louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02917759: Liver and Biliary Tumor Tissue Registry
Official title: Establishment of a Tissue and Blood Registry to Support Translational Investigations Into the Biology, Etiology and Therapy of Liver and Biliary Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Keywords: liver cancer
biliary tract cancer
cholangiocarcinoma
hepatocellular carcinoma
liver tumor
biliary tumor
hepatoma
liver mass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 1000
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: Individuals undergoing surgical removal of a liver or biliary mass at Mayo Clinic Florida

Brief summary: Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. A blood sample may also be collected at the time of enrollment.

Detailed description: The study establishes a tissue and blood registry at Mayo Clinic Florida to support translational investigations into the biology, etiology and prognosis of liver and biliary masses such as through the use of patient-derived xenografts.

Patients having surgery to remove a liver or biliary mass or having a biopsy of a mass or lesion will be asked to donate a portion of the removed mass for research purposes. Only portions of the mass not required for clinical diagnostic evaluation, or surgical waste, will be used in this research study.

The tissues acquired will be stored and used for any specific, hypothesis driven protocols that are IRB approved. Serum and plasma samples may also be obtained at enrollment.

Clinical patient data from medical charts that may be correlative to outcomes will be collected and stored in a password secure data base. Data will be extracted from medical records charts.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo surgical resection of a liver or biliary mass

Exclusion Criteria:

* Under 18 years of age. Prior radiation to mass.

Primary outcomes:
measure: Number of successful xenografts established
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Tushar C Patel, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01999959: Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Pertubation
Insemination
Keywords: Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.


Eligibility criteria: Inclusion Criteria:

* age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration \>15 million spermatozoa/ml and total sperm number \>39 million/ml according to WHO criteria

Exclusion Criteria:

* the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding

Primary outcomes:
measure: Pregnancy rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
state: Cankaya
Study officials:
References:
citation: Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.
Clinical trial NCT03890159: Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke
Official title: Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke in Attention, Functional Independence and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 45
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 aims to investigate the effects of computer assisted cognitive rehabilitation and conventional cognitive rehabilitation methods on patients' attention, quality of life and functional independence. Recruiting from 15 patients from each group, patients will be followed up for a month and the outcome measures will be repeated.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with stroke

Exclusion Criteria:

* Problems with sight
* Comorbid neurological disease
* Cognitive impairment prior to stroke
* Neglect Syndrome
* Wernicke or Global aphasia

Primary outcomes:
measure: Stroop test
timeFrame: 1 month
measure: Trail making
timeFrame: 1 month
Secondary outcomes:
measure: Beck Depression Index
timeFrame: Baseline, Month 1
measure: Quality of Life Assessment
timeFrame: 1 month
measure: Functional Independence
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
Clinical trial NCT06391359: Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
Official title: Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Acute Pancreatitis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound.

Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of 'EUS-negative' IAP.

Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization.

Study population: Adults with a first episode of 'EUS-negative' IAP.

Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment.

Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Eligible for early (laparoscopic)\* cholecystectomy
* Full required diagnostic work-up of patient has been performed, including EUS
* First episode of 'EUS-negative' IAP
* Informed consent for participation was obtained \*if required open cholecystectomy is allowed

Exclusion Criteria:

* Recurrent acute pancreatitis
* Diagnosis of chronic pancreatitis
* Diagnosis of necrotizing pancreatitis
* Current pancreatic malignancy
* Prior cholecystectomy
* Documented etiology of acute pancreatitis

Primary outcomes:
measure: Acute pancreatitis recurrence
timeFrame: Within 1 year after date of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location University of Amsterdam
state: Noord-Holland
Study officials:
References:
Clinical trial NCT00777959: Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
Official title: A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2008-10-22
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

Detailed description: Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.

Eligibility criteria: Inclusion Criteria:

* Confirmed adenocarcinomas of the prostate.
* Evidence of metastatic disease
* Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
* PSA level is greater or equal to 7 ng/ml.
* ECOG performance status less than or equal to 1

Exclusion Criteria :

* Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
* Prior chemotherapy for prostate cancer
* Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
* Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
* Patient has pain related to prostate cancer that warrants the initiation of chemotherapy

Primary outcomes:
measure: 30% Prostate specific antigen (PSA) decline within 12 weeks
timeFrame: 12 weeks
measure: Number of dose limiting toxicities (DLTs)
timeFrame: Day 1 to Day 35
Secondary outcomes:
measure: Prostate specific antigen (PSA) response rate
timeFrame: 12 weeks
measure: Number of patients with progression free survival (PFS)
timeFrame: 12 weeks
measure: Time to prostate specific antigen (PSA) progression
timeFrame: 12 weeks
measure: Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus
timeFrame: 30 Minutes to 24 hour postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.
Clinical trial NCT02473159: Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer
Official title: Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer: Interventional Pilot Study for 5 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Near-infrared fluorescence
Indocyanine green, ICG
breast cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-06-16
Enrollment: 5
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Detailed description: Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Eligibility criteria: Inclusion Criteria:

* nonpalpable breast tumor ≤ 2cm in patients with breast cancer.
* patients who need breast biopsy as treatment for breast cancer.
* Eastern Cooperative Oncology Group Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* nonpalpable breast tumor ≥ 2cm in patients with breast cancer.
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness

Primary outcomes:
measure: detection rate
timeFrame: one day
Secondary outcomes:
measure: determine the pathological stability
timeFrame: one day
Other outcomes:
measure: detection rate and reoperation rate
timeFrame: participants will be followed for the duration of return to clinic, an expected average of 1 weeks
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: So-Youn Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05177159: Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.
Official title: Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Postoperative Delirium
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 417
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be selected from patients who schedule to receive elective non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.

Brief summary: Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.


Eligibility criteria: Inclusion Criteria:

* With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
* Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
* Operation time is expected to be longer than 2 hours

Exclusion Criteria:

* Clinical diagnosis of dementia
* Clinical diagnosis of cerebrovascular disorders
* Clinical diagnosis of heart failure
* Clinical diagnosis of liver failure
* Clinical diagnosis of renal failure
* Clinical diagnosis of traumatic brain injury
* Alcohol abuse
* Can not complete the cognitive assessments
* Refuse to sign informed consent

Primary outcomes:
measure: The incidence of postoperative delirium within postoperative 5 days
timeFrame: the incidence of delirum within postoperative 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00958659: Study of Specimens From Young Patients With Neuroblastoma
Official title: Prognostic Multigene Expression Classification of Neuroblastoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-13
Enrollment: 350
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Neuroblastoma

Brief summary: This research trial studies specimens from young patients with neuroblastoma. Studying the genes expressed in specimens from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. Establish a robust messenger ribonucleic acid (mRNA) gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time polymerase chain reaction (PCR) to quantify mRNA levels from genes that have been shown in at least 2 independent studies to have predictive power.

II. Identify microRNA (miRNA) patterns that have prognostic significance in neuroblastoma (NB) as accumulating evidence indicates that alterations in miRNA expression play a critical role in tumorigenesis and can be used in prognostic evaluation.

III. To perform an integrated analysis of the established microRNA classifier with our mRNA signature to determine whether it results in even better classification of NB tumors.

OUTLINE:

Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Neuroblastoma

  * Untreated disease
* RNA samples from primary untreated NB-tumors available in Children's Oncology Group (COG) repository

  * At least 60% tumor cells
* At least 2 years of follow-up from the date of diagnosis
* Full clinical and biological annotation

Primary outcomes:
measure: mRNA expression levels from genes that have been shown (in at least two independent studies) to have power for outcome prediction in children with NB, assessed by real-time PCR
timeFrame: Baseline
measure: miRNA patterns that have prognostic significance in NB, assessed by a reverse transcription quantitative PCR-based 'stem-loop' method to quantify expression levels
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Michael Hogarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043459: Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL
Lead sponsor: Tularik
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)
* Subjects must have received prior chemotherapy for their NHL
* At least 18 years of age
* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
* Karnofsky performance status of at least 70%
* Estimated life expectancy of at least 12 weeks
* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
* Subject must be able to comply with study procedures and follow-up examinations.
* Signed written informed consent
* Lab Values (obtained ≤ 7 days prior to study enrollment):
* ANC at least 1.5x10e9/L,
* Platelet count at least 100x10e9/L,
* Hemoglobin at least 8.5 g/dL,
* Creatinine within 2 times upper limit of normal,
* AST and ALT within 3 times upper limit of normal,
* Bilirubin within 1.5 times upper limit of normal,
* Albumin great than 2.5 g/dL,

Exclusion Criteria

* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
* Patients who have received any investigational agent within 4 weeks of enrollment
* Patients who are pregnant or breast-feeding
* History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* History of central nervous system metastases or carcinomatous meningitis
* Major surgery within 4 weeks of enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Tularik
name: Kerrie Boyd
role: STUDY_CHAIR
References: