louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06261983: Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.
Official title: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe
Lead sponsor: Hospital Donostia
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 29
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital.

Brief summary: Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.


Eligibility criteria: Inclusion Criteria:

* Oral squamous cell carcinoma T1-T2, cN0.
* Absence of alterations to iron metabolism.

Exclusion Criteria:

* Previous neck surgery.
* Treatment with iron chelators.
* Pregnant

Primary outcomes:
measure: The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).
timeFrame: Six years
Secondary outcomes:
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Josué Hernando Vázquez
state: Guipuzkoa
Study officials:
References:
Clinical trial NCT00547183: Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
Official title: A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 298
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.


Eligibility criteria: Inclusion Criteria:

* History of erectile dysfunction for at least 3 months.
* Currently have diabetes mellitus of at least 3 months duration.
* Agree to not use any other ED treatment during the study.
* Anticipate the same female sexual partner for the study.
* Must be willing to make the required number of sexual attempts.

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates or potent CYP3A4 inhibitors
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Have kidney or liver problems

Primary outcomes:
measure: Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Genthin
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
citation: Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
Clinical trial NCT03229083: Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
Official title: Monitoring of Treatment Related Toxicities from Oral Targeted Agents and Immunotherapy Among Patients with Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
* Greater than 18 years of age
* A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
* Able to provide written informed consent
* Proficient in the English language and self-reports as literate
* Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria:

* Women cannot be breast-feeding
* Does not have regular access to the internet
* Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
* Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

Primary outcomes:
measure: Carevive Survey Usage Rates
timeFrame: 48 weeks
measure: Reasons Participants Do Not Complete Survey or Utilize Care Plans
timeFrame: 48 weeks
measure: Average Usability Score Using the Software Usability Scoring System
timeFrame: 48 weeks
measure: Reasons for Declining Study Participation
timeFrame: 48 weeks
Secondary outcomes:
measure: Patient Reported Toxicities Using PRO-CTCAE Questions
timeFrame: 48 weeks
measure: Clinician Reported Toxicities Using CTCAE
timeFrame: 48 weeks
measure: Quality of Life Determination Using the FKSI-DRS Survey
timeFrame: 48 weeks
measure: Distress Level Using the NCCN Distress Thermometer
timeFrame: 48 weeks
measure: • Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester - Wilmot Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT02220283: Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function
Official title: Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long-term Renal Dysfunction
Keywords: Acute kidney injury,aortic dissection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010\~2013

Brief summary: Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010\~2013.


Eligibility criteria: Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010\~2013 Age \> 20 years old

Primary outcomes:
measure: Long-term change of renal function (eGFR) after operation of aortic aneurysm
timeFrame: 30 days
Secondary outcomes:
measure: Survival after operation of aortic aneurysm
timeFrame: 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
name: Chun-Fu Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06521983: The Effect of Whole Body Vibration on Muscle Elasticity
Official title: The Effect of Whole Body Vibration on Pain and Muscle Elasticity in Individuals With Hyperlordosis and Normal Lordosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lordosis; Postural
Lordosis
Hyperlordosis
Keywords: Whole-body vibration
Lordosis
Hyperlordosis
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

Detailed description: This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

The viscoelasticity properties ( tone, stiffness, elasticity) of the Musculus Trapezius and Musculus Pectoralis were assessed with MyotonPro® (Myoton AS, Estonia) during prone position on both sides.

Individuals will be divided into two groups: hyperlordosis and normal lordosis. Whole body vibration will be applied twice a week for six weeks, with a frequency of 30 Hz and an intensity of 2 mm.

A total of 28 females and males (14 individuals for each group) with hyperlordosis (\>40°) and normal lordosis participated in the study.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age,
* Having pain \>5 according to VAS measurement,
* Having normal lumbar lordosis angle between 30°-40°,
* Having hyperlordosis angle \>40°

Exclusion Criteria:

* Having Scheurmann kyphosis, ,
* Having scoliosis (Cobb angle \>10°),
* Having other congenital spine abnormalities

Primary outcomes:
measure: Muscle viscoelastic properties
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain level
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islam Science and Technology University
Study officials:
affiliation: Gaziantep Islam Science and Technology University Physical Therapy and Rehabilitation Department
name: Gonul Elpeze
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279383: OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)
Official title: OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss, Surgical
Hemostasis
Keywords: Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.

