louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00846144: The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients
Official title: This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Diabetes
Keywords: Glucose stimulated insulin secretion
copper
cytokines
diabetes
Reduction in insulin secretion
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet, triggering a vicious sequence of events: exocrine damage, recruitment of macrophages expressing IL-1beta leading to oxidative stress and even more reduction in the activity of Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu status that may benefit from copper supplementation to normalize their GSIS. These patients will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS, pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different blood components before and every 4 weeks during treatments or placebo.


Eligibility criteria: Inclusion Criteria:

* diabetic subjects with BMI \< 33
* HbA1C \< 8
* plasma copper levels of \< 90 ul/dl

Exclusion Criteria:

* patients with bad physical conditions

Primary outcomes:
measure: Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Diabetes Unit, Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Itamar Raz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weksler-Zangen S, Raz I, Lenzen S, Jorns A, Ehrenfeld S, Amir G, Oprescu A, Yagil Y, Yagil C, Zangen DH, Kaiser N. Impaired glucose-stimulated insulin secretion is coupled with exocrine pancreatic lesions in the Cohen diabetic rat. Diabetes. 2008 Feb;57(2):279-87. doi: 10.2337/db07-0520. Epub 2007 Oct 31.
citation: Weksler-Zangen S, Yagil C, Zangen DH, Ornoy A, Jacob HJ, Yagil Y. The newly inbred cohen diabetic rat: a nonobese normolipidemic genetic model of diet-induced type 2 diabetes expressing sex differences. Diabetes. 2001 Nov;50(11):2521-9. doi: 10.2337/diabetes.50.11.2521.
Clinical trial NCT02874144: Anti-Inflammatory Agent in Sinusitis
Official title: A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasal Polyps
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 43
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: To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.

Detailed description: This is a Phase 2a, single-center, randomized, placebo-controlled, double-blind study that includes 12 weeks of treatment with experimental drug anti-inflammatory agent or placebo TID administered orally.

All subjects will be ≥18 years, have sinusitis with persistent symptoms despite standard of care treatment, and have failed a course of steroids in the past.

Eligibility criteria: Inclusion Criteria:

1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Use of any investigational drugs within 30 days of screening.
3. Acute infection needing antibiotic treatment at screening.

Primary outcomes:
measure: TOTAL POLYP SCORE (TPS)
timeFrame: Baseline and Week 12
measure: Sinus CT Scan Scores by Lund-Mackay Scores
timeFrame: Baseline and Week 12
measure: BSIT (Brief Smell Identification Test)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: SNOT-22 (Sino-Nasal Outcome Test-22) Score
timeFrame: Baseline and Week 12
measure: Visual Analog Scale (VAS)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Anju T Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price CPE, Guo A, Stevens WW, Cousens L, Vu TT, Suh LA, Erickson KA, Conley D, Grammer LC, Kern RC, Tan BK, Kato A, Schleimer RP, Smith SS, Welch KC, Peters AT. Efficacy of an oral CRTH2 antagonist (AZD1981) in the treatment of chronic rhinosinusitis with nasal polyps in adults: A randomized controlled clinical trial. Clin Exp Allergy. 2022 Jul;52(7):859-867. doi: 10.1111/cea.14158. Epub 2022 May 18.
Clinical trial NCT00959244: Study of Urine Samples From Women With Newly Diagnosed Breast Cancer Enrolled on Clinical Trial UNMC-08105
Official title: 1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-14
Enrollment: 100
Sex: FEMALE
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: Women with breast cancer

Brief summary: RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.

Detailed description: OBJECTIVES:

* To learn the effects of selected agents (tamoxifen and aromatase inhibitors) on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.

OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with tandem mass spectrometric detection.

Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption) is collected through medical record review.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed ductal carcinoma in situ or invasive breast cancer
* Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor

  o Urine specimens were collected at baseline, 6 months, and then annually
* Estrogen receptor or progesterone receptor positive
* ECOG performance status 0-2

Exclusion Criteria:

* Not pregnant or nursing
* No concurrent use of estrogen(s)

Primary outcomes:
measure: Estrogen compounds
timeFrame: at baseline at 6 months and annually
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Eppley Cancer Center, University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: Eppley Cancer Center, University of Nebraska Medical Center
name: Ercole Cavalieri, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04085744: A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
Official title: A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Intubation Complication
Sore Throat
Keywords: intubation
anesthesia
corticosteroids
lidocaine
complication of intubation
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 91
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.

Detailed description: In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.

Eligibility criteria: Inclusion Criteria:

* Being ages between 2 and 18
* undergoing elective surgery
* intubated patients over 1 hour
* ASA(American Society of Anesthesiologists) Class I-II patients

Exclusion Criteria:

* Urgent surgeries
* Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.

Primary outcomes:
measure: Visual analog scale (VAS) for pain
timeFrame: 1 hour
measure: Visual analog scale (VAS) for pain
timeFrame: 6 hours
measure: Visual analog scale (VAS) for pain
timeFrame: 12 hours
measure: Visual analog scale (VAS) for pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Derince
country: Turkey
facility: Health and Science University Derince Training and Research Hospital
state: Kocaeli
Study officials:
affiliation: HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL
name: Ayse Z Turan
role: STUDY_DIRECTOR
References:
Clinical trial NCT02594644: The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
Official title: The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratosis, Actinic
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 32
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 aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Detailed description: The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Subjects has actinic keratoses and qualifies for photodynamic therapy
* Do not meet any of the exclusion criteria

Exclusion Criteria:

* Subjects who smoke
* Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
* Subjects who have established allergy to topical ALA
* Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

Primary outcomes:
measure: Difference in the Percentage of Complete Clearance of the Actinic Keratoses
timeFrame: Baseline, 2 Months
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Immediately Post-Treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Raja Sivamani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.
Clinical trial NCT04981444: Optimization of an Automated Ultrasound Cardiac Guidance Tool
Official title: Optimization of an Automated Ultrasound Cardiac Guidance Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Therapy
Lead sponsor: UltraSight
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 75 cardiac patients will be enrolled in this study.

Brief summary: Open-label, single-arm, prospective study. Subjects will undergo one session of 2D Transthoracic Echocardiogram (2D-TTE) ultrasound. The ultrasound will be performed by a trained sonographer.

Detailed description: The study will use a commercially available handheld imaging device (Philips Lumify transducer).

Primary Objective:

To acquire images of multiple transducer position, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe positions.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and above.
2. Patients able to understand, read and sign the informed consent
3. Patient willing to answer a short questionnaire

Exclusion Criteria:

1. Pregnancy(females of childbearing potential will be tested with a urine pregnancy test prior to their inclusion in the study)
2. Not willing or not able to sign an inform consent
3. Physical limitation to maneuvering the probe on the body
4. Unable to lie flat for study
5. Patients experiencing a known or suspected acute cardiac event
6. Patients with severe chest wall abnormalities
7. Patients who have undergone pneumonectomy
8. Patients whose anatomy does not lend itself to echocardiography

Primary outcomes:
measure: ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Praveen Mehrotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03500744: Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
Official title: Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hysterectomy
Cystectomy
Regional Anesthesia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 12
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: Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.


Eligibility criteria: Inclusion Criteria:

Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.

Exclusion Criteria:

1. BMI \> 40
2. Non-English speaking
3. Patient refusal or inability to consent
4. Cognitive or psychiatric history that would make it difficult to assess pain score
5. Pre-existing chronic pain condition
6. Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
7. Infection over site of block placement
8. Allergy or contraindication to any study medication
9. Coagulopathy or thrombocytopenia
10. Postoperative ICU admission
11. Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases

Primary outcomes:
measure: Opioid consumption
timeFrame: First 12 postoperative hour
measure: Pain score
timeFrame: First 12 postoperative hour
Secondary outcomes:
measure: Length of stay in post-anesthetic recovery unit
timeFrame: until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively
measure: Length of stay in hospital
timeFrame: until discharge from hospital, up to 7 days postoperatively
measure: Number of participants with opioid related complication
timeFrame: Until discharge, up to 7 days postoperatively
measure: Number of participants with block related complication
timeFrame: Until discharge, up to 7 days postoperatively
measure: Pain score 12 - 24 hour
timeFrame: 12th to 24th postoperative hour
measure: Opioid consumption 12 - 24 hour
timeFrame: 12th to 24th postoperative hour
Other outcomes:
Locations:
city: London
country: Canada
facility: Cheng Lin
state: Ontario
Study officials:
affiliation: Western University
name: Cheng Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111344: Glizigen-Viudid-External Anogenital Warts in Children and Adolescents
Official title: Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: External Anogenital Warts
Keywords: Dietary supplement
Anogenital warts
Viusid
Glizigen
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 76
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in the treatment of external anogenital warts in children and adolescents. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 76. Variables to be assessed will be: time to disappearance of lesions, reduction of the number of lesions and change in the aspect of lesions.


Eligibility criteria: Inclusion Criteria:

* No previous treatment for anogenital warts
* Negative serology for HB and HIV.
* Signed informed consent.

Exclusion Criteria:

* Pregnancy
* Treatment with steroids, immune-suppressors, immune-modulators or local or systemic antiviral drugs.
* Hypersensitivity to Glizigen or Viusid:

Primary outcomes:
measure: Time to lesion regression
timeFrame: 12 weeks
Secondary outcomes:
measure: Occurrence of adverse effects within the 12 week treatment period
timeFrame: 12 weeks
measure: Reduction in the number of lesions
timeFrame: 12 weeks
measure: Lesion aspect
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: Pediatric Hospital "Dr. Juan Manuel Márquez".
Study officials:
affiliation: Pediatric Hospital "Dr. Juan Manuel Márquez.
name: Edelisa Moredo Romo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454544: A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: House Dust Mite Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 992
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: The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.


Eligibility criteria: Inclusion Criteria:

* A history of house dust mite allergy
* Use of symptomatice medication for treatment of house dust mite allergy
* Positive skin prick test to mites
* Positive specific IgE

Exclusion Criteria:

* History of uncontrolled asthma
* Overlapping symptomatice allergies
* Previous treatment with immunotherapy

Primary outcomes:
measure: Evaluation of allergy symptoms and use of symptomatic medication
timeFrame: 1 year with treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Respiratory Diseases, Lapeyronie Hospital
Study officials:
References:
citation: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.