louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04111666: A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
Official title: A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alector Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 88
Sex: ALL
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: A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

Detailed description: This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.

Eligibility criteria: Inclusion Criteria:

* BMI 18.0-35.0 kg/m2
* 45-120 kg, inclusive
* At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
* In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
* Willingness and able to comply with the study protocol, in the investigator's judgement.

Exclusion Criteria:

* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Positive drug or alcohol at screening and prior to first dose
* History of alcohol abuse or substance abuse

Primary outcomes:
measure: Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
timeFrame: either 57, 113, or 141 days, depending on the cohort
Secondary outcomes:
measure: Pharmacokinetics (PK) of AL101
timeFrame: either 57, 113, or 141 days, depending on the cohort
measure: Maximum plasma concentration (Cmax) for AL101
timeFrame: either 57, 113, or 141 days, depending on the cohort
measure: Area under the curve concentration (AUC) for AL101
timeFrame: either 57, 113, or 141 days, depending on the cohort
Other outcomes:
Locations:
city: Miami
country: United States
facility: Study site
state: Florida
city: Orlando
country: United States
facility: Study site
state: Florida
Study officials:
affiliation: Bioclinica Research
name: Jorge Kusnir
role: PRINCIPAL_INVESTIGATOR
affiliation: Quotient Sciences
name: Maria Bermudez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02880566: Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniotomy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 50
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: Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.


Eligibility criteria: Inclusion Criteria:

* Elective craniotomy for supratentorial lesion

Exclusion Criteria:

* Allergy to local anaesthetic
* Psychiatric disease
* Inability to consent
* Uncontrolled intracranial hypertension

Primary outcomes:
measure: Hemodynamic stability
timeFrame: 5 minutes
Secondary outcomes:
measure: Cumulative intraoperative remifentanil consumption
timeFrame: 24 hours
measure: Cumulative postoperative morphine consumption
timeFrame: 48 hours
measure: Postoperative pain scores
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.
Clinical trial NCT03881566: Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients
Official title: Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Immune Deficiency
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with presentation to ICU with critical illness compatible with sepsis.

Brief summary: This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 19 years
* Appropriate clinical data to enable classification into sepsis
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation

Exclusion Criteria:

* No informed consent
* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients.
timeFrame: up to 7 days
Secondary outcomes:
measure: survival at ICU discharge or day 28 after enrollment
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Jongmin Lee, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00478166: Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease
Official title: Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Alzheimer's Disease
Dementia
Adult Children
Risk
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2007-05-24
Enrollment: 206
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are enrolled in the Wisconsin Registry for AD Prevention (WRAP), recruited from Memory clinics and the community.

Brief summary: The purpose of this study is to use fMRI techniques to explore a certain part of the brain associated with Alzheimer's disease known as the posterior cingulate. Determining the functionality of this brain region may help us diagnose AD more accurately, thus allowing earlier treatment.

Detailed description: The posterior cingulate is a key brain region suggested by recent studies to be affected in people at risk for Alzheimer's Disease (AD). Because the PC is affected very early in the course of AD and the region may have reduced function even prior to the onset of symptoms, further understanding of its functional role and its relationship to other brain regions may be helpful in detecting AD earlier and in monitoring disease progression and treatment. This project examines the role of the PC and its connections to other brain regions using functional magnetic resonance imaging (fMRI), a technique that allows us to examine the brain at work during tests of memory and decision-making. The main goal is to see if functional connections between brain regions are modulated by risk for AD.

Eligibility criteria: Inclusion Criteria:

* Cognitively healthy
* (Controls Only) Parents survived past age 70 and did/do not have memory problems.

Exclusion Criteria:

* Claustrophobia
* Metallic or electronic implants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Wisconsin Comprehensive Memory Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin/VA GRECC
name: Sterling C Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06108466: RELIABILITY AND VALIDITY OF THE DT BALANCE TEST IN PATIENTS WITH TKA
Official title: RELIABILITY AND VALIDITY OF THE DUAL TASK BALANCE TEST IN PATIENTS WITH TOTAL KNEE ARTHROPLASTY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Injuries and Disorders
Osteo Arthritis Knee
Keywords: Total Knee Arthroplasty
dual test,
timed up and go
reliability
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 31
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Total Knee arthroplasty

Brief summary: The ability to perform a cognitive task while walking simultaneously is essential in real daily life. However, the psychometric properties of dual-task walking tests have not been well established in patients undergoing total knee arthroplasty (TKA). The aim of study assess the test-retest reliability and validity of dual conditions TUG, 3MBWT, 8FWT nad 4SST in patients with TKA.


Eligibility criteria: Inclusion Criteria: TKA -

Exclusion Criteria: revision knee arthroplasty

-

Primary outcomes:
measure: Performance test
timeFrame: 1 Hour
measure: Performance Test
timeFrame: 1 hour
measure: Perfromance Test
timeFrame: 1 hour
measure: Performance Test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
measure: Patient Reported
timeFrame: 1 hour
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT06706466: Evaluate the Prognostic Significance of Changes in the Systemic Immune-Inflammation Index in Patients with AGC Treated with ICI Therapy.
Official title: Systemic Immune-Inflammation Index As a Predictor of Neoadjuvant Treatment Efficacy in Advanced Gastric Cancer Based on a Dynamic Clinical Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunotherapy Gastrict Cancer
Inflammation Biomarkers
Gastric Cancers
Keywords: Inflammation Index
gastric cancer
immunotherapy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective analysis included 453 patients diagnosed with advanced gastric adenocarcinoma (T2-4aNx/+M0, according to the 7th edition of the American Joint Committee on Cancer \[18\]) who received treatment between January 2018 and December 2021. Finally, 410 patients met the inclusion criteria. Ethical approval for this study.

Brief summary: The SIIR during neoadjuvant therapy can serve as a specific biomarker for predicting the efficacy of immunotherapy in patients with advanced gastric cancer.

Detailed description: A total of 410 patients with advanced gastric cancer treated with neoadjuvant chemotherapy (NAC group, 178) or immunotherapy (ICIs group, 232) were enrolled in two tertiary referral centers. The SIIR (\[SIIpost-treatment - SIIpre-treatment\] / SIIpre-treatment) was calculated. The diagnostic threshold for SIIR was set at the median value (-0.3) A joint model based on longitudinal trajectory and time-to-event analysis was used to assess the correlation between SIIR and the risk of death in patients with advanced gastric cancer.

Eligibility criteria: Inclusion Criteria:

(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) All patients received neoadjuvant therapy, followed by gastrectomy.

Exclusion Criteria:

We excluded patients under 18 or over 80, those with distant metastasis, remnant gastric cancer, prior radiotherapy, other malignancies, abdominal surgery history (except laparoscopic cholecystectomy), recent unstable angina, myocardial infarction, cerebrovascular accidents, or those requiring emergency surgery due to disease progression

Primary outcomes:
measure: survival
timeFrame: 36 months
Secondary outcomes:
measure: recurrence
timeFrame: 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT04296266: Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Official title: Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Submandibular Gland Tumor
Parotid Gland Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement.

Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.

Detailed description: Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.

Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood

Eligibility criteria: Inclusion Criteria:

* Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor
* Ability to adhere to study visit schedule and other protocol requirements
* Operable candidate base on the surgeon's note
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Nursing or pregnant
* Diagnosis of kidney disease, history of renal disease with creatinine \> 1.5 mg/dL, or currently on dialysis
* Diagnosis of end stage liver disease
* Any unstable medical condition
* Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement
* Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement

Primary outcomes:
measure: Bioavailability of Alda-341 in salivary gland tissue using GCMS
timeFrame: 2 week
Secondary outcomes:
measure: Bioavailability of Alda-341 in saliva and blood
timeFrame: 2 week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891966: Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Official title: Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extremity Injury
Keywords: Upper Extremity Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 122
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 goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.


Eligibility criteria: Inclusion Criteria:

* Willing and able to participate in study and complete consent
* Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.

Exclusion Criteria:

* Pregnant women
* Patients with concomitant TBI or MR
* Polytrauma patients
* Pathologic Fractures
* Patients undergoing treatment for malignancy
* NYU SoM Students, Residents, Faculty
* Prisoners
* IV drug users or patients on chronic narcotics
* Gun shot wound victims

Primary outcomes:
measure: Percent change in Visual Analog Scale (VAS)
timeFrame: 14 Days
measure: Percent Change in Euro Quality of Life (EQ-5D)
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Philipp Leucht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267666: Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women
Official title: Comparative Study of Inspiratory Muscle Strength Training and Incentive Spirometer on Ventilatory Function in Postmenopausal Asthmatic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthmatic
Postmenopausal Symptoms
Keywords: Inspiratory
Spirometer
Postmenopausal
asthma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
Primary purpose: TREATMENT

Brief summary: Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from 50 to 60 years old, and their body mass index of the patient don't exceed 30kg/m2. They were recruited from patient chest clinic in Kasr -El- Ainy Teaching Hospital, Cairo University, Egypt.

Detailed description: They signed a consent form, confidentiality was assured. They assigned into two groups (A) who received inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) while patients in group (B): received traditional chest physical therapy intervention and incentive spirometer, three sessions per week for six weeks. Patients in both groups were assessed before treatment (pre-training) then after treatment (post-training) (after 6 weeks) to measure lung functions using electronic spirometer. The training program was carried in the duration from January 2019 to July 2019.

Eligibility criteria: Inclusion Criteria:

* Forty postmenopausal women suffering from asthma
* Their ages were ranged from 50 to 60 years,
* their body mass index (BMI) don't exceed 30kg/m2.
* All participants were asthmatic patient
* clinically and medically stable cases

Exclusion Criteria:

* participant who had chest infection,
* malignant diseases,
* Patients with chest trauma.

Primary outcomes:
measure: Electronic Spirometer (VIASYS- Health Care Microlab)
timeFrame: 6 weeks
measure: FVC (Forced vital capacity)
timeFrame: 6 weeks
measure: FEV1 (Forced expiratory volume)
timeFrame: 6 weeks
measure: MVV (Maximum voluntary ventilation)
timeFrame: 6 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Ebrahim Elrefaye
state: Dokki
Study officials:
affiliation: Department of Physical Therapy for Women's Health, Cairo University, Egypt.
name: ghada eb elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References: