louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03835299: Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
Official title: Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donors
Keywords: blood donor, fear, vasovagal reaction
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: New York Blood Center
First posted: 2019-02-08
Enrollment: 4035
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.

Detailed description: In this study the investigators will ask high school donors about their blood donation-related fears prior to their donation. Among those who report donation fear, half will be randomly assigned to receive a brief presentation of coping strategies administered via a computer tablet. The investigators will compare reaction rates and return behavior for the donors and high school drives where the study was conducted to the reaction and retention rates from similar blood drives where no data was collected. The investigators will also examine whether asking about the specific types of fear improves the prediction of syncopal or presyncopal reactions beyond the predictive value of a single fear question. Finally, the investigators will examine whether providing coping information to help manage the fear improves syncopal reaction rates and/or donor retention rates among fearful donors.

Eligibility criteria: Inclusion Criteria:

* To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process.

Exclusion Criteria:

* Less than 16 years of age; inability to read and comprehend English

Primary outcomes:
measure: Repeat Blood Donation Attempts
timeFrame: two years post-donation
Secondary outcomes:
measure: Blood Donation Confidence
timeFrame: immediately pre-donation
measure: Vasovagal Reactions to Blood Donation
timeFrame: immediately post-donation
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Christopher R France, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03013699: Diet Intervention, Head and Neck Cancer, Feasibility
Official title: Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: diet
nutrition
survival
recurrence
cruciferous
dark leafy greens
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.


Eligibility criteria: Inclusion Criteria:

Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking

Exclusion Criteria:

Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)

Primary outcomes:
measure: Number of patients excluded or not agreeing to participate
timeFrame: Baseline
measure: Adherence to study protocol activities (research records and diet intake self-report)
timeFrame: Throughout 12 week study period
measure: Attrition rates
timeFrame: Throughout 12 week study period
measure: Adverse events with reporting according to institutional review board policy
timeFrame: Throughout 12 week study period
measure: Questionnaire
timeFrame: At conclusion of 12 week study period
measure: Questionnaire
timeFrame: At conclusion of 12 week study period
Secondary outcomes:
measure: DNA methylation
timeFrame: At beginning and end of 12 week study period
measure: Serum cytokines
timeFrame: At beginning and end of 12 week study period
measure: Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
timeFrame: At beginning and end of 12 week study period
measure: Total energy and nutrient intakes
timeFrame: At beginning and end of 12 week study period
measure: Covariates
timeFrame: At beginning of 12 week study period
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Q. Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791799: Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
Official title: A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.


Eligibility criteria: Inclusion Criteria:

1. Systemic lupus erythematosus was confirmed
2. 18-37 years old

Exclusion Criteria:

1. History of sex chromosome abnormalities
2. History of abnormal thyroid function
3. History of abnormal adrenal function
4. History of pituitary disease
5. History of sexual hormone drug use in the past 3 months
6. History of ovarian tumors or invasive ovarian operations
7. Pregnancy
8. Have a birth plan in the next 1 year
9. Ovarian failure

Primary outcomes:
measure: Anti-Mullerian hormone (AMH) serum level
timeFrame: one year and three months
Secondary outcomes:
measure: Number of antral follicle
timeFrame: one year and three months
measure: Follicle-stimulating hormone (FSH) serum level
timeFrame: one year and three months
measure: luteinizing hormone (LH) serum level
timeFrame: one year and three months
measure: Estradiol (E2) serum level
timeFrame: one year and three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06951399: Tracking T-Cell Responses to Evaluate Pembrolizumab Effectiveness in Advanced Non-Small Cell Lung Cancer
Official title: T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-Small Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
NSCLC Stage IV Without EGFR/ALK Mutation
NSCLC Adenocarcinoma
Keywords: metastatic NSCLC adenocarcinoma first-line pembrolizumab
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: MSD Pharmaceuticals LLC
First posted: 2025-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study includes patients with advanced non-small cell lung cancer (NSCLC) - either unresectable stage III or stage IV adenocarcinoma without actionable driver mutations - who are treated with pembrolizumab in combination with platinum-based doublet chemotherapy, irrespective of PD-L1 expression levels.

The primary objective is to assess treatment response through integration of serial T-cell receptor (TCR) repertoire sequencing (Rep-seq), capturing longitudinal changes in T-cell clonality and diversity. These immune dynamics will be correlated with radiographic response assessed by RECIST 1.1, with the aim of improving the accuracy of response classification, including differentiation between progression, pseudo-progression, and hyperprogression.

Additionally, circulating tumor DNA (ctDNA) levels will be measured longitudinally (pre-treatment and during treatment) to evaluate their potential as a complementary biomarker of disease burden and treatment efficacy in the context of chemo-immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of NSCLC adenocarcinoma stage IV or unresectable stage III.
* Have measurable disease based on RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Adequate organ function.

Exclusion Criteria:

* Aberration in one or more of molecular drivers.
* Has received prior systemic anti-cancer therapy prior to allocation.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy.

Primary outcomes:
measure: Change in T-cell Receptor (TCR) Repertoire Clonality and Diversity Relative to Disease Response Assessed by RECIST v1.1
timeFrame: From date of randomization until the end of treatment, defined as a maximum of 35 cycles administered every 3 weeks (up to 2 years), or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Davidoff Comprehensive Cancer Center, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Ari Raphael
role: PRINCIPAL_INVESTIGATOR
References:
citation: Disis ML. Immune regulation of cancer. J Clin Oncol. 2010 Oct 10;28(29):4531-8. doi: 10.1200/JCO.2009.27.2146. Epub 2010 Jun 1.
Clinical trial NCT04054999: Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Official title: The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vasoplegic Syndrome
Liver Transplant; Complications
Keywords: hydroxocobalamin
methylene blue
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue
Primary purpose: TREATMENT

Brief summary: This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.


Eligibility criteria: * Patients scheduled to undergo liver transplantation
* Patients able to read and understand consent document (if patient is unable to provide an informed consent, the Legally Authorized Representative will be ask to consent on behalf of the patient).
* SVR lower than 500 dynes-sec/cm-5 intraoperatively (this criterion must be met after consent intraoperatively)

Primary outcomes:
measure: Systemic Vascular Resistance (SVR)
timeFrame: 15, 30, 60, 90 and 120 minutes after initiation of treatment
measure: Systolic Blood Pressure
timeFrame: 15, 30, 60, 90 and 120 minutes after initiation of treatment
measure: Diastolic Blood Pressure
timeFrame: 15, 30, 60, 90 and 120 minutes after initiation of treatment
measure: Vasopressin
timeFrame: 15, 30, 60, 90 and 120 minutes after initiation of treatment
Secondary outcomes:
measure: Post-operative Intensive Care Unit (ICU) Length of Stay
timeFrame: Up to 30 days after surgery
measure: Hospital Length of Stay
timeFrame: Up to 30 days after surgery
measure: Post-operative Complications
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Sher-Lu Pai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03628599: Two Daily Disposable Contact Lenses in Symptomatic Patients
Official title: Two Daily Disposable Contact Lenses in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Symptomatic
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 39
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: The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.


Eligibility criteria: Inclusion Criteria:

* Able to understand and must sign an IRB-approved informed consent form;
* Soft contact lens wearers in both eyes during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

* Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
* Intolerance, hypersensitivity, or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monocular (only one eye with functional vision).

Primary outcomes:
measure: Monocular Corrected Distance Visual Acuity (VA)
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Pittsburg
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigative Site
state: Rhode Island
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT03620799: Efffectiveness of a Roller Intervention in Anterior Knee Pain
Official title: Effectiveness of a Roller Intervention in Patients With Anterior Knee Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Keywords: Roller intervention
Knee pain
Algometry
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior knee pain is one of the most frequent reasons for consultation within knee conditions in adolescents and young adults. However, despite the high prevalence of this disorder, its pathogenesis and therefore its treatment are not clearly understood. Foam rolling has become a common intervention to enhance joint mobility and muscle recovery after exercise. the aim of this study is analyze the effectiveness of a roller intervention in patients with anterior knee pain.

Detailed description: Randomized controlled trial. patients were divided into two groups, intervention and control.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years.
* Knee anterior pain diagnosis

Exclusion Criteria:

* Concomitant somatic or psychiatric disorder
* Previous knee surgery
* Other lower limb traumatological pathologies

Primary outcomes:
measure: Changes in mechanosensitivity
timeFrame: Changes from baseline mechanosensitivity at 4 weeks
Secondary outcomes:
measure: Vertical jump assessment with a mat
timeFrame: Baseline, 4 weeks
measure: Isokinetic strength
timeFrame: Baseline, 4 weeks
measure: Pain intensity assessed by the Brief Pain Inventory
timeFrame: Baseline, 4 weeks
measure: Functional knee limitation assessed by the Kujala Knee Score
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00700999: Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Official title: Neurofunctional Markers of SSRI Treatment Response in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-traumatic Stress Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-19
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine if treatment of post-traumatic stress disorder in combat veterans with paroxetine changes brain responses as measured by functional magnetic resonance imaging and if brain responses can predict who will get better with treatment.


Eligibility criteria: Inclusion Criteria:

* Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)

Exclusion Criteria:

* Intolerance or sensitivity to paroxetine
* Major medical or neurologic illness
* Current psychotropic medication or active psychotherapy treatment
* Other major psychiatric illness

Primary outcomes:
measure: Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: K. Luan Phan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358899: Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia
Official title: The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Metabolic Disturbance
Eating Behavior
Transcranial Magnetic Stimulation
Keywords: schizophrenia
metabolic disturbance
cTBS
Event related potentials
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Quadro-blind clinical trial
Primary purpose: TREATMENT

Brief summary: cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with schizophrenia in accordance with DSM-5
* BMI over 24
* Accepting antipsychotics stable treatment for more then 2 months

Exclusion Criteria:

* Diagnosed with other mental disease in accordance with DSM-5
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating Contraindication to rTMS

Primary outcomes:
measure: Change of body weight
timeFrame: from baseline to 6 weeks
measure: Change of body mass index
timeFrame: from baseline to 6 weeks
Secondary outcomes:
measure: Positive and Negative syndrome rating scale
timeFrame: from baseline to 6 weeks
measure: Three Factor Eating Questionnaire
timeFrame: from baseline to 6 weeks
measure: Barrat impulsiveness scale
timeFrame: from baseline to 6 weeks
measure: Self-Control Scale
timeFrame: from baseline to 6 weeks
measure: Food picture stimulation Event-related potentials
timeFrame: from baseline to 6 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Second Xiangya Hospital Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03445299: Music for Dementia-related Sleep Problems
Official title: Dementia and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Insomnia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2018-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject design
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems.

Detailed description: The study is a clinical trial to assess the effect of music listening as intervention for improving sleep in elderly persons with dementia and sleep problems. We use a within-subject design to evaluate the effect of the music intervention. Participants are persons above the age of 60 diagnosed with dementia and suffering from sleep problems. We will examine the effect of the intervention on sleep, mood and cognition.

Eligibility criteria: Inclusion Criteria:

* Dementia
* Sleep problems

Exclusion Criteria:

* Use of hypnotic medications
* Substance abuse
* Severe hearing deficits
* Not out of bed during daytime

Primary outcomes:
measure: Sleep
timeFrame: 14 days baseline and 14 days intervention
Secondary outcomes:
measure: Sleep quality
timeFrame: After 14 days intervention period
measure: Depression
timeFrame: Measured at baseline and after 14 days intervention period
measure: Cognition
timeFrame: Measured at baseline and after 14 days intervention period
measure: Mood
timeFrame: After 14 days intervention period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Center for Music in the Brain
Study officials:
affiliation: Technical University of Denmark
name: Jan Larsen
role: STUDY_CHAIR
References: