louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03047616: A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
Official title: A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with non-small cell lung cancer (NSCLC)

Brief summary: Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced Metastatic NSCLC
* Scheduled to initiate an immune checkpoint inhibitor
* Age \>= 18 years
* Able to provide informed consent

Exclusion Criteria:

* Other, unrelated, concomitant active, invasive malignancy

Primary outcomes:
measure: the correlation between markers identified in the blood and in the primary tumor.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Charu Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aggarwal C, Thompson JC, Chien AL, Quinn KJ, Hwang WT, Black TA, Yee SS, Christensen TE, LaRiviere MJ, Silva BA, Banks KC, Nagy RJ, Helman E, Berman AT, Ciunci CA, Singh AP, Wasser JS, Bauml JM, Langer CJ, Cohen RB, Carpenter EL. Baseline Plasma Tumor Mutation Burden Predicts Response to Pembrolizumab-based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 May 15;26(10):2354-2361. doi: 10.1158/1078-0432.CCR-19-3663. Epub 2020 Feb 26.
Clinical trial NCT03591016: Prospective Observational Study of Difficult Intravenous Access in the Operating Room
Official title: Prospective Observational Study of Difficult Intravenous Access in the Operating Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Intravenous Access
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.

Brief summary: This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.


Eligibility criteria: Inclusion Criteria:

* Patients 0-18 years of age
* Having surgery at Nationwide Children's Hospital

Exclusion Criteria:

* Pre-existing IV upon arrival to the operating room

Primary outcomes:
measure: Time it takes to insert an IV
timeFrame: between 1 to 30 minutes
Secondary outcomes:
measure: Anticipated difficulty
timeFrame: Baseline
measure: Actual difficulty
timeFrame: between 1 to 30 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Ralph Beltran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06170216: Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)
Official title: A Single-center, Non-interventionary Clinical Study Evaluating the Efficacy and Safety of Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibale patients who ≥ 18 years old, Initial or first recurrent iNHL, with no contraindications to any medication in the treatment plan are enrolled. They will sign an informed consent form. Pregnant or lactating women were excluded. And patients who may not benefit from receiving immunochemotherapy evaluated by researchers are also excluded.

Brief summary: Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities.

Detailed description: Evaluated the efficacy and safety of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Initial or first recurrent iNHL confirmed by histopathology, including FL (1-3a), MZL, MCL;
* Sign an informed consent form;
* Researchers evaluate patients who can benefit from receiving immunochemotherapy.

Exclusion Criteria:

* There are contraindications to any medication in the treatment plan;
* Pregnant or lactating women or male and female participants of childbearing age did not take contraceptive measures during the trial period and within 30 days after the last medication;
* Researchers believe that patients who are not suitable for enrollment.

Primary outcomes:
measure: ORR
timeFrame: up to 6 months
Secondary outcomes:
measure: 2-year progression-free survival (PFS)
timeFrame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
measure: 2-year event-free survival (EFS)
timeFrame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
measure: overall survival
timeFrame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
measure: Hematology and non hematology toxicity
timeFrame: Throughout the treatment period，up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02902016: Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies
Official title: Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Intolerance
Keywords: PPARgamma
Lactose intolerance
Lactase
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: French National Society of Gastroenterology
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-09-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing gastroduodenal endoscopy for digestive cancer screening
* Subjects undergoing gastroduodenal endoscopy for ulcerative gastroduodenal diseases
* Subjects undergoing gastroduodenal endoscopy for epigastric pains
* Subjects undergoing gastroduodenal endoscopy for gastroesophageal reflux diseases

Exclusion Criteria:

* Subjects with macroscopic duodenal lesions detected at endoscopy
* Subjects suffering from coeliac disease
* Subjects suffering from atrophic gastritis
* Subjects who use anticoagulant
* Pregnancy or breast feeding

Primary outcomes:
measure: LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM)
timeFrame: 2 years
Secondary outcomes:
measure: LCT mRNA expression measured by quantitative RT-PCR in primary intestinal epithelial cells (isolated from duodenal biopsies) stimulated with a new PPARgamma agonist (GED, 1mM)
timeFrame: 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Pierre Desreumaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03074916: Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint
Official title: Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Interphalangeal Arthroplasty
Distal Interphalangeal Arthrodesis
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 111
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP arthrodesis

Brief summary: The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.


Eligibility criteria: Inclusion Criteria:

Arthroplasty group:

* DIP silicone arthroplasty at least one year ago
* Informed consent as documented by signature

Arthrodesis group:

* Matched patients with an DIP arthrodesis
* Informed consent as documented by signature

Exclusion Criteria:

Arthroplasty group:

* Silicone arthroplasty at the thumb IP joint
* Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Arthrodesis group:

* Arthroplasty at another DIP joint
* Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Primary outcomes:
measure: satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up
timeFrame: at least 1 year up to 7 years
Secondary outcomes:
measure: Michigan Hand Questionnaire
timeFrame: at least 1 year up to 7 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT00637416: Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Official title: The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dysphonia
Keywords: horseness
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: TAP Pharmaceutical Products Inc.
First posted: 2008-03-18
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.


Eligibility criteria: Inclusion Criteria:

1. Healthy children with a diagnosis of dysphonia age 3-18 years.
2. Dysphonia must be present for at least one month duration.
3. May have vocal cord nodules present.
4. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.
5. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
6. Caregiver must be able to read, write, and understand English.
7. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.

Exclusion Criteria:

1. Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy.
2. Dysphonia must not be due to an acute upper respiratory infection.
3. Must not have been treated with proton pump inhibitor medication in the past 12 months.
4. Inability of child to cooperate with recording of voice for analysis.
5. Inability of caregiver to read, write, and understand English.
6. Mental retardation, cognitive impairment, or developmental delay.
7. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.

Primary outcomes:
measure: Change in Condition Over Treatment Period
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Julie Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478516: Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
Official title: Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema
Keywords: autologous plasmin
macular edema
vitreous
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
Collaborators: name: Hallym University
First posted: 2011-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 evaluate in a prospective study the efficacy of intravitreal autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous body.

Detailed description: Autologous plasmin enzyme has been used to liquefy the gel structure of the vitreous body and to decrease the adherence of the posterior vitreous cortex to the inner limiting membrane in clinical studies. The investigators performed intravitreal autologous plasmin enzyme for macular edema. in addition, the investigators collected vitreous body in macular edema and analyzed fibrinolytic system.

Eligibility criteria: Inclusion Criteria:

* eyes with macular edema
* those who showed poor outcomes in visual acuity or macular thickness after grid laser,triamcinolone,or bevacizumab therapy or a combination of these treatments.

Exclusion Criteria:

* uncontrolled blood pressure (systolic and diastolic blood pressure greater than 150 and 90 mm Hg, respectively)
* renal insufficiency
* intraocular surgery or any intravitreal treatment during the previous 3 months
* history of ocular hypertension and/or glaucoma

Primary outcomes:
measure: Central macular thickness after intravitreal autologous plasmin injection
timeFrame: 1 month after intervention
measure: Visual acuity after intravitreal autologous plasmin
timeFrame: 1 Month after intervention
Secondary outcomes:
measure: fibrinolytic system
timeFrame: baseline
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Ji Won Lim
state: Kangwon-do
Study officials:
affiliation: Chuncheon Sacred Heart Hospital
name: Jiwon Lim, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496416: Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis
Official title: Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2015-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of aquatic therapy on a range of MS-related symptoms such as cognition, mood, fatigue and quality of life (QOL).

Detailed description: Aim 1. Examine the impact of aquatic exercise on cognitive abilities. The proposed study will test the hypotheses that, compared to the wait-list control group, the treatment group will demonstrate significantly greater improvements in cognitive outcomes, specifically: processing speed, executive functioning, working memory and long-term memory.

Aim 2. The current study will examine the impact of an aquatic exercise on fatigue, mood, wellness, QOL and physical functioning. Specifically the investigators predict that aquatic exercise will lead to improvements in: 1.Fatigue 2. Health related QOL 3. Depression/anxiety 4. Self-efficacy 5. Physical Functioning (i.e. gait and walking).

Aim 3: Examine the long-term effects of aquatic exercise on all outcome measures.

Eligibility criteria: Inclusion Criteria:

* diagnosis of MS.
* between the ages of 18-65.
* read and speak English fluently.

Exclusion Criteria:

* history of significant substance abuse.
* history of neurological disease other than MS (for example, stroke, epilepsy, or brain injury).
* history of significant psychiatric illness (for example, bipolar disorder or schizophrenia).
* has engaged in more than 30 minutes of moderate to strenuous exercise per week during the past six months.

Primary outcomes:
measure: Cognition measured by results of standardized neuropsychological tests
timeFrame: 8 weeks
Secondary outcomes:
measure: Fatigue measured by self-report questionnaires
timeFrame: 8 weeks
measure: Quality of Life measured by self report questionnaires
timeFrame: 8 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Helen Genova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860416: Additional Post Hoc Analysis and Clinical Data Collection
Official title: Additional Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Observations
Keywords: Neurology
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who completed a BNA test with the Auditory Oddball Task, from both genders, aged 3-99 years.

Brief summary: The purpose of this study is to collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).

Detailed description: To collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).

The BNA™ technology was developed and is utilized by ElMindA Ltd. The (BNA™) Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP').

Eligibility criteria: Inclusion Criteria:

* Completed a BNA test in the past
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate

Exclusion Criteria:

* Significant Sensory deficit

Primary outcomes:
measure: engineering development according to clinical assessments
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Glenview
country: United States
facility: ElMindA
state: Illinois
city: Lincoln
country: United States
facility: Premier Psychiatric Group
state: Nebraska
Study officials:
affiliation: ElMindA Ltd
name: Mark Skopin, PhD
role: PRINCIPAL_INVESTIGATOR
References: