louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02617992: Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Official title: Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyps
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 200
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: Patients who have had endoscopic mucosal resection of colonic polyps that are undergoing surveillance colonoscopy.

Brief summary: The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.

Detailed description: Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic polyps.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
* Age \> 18 years
* Able to give informed consent to involvement in the clinical study

Exclusion Criteria:

* Unable to provide informed consent for involvement

Primary outcomes:
measure: Presence of post-EMR recurrence
timeFrame: one year
Secondary outcomes:
measure: Histological characteristics of post-EMR scar biopsies
timeFrame: one year
measure: Scar size
timeFrame: one year
measure: Presence of post EMR scar with clip artifact
timeFrame: one year
measure: Number of sites of recurrence
timeFrame: one year
measure: Location of recurrence
timeFrame: one year
measure: Morphology of recurrence
timeFrame: one year
measure: Kudo pit pattern assessment
timeFrame: one year
measure: NICE classification
timeFrame: one year
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00640692: Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial
Official title: Kinase Genotyping of Gastrointestinal Stromal Tumors (GIST) From Patients Enrolled in the A6181112 Phase IIIb Trial at Participating U.S. and Ex-U.S. Medical Centers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastrointestinal Neoplasm
Keywords: Gastrointestinal stromal tumor
GIST
Sunitinib
Imatinib
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in Pfizer A6181112

Brief summary: The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Detailed description: In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled in Pfizer A6181112

Exclusion Criteria:

* Patients who do not consent for analysis of their tumor in this companion study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Christopher L Corless, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05724992: Familial Pancreatic Cancer PROPHilation Program in Italy
Official title: Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Candidates for Hereditary Pancreatic Cancer Testing
Keywords: Pancreatic Cancer
Pancreatic Cancer familiarity
Genetic profiling
Genetic predisposition
Pancreatic Cancer surveillance
Lead sponsor: Associazione Italiana per lo Studio del Pancreas
Sponsor class: OTHER
Collaborators: name: General and Pancreatic Surgery Unit, University of Verona
name: Fondazione Valsecchi
name: Associazione Oltre La Ricerca
name: Genomica srl
First posted: 2023-02-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.

Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.

Up to 3,000 participants will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

* Being enrolled on the IRFARPC registry
* Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
* Willingness to participate in saliva-swab-based genetic testing

Exclusion Criteria:

- Already known genetic mutation

Primary outcomes:
measure: Presence - absence of predisposing mutations
timeFrame: 5 years
Secondary outcomes:
measure: Correlation of genetic mutations with personal oncological history
timeFrame: 5 years
measure: Correlation of genetic mutations with familial oncological history
timeFrame: 5 years
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata
Study officials:
References:
Clinical trial NCT04326192: Brown Adipose Tissue Activation by Spinal Cord Stimulation
Official title: Brown Adipose Tissue Activation by Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Back
Obesity, Morbid
Type 2 Diabetes
Keywords: Obesity
Diabetes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.

Detailed description: This research study aims to investigate possible activation of brown adipose tissue (BAT) metabolism by upper thoracic spinal cord stimulation (SCS). We believe that our multidisciplinary research team presents a unique opportunity to test whether SCS can activate BAT metabolism, as tested during a routine screening procedure for spinal cord stimulation (SCS) for pain control. Our marker for BAT activation is 18F-fluorodeoxyglucose (FDG) - positron emission tomography (PET), which has previously been used to gauge cold-evoked BAT activation, and other studies of BAT in humans. We believe this proof-of-concept study could pave the way for a new therapeutic modality for the treatment of morbid obesity, and Type 2 Diabetes Mellitus.

Eligibility criteria: Inclusion Criteria:

1. Age: 21-70 years
2. Persistent neuropathic leg and back pain
3. Subjects who are already planning to undergo SCS for pain
4. Subjects who have not received a prior SCS trial for pain
5. Subjects with a BMI of 25-45, using formula; weight (lb) / \[height (in)\]2 x 703

Exclusion Criteria:

1. Not considering SCS for pain
2. Forensic patient
3. Taking beta blockers
4. Weight change \> 5% within last 3 months
5. Habitual tobacco use
6. Habitual excessive alcohol use
7. Pregnancy
8. Decisionally impaired adults
9. Children
10. Neonates
11. Subjects with a BMI of \<25 or \>45

Primary outcomes:
measure: SUVmax
timeFrame: 1 week
Secondary outcomes:
measure: Ipsi- and contralateral BAT during SCS-activation
timeFrame: 1 week
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kim Burchiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00331292: A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients
Official title: A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Keywords: Asthma bronchoscopy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.


Eligibility criteria: Inclusion criteria:

* Have a history of intermittant asthma.
* Have asthma symptoms less than once per week.
* Have no other significant disease.
* Do not take regular oral or inhaled steroids.
* Are a non-smoker for the past 12 months with a pack history of less than 5 years.

Exclusion criteria:

* Have a history of drug or alcohol abuse.
* Have poorly controlled asthma or a history of life-threatening asthma.
* Have a history of hypersensitivity to bronchodilators.
* Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.
* Have received oral steroids within 3 months of study entry.
* Have been hospitalized for your asthma within 3 months of study entry.
* Have had treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02651792: Ketamine- Propofol Versus Pethidine- Propofol in ERCP
Official title: Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation in ERCP
Keywords: ketamine
propofol
pethidine
ERCP
endoscopist
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

Detailed description: The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to \<90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

Eligibility criteria: Inclusion Criteria:

* both gender
* age between 18-70

Exclusion Criteria:

* pregnant patients.
* morbid obesity.
* chronic obstructive pulmonary disease.
* complicated airway.
* American society of anesthesia (ASA) physical classification IV-V.
* history of allergy or contraindications to the drugs used in the study
* emergency need for ERCP.
* those whose informed consent could not be signed.
* those with possible complex ERCP.

Primary outcomes:
measure: endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)
timeFrame: Immediately after procedure.
Secondary outcomes:
Other outcomes:
measure: amount of propofol consumed during procedure
timeFrame: Immediately after procedure.
Locations:
city: Asyut
country: Egypt
facility: Al Rajhy liver hospital
Study officials:
affiliation: Assiut University
name: Mostafa S Abbas, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03297892: Health Status of the Patients Followed for a Disease of Cushing in the Region Large-West of 1990 to 2015
Official title: Etat de santé Des Patients Suivis Pour Une Maladie de Cushing Dans la région Grand-Ouest de 1990 à 2015
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cushing Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 60
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: All patients over the age of 18 at inclusion, formerly or currently being followed for Cushing's disease diagnosed between 1 January 1990 and 31 December 2015 in one of the six university centers in the French West.

Brief summary: Cushing's disease is a rare disease that can reduce patients' expectations or quality of life, and for which predictive factors for cardiovascular mortality and recurrence are not well defined.

The primary objective is to determine the rates of remission and recurrence of patients with Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers, Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods : that after the first pituitary surgery and that on the day of the last news.

The secondary objective is to study the possible prediction of clinical and biological data perioperative of remission and recurrence during follow-up.

Detailed description: Investigators are interested in the prevalence of complications of the pathology (cardiovascular, metabolic, neuropsychological, infectious, rheumatological, etc.) within this cohort, the mortality rate, the rate of remission and recurrence and the quality of life history using the history of patient illness and a questionnaire.

All patients over the age of 18 years at the time of inclusion, formerly or currently being monitored for Cushing's disease diagnosed between January 1, 1990 and December 31, 2015, in one of the six university centers in the West part of France can be included.

Eligibility criteria: Inclusion Criteria:

* patients over the age of 18 at inclusion,
* formerly or currently being followed for Cushing's disease diagnosed between 1 January 1990 and 31 December 2015 in one of the six university centers in the French West.

Exclusion Criteria:

* Minor patients,
* patients with a pathologic analysis in favor of a mixed secretion adenoma (positive immunohistochemical analysis for ACTH and another hormone of the anterior pituitary).
* patients who have undergone a pathologic diagnosis of "adenoma to ACTH" without clinical-biological Cushing syndrome, ie silent adenoma

Primary outcomes:
measure: Rates de remission and recurrence after the first surgery
timeFrame: between 1 January 1990 and 31 December 2015
Secondary outcomes:
measure: predictive factors of remission and recurrence
timeFrame: between 1 January 1990 and 31 December 2015
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04021992: GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
Official title: GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 48
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: The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* biopsy proved CD20+ DLBCL;
* previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
* at least one evaluable lesion；
* ECOG PS 0-1;
* 18-65 years;
* proper functioning of the major organs.

Exclusion Criteria:

* involvement of central nervous system;
* with other malignancy;
* patients receiving or received drug of other clinical trial within 30 days；
* previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
* patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
* grade 2 or more peripheral neuropathy.

Primary outcomes:
measure: ORR
timeFrame: 4-years
Secondary outcomes:
measure: success rates in autologous stem cell mobilization
timeFrame: 4-years
measure: PFS
timeFrame: 4-years
measure: EFS
timeFrame: 4-years
measure: OS
timeFrame: 4-years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02185092: Probiotic Use in Patients With Prior COPD Exacerbation
Official title: Probiotic Use in Patients With Prior COPD Exacerbation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COPD
Obstructive Lung Disease
Keywords: exacerbations
COPD
pneumonia
probiotic
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.


Eligibility criteria: Inclusion Criteria:

1. Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened.
2. Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows clinic at PPOB who have had a COPD exacerbation within the last year.
3. Patients over age 18
4. Patients who have a pulmonary function test (PFT) showing COPD within 1 year of enrollment in the study or if the treating physician plans to obtain PFT as part of the patient's care plan.
5. Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD criteria).

Exclusion Criteria:

1. Patients with less than one year of life expectancy from a concomitant diagnosis
2. Any GI motility disorders or previous bowel resection surgery (short gut syndrome)
3. Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper).
4. Patients admitted within the last one year with a diagnosis of pancreatitis
5. Patients unable to give consent will not be included in the study.
6. Patients unable to sign consent
7. Patients already on azithromycin daily for COPD exacerbations
8. Patients under department of corrections custody.

Primary outcomes:
measure: COPD exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Antibiotic Use
timeFrame: 1 year
Other outcomes:
measure: Systemic Steroid Use
timeFrame: 1 year
Locations:
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Karen S Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: