louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03238378: Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
Official title: SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Recurrent Head and Neck Cancer
Keywords: head and neck cancer
Locally recurrent head and neck cancer
Brachytherapy
Hyperthermia
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 96
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 aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed recurrent carcinoma of the head and neck region
* Stage rcT1-3
* Tumor anatomy and location suitable for brachytherapy techniques.
* cN0/pN0 or rpN+ \& R0 with \<3 pos. LND \& without invasion of capsula.
* M0
* ECOG 0-2
* Previous radiation therapy up to at least 50 Gy
* Previous radiation therapy completed more than 6 months ago
* Written study-specific informed consent

Exclusion Criteria:

* cT4
* rpN+ with \>2 pos. LND or invasion of capsula
* Pregnant or lactating women
* Collagen vascular disease
* The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
* Psychiatric disorders

Primary outcomes:
measure: Late side effects
timeFrame: Effects are followed up to 5 years after therapy
Secondary outcomes:
measure: Quality of life
timeFrame: up to 5 years after therapy
measure: Rate of local recurrencies
timeFrame: up to 5 years after therapy
measure: Overall survival
timeFrame: up to 5 years after therapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Dept. of Radiation Therapy, University Hospital Erlangen
Study officials:
affiliation: Dept. of Radiation Therapy, University Hospital Erlangen
name: Vratislav Strnad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995278: Usage and Plan of Care Changes Due to Drug Screenings
Official title: Clinical Researcher Experience Assessment Documenting Usage and Plan of Care Changes Due to Drug Screenings ©
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Management
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
Collaborators: name: PAS Research Services
First posted: 2016-12-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers who already drug screen for their current patient population.

Brief summary: The purpose of this minimal risk, observational survey is to document the accuracy, benefits, and how qualitative and quantitative results affect patients' plan of care.

Detailed description: Pain is the most common reason patients consult primary care providers. According to recent surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120 billion a year in medical costs in the United States. Oral opioids are the common treatment options for various chronic pains including joint pain, musculoskeletal pain, neuropathic pain and migraines. This narcotic-based management of pain is often associated with undesirable side effects with addictive and potential abuse.

To ensure proper usage of prescribed medications, physicians use drug screens to monitor therapeutic levels and test for presence of illegal drugs or medications that may cause a drug-drug interaction. Upon receiving quantitative or qualitative results from these drug screens, the physician may change the treatment plan for patients to improve efficacy of prescribed medications.

Eligibility criteria: Inclusion Criteria:

* Must be a Medical Practioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.

Primary outcomes:
measure: Plan of Care Changes due to Drug Screenings
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04423978: Implications of Covid-19 on the Lifestyle Changes
Official title: Implications of Covid-19 on the Lifestyle Changes and Supports Used (ICOLS): a Survey in the Province of Reggio Emilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Italy
Lifestyle
Pandemics
Quarantine
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 1826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in the province of Reggio Emilia (Italy), an area of high spread of Sars-CoV-2.

Brief summary: Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks of contagion, the Italian government imposed 2.months of complete lock-down, which imposed the social isolation for the whole population and, for those positive to the Covid-19, the complete confinement at home. Despite the recommendations for conserving healthy lifestyle of the Italian Government, during the lock-down the likelihood to fall into unhealthy behaviours might have increased.

This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in an area of high spread of Sars-CoV-2.

Detailed description: The aims of this study were to detect the changes in lifestyles occurred during the imposed lock-down phase and the support services used the most by participants.

This study consists in the administration of an on-line survey addressed to adult individuals living in the province of Reggio Emilia (Italy). The survey was posted on-line on the website of the Azienda USL- IRCCS di Reggio Emilia and it was spread to the community through apps and social networks.

The on-line survey is free to access, self-administered and it consists of 50 questions. The questions investigates the changes occurred in employment status, physical exercise, diet, tobacco and alcohol consumption, sleep quality and leisure activities during the pandemic lock-down phase as well as the available local support services used and perceived as useful.

Eligibility criteria: Inclusion Criteria:

* adult individuals living in the province of Reggio Emilia (Italy)

Exclusion Criteria:

-

Primary outcomes:
measure: The ratio of individuals living in the province of Reggio Emilia who completed the survey
timeFrame: 1 month and a half
Secondary outcomes:
measure: The ratio of individuals who changed the lifestyles during the lock-down
timeFrame: 1 month and a half
measure: The number and the type of support services used the most by participants
timeFrame: 1 month and a half
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Elisa Mazzini
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Elisa Mazzini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699278: Investigating the Experiences of Individuals With Gastric Cancer Participating in Clinical Trials
Official title: An Observational Study Evaluating The Experiences of Gastric Cancer Patients In Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Gastric Cancer Stage
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer patients who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.

Brief summary: This study is observational, meaning that it does not include any interventions or new treatments. As a result, there may not be an immediate benefit for the patient with gastric cancer.

However, the data collected from this trial can contribute to a better understanding of the factors that affect withdrawal and enrolment rates in gastric cancer clinical trials, and may ultimately lead to improved patient outcomes in the future.


Eligibility criteria: Inclusion Criteria:

* Patient is a minimum of 18 years or older
* Patient has been diagnosed with gastric cancer
* Patient has been self-identified as planning to enroll in an observational clinical study

Exclusion Criteria:

* Patient is breastfeeding or pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to enroll in a gastric cancer clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in a gastric cancer clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Sexton RE, Al Hallak MN, Diab M, Azmi AS. Gastric cancer: a comprehensive review of current and future treatment strategies. Cancer Metastasis Rev. 2020 Dec;39(4):1179-1203. doi: 10.1007/s10555-020-09925-3. Epub 2020 Sep 7.
citation: Mihaljevic AL, Friess H, Schuhmacher C. Clinical trials in gastric cancer and the future. J Surg Oncol. 2013 Mar;107(3):289-97. doi: 10.1002/jso.23120. Epub 2012 Apr 18.
citation: Petryszyn P, Chapelle N, Matysiak-Budnik T. Gastric Cancer: Where Are We Heading? Dig Dis. 2020;38(4):280-285. doi: 10.1159/000506509. Epub 2020 Feb 17.
Clinical trial NCT01593878: Media Background and Test Performance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Test Performance When Distracted or Not
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to test whether middle school students test performance is affected by background TV. Students will complete a high school entrance exam either with or without a TV on in the test room. Scores will be compared.


Eligibility criteria: Inclusion Criteria:

* Grades 6-8

Exclusion Criteria:

* non english speaking

Primary outcomes:
measure: ISEE test prep evaluation
timeFrame: immediate (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT04305678: Mepolizumab for Eosinophilic Fasciitis
Official title: Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Eosinophilic Fasciitis
Keywords: Mepolizumab
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mepolizumab for the treatment of eosinophilic faciitis.
Primary purpose: TREATMENT

Brief summary: This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.

Detailed description: This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.

Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years or older.
* History and physical examination consistent with EF
* Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
* Documented peripheral eosinophilia (≥500 microliter)
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

* Eosinophilic fascitis disease duration \> 5 years
* Known history of adverse reaction to mepolizumab (Nucala)
* Pregnant females
* Females actively trying to conceive
* Vulnerable study population
* Asthma requiring inhaled cortiosteroids

Primary outcomes:
measure: Modified Rodnan Skin Score (mRSS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Localized Scleroderma Skin Severity Index (mLoSSI) score
timeFrame: 24 weeks
measure: Localized Scleroderma Damage Index (LoSDI) score.
timeFrame: 24 weeks
measure: Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
timeFrame: 24 weeks
measure: Physician's Global Assessment of Disease Activity (PhysGA-A)
timeFrame: 24 weeks
measure: Physician's Global Assessment of Disease Damage (PhysGA-D)
timeFrame: 24 weeks.
measure: Dermatology Quality of Life Index (DLQI)
timeFrame: 24 weeks.
measure: Patient Global Assessment of Disease Severity (PtGA-S)
timeFrame: 24 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Jason C Sluzevich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398978: The Effect of e-Registration and mHealth on Institutional Deliveries in the Hazard-prone Areas
Official title: The Effect of e-Registration and mHealth on Institutional Deliveries in the Hazard-prone Areas of Southern Bangladesh: A Protocol for an Open-label Two-arm Non-randomized Controlled Cluster Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Place of Delivery
Keywords: Non-randomized controlled cluster trial; institutional delivery; e-Registration; mHealth
Lead sponsor: North South University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2022-06-01
Enrollment: 536
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pregnant mothers will be registered in the electronic database, they will be called by the midwives to motivate them for facility delivery and they will receive a text message regarding this.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to determine the effect of the eRegistration tracking system and mHealth counseling on institutional deliveries to pregnant mothers in the hazard-prone areas of Southern Bangladesh.

Detailed description: The study will be an open-label two-arm non-randomized controlled cluster trial for six months period. Chandpur Sadar, Kachua, and Faridganj sub-districts will be the intervention arm and Bhola Sadar, Charfesson, and Lalmohan sub-districts of the Bhola district will be the control arm. ased system. 28 - 36 weeks of pregnant women will be enrolled, given the intervention, and followed-up until their delivery.

Eligibility criteria: Pregnant mothers registered in the FWA register, 19 - 45 years, 28 - 36 weeks pregnant, have access to a mobile phone

Primary outcomes:
measure: Rate of Institutional delivery
timeFrame: 22 weeks
Secondary outcomes:
measure: Proportion of different mode of deliveries
timeFrame: 22 weeks
measure: Proportion of different birth outcomes
timeFrame: 22 weeks
Other outcomes:
Locations:
Study officials:
affiliation: North South University
name: Ahmed Hossain, Ph.D, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01578278: Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 606
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy

Exclusion Criteria:

* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Primary outcomes:
measure: Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS
timeFrame: Baseline, 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05410678: Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries
Official title: Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Ectasia
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 63
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: The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.

Detailed description: In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare metal coronary stent (BMCS) implantation (BMCS group) at our centre between 2015 and 2020 were included in the study. Control coronary angiography (CAG) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during PCI. The primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.

Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome patients

  * 18 year age
* ectatic/aneurysmatic coronary arteries

Exclusion Criteria:

* Patients who underwent elective procedures,
* experienced unsuccessful attempts
* referred to surgical revascularization

Primary outcomes:
measure: primary endpoints
timeFrame: 2 year
Secondary outcomes:
measure: secondary endpoints
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03451578: Alpha MSH in Ocular Disease
Official title: The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Dry Macular Degeneration
Keywords: macular degeneration
blindness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule we hope to better understand if it may be a good target for future treatment.

Detailed description: A small amount (0.1 mL) of aqueous humor would be removed from the study eye in the clinic setting. This sample will be processed and then sent off for measurement of alpha MSH levels.

Eligibility criteria: Inclusion Criteria:

* 60 years or older
* diagnosis of advanced dry macular degeneration with foveal geographic atrophy
* limited vision or blindness (20/100 or worse) in that eye
* pseudophakia (prior cataract surgery in that eye)

Exclusion Criteria:

Primary outcomes:
measure: Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Sharon Fekrat, MD
role: PRINCIPAL_INVESTIGATOR
References: