louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00024076: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
Official title: Radiofrequency Ablation of Pulmonary Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Thymoma and Thymic Carcinoma
Keywords: recurrent non-small cell lung cancer
recurrent small cell lung cancer
recurrent malignant mesothelioma
recurrent thymoma and thymic carcinoma
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
pulmonary carcinoid tumor
lung metastases
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:

* Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
* Determine the efficacy of this treatment, in terms of local control, in these patients.
* Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.

OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.

Patients are followed at 1, 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a primary or secondary intrathoracic malignancy

  * Any cell type or origin
  * Involving the intrapulmonary, mediastinal, or pleural/chest wall
  * Inoperable primary or metastatic cancer to the lung
* Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
* Single or multiple lesions that are non-contiguous with vital structures or organs such as:
* Trachea
* Heart
* Aorta
* Great vessels
* Esophagus
* Less than 5 cm in largest dimension
* Accessible via percutaneous transthoracic route
* Hepatic:

  * Coagulation profile normal

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Robert D. Suh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06548776: Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
Official title: Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To learn if MRS can effectively assess spinal cord lesions.

Detailed description: Primary Objective:

Establish the feasibility and spectrum of MRS for adult patients while mapping the total spine spectrum at different TEs to allow for future comparison with patients to assess spinal cord lesions malignant potential and grade.

Secondary Objective:

Test success of the spectrum by implementing the protocol on 3 patients with spinal LMD receiving CSI. This will allow us to test reproducibility of the protocol and test effect of radiation on spinal cord at different time frames. This will serve as secondary data for subsequent trials targeting functional statues after radiation and tumor grading predictability of MRS.

Eligibility criteria: Inclusion Criteria:

Volunteers:

* Adults \> 18 years
* Healthy with no malignancy, demyelinating disease, back pain, degenerative disease, or spinal cord lesions.
* Consent able patients.

Patients with high risk for LMD to receive prophylactic CNS radiation:

* Adults \> 18 years old.
* MR or CSF without evidence of LMD.
* Patients with high risk for LMD to receive CSI as part of standard treatment of prophylactic LMD disease.
* Consent able patients, willingness and ability to comply with the study procedures.
* No spinal cord lesions.

Exclusion Criteria:

Volunteers:

* Age \< 18 years
* Pregnant or breastfeeding individuals.
* History of cancer.
* History of spinal cord lesions including malignant, demyelinating, or inflammatory.
* History of prior spinal surgery.
* History of implantable devices.
* History of MR claustrophobia.
* Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
* Scoliosis.

Patients with high risk for spinal LMD:

* Age \< 18 years
* History of spinal cord lesions including malignant, demyelinating, or inflammatory.
* History of prior spinal surgery.
* History of implantable devices.
* History of MR claustrophobia.
* Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
* Scoliosis.

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Rami Eldaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163176: Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors
Official title: Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Keywords: cell proliferation
PET
radiotherapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage II-IV squamous cell carcinoma of the head and neck

Brief summary: Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired during inspection under general anaesthesia before treatment.

18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of active proliferation. The aim of this study is to assess the value of the functional information gained by 18F-FLT-PET for radiotherapy planning and early tumor response assessment.

Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After approximately two weeks of radiotherapy a further PET scan is obtained.


Eligibility criteria: Inclusion Criteria:

1. Stage II - IV squamous cell carcinoma of the head-and-neck region, treated with radiotherapy or radiochemotherapy with curative intent.
2. 18 years or older
3. Informed consent

Exclusion Criteria:

1. Patients who have undergone surgery as primary tumor therapy.
2. Patients treated with palliative intent.
3. Pregnancy

Primary outcomes:
measure: Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control)
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy.
timeFrame: 2 months
measure: Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.
timeFrame: 2 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen, Department of Radiotherapy
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Johannes HA Kaanders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04338776: Comparing UroLift Experience Against Rezūm
Official title: C.L.E.A.R. - Comparing UroLift Experience Against Rezūm
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 120
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

Detailed description: Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.

All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.

Eligibility criteria: Inclusion Criteria:

1. Male gender
2. Age ≥ 50 years
3. Diagnosis of symptomatic BPH
4. Prostate volume 30cm3 ≤ 80cm3
5. Willing to sign study informed consent form

Exclusion Criteria:

1. Current urinary tract infection
2. Current catheter dependent urinary retention or PVR \>= 500 mL
3. Urethra conditions that may prevent insertion of delivery system into bladder
4. Previous BPH surgical procedure
5. Urinary incontinence presumed due to incompetent sphincter
6. Current gross hematuria
7. Patients with a urinary sphincter implant
8. Patients who have a penile prosthesis
9. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint

Primary outcomes:
measure: Catheter Independent
timeFrame: Through 1-week
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Garden City
country: United States
facility: NYU Winthrop Urology
state: New York
city: New York
country: United States
facility: Weil Cornell Medical College, Cornell University
state: New York
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Camberley
city: Norwich
country: United Kingdom
facility: NORFOLK and Norwich University Hospital
state: Norfolk
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02118376: Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status
Official title: Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity; fat distribution; inflammation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

Detailed description: As a treatment for type 2 diabetesGlucagon like peptide -1 (Glucan-like peptide-1, GLP-1) receptor agonists plays the role of promoting insulin secretion, inhibiting glucagon secretion，and also has the central and peripheral effects,it can inhibit appetite,reduce weight.GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of overweight and type 2 diabetes mellitus

Exclusion Criteria:

* Poor body condition (severe liver and kidney dysfunction)
* Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete
* serious endocrine disease
* genetic disease

Primary outcomes:
measure: Dual energy X-ray absorptiometry
timeFrame: 3 month
Secondary outcomes:
measure: lab testing
timeFrame: 3 month
Other outcomes:
measure: lab testing
timeFrame: 3 months
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shang Tenth People's Hospital
name: Qu Shen
role: STUDY_DIRECTOR
References:
citation: Wang X, Chen J, Li L, Zhu CL, Gao J, Rampersad S, Bu L, Qu S. New association of bone morphogenetic protein 4 concentrations with fat distribution in obesity and Exenatide intervention on it. Lipids Health Dis. 2017 Apr 4;16(1):70. doi: 10.1186/s12944-017-0462-1.
Clinical trial NCT03515876: Dexmedetomidine on Segmental EEG Power Spectra
Official title: The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
EEG Power Spectra
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2018-05-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients for hysteroscopic examination and surgery under general anesthesia.

Brief summary: To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.

Detailed description: Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia.

Each group will have 20 patients.

General conditions including blood pressure, respiration, and heart rates will be recorded.

EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical status I to II grade.
* body mass index 18 to 25 kg/m2
* no vision or hearing impairment
* will receive general anesthesia

Exclusion Criteria:

* with psychological or mental diseases
* with neurological diseases
* treating with steroids or with alcohol dependence.

Primary outcomes:
measure: EEG power spectra
timeFrame: From prior to anesthesia to 10 min after anesthesia.
Secondary outcomes:
measure: Blood pressure
timeFrame: From prior to anesthesia to 10 min after anesthesia.
measure: Respiration
timeFrame: From prior to anesthesia to 10 min after anesthesia.
measure: Heart rates
timeFrame: From prior to anesthesia to 10 min after anesthesia.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02305576: Effect of Perioperative Factors on the Analgesia Nociception Index
Official title: Effect of Perioperative Factors on the Analgesia Nociception Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraoperative Neurophysiological Monitoring
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patietns undergoing planned surgery under general anesthesia

Brief summary: The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing scheduled surgery

Exclusion Criteria:

* Non sinusal rhythm
* Pace maker or defibrillator holders
* Pregnancy or feeding
* American Society of Anesthesiology physical status 4

Primary outcomes:
measure: Variation of the ANI index
timeFrame: Before and 2 minutes afer the factor occurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Georges Daccache, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06680076: Study on Lipid Profile Changes in Plasma and Intestinal Mucosa of Patients With Inflammatory Bowel Disease
Official title: Observational Study of Changes in Plasma and Intestinal Mucosa Lipid Profiles in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: IBD
lipid metabolism
activity
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patients who have inflammation bowel disease.

Brief summary: This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

Detailed description: This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

The investigators followed up with patients with different stages of IBD and collected plasma and lesion tissues from patients and healthy volunteers for lipid metabolism-related substances to assess the changes in lipid metabolism in patients with different stages of IBD and their impact on disease.

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory bowel disease; aged 18-80 years; all cases agreed to participate in the study.
* Healthy volunteers who agreed to participate in the study.

Exclusion Criteria:

* Patients with severe heart disease; patients with severe kidney disease; patients with low blood pressure; patients with severe infections such as sepsis or pneumonia; patients who have used immunosuppressants such as 6-mercaptopurine, imidazole thiopurine, and cyclosporine within a short period, and women during pregnancy; patients who are post-colon resected; patients who disagreed to participate in the study.

Primary outcomes:
measure: Differential lipid composition between disease and healthy groups
timeFrame: 14 weeks
measure: Differences in lipid composition between active and remission disease
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Carol
state: Heilongjiang
Study officials:
affiliation: Harbin Medical University
name: Hongyu D Xu, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00060476: Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2003-05-07
Enrollment: 15000
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.

Detailed description: The duration of treatment is 6 years.

Eligibility criteria: Regular PSA testing and study biopsies required.

Primary outcomes:
measure: Time to prostate cancer
timeFrame: Duration of Treatment
Secondary outcomes:
measure: Time to aggressive prostate cancer
timeFrame: Duration of Treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: van Adelsberg J, Gann P, Ko AT, Damber JE, Logothetis C, Marberger M, Schmitz-Drager BJ, Tubaro A, Harms CJ, Roehrborn C. The VIOXX in Prostate Cancer Prevention study: cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. Curr Med Res Opin. 2007 Sep;23(9):2063-70. doi: 10.1185/030079907X219526.