louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03317730: Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
Official title: Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Locally Advanced Head and Neck Cancer
Keywords: Xtampza ER
LAHNC
Head and neck cancer
Pain management
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.

Detailed description: To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC) as part of a prospective clinical trial. Investigators will also assess pain control, quality of life, and drug related toxicity during RT and during short term follow-up.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed locally advanced cancer of mucosa of the head and neck.
* Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases.
* Clinical or pathologic stage III-IV
* Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 Gray.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Age \> 19 years
* Subjects given written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility of Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC).
timeFrame: 1 year
Secondary outcomes:
measure: Determine Pain Control (at time of enrollment)
timeFrame: 1 year
measure: Determine Pain Control (weekly during RT)
timeFrame: 1 year
measure: Determine Pain Control (at follow-up)
timeFrame: 1 year
measure: Access Toxicity
timeFrame: 1 year
measure: Access Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hazelrig-Salter Radiation Oncology Center
state: Alabama
Study officials:
References:
Clinical trial NCT01344330: Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
Official title: Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Colon cancer
Prevention
Cruciferous vegetables
Histone status
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Cancer Institute (NCI)
First posted: 2011-04-29
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for screening colonoscopy

Brief summary: This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.


Eligibility criteria: Inclusion criteria:

* scheduled for screening colonoscopy
* off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines
* INR 0.90-1.20
* hemoglobin ≥ 13.5 (men) or 12.0 (women)
* platelets ≥100,000/μL
* Chem screen results within normal limits
* negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only
* ASA performance status \<2

Exclusion criteria:

* history of colon cancer or adenomatous polyps
* current smoker
* medical history of chronic obstructive pulmonary disease
* current oral steroid therapy
* current therapy with valproate or other pharmacological drugs associated with HDAC inhibition
* use of oral antibiotics within 3 months prior to entry into study
* significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue
* diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder
* use of warfarin or other blood thinning agents
* inflammatory bowel disease.

Primary outcomes:
measure: Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites
timeFrame: At colonoscopy (day 1)
Secondary outcomes:
measure: Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)
timeFrame: at colonoscopy
measure: Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),
timeFrame: at colonoscopy
measure: Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)
timeFrame: at colonoscopy
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Rod Dashwood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00451230: Metabolic Effects of Cocaine
Official title: Elucidating the Role of the Hypothalamic-Pituitary-Adrenal (HPA) Axis in the Mechanisms Underlying Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Keywords: craving, insulin, leptin
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2007-03-23
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence


Eligibility criteria: Inclusion Criteria:

* Individuals with DSM IV diagnosis of cocaine dependence, medically healthy

Exclusion Criteria:

* Other than cocaine dependence DSM-IV axis I diagnosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Igor Elman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rott D, Langleben DD, Elman I. Cocaine decreases plasma insulin concentrations in non-diabetic subjects: a randomized double-blind study. Diabet Med. 2008 Apr;25(4):510-1. doi: 10.1111/j.1464-5491.2008.02412.x. Epub 2008 Mar 13. No abstract available.
Clinical trial NCT00598130: Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
Official title: A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemostatic Techniques
Nephrectomy
Keywords: Patients undergoing elective open partial nephrectomy surgery
Excision of a kidney
Lead sponsor: OMRIX Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 30
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: This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective open partial nephrectomy
* Patients must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

* Patients with a tumor diameter greater than 4 cm
* Any additional surgical intervention other than partial nephrectomy
* Patients with only one functional kidney
* Patients with known intolerance to blood products or other components of the product

Primary outcomes:
measure: Proportion of successes at 10 minutes following randomization
timeFrame: 10 minutes
Secondary outcomes:
measure: Proportion of successes at 5 minutes following randomization
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei-Zion MC
city: Kfar Saba
country: Israel
facility: Meir MC
city: Tel Aviv
country: Israel
facility: Rabin MC
city: Tel-Aviv
country: Israel
facility: Sheaba MC
Study officials:
affiliation: Rabin MC
name: Yoram Dekel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147.
Clinical trial NCT06125730: A Single-Group Study to Evaluate the Effects of an Eyelash Serum on Improving Eyelash Growth
Official title: A Single-Group Study to Evaluate the Effects of an Eyelash Serum on Improving Eyelash Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelash Growth
Lead sponsor: Dime Beauty Co.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-09
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the efficacy of the DIME Beauty Eyelash Boost Serum in improving the growth of the eyelashes and their appearance in terms of length, fullness, and thickness. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test product. Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert eyelash grading will take place at Baseline and Day 60.


Eligibility criteria: Inclusion Criteria:

Females aged 18-65. Wish to improve their eyelash growth. Wish to improve their eyelash length, thickness, and fullness. Have a smartphone or camera to take before-and-after selfies.

Exclusion Criteria:

Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.

Anyone who has undergone any procedures that target the eyelashes in the past 3 months, or is planning to in the next 60 days. This includes eyelash lifts, tints, and extensions.

Anyone who has recently started using any product or taking any supplements that target eyelash growth, or who is planning to in the next 60 days.

Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.

Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.

Anyone who cannot/will not commit to the study protocol. Anyone with a history of substance abuse.

Primary outcomes:
measure: Changes in eyelash growth as per expert grading. [Timeframe: Baseline to Day 60]
timeFrame: 60 days
measure: Changes in participant-perceived eyelash growth. [Timeframe: Baseline to Day 60]
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01886430: Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF
Official title: Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.

Detailed description: The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced heart failure,
* Class Functional IV, according to the criteria of New York Heart Association (NYHA),
* Aged over 18 years,
* Etiology hypertensive, ischemic, idiopathic or chagas disease,
* Left ventricular ejection fraction ≤ 30%.

Exclusion Criteria:

* Patients with hypertension lung disease and oxygen-dependent,
* Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
* Insulin-dependent diabetes mellitus (type I),
* Peripheral arterial occlusive disease,
* Peripheral neuropathy,
* Use of pacemaker or implantable cardiodefibrillator.

Primary outcomes:
measure: Functional assessment
timeFrame: 10 days
Secondary outcomes:
measure: Peripheral function
timeFrame: 10 days
measure: Peripheral muscle strength
timeFrame: 10 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - HC/FMUSP
Study officials:
References:
Clinical trial NCT00786630: Intervention to Reduce Injection Drug Use
Official title: Intervention to Reduce Injection Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Drug treatment entry and retention
Drug injection frequency
HIV risk behaviors
Hepatitis C risk behaviors
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2008-11-06
Enrollment: 726
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: This is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and to improve client overall functioning. The overall goal of this project is to compare strengths-based case-management (CM) to an enhanced version of CM that uses case managers to facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.


Eligibility criteria: Inclusion Criteria:

* opiate injection at least 3 times a week during the last 6-months
* 18 years of age or older
* no drug abuse treatment in the 30-days prior to the interview
* not transient
* no known reason (e.g. pending jail time) why they will not be available for follow-up interviews
* not involved in Project Safe research activities in the previous 12 months
* willing to meet with an Addiction Research and Treatment Services (methadone clinic) counselor
* eligible to be treated at ARTS

Exclusion Criteria:

* too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

Primary outcomes:
measure: Treatment entry and retention
timeFrame: Baseline, 6 months after baseline, 12 months after baseline
Secondary outcomes:
measure: Drug injection and HIV/HCV risk behaviors
timeFrame: Baseline, 6 months after baseline, 12 months after baseline
Other outcomes:
Locations:
city: Denver
country: United States
facility: Project Safe
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert E. Booth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04283825: Humanistic Care in Patients With Coronavirus Disease 2019
Official title: The Therapeutic Efficacy of Psychological and Physical Rehabilitation Based Humanistic Care in Patients With Coronavirus Disease 2019
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronavirus Disease 2019
Keywords: coronavirus disease 2019
physical rehabilitation
psychological rehabilitation
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019.

Detailed description: As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown their potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019. As the national medical team sent to Wuhan, investigators proposed a Psychological and physical rehabilitation based humanistic care regimen generated from our experience in treating patients with COVID-2019. In addition to routine therapy, investigators will apply this comprehensive humanistic care regimen to the patients according to their condition to see the efficacy to this regimen.

Eligibility criteria: Inclusion Criteria:

* Inpatients with 2019 Novel Coronavirus infection

Exclusion Criteria:

* Patients can not follow-up;
* Investigator considering inappropriate.

Primary outcomes:
measure: Recovery Time
timeFrame: 1 month
Secondary outcomes:
measure: Self-rating depression scale
timeFrame: 1 month
measure: Survival rate
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shouping Gong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083430: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Official title: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Healthy
Cytotoxicity
Yellow Fever Vaccination Reaction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

Detailed description: CD: cluster of differentiation YF: yellow fever

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 60 years
* Informed consent given

Exclusion Criteria:

* Fever (orally \>37,5 C) on day of vaccination
* Immunosuppressants
* Pregnant or breast feeding
* Severe immunodeficiency
* Known thymus dysfunction
* Allergy against egg
* Known haemophilia
* Previous severe reaction to vaccine
* Not willing to use anticonceptives 4 weeks after vaccination

Primary outcomes:
measure: Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D
timeFrame: 21(+/-3) days
measure: Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D
timeFrame: 100 (+/- 40) days
Secondary outcomes:
measure: % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
timeFrame: 21(+/-3) days
measure: % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing
timeFrame: 100 (+/- 40) days
measure: Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
timeFrame: 21(+/-3) days
measure: Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells
timeFrame: 100 (+/- 40) days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jesper D Gunst, MD
role: PRINCIPAL_INVESTIGATOR
References: