louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01101919: CP-690,550 Pharmacokinetics In Healthy Chinese Subjects
Official title: An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese Volunteers
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

* Clinically significant infections within the past 3 months
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
* Pregnant or nursing women

Primary outcomes:
measure: Single-dose: Cmax, Tmax, t½, AUCinf and AUClast
timeFrame: 1 day
measure: Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac
timeFrame: 5 days
Secondary outcomes:
measure: Number of adverse events and number of participants with adverse events
timeFrame: 6 days
measure: Changes in complete blood count and serum chemistry profile
timeFrame: 6 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Krishnaswami S, Wang T, Yuan Y, Alvey CW, Checchio T, Peterson M, Shi H, Riese R. Single- and multiple-dose pharmacokinetics of tofacitinib in healthy Chinese volunteers. Clin Pharmacol Drug Dev. 2015 Sep;4(5):395-9. doi: 10.1002/cpdd.202. Epub 2015 Jul 16.
Clinical trial NCT06789419: Predicting Epileptogenic Tubers in Patients with Tuberous Sclerosis Complex
Official title: Predicting Epileptogenic Tubers in Patients with Tuberous Sclerosis Complex Using a Fusion Model Integrating Lesion Network Mapping and Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberous Sclerosis Complex
Keywords: TSC
TSC MRI
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE

Brief summary: Accurate localization of epileptogenic tubers (ETs) in patients with tuberous sclerosis complex (TSC) is essential but challenging because ETs lack distinct pathological or genetic markers that differentiate them from other cortical tubers. Approximately 60% of patients fail to have their ETs identified through noninvasive preoperative evaluations, highlighting the clinical need for an efficient, noninvasive ET localization method.

Using MRI data from training datasets, we developed a novel noninvasive fusion model that combines a risk model based on lesion network mapping with a prediction model using brain functional connectivity and random forest algorithms. A retrospective analysis was conducted on TSC patients with epilepsy who underwent resective surgery. Tubers were classified as true-ETs, false-ETs, or true non-ETs based on resection locations and postoperative seizure-freedom. The model calculated and ranked the ET probability for each tuber for every patient, and its accuracy was assessed based on postoperative seizure outcomes.


Eligibility criteria: Inclusion Criteria:

(1) male or female patients aged ≥6 months; (2) patients meeting the diagnostic criteria for TSC according to Northrup's guidelines;17 (3) patients in whom the clinical evaluation determined that a single surgical target, or hypothesized primary EZ, was identified by a multidisciplinary specialist team at epilepsy centers of Beijing Children's Hospital, PLA General Hospital, or Shenzhen Children's Hospital in China; (4) patients who underwent resective surgery between July 2016 and June 2023, with a 1-year follow-up completed by June 2024; and (5) availability of patients with available preoperative and postoperative MRI T2-Flair imaging.

Exclusion Criteria:

* (1) patients with a history of craniotomy, serious head injury, neuromodulation therapy, or corpus callosotomy before or within one year after the resective surgery; and (2) subjects lacking key clinical or MRI data. This study was approved by the Ethics Commission of Beijing Children's Hospital.

Primary outcomes:
measure: seizure freedom after surgery
timeFrame: From enrollment to the end of treatment at 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01499719: Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
Official title: Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Keywords: Sinusitis
Disease
Chronic
Sinonasal
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resident and fellow surgeons.

Brief summary: The purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and to measure the frequency of compliance by surgical personnel at OHSU with specific daily safety protocols before and after introduction of the checklist. The investigators hypothesized that the use of an ESS specific surgical checklist will improve the frequency of compliance by surgical personnel at OHSU to internal safety concerns and protocols.

Detailed description: A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated as "pre-intervention" cases by research personnel while the second 100 surgical cases will be evaluated as "post-intervention" cases after the introduction and discussion of the surgical checklist to operating room staff.

Eligibility criteria: Inclusion Criteria:

* CRS defined by 2007 Adult Sinusitis Guidelines.13
* Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.

Exclusion Criteria:

* Unable to complete surgical procedures due to perioperative complications.

Primary outcomes:
measure: Sinus surgery checklist
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02387619: The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 41
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Detailed description: A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Eligibility criteria: Inclusion Criteria:

* 19\~55 years healthy male
* Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
* Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Primary outcomes:
measure: AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
timeFrame: 72hours, 144hours
Secondary outcomes:
measure: AUClast,ss of Rosuvastatin
timeFrame: 72hours
measure: AUCinf,ss of Rosuvastatin
timeFrame: 72hours
measure: Tmax,ss of Rosuvastatin
timeFrame: 72hours
measure: t1/2 of Rosuvastatin
timeFrame: 72hours
measure: AUClast,ss of Telmisartan, Amlodipine
timeFrame: 144hours
measure: AUCinf,ss of Telmisartan, Amlodipine
timeFrame: 144hours
measure: Tmax,ss of Telmisartan, Amlodipine
timeFrame: 144hours
measure: t1/2 of Telmisartan, Amlodipine
timeFrame: 144hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
state: Seodaemun-gu
Study officials:
affiliation: Yonsei University
name: Kyungsoo Park, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04751019: The Use of Amber Glasses in Improving Sleep
Official title: The Use of Amber Glasses in Improving Sleep and Reducing the Use of Hypnotic Medication in an Inpatient Mental Health Setting: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Lead sponsor: Surrey and Borders Partnership NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 15
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: The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

Detailed description: Sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. Moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (Baglioni, 2016). We hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.A prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. Data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. Hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. Medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. Each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Male or female gender
* Presentation of mental illness (of psychotic nature, severe depression or anxiety)
* Able to provide informed consent

Exclusion Criteria:

* Patient does not consent
* High risk assessment of self-harm or harm to others

Primary outcomes:
measure: The difference in the use of hypnotic medication as compared with existing data from a similar population.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in sleep quality as measured by a point score change in the PSQI.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust
state: Surrey
Study officials:
References:
Clinical trial NCT04722419: Responses to a Comfort Meal in Functional Dyspepsia
Official title: Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: meal ingestion
postprandial responses
hedonic sensations
homeostatic sensations
functional dyspepsia
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Parallel studies in patients with symptoms induced by meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. Participants will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.


Eligibility criteria: Inclusion Criteria for Patients with Functional Dyspepsia:

* Rome IV Criteria for Functional Dyspepsia

Inclusion Criteria for Healthy Subjects

* absence of digestive symptoms

Exclusion Criteria for all participants:

* history of anosmia and ageusia
* alcohol abuse
* psychological disorders
* eating disorders

Inclusion Criteria for Healthy Subjects:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Meal enjoyment
timeFrame: 100 minutes
Secondary outcomes:
measure: Change in digestive well-being induced by the probe meal
timeFrame: 1 day
measure: Change in fullness sensation induced by the probe meal
timeFrame: 1 day
measure: Change in mood induced by the probe meal
timeFrame: 1 day
measure: Change in abdominal discomfort induced by the probe meal
timeFrame: 1 day
measure: Change in hunger/satiety induced by the probe meal
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
Clinical trial NCT04001218: Head Repositioning Accuracy During Experimental Neck Pain
Official title: Neck Pain - Motor and Sensory Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Neck Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
First posted: 2019-06-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.

Detailed description: Healthy volunteers will participate in a single session study with a crossover design.

During the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.

Head repositioning accuracy will be assessed with and without performing a cognitive task.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged 18-50 years
* Right handed
* Able to speak, read and understand Danish or English
* Normal pain free neck and shoulder range of motion

Exclusion Criteria:

* Pain from the neck or shoulder area
* Prior surgery in neck or shoulder
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Self reported neurologic, musculoskeletal or mental illnesses

Primary outcomes:
measure: Change in head repositioning accuracy
timeFrame: Within session (session lasts approximately 2 hours)
Secondary outcomes:
measure: Change in perceived pain
timeFrame: Within session (session lasts approximately 2 hours)
measure: Change in perceived performance of head repositioning accuracy test
timeFrame: Within session (session lasts approximately 2 hours)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. Of Health Science and Technology, SMI, Aalborg University
Study officials:
affiliation: Aalborg University
name: Steffan W Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194318: First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Official title: Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Vaccination
Keywords: Respiratory Syncytial Virus vaccination
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults

Detailed description: A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) in healthy adults

Eligibility criteria: Inclusion Criteria:

1. Male and female participants 60 to 85 years of age at the screening visit.
2. Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
3. Individuals willing and able to give an informed consent, prior to screening. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.

Exclusion Criteria:

1. Acute disease or fever (≥38°C) at time of vaccination.
2. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
3. Any progressive unstable or uncontrolled clinical conditions.
4. Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Primary outcomes:
measure: Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
timeFrame: Within 7 days after vaccination
measure: Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
timeFrame: Within 28 days after vaccination
measure: Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
timeFrame: Throughout the study period, from enrollment to 6 months follow up
measure: Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
timeFrame: Screening and Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Fusion Clinical Research
state: Southern Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: CMAX Clinical Research
name: Christopher Rook, MD
role: PRINCIPAL_INVESTIGATOR
References: