention
sedentary
overweight
obesity
breast cancer
post-menopausal
women
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.


Eligibility criteria: Inclusion Criteria:

* Female
* Postmenopausal
* BMI \>= 25.0 kg/m2
* Physically inactive
* Internet user with regular access to high-speed internet
* Willing and able to complete study requirements

Exclusion Criteria:

* History of invasive breast cancer
* Medical contraindication to exercise
* Medical problem or other issue that would interfere with intervention
* Current participation in another physical activity study

Primary outcomes:
measure: Change in objectively-measured physical activity
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Self-reported physical activity
timeFrame: Baseline to 16 weeks
measure: Body weight (kg)
timeFrame: Baseline to 16 weeks
measure: Uptake of technology-based intervention components
timeFrame: During 16-week intervention
measure: Quality of life
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Lisa A Cadmus-Bertram, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cadmus-Bertram L, Marcus BH, Patterson RE, Parker BA, Morey BL. Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. JMIR Mhealth Uhealth. 2015 Nov 19;3(4):e96. doi: 10.2196/mhealth.4229.
citation: Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
Clinical trial NCT00361647: Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2006-08-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective controlled randomized study. Aim of this study is to assess the feasibility and sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute idiopathic venous thromboembolism, free from already known cancer and in whom a routine battery screening has excluded the presence of cancer, are randomized to receive either a CT scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult) or a diagnostic programme freely decided by attending physicians. Patients of either group in whom the search for cancer is negative are followed-up for two years to register the development of clinically symptomatic malignant disease. The rate of cancer detection and that of cancer development are compared between the two study groups.


Eligibility criteria: Inclusion Criteria:

* idiopathic venous thromboembolism

Exclusion Criteria:

* cancer already known or shown by routine battery tests
* previous venous thromboembolism
* geographic inaccessibility for long-term follow-up
* allergy to contrast medium
* refusal of informed consensus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Study officials:
affiliation: Department of Medical and Surgical Sciences, University of Padua, Italy
name: Paolo Prandoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10(10):CD010837. doi: 10.1002/14651858.CD010837.pub5.
citation: Prandoni P, Bernardi E, Valle FD, Visona A, Tropeano PF, Bova C, Bucherini E, Islam MS, Piccioli A. Extensive Computed Tomography versus Limited Screening for Detection of Occult Cancer in Unprovoked Venous Thromboembolism: A Multicenter, Controlled, Randomized Clinical Trial. Semin Thromb Hemost. 2016 Nov;42(8):884-890. doi: 10.1055/s-0036-1592335. Epub 2016 Oct 20.
Clinical trial NCT01263847: Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls
Official title: The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoporosis
Keywords: Dietary Supplement: Galactooligosaccharide
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Friesland Foods
First posted: 2010-12-21
Enrollment: 31
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of galactooligosaccharide (GOS) supplementation on calcium absorption and and gut microbe profiles.

Detailed description: Galactooligosaccharides (GOS) have been shown to have positive effects on calcium absorption in animals and postmenopausal women. This study aims to see whether the addition of fiber in the form of GOS to a calcium-containing yogurt drink will increase calcium absorption compared to placebo in a group of girls near menarche. Secondary outcomes are to assess physical fitness and determine the relationship between physical fitness and calcium absorption in adolescent girls as well as assess changes in gut microbiota. During this three phase, randomized, controlled crossover study, participants will consume yogurt drinks supplemented with 0, 2.5 or 5 grams of GOS twice daily for three weeks. Following each three week period, participants will complete a weekend clinical visit to measure calcium absorption. Height, weight, bone density and geometry, calcium absorption, gut microbiota and physical fitness will be measured. Effects of this GOS fiber intervention may help elucidate a mechanism of action for improving bone health with fiber supplementation.

Eligibility criteria: Inclusion Criteria:

* Female between ages of 10 and 12
* Calcium intake of 900-1300 mg/d

Exclusion Criteria:

* Take medication that influences calcium metabolism
* Any disorder of calcium or bone homeostasis
* BMI\>90th percentile for age
* Smoking, illegal drug consumption
* Any gastrointestinal disease (crohn's disease, celiac disease, inflammatory bowel disease)
* Any disease affecting kidney function
* Broken bone within last 6 months
* Dislike of yogurt or yogurt drinks
* Regular use of foods containing probiotics or prebiotics

Primary outcomes:
measure: Calcium Absorption
timeFrame: baseline and 48 h urine and blood
Secondary outcomes:
measure: Change in fecal microbiota
timeFrame: after 3 weeks of product consumption
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06809647: A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of Open Angle Glaucoma
Official title: A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma Open-Angle
Lead sponsor: PLU Ophthalmic
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 10
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: The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a period of one year.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe open angle glaucoma
* Central corneal thickness between 480 and 610 microns

Exclusion Criteria:

* surgical history of corneal graft
* presence of corneal opacities
* Failed prior trabeculectomy

Primary outcomes:
measure: Intra Ocular pressure
timeFrame: 12 months
measure: Use of concomitant topical glaucoma medications
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Storm Eye Institute
state: South Carolina
Study officials:
References:
Clinical trial NCT06050447: Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Official title: Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Adenocarcinoma
Colorectal Neoplasms Malignant
Rectal Adenocarcinoma
Keywords: Colorectal cancer
Rectal cancer
Colon cancer
Colorectal surgery
anastomotic leakage
postoperative complications
recurrence rate
cancer-specific survival
recurrence-free survival
Lead sponsor: Immanuel Kant Baltic Federal University
Sponsor class: OTHER
Collaborators: name: Center of Endourology "Endocenter"
First posted: 2023-09-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Brief summary: The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.


Eligibility criteria: Inclusion Criteria:

* Histologically proven primary adenocarcinoma of bowel;
* All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
* Signed informed consent with agreement to attend all study visits;

Exclusion Criteria:

* Unresectable tumor or contradictions to surgery;
* Indications for chemotherapy or radiation therapy prior to surgery;
* Patient withdrawal from the trial or loss of follow-up;
* Emergent operation;
* Pregnancy.

Primary outcomes:
measure: Anastomotic leakage rate
timeFrame: 3 months after surgery
measure: Mortality rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: 30-day complication rate
timeFrame: 30 days after surgery
measure: Recurrence rate
timeFrame: 3 years after surgery
measure: Cancer-specific survival
timeFrame: 3 years after surgery
measure: Recurrence-free survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Kaliningrad
country: Russian Federation
facility: Baltic Federal University
state: Kaliningrad Region
Study officials:
affiliation: Baltic Federal University
name: Mikhail A Agapov, PhD
role: PRINCIPAL_INVESTIGATOR
References: