louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06762327: Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
Official title: Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 20
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: TREATMENT

Brief summary: In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.


Eligibility criteria: Inclusion Criteria:

* Advanced/metastatic solid tumors other than primary lung cancer
* Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR
* Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment
* Adequate liver and kidney function
* Adequate bone marrow function
* ECOG PS 0-3
* Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided

Exclusion Criteria:

* Active viral, bacterial, or fungal infection detected 2 weeks before enrollment
* Pregnancy or lactation
* receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior)
* Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)
* Ineligible cardiac function
* Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease
* Lack of adequate bone marrow reserve or organ function

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
measure: Overall responce rate
timeFrame: 1year
Secondary outcomes:
measure: Disease control rate
timeFrame: 1year
measure: Overall survival
timeFrame: 3 years
measure: Duration of responce
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05490927: Ethnic Microaggressions and Smoking Behaviors Among Latinx Adults
Official title: Latinx Smokers: Evaluating Ethnic Microaggressions on Smoking Behavior and Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Discrimination, Racial
Keywords: Smoking
Hispanic
Latinx
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine whether microaggressions relate to multimodal facets of smoking behavior, subjective withdrawal, and urge/craving. Additionally, the second aim is to examine whether smoking deprivation moderates the relation between microaggressions and multiple facets of smoking behavior, subjective withdrawal, and urge/craving.

Detailed description: This proposal will employ a novel multi-modal approach to evaluate the role of microaggressions in relation to smoking lapse and topography among a sample of Latinx smokers. Adult Latinx daily smokers will attend two counterbalanced experimental sessions - (1) smoking deprivation (16 hours of smoking abstinence) and (2) smoking as usual - during which microaggressions during the relapse analog task will be assessed.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Current regular (daily) cigarette smoking for \>= 1 year
* Current smoking \>= 5 cig/day and biochemically confirmed via carbon monoxide (CO) analysis
* Being self-identified as Hispanic or Latino
* Able to provide written, informed consent
* Endorsement of at least one microaggression experience over the past 6-months

Exclusion Criteria:

* Endorsement of current psychotic symptoms
* Active suicidality
* Currently pregnant

Primary outcomes:
measure: Smoking Behaviors
timeFrame: During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)
measure: Subjective Withdrawal
timeFrame: During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)
measure: Urge/Craving
timeFrame: During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)
measure: Smoking Lapse Behaviors
timeFrame: During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
state: Texas
Study officials:
affiliation: University of Houston
name: Brooke Y Kauffman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234427: Pharmacogenomics of Antiplatelet Response
Official title: Pharmacogenomics of Antiplatelet Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Keywords: aspirin, atherosclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

Detailed description: In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

Eligibility criteria: Inclusion Criteria:

* 45-75 years
* GeneSTAR participant
* No personal History of Coronary Artery Disease
* Women who are post-menopausal
* Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP

Exclusion Criteria:

* Taking aspirin prescribed by physician
* weight \< 60 kg
* History of recent or current bleeding
* allergy to aspirin or history of adverse events to aspirin
* serious comorbid conditions (such as AIDS, active cancer)
* high blood pressure (\>160/95)
* History of gastrointestinal ulcer/bleeding
* Mental incompetence to make decision to participate.

Primary outcomes:
measure: Differential Gene Expression
timeFrame: 2-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Rehan Qayyum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382927: Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
Official title: Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Hip Arthroplasty
General Anesthesia
Spinal Anesthesia
Atelectasis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese Patients aged 18-85, scheduled for elective hip arthroplasty

Brief summary: General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (EIT).


Eligibility criteria: Inclusion Criteria:

* BMI \>30
* age 18-85
* elective hip arthroplasty in general anesthesia or spinal anesthesia

Exclusion Criteria:

* pregnancy/breastfeeding
* allergies against drugs used for the anesthesia
* contraindications for EIT
* severe cardiac or pulmonary comorbidities
* unable to consent or understand/follow study

Primary outcomes:
measure: arterial pO2 on room air
timeFrame: 24hrs
measure: Center of Ventilation
timeFrame: 24hrs
Secondary outcomes:
measure: Peak Flow
timeFrame: 24hrs
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl-Gustav-Carus
Study officials:
References:
Clinical trial NCT00761527: Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Urticaria
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 2980
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines

Brief summary: The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.

Detailed description: Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Eligibility criteria: Inclusion Criteria:

* Outpatient pediatric participants, male or female, aged 6 months to 11 years
* Diagnosis of allergic rhinitis or chronic idiopathic urticaria

Exclusion Criteria:

* Known hypersensitivity to desloratadine

Primary outcomes:
measure: Number of Adverse Events Reported By Category After 14 Days of Treatment
timeFrame: 15 Days
measure: Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment
timeFrame: 15 Days
measure: Participant Global Tolerability Assessment
timeFrame: Day 15
Secondary outcomes:
measure: Investigator Assessment of Clinical Efficacy
timeFrame: Day 15
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04697927: A Study of Risk Factors for the COVID-19 Virus Infection
Official title: Ascertainment of Epidemiologic Risk Information to Assess Susceptibility to and Severity of SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Infections in Cancer Patients
Keywords: SARS-CoV-2 infection
Questionnaires
20-418
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As this is an institution-wide registry, potential research subjects will be identified by the Health Informatics group.

Brief summary: The purpose of this study is to collect information that will help the reasearchers learn more about COVID-19 infections in cancer patients, and to find out about the effects of these infections on cancer treatment and outcomes. The research study involves asking people to complete a series of online questionnaires that include questions about their medical history, lifestyle, and risk factors related to the COVID-19 infection. The study will enroll both MSK patients and their household family members.


Eligibility criteria: Inclusion Criteria:

MSK Patients

* All individuals who have had at least one point of contact since January 1st 2019 as a patient, including visiting an MSK facility for treatment, clinical evaluation, follow-up or screening, COVID-related screening, or a telehealth visit. Household Members of MSK Patients
* Individuals aged 18 or older
* Currently reside in the same household of MSK patients enrolled onto this protocol
* Have an email account

Exclusion Criteria:

* Impaired decision-making capacity as noted in EHR
* Current MSK employee

Primary outcomes:
measure: develop a comprehensive registry database
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonine Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06962527: Test of Target Engagement of Ambiguity Aversion
Official title: Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intolerance of Uncertainty
Anxiety
Intolerance of Uncertainty; Anxiety
Depression, Anxiety
Keywords: Ambiguity aversion
Intolerance of uncertainty
Computational modeling
EEG/ERP
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-05-08
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.

Detailed description: In this trial, participants will be randomized to one of two single session interventions (SSI). They will complete a decision making task before and after the SSI to measure their behavioral and brain responses to ambiguity, all on the same day. They will also complete a brief measure of hopelessness before and after the SSI. The main analysis will compare changes in ambiguity aversion before and after the interventions. Participants will also be asked to complete questionnaires before completing the task and SSI. The questionnaires will be about the participant's emotions and symptoms of depression and anxiety, personality, and avoidance/tolerance of uncertainty.

Eligibility criteria: Inclusion Criteria:

1. Ages 25 to 60
2. Right-handed
3. Ability to read and write English
4. Capacity to provide informed consent
5. Intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile)

Exclusion Criteria:

1. Personal history of psychosis, mania, or hypomania
2. Personal history of autism spectrum disorder
3. IQ \< 80 as determined by the Wechsler Test of Adult Reading
4. Head injury with greater than 120 seconds loss of consciousness
5. Neurological condition (e.g., epilepsy, Parkinson's, cerebral palsy, history of stroke)
6. Currently pregnant
7. Use of any implanted electrical device (e.g., pacemaker, spinal stimulator, vagal nerve stimulator, Inspire sleep apnea device, etc.).

Primary outcomes:
measure: Beck Hopelessness Scale-4 (BHS-4)
timeFrame: 1 hour
measure: Behavioral ambiguity aversion
timeFrame: 1 hour
measure: Event-related potential responses to ambiguous choices
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT04404127: Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Official title: Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: basiliximab
Rejection
De no vo donor specific antibodies
Low immunological risk
Induction
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated

Aims:

To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)

Methods:

Prospective, randomized, double blind, non-inferiority, controlled clinical trial

Expected Outcomes:

1. Primary outcomes:

   Biopsy proven acute rejection within first year following transplant
2. Secondary outcomes:

   1. Patient and graft survival at 1 year
   2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
   3. Emergence of de novo donor specific antibodies (DSAs)


Eligibility criteria: Inclusion Criteria:

* • Male or female ≥ 18 years

  * Living donor
  * Low immunological risk (defined as):

    1. First (primary) transplant
    2. ≤ 4 antigen mismatches (HLA matching scheme)
    3. Negative HLA Ab screening

Exclusion Criteria:

* • High immunological risk

  * HLA identical or zero mismatched transplants
  * Receiving cyclosporin as primary maintenance immunosuppressant
  * Human immunodeficiency virus (HIV) co-infection
  * Pregnant or nursing female
  * Has received an investigational medication within the past 30 days
  * Has a known contraindication to the administration of Basiliximab
  * Suspected or known to have a serious infection
  * Multi-organ transplant

Primary outcomes:
measure: Rate of biopsy proven acute rejection within first year following transplant
timeFrame: 1 year after transplant
Secondary outcomes:
measure: Rate of graft survival at 1 year
timeFrame: 1 year after transplant
measure: Rate of decline in eGFR at 6 months and at 12 months
timeFrame: 1 year after transplant
measure: Rate of emergence of de novo donor specific antibodies (DSAs)
timeFrame: 1 year after transplant
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Centre (KFSHRC)
Study officials:
References:
Clinical trial NCT00917527: Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
Official title: Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Subjects with family history of coronary heart disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.


Eligibility criteria: Inclusion Criteria:

* within 1 year
* the siblings of premature coronary heart disease(male\<55years old, female\<65years old: Framingham Heart Study)patients admitted relevant hospital

Exclusion Criteria:

* Documented coronary heart disease
* Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.

Primary outcomes:
measure: improvement of endothelial dysfunction with endo-PAT2000
timeFrame: 6 weeks later drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
name: Hyuk-Jae Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nasir K, Michos ED, Rumberger JA, Braunstein JB, Post WS, Budoff MJ, Blumenthal RS. Coronary artery calcification and family history of premature coronary heart disease: sibling history is more strongly associated than parental history. Circulation. 2004 Oct 12;110(15):2150-6. doi: 10.1161/01.CIR.0000144464.11080.14. Epub 2004 Oct 4.
citation: Hong SJ, Chang HJ, Park S, Kang DR, Shin S, Cho IJ, Shim CY, Hong GR, Ha JW, Chung N. Impact of atorvastatin treatment in first-degree relatives of patients with premature coronary artery disease with endothelial dysfunction: a double-blind, randomized, placebo-controlled crossover trial. Clin Cardiol. 2013 Aug;36(8):480-5. doi: 10.1002/clc.22152. Epub 2013 Jun 10.