louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04074720: Prospective Breast Cancer Biospecimen Collection
Official title: Prospective Breast Cancer Biospecimen Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Invasive Breast Cancer
Carcinoma in Situ of the Breast
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years old at time of consent
* Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
* Patients with carcinoma in situ or invasive breast cancer
* Patient must be undergoing one of the following:

  * definitive surgical tumor resection for breast cancer OR
  * placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR
  * neurosurgical resection of a brain metastasis from primary breast cancer.

Exclusion Criteria:

* \<18 years old
* Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
* Active drug/alcohol dependence or abuse history

Primary outcomes:
measure: Tumor biomarker identification
timeFrame: Up to 5 years
Secondary outcomes:
measure: Laboratory-based breast cancer tumor genomic profile
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Nicole Simone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835520: Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
Official title: Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Immunotherapy
Molecular Targeted Therapies
Tumor Biopsy
Plasma Samples
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:

* I: Molecular targeted agent
* II: Immunotherapy
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy
* Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.
* Patient able to give written informed consent.

Exclusion Criteria:

* Patients with cancer treated with other regimen

Primary outcomes:
measure: efficacy of treatment against Cancer
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of first documented progression assessed up to 120 months
measure: Progression free survival
timeFrame: From date of randomization until the date of first documented progression , assessed up to 120 months
measure: Objective tumor response
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01559220: Deep Brain Stimulation for the Treatment of Alzheimer's Disease
Official title: Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Detailed description: Open label pilot study

* Expected direct benefit on the modulation of neuronal networks.
* Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.

Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.

* Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.
* Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.
* Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.
* Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.
* Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.
* Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.
* Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

Exclusion Criteria:

* Has significant neurological disease, other than Alzheimer's disease, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
* Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).

Primary outcomes:
measure: Clinical Dementia Rating Scale
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Wexner Medical Center at the Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ali Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01166620: Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics
Official title: Observational Real-world Evaluation of Cost of Infections of RA Patients on Biologics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercial health plan members

Brief summary: To quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older;
* Have a diagnosis of of rheumatoid arthritis (ICD-9:714x.xx);
* Have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
* are enrolled in a health plan between February 2006 and June 2009
* have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment

Exclusion Criteria:

* Patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
* Patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
* Patients on biologics 6 months prior to the biologic index date will also be excluded
* Patients with diagnosis for other non-RA conditions commonly treated with biologics (ex. Crohn's disease) during the 6 month pre-index period.

Primary outcomes:
measure: Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept
timeFrame: 6 months
measure: Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03765320: Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection
Official title: Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection for Early Gynecological Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocele
Gynecologic Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 204
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early gynecologic cancer patients who underwent retroperitoneal lymph node dissection in Far Eastern Memorial Hospital between January 2011 and December 2017.

Brief summary: To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.

Detailed description: To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection by reviewing the medical records of patients who underwent retroperitoneal lymph node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital, January 2011\~December 2017.

Eligibility criteria: Inclusion Criteria:

* Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer, ovarian cancer, and fallopian tube cancer)
* Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal lymphadenectomy.

Exclusion Criteria:

* nil

Primary outcomes:
measure: Factors predicting lymphocele occurrence
timeFrame: 10 year
Secondary outcomes:
measure: Factors predicting surgical complication
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02009020: Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective abdominal or urological surgery

Brief summary: Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med 2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz technique, a non-invasive measurement device is now available commercially. In this study, the reference technique based on arterial measurement and a respiratory variation monitor (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1: 307-10)


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 80 years old
* Written informed consent obtained
* Patients scheduled for elective urological or abdominal surgery procedures in supine position
* qualifying for arterial line

Exclusion Criteria:

* pregnancy
* cardiac insufficiency (NYHA 4, EF \< 25 %)
* coronary artery disease (CCS 4)
* coagulopathy
* symptoms of infection or sepsis
* malignant hyperthermia
* absence of sinus rhythm
* BMI \> 30
* M. Raynaud

Primary outcomes:
measure: Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Study officials:
References:
citation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
citation: Pestel G, Fukui K, Hartwich V, Schumacher PM, Vogt A, Hiltebrand LB, Kurz A, Fujita Y, Inderbitzin D, Leibundgut D. Automatic algorithm for monitoring systolic pressure variation and difference in pulse pressure. Anesth Analg. 2009 Jun;108(6):1823-9. doi: 10.1213/ane.0b013e3181a2a8bf.
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Clinical trial NCT01236820: A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients
Official title: L5 as a Risk Factor of Cardiovascular Disease in Chronic Kidney Disease and Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Chronic Kidney Disease Patients
Hemodialytic Patients
High LDL Level
High L5 Level
Keywords: L5
LDL
Cardiovascular disease
Chronic kidney disease
Hemodialysis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in Taiwan, mostly in Taichung area

Brief summary: The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.

Detailed description: Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of CKD
* clinical diagnosis of HD

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT06761274: Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow up of Patients With Hodgkin's Lymphoma
Official title: Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow-up of Patients With Hodgkin's Lymphoma in Complete Remission for at Least 2 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hodgkin Lymphoma in Remission
Keywords: epigenetic markers
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study design: It is a monocentric and exploratory study, experimental on human tissues in vitro which involves the analysis of peripheral blood in patients with Hodgkin's lymphomas with the following characteristics:

* in complete remission for at least two years after first-line therapy with stage IIb, III or IV at onset (Ann Arbor classification).
* newly diagnosed (stage IIb, III or IV, Ann Arbor Classification).

Detailed description: The study aims to evaluate patients with hodgkin lymphoma in complete remission for at least 2 years and newly diagnosed (stage II b, stage III or stage IV) as they are currently characterised by a long life expectancy during which there is an increased and early incidence of non-neoplastic systemic complications as well as, of course, manifestations of secondary malignancies.

Eligibility criteria: Inclusion Criteria:

* hodgkin lymphoma stage II b, III or IV at onset in remission for at least two years after the first line of therapy for lymphoma
* Newly diagnosed histologically confirmed stage II b, III or IV patients who require first-line therapy
* Patients of both sexes aged ≥ 18 years at enrollment
* Signature of informed consent

Exclusion Criteria:

* Concomitant second neoplasm

Primary outcomes:
measure: evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
timeFrame: through study completion, an average of 2 year
measure: DNA methylation (methylation rate)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
timeFrame: through study completion, an average of 2 year
measure: DNA methylation (methylation rate)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168220: Predictors of Drug Hypersensitivity in HIV Infected Subjects
Official title: Predictors of Drug Hypersensitivity in HIV Infected Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infections
Hypersensitivity
Keywords: Treatment Experienced
HIV
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Monash University
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infection, exposed to antiretroviral treatment, either tolerant or hypersensitive to treatment

Brief summary: A case-control study to look at hypersensitive and tolerant individuals matched for HLA genetic predisposition, when considering predictors of drug hypersensitivity.The study aims to identify the immunological factors increasing the risk of drug reactions in HIV positive individuals.

Detailed description: 1. To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.
2. To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR.
3. Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity.
4. To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients.
5. To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.

Eligibility criteria: Inclusion Criteria:

* HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir.
* Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Paul Cameron, Dr
role: PRINCIPAL_INVESTIGATOR
References: