louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06869707: Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT
Official title: Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Neoplasms
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal neoplasms

Brief summary: Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies.

Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low.

The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.

Detailed description: After being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the NRS-2002 (Nutrition Risk Screening) will be administered.

Patients who will be assessed at risk will be notified to the center nutritionist.

Eligibility criteria: Inclusion Criteria:

* \<18 years
* ECOG grade 0-2
* Patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged I-III colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers

Exclusion Criteria:

* \>18 years
* Pregnancy
* Emergency
* ECOG ≥ 3
* M+
* Peritoneal involvement
* Inability to provide informed consent
* Informed consent refusal

Primary outcomes:
measure: Nutritional intervention
timeFrame: 15 days
Secondary outcomes:
measure: Complications
timeFrame: up tp 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Domenico D'Ugo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672407: The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
Official title: The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Eyelid Diseases
Periorbital Disorder
Hemorrhage
Surgical Blood Loss
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR).

Exclusion Criteria:

* - Adults unable to consent
* Individuals less than 18 years of age
* Prisoners
* Pregnant women.
* Known contradictions or sensitivities to study medication (tranexamic acid)
* Patients with known prior thromboembolic events
* Previous eyelid surgery or same-side DCR (RE-DCR)
* Has any type of coagulopathy

Primary outcomes:
measure: Postoperative patient ecchymosis
timeFrame: Up to 3 months
Secondary outcomes:
measure: Postoperative patient chemosis
timeFrame: Up to 3 months
measure: Eyelid edema
timeFrame: Up to 3 months
measure: Intraoperative patient bleeding
timeFrame: Postoperative day 0 (day of surgery)
measure: Physician Perception of Intraoperative Bleeding
timeFrame: Postoperative day 0 (day of surgery)
measure: Patient-perceived outcomes
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Wendy W Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769207: Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Official title: Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Flutter
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 17
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.


Eligibility criteria: Inclusion Criteria:

1. Possession of the following at time of eligibility screening:

   * iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
   * Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility
2. At least one of the following by self-report before consent:

   * Irregular Rhythm Notification
   * ECG app classification of Atrial Fibrillation
   * ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"
3. Age ≥ 22 years at time of eligibility screening
4. Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
5. Proficient in written and spoken English
6. Valid phone number associated with iPhone, ascertained from self-report
7. Valid email address, ascertained from self-report

Exclusion Criteria:

1. Shared iCloud account
2. Shared AppleWatch

Primary outcomes:
measure: Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
timeFrame: During ambulatory ECG Monitoring (up to 8 days)
Secondary outcomes:
measure: Arrhythmias Other Than AF
timeFrame: During ambulatory ECG Monitoring (up to 8 days)
measure: Self-reported Contact With Healthcare Provider
timeFrame: Between 15 to 90 days following enrollment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Marco V Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Minang (Mintu) Turakhia, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242307: Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
Official title: A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bronchial Asthma
Keywords: Asthma
Roflumilast
phosphodiesterase 4 inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-10-20
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria: Main inclusion criteria:

* Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
* No change in asthma treatment during the last 4 weeks prior to the registration
* Non-smokers or ex-smokers for 12 months or more
* %FEV1 ranging between 60 and 80%

Main exclusion criteria:

* Patients with poorly controlled asthma
* Inhalation therapy exceeding low dose during 4 weeks prior to the registration
* Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation

Primary outcomes:
measure: change in lung function parameters.
Secondary outcomes:
measure: pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT01827007: Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Official title: Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: norepinephrine infusion
under 48 hours in ICU
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.


Eligibility criteria: Inclusion Criteria:• Written informed consent by patient or relative

* Time in ICU \< 48 hours
* Septic shock
* Pulmonary artery catheter and radial arterial catheter
* Age 18 - 75 years
* Sinus rhythm
* Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study
* Mechanical ventilation with sedation
* Pwcp \<18 mmHg

Exclusion Criteria:

* Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
* Contraindication to fluid challenge
* Contraindication to TEE
* Previous heart failure, heart valve stenosis of insufficiency

Primary outcomes:
measure: Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.
timeFrame: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes
Secondary outcomes:
measure: Pulmonary function and oxygenation
timeFrame: 0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O
Other outcomes:
measure: blood gas sample, for assessment of pH, base excess and blood lactate
timeFrame: 0, 60 min
Locations:
city: Helsinki
country: Finland
facility: Intensive Care Unit 20, Meilahti Hospital
state: HUS
Study officials:
affiliation: Anesthesia and Intensive Care, Department of Surgery
name: Erika Wilkman, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00299507: Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
Official title: Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: exudative AMD
age-related macular degeneration (AMD)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-03-07
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Less than 50 years of age.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
timeFrame: Month 12
Secondary outcomes:
measure: Mean change in lesion growth at Month 12 from baseline
timeFrame: Month 12
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Study Sites
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon Investigators
role: PRINCIPAL_INVESTIGATOR
affiliation: Alcon Research
name: Patricia Zilliox, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02755207: Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
Official title: Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected ACS patients (STEMI, NSTEMI, and UA)

Brief summary: The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).

Detailed description: The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS.

We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters.

The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.

Eligibility criteria: Inclusion Criteria:

Suspected ACS patients (STEMI, NSTEMI, and UA):

Age\>18 years; Informed consent.

Exclusion Criteria:

Patients who will undergo immediate PCI; Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed.

Primary outcomes:
measure: Evaluate the diagnostic value of microRNAs in qPCR，in ACS
timeFrame: Day 7
Secondary outcomes:
measure: Evaluate the prognostic value of microRNAs in ACS
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00215007: Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)
Official title: Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Malignancy
Allogeneic Stem Cell Transplantation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).


Eligibility criteria: Inclusion Criteria:

* Allogeneic SCT
* Postneutropenic period
* Written consent

Exclusion Criteria:

* Fever
* Antibiotic therapy
* Neutropenia
* Refusal by the patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, CBF
Study officials:
affiliation: Charite, CBF, Berlin, Germany
name: Igor Wolfgang Blau, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06159907: Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.
Official title: Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecological Tumors
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, all patients referred to the gynecology oncology unit of the IRCCS San Raffaele from 01/01/2009 to July 2021 who underwent a PET examination with 18 F FDG at the unit of Nuclear Medicine at the IRCCS San Raffaele for clinical reasons will be considered.

Brief summary: Gynecological cancers involve several tumors of the female reproductive system. The five most common gynecological tumors are those of the uterine cervix, endometrium, ovary, vagina and vulva. Furthermore, although rarer, there is a further gynecological tumor, which is generated from the gestational trophoblast tissue.These pathologies represent an important burden for society since there are over nine hundred thousand cases in Europe.

Ultrasound examination is the investigation commonly used to monitor high-risk women.

Magnetic resonance imaging (MRI) is considered the most accurate imaging technique for presurgical staging of gynecological tumors. Computed tomography (CT), on the other hand, is not usually used for diagnosis, but is considered very useful for investigating possible distant metastases.Finally, integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting, including gynecological malignancies.

The present study is of considerable clinical relevance as at our Institute it is possible to have a significant number of patients suffering from gynecological neoplastic pathologies that are studied using PET, thus allowing the identification and validation of innovative imaging biomarkers, with the use of both traditional imaging parameters and radiomic features.


Eligibility criteria: Inclusion Criteria:

* adult patients suffering from a gynecological oncological disease; Patients who have performed at least one PET study with 18F FDG for the staging or restaging of their oncological pathology; patients who give written informed consent to the study

Exclusion Criteria:

* patients \<18 years lack of availability of clinical and PET imaging data useful for analyses.

Primary outcomes:
measure: PET/MRI and PET/CT with 18F-FDG in patients with gynecological tumors.
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
state: Italia
Study officials:
References:
Clinical trial NCT00000207: Multicenter Clinical Trial of Buprenorphine - 3
Official title: Multicenter Clinical Trial of Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Keywords: Buprenorphine
Opioid
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the efficacy and safety of buprenorphine.

Detailed description: 12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in the 1 year extension)

Eligibility criteria: Inclusion Criteria:

M/F, ages 21-50. opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Retention
measure: Opiate use
measure: Opiate craving
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1) Bup maintenance Tx of opiate dependence: A multicenter randomized tiral (Addiction, submitted) 2) Bup as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996;5(3): 220-222.. (1) Buprenorphine maintenance treatment of opiate dependence: A multicenter randomized trial ( Addiction, submitted). (2) Buprenorphine as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996; 5(3):220-222.