Brief summary: OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. The availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.


Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT02788383: Fetal RhD Genotye Non Invasive Prenatal Determination
Official title: Aplicación en la práctica clínica de la determinación Prenatal no Invasiva en el Genotipo RhD Fetal Durante el Primer Trimestre de la gestación en Gestantes RhD Negativas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Rh-Hr Blood-Group System
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant RhD negative women since January 2013 until December 2015

Brief summary: Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD negative pregnant women.

The investigator want to demonstrate that this is an useful and efficient method.

Detailed description: This is a retrospective observational study that pretend to demonstrate that the prenatal determination of RhD fetal genotype is useful and efficient in our clinical practice.

I'm going to check the clinical history of all negative RhD pregnant women since January 2013 until December 2015.

I'll check if prenatal determination matches with postnatal RhD determination of newborn.

Usually, when a RhD negative woman is pregnant we administrate gammaglobulin in 28 gestation weeks, after invasive procedures and after delivery if the baby is positive RhD.

Althought, the investigators know that the 40 percent of RhD negative pregnant have a negative RhD baby.

This study will do posible to know how many gammaglobulins hasn't been necessary thanks to prenatal determination.

This is an important thing because gammaglobulin is an humanoid product ( it isn't without heatlth risks,...) and because is expensive.

For this reason, if the investigators do universal determination of RhD fetal genotype the investigators can avoid the administration of humanoid product in pregnant women.

I want to demonstrate that this practice is very useful and efficient in our population.

Eligibility criteria: Inclusion Criteria:

* Pregnant RhD negative women

Exclusion Criteria:

* Pregnant RhD positive women

Primary outcomes:
measure: Prenatal determination fetal RhD genotype
timeFrame: Ten months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT00642083: Stenting of Haemodialysis Acces Trial
Official title: Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Outflow Stenosis
Keywords: outflow stenosis
stentgraft
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
First posted: 2008-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.


Eligibility criteria: Inclusion Criteria:

* Patients of 18 years of age
* Patients have a life expectancy of at least 2 years
* Signed informed consent
* Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis.

Exclusion Criteria:

* Patient unsuitable for administration of contrast agent
* Pregnancy
* Dementia or altered mental status that would prohibit giving conscious informed consent
* Need for adjunctive major surgical or vascular procedures within one month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References:
Clinical trial NCT02346383: Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Official title: Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: back pain
neuromodulation
spinal peripheral neuromodulation
spinal cord stimulation
postlaminectomy pain syndrome
Lead sponsor: Carolinas Center for Advanced Management of Pain
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2015-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the best parameters with various leads to cover back and leg pain and provide best pain relief

Detailed description: Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.

Eligibility criteria: Inclusion Criteria:

* spinal cord stimulator implant within last 3 weeks
* NRS \> 6
* at least 22 years old
* patients who agree not to add or increase their pain medications during the study

Exclusion Criteria:

* patients with prior spinal cord stimulators
* pregnancy
* infusion pump
* history of substance abuse or dependency in last 6 months

Primary outcomes:
measure: Numeric Rating Scale (Pain)
timeFrame: Weeks 4, 6 and 8
Secondary outcomes:
measure: Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
timeFrame: weeks 4, 6, and 8
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Carolinas Center For Advanced Management of Pain
state: South Carolina
Study officials:
References:
Clinical trial NCT01566383: Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
Official title: Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Identify Normal MII-pH Parameters
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 19
Sex: ALL
Minimum age (years): 33
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.

Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults between the ages of 33-65
* BMI range of 23.9 - 38.9
* Ability to give consent to participate in study

Exclusion Criteria:

* History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
* History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
* History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
* History of thoracic, gastric or esophageal surgery.
* Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
* Pregnancy or nursing mothers.
* Alcohol consumption \>40g/day, smoking \>10cigarettes/day.

Primary outcomes:
measure: Identify normal esophageal MII-pH parameter ranges in healthy volunteers
timeFrame: Following 24-hr pH monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Michael F Vaezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: