louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139944: Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
Official title: Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-09
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with early stage non-small cell lung cancer and previously enrolled on ACOSOG-Z0040 and Z0030.

Brief summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

Detailed description: OBJECTIVES:

* Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
* Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
* Develop prognostic indicators for disease-specific and overall survival.
* Define new potential molecular targets for therapy.

OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of early-stage non-small cell lung cancer

  * T1 or T2, N0 disease
  * Had a lobectomy or greater resection with negative surgical margins (R0 resection)
* Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials

  * Node-negative with recurrent disease within 3 years (cases)
  * Node-negative patients without recurrent disease (controls)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: disease specific survival
timeFrame: Up to 10 years
measure: overall survival
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Malcolm V. Brock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550844: EMPHYSEMA AND FLNA MUTATION
Official title: Frequency and Characteristics of Emphysema in Patients With a FLNA Gene Mutation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emphysema
Keywords: Emphysema
Lung function
Filamin A
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Santelys Association
First posted: 2022-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients carrying FLNA mutation identified in Lille University Hospital in BAMARA registry

Brief summary: Some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA mutation. This prospective, monocentric, cross-sectional study aimed to describe the frequency of emphysema in patients carrying an FLNA mutation. Patients with FLNA mutations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA mutation. The other objectives are to describe emphysema's features in these patients and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.


Eligibility criteria: Inclusion Criteria:

* patients with an FLNA mutation (or gene alteration)
* patient who has given written consent to participate in the trial
* socially insured patient
* patient willing to comply with all study procedures and duration

Exclusion Criteria:

* Patient refused or unable to give informed consent
* Administrative reasons: inability to receive information, inability to participate in the entire study, lack of coverage by the social security system,
* Pregnant or breastfeeding women
* Patient under guardianship
* Persons deprived of liberty

Primary outcomes:
measure: Frequency of emphysema in patients carrying FLNA mutation
timeFrame: Baseline
Secondary outcomes:
measure: Morphological of emphysema
timeFrame: Baseline
measure: Topographical characteristics of emphysema
timeFrame: Baseline
measure: The severity of emphysema
timeFrame: Baseline
measure: Descriptive analysis of functional respiratory abnormalities measured by the functional respiratory test
timeFrame: Baseline
measure: Frequency of unexplained emphysema in patients carrying a FLNA mutation
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Cécile Chenivesse, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04835844: RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation
Official title: RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation: MAP-AF Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2021-04-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation.

Brief summary: The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Detailed description: Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy.

The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s).
* Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion.

Exclusion Criteria:

* Persistent AF
* Prior cardiac surgery
* Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s).

Primary outcomes:
measure: System is able to accurately identify gaps
timeFrame: At the time of procedure
Secondary outcomes:
measure: Treatment success
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ayman Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03309644: Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery
Official title: Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Unplanned admissions
Visits to the ED
Readmissions
Death
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 1623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a retrospective, population-based, cohort study based in Ottawa, Ontario, Canada.

Brief summary: This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ottawa, Ontario.

Detailed description: The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Eligibility criteria: Inclusion Criteria:

* Ontario residents
* Aged 18 years and older
* Elective ambulatory shoulder surgery

Exclusion Criteria:

* Emergency Surgery

Primary outcomes:
measure: Postoperative Complication
timeFrame: From day of surgery to 30 days after surgery
Secondary outcomes:
measure: Health System Costs in the 30 Days After Surgery
timeFrame: From day of surgery to 30 days after surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, University of Ottawa
name: Daniel I McIsaac, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton GM, Ramlogan R, Lui A, McCartney CJL, Abdallah F, McIsaac DI. Association of peripheral nerve blocks with postoperative outcomes in ambulatory shoulder surgery patients: a single-centre matched-cohort study. Can J Anaesth. 2019 Jan;66(1):63-74. doi: 10.1007/s12630-018-1234-8. Epub 2018 Oct 17.
Clinical trial NCT03464240: Glucose-stimulated Gut Lipid Release
Official title: Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Kensington Screening Clinic
First posted: 2018-03-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines how glucose ingestion releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

Detailed description: Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

Eligibility criteria: Inclusion Criteria:

* Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by endoscopy doctor.
* Body mass index 20 to 27 kg/m2

Exclusion Criteria:

* Patients with active inflammatory bowel disease
* Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
* Patients with active bowel malignancy
* Patients with diabetes mellitus or known/ suspected motility disorders of the gut
* Patients with decompensated liver disease
* Patients on ezetimibe or bile acid sequestrants
* Unstable cardiac or respiratory disease
* Any changes to medication in the preceding month

Primary outcomes:
measure: Visualization of lipid stores in the gut
timeFrame: 6-10 hours
Secondary outcomes:
measure: Analysis of proteins in the gut
timeFrame: 6-10 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Tornto General Hospital, UHN
state: Ontario
city: Toronto
country: Canada
facility: Kensington Screening Clinic
state: Ontario
Study officials:
References:
Clinical trial NCT01293240: Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Official title: Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.


Eligibility criteria: Inclusion Criteria:

* Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
* Good general health.
* Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
* Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
* Administration of any investigational drug or device within 14 days of study initiation.
* Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
* Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
* Post-refractive surgery.
* Currently pregnant or lactating by case history.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Comfort
timeFrame: 2 weeks
measure: Overall Comfort
timeFrame: 4 weeks
measure: End of Day Dryness
timeFrame: 2 weeks
measure: End of Day Dryness
timeFrame: 4 weeks
measure: Ocular Redness
timeFrame: 2 weeks
measure: Ocular Redness
timeFrame: 4 weeks
measure: Visual Clarity
timeFrame: 2 weeks
measure: Visual Clarity
timeFrame: 4 weeks
measure: Lens Deposits
timeFrame: 2 weeks
measure: Lens Deposits
timeFrame: 4 weeks
measure: Corrected Visual Acuity
timeFrame: 2 weeks
measure: Corrected Visual Acuity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04162340: CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
Official title: CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T Cell Lymphoma in Relapse
Refractory T-Cell Lymphoma
Keywords: CD4-specific CAR T
T cell leukemia
T cell lymphoma
CD4CAR
Lead sponsor: iCell Gene Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iCAR Bio Therapeutics Ltd.
name: Peking University Shenzhen Hospital
First posted: 2019-11-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
Primary purpose: TREATMENT

Brief summary: This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.

Detailed description: CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent; Patients volunteer to participate in the research
* Diagnosis is mainly based on the World Health Organization (WHO) 2008
* Patients have exhausted standard therapeutic options
* Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
* Female must be not pregnant during the study

Exclusion Criteria:

* Patients declining to consent for treatment
* Prior solid organ transplantation
* Potentially curative therapy including chemotherapy or hematopoietic cell transplant
* Any drug used for GVHD must be stopped \>1 week

Primary outcomes:
measure: Number of adverse events after CD4 CAR T cells cell infusion
timeFrame: 2 years particularly the first 28 days after infusion
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: up to 6 months
measure: Disease Free Survival (DFS)
timeFrame: up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Chengdu
country: China
facility: Chengdu Military General Hospital
state: Sichuan
Study officials:
affiliation: Peking University Shenzhen Hospital, China
name: Hongyu Zhang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chengdu Military Hospital
name: Fang Liu, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493644: A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Official title: A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-70 with previous Helicobacter pylori eradication failure.

Brief summary: The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Detailed description: Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

Primary outcomes:
measure: The most suitable re-eradication time
timeFrame: 12 months
Secondary outcomes:
measure: Eradication rates in three groups
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03719144: Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation
Official title: Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-10-25
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is targeting AF patients and providers.

Brief summary: This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.


Eligibility criteria: Inclusion Criteria:

Retrospective Analysis:

1. NVAF documented in at least 2 claims between January 2015 and December 2016
2. CHA2DS2-VASc scores of 2 or higher

Prospective Analysis:

1. Patient Analysis: All patients in ResearchMatch with diagnosed AF.
2. Provider Analysis: All providers who contributed at least 25 AF patients treated with DOACs to the Symphony claims dataset. All provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included.

Exclusion Criteria:

Retrospective Analysis:

1. Patients with bioprosthetic or mechanical valves in the mitral position.
2. Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
3. Patients with mitral stenosis.
4. Patients without 12-month follow-up data.

Prospective Analysis:

1. Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
2. Patient Analysis: Patients unwilling or unable to consent.

Primary outcomes:
measure: The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.
timeFrame: up to 12 months
measure: The co-primary outcome for the retrospective analysis is 12-month adherence rates.
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
measure: Prevalence of under-dosing
timeFrame: up to 12 months
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute, Duke University
name: Tracy Y Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: