louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04173325: Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Official title: Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Small-cell Lung Cancer
Small Cell Lung Carcinoma
Keywords: Lung cancer
Relapsed lung cancer
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 10
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: This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed SCLC with known UGT1A genotype.
* Patients who have received at least 1 prior platinum-based chemotherapy.
* Life expectancy of 3 months or more.
* Measurable disease.

Exclusion Criteria:

* Patients with UGT1A polymorphism.
* Currently receiving chemotherapy.
* Pregnant and nursing women.

Primary outcomes:
measure: Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall response rate
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Cancer Center at AU Medical Center
state: Georgia
Study officials:
affiliation: Augusta University Georgia Cancer Center
name: Nagla A Karim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017625: Platelet Activation and Reactivity in Acute Exacerbations of COPD
Official title: Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Keywords: COPD
Cardiovascular Disease
Platelets
Inflammation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria

Brief summary: Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.


Eligibility criteria: Inclusion Criteria:

* \>40 years
* Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC \< 70% and less than 12% on reversibility testing\< Lower limit of normal (LLN))
* ≥10 pack years of smoking

Exclusion Criteria:

* Use of anti-coagulation or other platelet function inhibitors
* Asthma
* Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
* Malignancies

Primary outcomes:
measure: Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.
timeFrame: Measured at presentation with an AE-COPD and after 8 weeks
Secondary outcomes:
measure: Platelet-monocyte interaction (CD14 cells positive for CD61)
timeFrame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Monocyte activation (CD11b expression on CD14 positive cells)
timeFrame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Tissue factor triggered thrombin generation capacity
timeFrame: Measured at presentation with an AE-COPD and after 8 weeks
measure: Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer
timeFrame: Measured at presentation with an AE-COPD and after 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Yvonne F Heijdra, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832325: Adolescent and Young Adult Cancer Survivors: Identity Development
Official title: Adolescent and Young Adult Cancer Survivors: Identity Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: Childhood Survivor
survivors
Young Adult Cancer Survivors
Childhood cancers
09-001
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adolescent survivors from MSKCC

Brief summary: The purpose of this study is to better understand how the illness has affected the identity and what needs the survivor may have. We hope that this information will help us provide better care to future adolescent and young adult cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Current age greater than and including 15 and up to and including 25 years of age at time of consent
* Diagnosis of a first cancer \> or = to 14 and up to and including 21 years of age
* At least 6 months post-treatment according to participant's self-report.
* Able to provide informed consent (or parent or legal guardian consent and participant assent for those participants under 18 years of age)
* Able to speak English. This inclusion criterion is included because study assessments were designed and validated in English and many of them are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the assessments.

Exclusion Criteria:

* Will exclude survivors with severe cognitive impairment that precludes them from being able to give information consent and/or complete the questionnaires.

Primary outcomes:
measure: Conduct a comprehensive qualitative assessment through individual interviews and focus groups of identity development, peer and family relationships, and psychosocial concerns among survivors diagnosed during adolescence.
timeFrame: 3 years
Secondary outcomes:
measure: Conduct a prospective longitudinal assessment of identity development and peer and family relationships among survivors diagnosed during adolescence.
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marie Barnett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02667522: Shaping Neural Activity Through Parenting
Official title: Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors, using a parenting intervention.

Detailed description: Depression and anxiety are among the most frequently diagnosed psychological disorders, with persistent patterns of impairment evident from childhood through adulthood. Impaired functioning of core brain systems that respond to reward and errors may increase risk for depression and anxiety. Importantly, these neural risk markers for depression and anxiety appear to be shaped, at least in part, by environmental input. Problematic parenting is a key environmental factor involved in the intergenerational transmission of depression and anxiety. Low positive parenting is associated with blunted brain responses to reward and harsh parenting is associated with heightened brain responses to errors. This study uses an evidence-based parenting program to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors. Participants will include 80 6- to 7-year-old children and their mothers who will be randomly assigned to participate in a parenting program (Parent Child Interaction Therapy: PCIT) or to a waitlist control group, and brain responses to rewards and errors will be assessed pre- and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Child is 6-7 years old
* Maternal history of anxiety or depression
* Maternal self-report of low positive/high harsh parenting

Exclusion Criteria:

* Child has developmental disorder

Primary outcomes:
measure: Event-Related Potentials (ERP)
timeFrame: On average, 1 month after intervention
Secondary outcomes:
measure: Parenting quality
timeFrame: On average, 1 month after intervention
measure: Child anxiety symptoms
timeFrame: On average, 1 month after intervention
measure: Child depressive symptoms
timeFrame: On average, 1 month after intervention
measure: Child anxiety
timeFrame: On average, 1 month after intervention
measure: Child depression
timeFrame: On average, 1 month after intervention
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Kristin Bernard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684522: Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis
Official title: Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Eyelid Dermatitis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy of upadacitinib in eyelid dermatitis that has not resolved with topical therapies and patch testing.


Eligibility criteria: Inclusion Criteria:

* Individuals age 18-70 years old with eyelid dermatitis for at least two months
* Failure of at least one topical prescription cream for the eyelid dermatitis (steroid, pimecrolimus, tacrolimus, crisaborole, or ruxolitinib)
* Women of reproductive potential must agree to using effective contraception during treatment and for 4 weeks following the final dose of Upadacitinib.
* Willing and able participants that provide informed consent
* Willing and able participants that comply with study activities

Exclusion Criteria:

* Self-reported history of allergic response to upadacitinib
* Subject with self-reported history of heart disease, stroke, or neurological conditions
* Currently taking topical medications for eyelid dermatitis within one week of starting study drug
* Women who are pregnant, nursing, or who may become pregnant during the study
* Non-English-speaking subjects
* Patients with an active serious infection
* Patients with active TB or latent TB, patients should be tested for TB prior to upadacitinib treatment.
* Patients with active HBV/HCV or abnormal lab ranges, Lab Data: Hb\<8g/dL, ALC\<500 cells/mm3 and ANC \<1000 cells/mm3
* Patients with a history of malignancy within the last 5 years other than successfully treated NMSC.

Primary outcomes:
measure: Reduction in Investigator Global Assessment (IGA)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Walter Liszewski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06355622: Prevalence and Characterization of Pain in RASopathies
Official title: Pain in RASopathies: New Investigative Techniques and Possible Treatments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: RASopathy
Costello Syndrome
Cardio-Facio-Cutaneous Syndrome
Noonan Syndrome
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals.

Detailed description: To detect prevalence and characteristics of pain in RASopathies by using scales, questionnaires, biochemical analysis and neurophysiological assessment tests.

Eligibility criteria: Inclusion Criteria:

* All individuals with clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Individuals with a RASopathy con confirmed by genetic analysis

Primary outcomes:
measure: Prevalence of pain in verbal patients with RASopathies
timeFrame: 2 years
measure: Prevalence of Pain in no-communitating patients with RASopathies
timeFrame: 2 years
Secondary outcomes:
measure: Characterization of pain in RASopathies
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli, IRCCS
name: Chiara Leoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423222: Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)
Official title: Prevalence of Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women Who Have Given Birth, and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Incontinence
Keywords: Anal Incontinence
Quality of Life
Physical Activity
Questionnaire
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to include subjects who are female, over the age of 18, under the age of 50 and who have given birth at least once before.

Brief summary: The aim of the study is to assess the prevalence of anal incontinence among Hungarian women who have given birth at least once before, and to examine the impact of anal incontinence on the quality of life and physical activity of these women. A further aim of our study is to adapt the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) and to assess its validity and reliability.


Eligibility criteria: Inclusion Criteria:

* Have given birth at least once before
* Native Hungarian language

Exclusion Criteria:

* Menopause
* Irritable Bowel Syndrome (IBS)
* Chron's disease
* Ulcerative colitis
* Developmental abnormalities at the level of the pelvic organs
* Uninvestigated pelvic pain
* Malignant pelvic tumor
* Radiotherapy involving the pelvis
* Neurological diseases with muscle weakness
* Parkinson's disease
* Intellectual disability

Primary outcomes:
measure: Anal Incontinence Impact on Quality of Life
timeFrame: Through study completion, an average of 3 years
measure: Anal Incontinence Impact on Physical Activity
timeFrame: Through study completion, an average of 3 years
measure: Adaptation, validity and reliability of the Hungarian version of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Additional pelvic floor symptoms
timeFrame: Through study completion, an average of 3 years
measure: Global Quality of Life
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs
state: Baranya
Study officials:
affiliation: University of Pécs Faculty of Health Sciences
name: Márta Hock, PhD
role: STUDY_DIRECTOR
affiliation: Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, Pécs, Hungary
name: Eszter Ambrus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06408922: Comparison of the Effects of Single Versus Triple Injections of Platelet-Rich Plasma in Patients With Knee Osteoarthritis
Official title: Comparison of the Effects of Single Versus Triple Injections of Platelet-Rich Plasma in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 80 patients diagnosed with knee osteoarthritis were randomized into two groups: patients in Group 1 received a single intraarticular injection of PRP whereas those in group 2 were administered three intraarticular injections of PRP within an interval of 2 weeks between each application. Patients were evaluated before the treatment and at the 6 month after the treatment with a Visual Analog Scale (VAS) and The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index.


Eligibility criteria: Inclusion Criteria:

* ages of 35 and 80
* Kellgren-Lawrence grade of 2, 3, or 4

Exclusion Criteria:

* rheumatic diseases, coagulopathies, severe cardiovascular diseases, local infections, malignancies, immunodeficiency, schizophrenia, mental retardation, anticoagulant therapy, a hemoglobin concentration of 11 g/dL and platelets of 150,000/L, a history of severe trauma, or a history of hyaluronic acid or corticosteroid injection within the previous 6 months

Primary outcomes:
measure: The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Buca Seyfi Demirsoy Training and Research Hospital
Study officials:
References:
Clinical trial NCT03875222: New Criteria for Accessory Pathway Localization From Surface ECG
Official title: Studying New Criteria for Prediction of Site of Accessory Pathway From Surface ECG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Accessory Pathway
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any patient with manifest accessory pathway between 10 and 90 years of age undergoing EP maping and ablation.

Brief summary: study for discovering new criteria for localization of site of accessory pathway from surface ECG

Detailed description: the study aims for discovering new criteria for percise localization of accessory pathway from surface ECG in referance to final flouroscopic ablation site

Eligibility criteria: Inclusion Criteria:

* any patient with manifest accessory pathway .

Exclusion Criteria:

* multiple accessory pathways .previous ablation.

Primary outcomes:
measure: percise localization of accessory pathway from surface ECG in referance to successful ablation site
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05050422: The Effects of Trunk Impairment on Fatigue and Balance
Official title: The Effects of Trunk Impairment on Fatigue and Balance in Children With CP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Fatigue is a common symptom associated with cerebral palsy (CP); it has been estimated that up to 40% of adolescents with CP experience fatigue that impacts their quality of life and daily activities. Although fatigue was stated as the primary symptom, a limited number of studies were found on secondary motor and nonmotor symptoms related to trunk control in children when the literature was examined.


Eligibility criteria: Inclusion Criteria:

aged between 2-18 years old; (2) had a form of CP; (3) had the cognitive competence to participate to the all assessments.

Exclusion Criteria:

The sufferers who had an additional neurological or musculoskeletal disability, unstable medical conditions, any recent medical intervention (such as tendon lengthening surgery or botulinum toxin injection...) were excluded

Primary outcomes:
measure: Trunk Impairment Scale (TIS)
timeFrame: 1 month
measure: PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS)
timeFrame: 1 month
measure: Pediatric Balance Scale (PBS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: