louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06645704: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
Official title: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Escient Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\]-EP262 in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Males aged 18 to 55 years
* Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
* Negative result for HIV, HBV, and HCV at Screening
* Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
* No use of tobacco or nicotine containing products within the past 6 months

Exclusion Criteria:

* History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
* History of malignancy within the past 5 years
* History of any serious allergic reactions or hypersensitivity
* Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
* Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day

Primary outcomes:
measure: Mass balance of [14C]-EP262
timeFrame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
measure: Pharmacokinetics (PK) of EP262 and [14C]
timeFrame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Secondary outcomes:
measure: Metabolite profile of EP262
timeFrame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
measure: Safety and tolerability of [14C]-EP262
timeFrame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron Clinical Pharmacology Center (CPC)
state: Maryland
Study officials:
References:
Clinical trial NCT00899704: Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
Official title: Molecular Mechanisms of OSCC Tumor Invasion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Head and Neck Cancer
Keywords: stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
tongue cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes. are

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.

Detailed description: OBJECTIVES:

* To test preliminary data from node-positive oral squamous cell carcinoma (OSCC) signatures for their ability to predict lymph-positive primaries using a cohort of OSCC tumors.
* To perform lymph node prediction using sentinel lymph node-biopsied primaries.
* To validate the preliminary data node-positive OSCC signature and test its ability to predict nodal status.

OUTLINE: Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.

Eligibility criteria: * Have a primary tumor specimen banked by the American College of Surgeons Oncology Group (ACOSOG) as part of clinical trial ACOSOG-Z0360

  \* All tumor specimens are squamous cell carcinomas of the tongue, floor of the mouth, or gingiva
* All patients have undergone neck dissections \* Pathologically confirmed nodal stage (negative or positive)

Primary outcomes:
measure: overall survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Barry Ziober, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06046404: Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Official title: Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wrist Fractures
Distal Radius Fractures
Closed Reduction of Fracture and Application of Plaster Cast
Wrist Injuries
Radius Fracture Distal
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

Detailed description: in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.

Eligibility criteria: Inclusion Criteria:

* displaced distal radial fracture eligible for surgery

Exclusion Criteria:

* ISS traumascore \>16
* open fracture
* multiple fractures in ipsilateral extremety
* neurovascular damage
* previous injury in the same wrist
* inability to complete questionnaires

Primary outcomes:
measure: daily pain scores
timeFrame: usually 2-10 days
Secondary outcomes:
measure: function
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Number of complications
timeFrame: 1 year
measure: Wrist mobility
timeFrame: 6 weeks and 3 months
measure: length of stay in emergency department
timeFrame: baseline
measure: quality of life in EQ5D5L
timeFrame: 1 year
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Maasstadweg 21
Study officials:
References:
Clinical trial NCT04553601: Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
Official title: Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
PET/CT
Biopsy
Radiomics
Genomics
Whole-exome Sequencing
Keywords: NSCLC, PET/CT, radiogenomics
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.
Primary purpose: DIAGNOSTIC

Brief summary: To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.

Detailed description: Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors. The LIFEx package was used to extract PET and CT radiomic features from primary and metastatic lesions. The radiomic ROI sites of primary and distant metastatic tumors were point-to-point corresponding to the PET/ CT-guided targeted biopsy sites. Whole exon sequencing of primary and distant metastatic tumor samples obtained by PET/CT-guided targeted biopsy was used to get genomic data of primary and distant metastatic tumor. Predictive radiogenomics models were established and validation.

Eligibility criteria: Criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
* (iii) patients who had scheduled both 18F-FDG PET/CT scans and PET/CT guided biopsy;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions;
* (ii) patients with pregnancy;
* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Radiomic feature selection and model establishment
timeFrame: 3 years
Secondary outcomes:
measure: Genes mutation detection
timeFrame: 30 days
measure: Image acquisition
timeFrame: 30 days
measure: Radiomic feature extraction
timeFrame: 30 days
Other outcomes:
Locations:
city: XiaMen
country: China
facility: First affiliated hospital of xiamen university
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Long Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06997601: Serratus Posterior Superior Intercostal Plane Block Versus Suprascapular Nerve Block and Axillary Nerve Block for Analgesia in Shoulder Arthroscopic Surgery
Official title: Serratus Posterior Superior Intercostal Plane Block Versus Suprascapular Nerve Block and Axillary Nerve Block for Analgesia in Shoulder Arthroscopic Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Serratus Posterior Superior Intercostal Plane Block
Suprascapular Nerve Block
Axillary Nerve Block
Analgesia
Shoulder Arthroscopic Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 50
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: This study aims to compare the serratus posterior superior intercostal plane block and suprascapular nerve block and axillary nerve block for analgesia in shoulder arthroscopic surgery.

Detailed description: Controlling postoperative pain while minimizing opioid administration is particularly important because poor pain control is thought to be responsible for more than 60% of unplanned or prolonged hospitalizations.

Suprascapular nerve block (SSNB) has been proposed based on the anatomic fact that the suprascapular nerve innervates approximately 70% of the shoulder joint, capsule, subacromial space, acromioclavicular joint, and coracoacromial ligament, with the remaining 30% thought to be innervated by the lateral pectoral and axillary nerve.

The combined SSNB and axillary nerve block (ANB) was proposed as a safe alternative to interscalene brachial plexus block (ISB) for providing anesthesia and postoperative analgesia for shoulder surgery.

Serratus posterior superior intercostal plane block (SPSIPB) was described as a novel technique in a case series study of cadavers and five patients.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Infection at the site of regional blocks.
* Allergy to any drug used in this study.
* Use of psychotropic and/or narcotic medications on a regular basis.
* Cognitive dysfunction.
* Cardiovascular disease.
* Pulmonary disease.
* Coagulation abnormalities.
* Anatomical abnormalities.
* Neuropathic pain.
* Body mass index \>40.
* History of substance abuse.
* Previous surgery in the same shoulder.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04526301: Home With TablO outcoMEs (HOME) Registry
Official title: Home With TablO outcoMEs (HOME) Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Keywords: Tablo
Outset Medical
ESRD
Home Hemodialysis
HHD
ESKD
Lead sponsor: Outset Medical
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.

Brief summary: Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.


Eligibility criteria: Inclusion Criteria:

* Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
* Participant weighs ≥ 34kg.
* Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
* Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
* Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.

Exclusion Criteria:

* Participant and/or care partner is unable to read English or Spanish.
* Participant has a home environment that is deemed inappropriate for home dialysis.
* Participant and/or care partner is unable to successfully complete the Tablo training program
* Participant is pregnant or plans to become pregnant.

Primary outcomes:
measure: Weekly Standardized Dialysis Adequacy
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
measure: Health Outcomes
timeFrame: Change from Baseline at 12-months
measure: Sleep Outcomes
timeFrame: Change from Baseline at 12-months
measure: Care Partner Burden
timeFrame: Change from Baseline at 12-months
Locations:
city: San Jose
country: United States
facility: Satellite Healthcare, Inc.
state: California
city: Victorville
country: United States
facility: Desert Cities Dialysis
state: California
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Massachusetts
city: Helena
country: United States
facility: St. Peter's Health
state: Montana
city: Lincoln
country: United States
facility: Dialysis Center of Lincoln
state: Nebraska
city: New Hyde Park
country: United States
facility: Parker Jewish Institute
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Rogosin Institute
state: New York
city: Plano
country: United States
facility: USRC Kidney Research
state: Texas
city: Staunton
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT02559401: Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
Official title: Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Lesions
Keywords: Eloquent cortex
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with brain lesions near eloquent cortex

Brief summary: Currently, standard-of-care tractography is based on information obtained from diffusion tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary objective of the proposed study is to determine the ability of msHARDI-based tractography to discern fibers in edematous brain regions.


Eligibility criteria: Inclusion Criteria:

* brain lesions, including but not limited to tumors, epileptic foci, and vascular abnormalities, in or around eloquent brain regions (i.e., motor, language);
* clinical need for pre-operative 'advanced imaging' (which includes conventional DTI);
* age between 18-80 years of age;
* male or female gender. Eloquent regions include: Temporal and frontal lobes (speech/language); bilateral occipital lobes (vision); bilateral parietal lobes (sensation); and bilateral motor cortex (movement).

Exclusion Criteria:

* a contraindication for obtaining an MRI scan (e.g. implanted devices, retrained foreign body)
* pregnancy
* absence of the capacity to make medical decisions or provide informed consent.

Primary outcomes:
measure: Number of subjects providing completion of the neurocognitive battery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Steven Brem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450601: A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
Official title: A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 249
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 19 years
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

   * Blood pressure medication taken patients: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
   * Blood pressure medication free patients: 160mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
4. Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
3. Secondary hypertension patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia(Ca ≥ 10.5mg/dL)
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: week 8
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: week 2
measure: Change from baseline in mean sitting diastolic blood pressure(mmHg)
timeFrame: week 2, 8
measure: Change from baseline in mean pulse blood pressure(mmHg)
timeFrame: week 2, 8
measure: Target blood pressure reaching rate(%)
timeFrame: week 2, 8
measure: Blood pressure responder rate(%)
timeFrame: week 2, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
References: