louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06622876: Incidental Discovery of Pulmonary Emboli Via CT Scan: Impact of Detections on Patient Care and Resulting Complications
Official title: Incidental Discovery of Pulmonary Emboli Via CT Scan: Impact of Detections on Patient Care and Resulting Complications. A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were admitted to the ICU between 8/2020 and 8/2024 and underwent chest CT during ICU stay

Brief summary: In recent years, with an increase in the frequency of CT examinations, there has also been an increase in the random discovery of pulmonary emboli, often small, as part of examinations performed for other indications. Most of the literature so far deals with the discovery of such findings mainly in oncological patients, and there is relatively little information regarding the frequency of such random discovery in other patient populations. Specifically in the intensive care patient population, we have not yet found any study that examined the detection rates of these findings. Also, there is no consensus regarding how these random findings should be treated from a therapeutic point of view (whether to start treatment with full anticoagulation, and if so, for what period of time).

Random pulmonary embolism is often discovered as part of a CT scan done to assess acute lung disease or lung cancer staging. In a study done in oncology patients, 385 chest CT examinations were examined, with a random discovery of pulmonary emboli at a rate of 2.6% . A larger analysis of 8 studies involving 8491 cancer patients found a slightly higher incidence of 3.6%.

We would like to check the rate of pulmonary emboli that were randomly discovered in chest CT examinations performed in the intensive care unit for other indications, and the consequences of discoveries - ie starting anti-coagulant treatment and whether there were any complications for starting such treatment (bleeding).


Eligibility criteria: Inclusion Criteria: All patients who were admitted to the ICU between 8/2020 and 8/2024 and underwent chest CT during ICU stay -

Exclusion Criteria: Missing information

-

Primary outcomes:
measure: Rate of incidental pulmonary embolism and related therapeutic consequences
timeFrame: 1.8.2020 - 1.8.2024
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT04216576: A Study of the Use of Text Message Reminders to Take Palbociclib
Official title: Oral Self-Management of Palbociclib (Ibrance®) Using Mobile Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Palbociclib
Memorial Sloan Kettering Cancer Center
19-458
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to find out whether it is feasible (acceptable to participants) to use a smartphone app to send text message reminders to take palbociclib, and whether these reminders are effective at helping people remember to take palbociclib according to the treatment schedule.


Eligibility criteria: Inclusion Criteria:

* Patients with a breast cancer diagnosis who are initiating therapy on palbociclib (Ibrance)
* \>/= 18 years of age
* Able to speak, read and write English
* Willingness and ability to send and receive text messages with intervention app
* Own a mobile telephone "smartphone" with text messaging capabilities. Only iPhone or Android operating systems support OhMD Application
* Criteria applicable for both Control and Intervention groups
* Flip-phones do not support OhMD Application and thus ineligible to participate
* Initiation palbociclib (Ibrance) for the first time, either as monotherapy or in conjunction with other medication such as Lstrozole (Femara) or Fulvestrant (Faslodex)

Exclusion Criteria:

* History of taking palbociclib (Ibrance)
* Patients whose caregivers coordinate their health care

Primary outcomes:
measure: Accuracy rate of medication self-administration
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Margaret Barton-Burke, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372476: Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer
Official title: Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast cancer
Tyrosine inhibitor
Chemotherapy
Imatinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer


Eligibility criteria: Inclusion criteria:

* Histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
* Previous anthracycline containing chemotherapy
* Presence of a certain protein on the cell surface (c-kit (CD117) and /or PDGF-receptor)
* Preferably tumor samples should be taken within 6 weeks of study entry. Most recent primary tumor tissue has to be available for analysis
* Acceptable health status (Eastern Cooperative Oncology Group \[ECOG\]-performance status 0,1, 2 or 3)

Exclusion criteria: (for the second-line therapy)

* Patient with Grade III/IV cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (HIV) infection.
* Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
* Patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
* Patient received either Vinorelbine or Imatinib in previous treatment regimens

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: at least 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Maass N, Schem C, Bauerschlag DO, Tiemann K, Schaefer FW, Hanson S, Muth M, Baier M, Weigel MT, Wenners AS, Alkatout I, Bauer M, Jonat W, Mundhenke C. Final safety and efficacy analysis of a phase I/II trial with imatinib and vinorelbine for patients with metastatic breast cancer. Oncology. 2014;87(5):300-10. doi: 10.1159/000365553. Epub 2014 Aug 26.
Clinical trial NCT00116376: Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
Official title: A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: GBM
recurrent/relapse
EGFR
VEGFR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-06-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed GBM in first or second recurrence or relapse
* Adequate hematologic, hepatic and renal function
* Age ≥ 18 years
* Karnofsky performance status score ≥ 70%
* Life expectancy ≥ 12 weeks

Exclusion Criteria:

* Peripheral neuropathy \> grade 1
* Diarrhea \> grade 1
* Gastrointestinal dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 2 years
measure: Dose limiting toxicity
timeFrame: 2 years
Secondary outcomes:
measure: Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Box 3624 DUMC, Trent Drive, Durham
country: United States
facility: The Brain Tumor Center at Duke, Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Duke University
name: David Reardon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Charles Conrad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Timothy Cloughesy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Michael Prados, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00306176: Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus
Official title: Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type II Diabetes Mellitus
Keywords: rosiglitazone,exercise,cardiovascular risk factors
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2006-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors


Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus
* Poor glycemic control

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Cardiovascular event

Primary outcomes:
measure: Cardiovascular risk factors alterations
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
Study officials:
affiliation: University of Athens,Greece
name: Christos Liapis, PhD,MD
role: STUDY_CHAIR
References:
citation: Kadoglou NPE, Korakas E, Lampropoulos S, Maratou E, Kassimis G, Patsourakos N, Plotas P, Moutsatsou P, Lambadiari V. Plasma nesfatin-1 and DDP-4 levels in patients with coronary artery disease: Kozani study. Cardiovasc Diabetol. 2021 Aug 13;20(1):166. doi: 10.1186/s12933-021-01355-x.
citation: Kadoglou NP, Vrabas IS, Kapelouzou A, Angelopoulou N. The association of physical activity with novel adipokines in patients with type 2 diabetes. Eur J Intern Med. 2012 Mar;23(2):137-42. doi: 10.1016/j.ejim.2011.10.020. Epub 2011 Nov 29.
citation: Kadoglou NP, Vrabas IS, Sailer N, Kapelouzou A, Fotiadis G, Noussios G, Karayannacos PE, Angelopoulou N. Exercise ameliorates serum MMP-9 and TIMP-2 levels in patients with type 2 diabetes. Diabetes Metab. 2010 Apr;36(2):144-51. doi: 10.1016/j.diabet.2009.11.004. Epub 2010 Feb 9.
citation: Kadoglou NP, Iliadis F, Angelopoulou N, Sailer N, Fotiadis G, Voliotis K, Vitta I, Liapis CD, Alevizos M. Cardiorespiratory capacity is associated with favourable cardiovascular risk profile in patients with Type 2 diabetes. J Diabetes Complications. 2009 May-Jun;23(3):160-6. doi: 10.1016/j.jdiacomp.2007.12.008. Epub 2008 Apr 16.
citation: Kadoglou NP, Iliadis F, Liapis CD, Perrea D, Angelopoulou N, Alevizos M. Beneficial effects of combined treatment with rosiglitazone and exercise on cardiovascular risk factors in patients with type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2242-4. doi: 10.2337/dc07-0341. Epub 2007 Jun 22. No abstract available.
Clinical trial NCT02393976: IMMUNONUTRITION IN FAST-TRACK SURGERY
Official title: NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IMMUNONUTRITION
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2015-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colorectal surgery.
* Signing informed consent.

Exclusion Criteria:

* Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
* Patients with contraindications for electrical stimulation.
* Psychiatric Disorders
* HIV
* Pregnant or breastfeeding
* intestinal obstruction
* uncontrolled infection
* ASA IV
* No acceptance or failure to follow protocol multimodal rehabilitation.

Primary outcomes:
measure: Infectious complications
timeFrame: UP TO 30 DAYS POST-OPERATIVE
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Pedro Moya
state: Alicante
Study officials:
References:
citation: Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
Clinical trial NCT04106076: Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
Official title: Phase I, Open Label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of Multiple Infusions of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor) in Patients With Adverse Genetic Risk Acute Myeloid Leukaemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Myeloid Leukaemia
Keywords: Acute Myeloid Leukaemia
Newly diagnosed AML
ELN adverse genetic risk group
Chimeric Antigen Receptor T-Cell (CAR-T) therapy
Allogeneic
Transcription Activator-Like Effector Nuclease (TALEN)
Lead sponsor: Cellectis S.A.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).


Eligibility criteria: Main Inclusion Criteria:

* Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017)
* Eastern Cooperative Oncology Group performance status of 0 or 1
* No prior gene or experimental cellular therapy
* No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

Primary outcomes:
measure: Incidence of AE/SAE/DLT [Safety and Tolerability]
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kings college London NHS Foundation Trust
name: Ghulam Mufti, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002176: A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
Official title: A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Pilot Projects
Didanosine
Drug Therapy, Combination
Stavudine
Hydroxyurea
Nelfinavir
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of this therapy over CD4 cell counts.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \> 500 cells/mm3.
* No HIV-associated symptoms.
* Written, informed consent from parent or legal guardian for patients \< 18 years old.
* Availability for follow-up for at least 96 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
* Intractable diarrhea.
* Signs and symptoms of bilateral peripheral neuropathy \>= Grade 2.
* Inability to tolerate oral medication.
* Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.

* No other anti-HIV therapy allowed.
* Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).

  1. Any prior antiretroviral therapy.
* Prior vaccination with a candidate HIV therapeutic vaccine.
* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
* Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.

Active alcohol or substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Univ of California at San Francisco Gen Hosp
state: California
Study officials:
name: . ., .
role: PRINCIPAL_INVESTIGATOR
References: