louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02848469: Irish Omega-3 Study
Official title: Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psychotic Disorders
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3 fatty acids in the reduction of risk of psychosis.

The study is being coordinated by the HRB Clinical Research Facility at University College Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy University Hospital, Cork. The study will be carried out in collaboration with the HRB Clinical Research Facility in Dublin in prior to rolling out to other centres around Ireland.

The Study is funded by Stanley Medical Research Institute, a non-profit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. It is the largest provider of funding for research in serious mental illness outside of the U.S. government.


Eligibility criteria: Inclusion Criteria:

* Subjects will be aged between 13 and 50 years.
* Written informed consent will be obtained from subjects, or, in the case of those under - eighteen, from their parent or guardian, with the assent of the participant.
* Subjects meet the criteria of UHR, according to the Structured Interview for Prodromal Syndromes (SIPS) (Cannon et al., 2008, Woods et al., 2009).

Exclusion Criteria:

* Previous psychotic episode of at least one week's duration.
* Previous manic episode of at least one week's duration.
* Acute suicidal or aggressive behaviour.
* Substance dependence.
* Lactose intolerance/Milk allergy
* Intellectual disability, which in the opinion of the investigator would affect the person's ability to participate in the trial.
* Previous treatment with an antipsychotic or mood stabiliser for a psychiatric indication longer than 2 weeks in the previous three months.
* Consumption of over the counter or prescribed omega-3 fatty acids supplements within 12 weeks of entering the trial.
* Pregnancy/breast-feeding.
* Severe inter-current illness that may affect the ability of the participant to take part in the trial.

Primary outcomes:
measure: To ascertain the effectiveness of Omega-3 fatty acid supplements in reducing transition to psychosis in individuals who are at ultra high risk of developing psychosis.
timeFrame: Assessments at baseline, 12 weeks, 24 weeks and 52 weeks
Secondary outcomes:
measure: 2. To assess in a subgroup of subjects the association of fatty acid changes, that is the blood Omega-3 to Omega-6 ratio, with the primary outcome.
timeFrame: Samples taken at baseline and 12 weeks
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Clinical Research Facility
Study officials:
References:
Clinical trial NCT03406546: Sedation Strategies for Therapeutic Bronchoscopy
Official title: Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchoscopy
Sedation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2018-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for flexible therapeutic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts

Primary outcomes:
measure: Recovery time
timeFrame: After termination of the sedation medication, assessed up to 3 hours
Secondary outcomes:
measure: Satisfaction score of the patients and bronchoscopists
timeFrame: Across the procedure, assessed up to 3 hours
measure: Prevalence of the side effects of respiratory and circulatory system
timeFrame: Across the sedation or anesthesia, assessed up to 3 hours
measure: Cost of anesthesia or sedation
timeFrame: Across the sedation or anesthesia, assessed up to 3 hours
measure: Cough score
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
measure: The numbers of the times of body movement
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Faculty of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05444569: A Study of LY3537021 in Healthy Participants
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two parts. Part A is parallel model and part B is crossover.
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined through medical evaluation
* Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
* Males, or females who are not of childbearing potential.
* Capable of giving signed informed consent form
* Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)

Exclusion Criteria:

* Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
* History of malignancy within 5 years prior to screening
* Have evidence of significant active psychiatric disorder(s)
* Have undergone any form of bariatric surgery
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Are females who are lactating

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 22
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05100069: Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
Official title: General Use-results Survey of Alunbrig Tablets "Non-small Cell Lung Cancer"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.

Brief summary: This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, participants with non-small cell lung cancer will take Brigatinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Brigatinib for 1 year.


Eligibility criteria: Inclusion criteria Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.

Exclusion criteria Participants who has a history of hypersensitivity to any component of birigatinib.

Primary outcomes:
measure: Number of Participants with Adverse Events Related to Interstitial Lung Disease
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01600469: NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Official title: NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Alzheimer's disease
mild cognitive impairment
NMDA
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
* MMSE between 17-26
* CDR 0.5 or 1

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* substance abuse/dependence
* Parkinson disease
* epilepsy
* major depressive disorder
* dementia with psychotic features
* major physical illnesses
* severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
timeFrame: Week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
timeFrame: Week 0, 8, 16, 24
measure: Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
timeFrame: Week 0, 8, 16, 24
measure: Change from baseline in Verbal learning and memory at week 24
timeFrame: Week 0, 24
measure: Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24
timeFrame: Week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
name: Hsien-yuan Lane, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04932369: The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
Official title: The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Emotion Regulation
Keywords: University's students
COVID-19
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The important role of Emotion Regulation (ER) in managing stress and anxiety is well recognized. Aims: 1) assessing the level of anxiety, and the level of difficulties in emotion regulation (DER) among University Students during COVID-19, 2) investigating the effect of the emotional regulation training program on the anxiety of University Students during the COVID-19. Methods: Part I, students will be assessed for their anxiety, DER, and the general impact of COVID-19 on their lives. The students will complete Beck Anxiety Inventory (BAI) and Difficulties in Emotion Regulation Scale (DERS). Part II will be a Randomized Control Trial (RCT) using a pre-assessment and a post-assessment. A voluntary sample of students will randomly assigned to either a group that will receive emotion regulation training or a control group. The training program is an adapted version of DBT skills training. The training program will include mindfulness, emotion regulation, and problem-solving skills through eight 90- min group sessions.


Eligibility criteria: Inclusion Criteria:

* Being an active student at the University

Exclusion Criteria:

1. Receiving treatment at the hospital during the time that the study was in progress
2. Having been diagnosed with psychotic disorders
3. Having mental retardation

Primary outcomes:
measure: Change in anxiety from Baseline to the completion of training three months later using Beck Anxiety Inventory (BAI)
timeFrame: 3 months. Assessments of anxiety will be collected from all students two times, three months apart
measure: Change in difficulties in emotion regulation from Baseline to the completion of training three months later using Emotion regulation difficulties Scale
timeFrame: 3 months. Assessments of DER will be collected from all students two times, three months apart
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British university in Egypt
Study officials:
affiliation: The British University in Egypt
name: Amani Elbarazi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03476369: Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
Official title: A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 38
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: During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.


Eligibility criteria: Inclusion Criteria:

* Undergoing clinically indicated elective or non-elective PCI
* Able to swallow oral medications

Exclusion Criteria:

* Contraindications to ticagrelor or fentanyl (or other opiates)
* Pregnancy
* Any use of P2Y12 inhibitors within 14 days
* Known coagulation disorders
* Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
* Platelet count \< 100,000/mm3
* Impaired renal function (Estimated glomerular filtration \< 45 ml/min/1.73 m2)
* Impaired hepatic function (Based on medical history)
* Prior or planned transcatheter aortic valve replacement

Primary outcomes:
measure: Platelet Function Testing
timeFrame: 6 hours
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 30 days
measure: Recurrent myocardial infarction
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: TIMI minor and major
timeFrame: 30 days
Other outcomes:
Locations:
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03530969: Geriatric Communication Skills Training Program for Oncology Clinicians
Official title: Geriatric Communication Skills Training Program for Oncology Clinicians to Improve Management of Care for Geriatrics Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GI Cancer
Lymphoma
GU Cancer
Bone Marrow Transplant
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.


Eligibility criteria: Inclusion Criteria:

Clinician Eligibility

* MSK medical oncology Health Care Professionals (HCP) - specifically identified as Attendings, fellows, or Advance Practice Professional (APP) - either a Nurse Practitioner (NP) or Physician Assistant (PA) from GI, GU Oncology, Lymphoma, Bone Marrow Transplant or Geriatrics Service (five services with a large number of geriatric patients)
* Willingness to be audio-recorded as per self-report
* Clinician has individual clinic consultations with patients in the target population: 65 years of age and over, English speaking, and patients who have had a new visit within the last 6 months.

Patient Eligibility

* MSK patients 65 years of age and over as per EMR
* English speaking as per EMR
* Being seen by one of the consented HCPs as per the HCP and/or electronic medical record (EMR)
* Willingness to be audio-recorded as per self-report
* Patient had their first visit with the clinician within the last 6 months

Caregiver Eligibility

* English speaking as per EMR
* Accompanying an MSK patient being seen by one of the consented HCPs as per the HCP and/or EMR

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Feasibility of Health Care Provider (HCP) training
timeFrame: 8 weeks
measure: Participants satisfaction with Health Care Provider (HCP) training
timeFrame: 1 week
Secondary outcomes:
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: Smita Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000269: Pergolide Treatment for Substance Abusers - 4
Official title: Pergolide Treatment for Substance Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York State Psychiatric Institute
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Craving
measure: Drug use
measure: Improvement in functioning
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References: