louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890277: Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound
Official title: Treatment of Nonneoplastic Epithelial Disorders of Skin and Mucosa of Vulva With High Intensity Focused Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulva Intraepithelial Nonneoplastic
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.


Eligibility criteria: Inclusion criteria:

* patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).

Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion criteria:

* atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
* vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
* combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
* other type of cancers that require urgent care.

Primary outcomes:
measure: Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology
timeFrame: One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT02929277: Protection Against Allergy: Study in Rural Environment - Part IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Atopy
Keywords: farm children
non-farm children
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 131
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive strategies.

Previous results show a protective effect of farm exposure on allergic risk by livestock contacts and microbial exposures and by raw cow milk consumption in early age.

PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis) and to explain how early age exposures and particularly milk products consumption contribute in the process of allergic illness in childhood. A focus on the characterization of the protective biologically active components in raw milk and identification of immunological mechanisms are involved.


Eligibility criteria: Inclusion Criteria:

* PATURE IV is a birth cohort. All children enrolled at the beginning and who still agree to participate will be included at 10-year follow-up.

Exclusion Criteria:

-

Primary outcomes:
measure: Asthma
timeFrame: 10 years old
measure: Rhinitis
timeFrame: 10 years old
measure: Atopic Dermatitis
timeFrame: 10 years old
measure: Food Allergy
timeFrame: 10 years old
measure: Skin prick tests
timeFrame: 10 years old
measure: Specific Immunoglobulin E (IgEs)
timeFrame: 10 years old
measure: Blood cytokine profiles
timeFrame: 10 years old
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chauveau A, Dalphin ML, Mauny F, Kaulek V, Schmausser-Hechfellner E, Renz H, Riedler J, Pekkanen J, Karvonen AM, Lauener R, Roduit C, Vuitton DA, von Mutius E, Dalphin JC; PASTURE Study Group. Skin prick tests and specific IgE in 10-year-old children: Agreement and association with allergic diseases. Allergy. 2017 Sep;72(9):1365-1373. doi: 10.1111/all.13148. Epub 2017 Apr 12.
citation: Chauveau A, Dalphin ML, Kaulek V, Roduit C, Pugin A, von Mutius E, Vuitton DA, Dalphin JC. Disagreement between Skin Prick Tests and Specific IgE in Early Childhood. Int Arch Allergy Immunol. 2016;170(2):69-74. doi: 10.1159/000446776. Epub 2016 Jul 26.
Clinical trial NCT01845077: Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Official title: Relative Bioavailability of Two Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the Free Combination of Linagliptin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-05-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.


Eligibility criteria: Inclusion criteria:

1. Healthy males or females
2. Age 18 -50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition

Primary outcomes:
measure: AUC0-72 of Linagliptin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
measure: Cmax of Linagliptin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
measure: AUC0-tz of Metformin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
measure: Cmax of Metformin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Secondary outcomes:
measure: AUC0-infinity of Linagliptin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
measure: AUC0-infinity of Metformin
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Other outcomes:
Locations:
city: Austin
country: United States
facility: 1288.8.1 Boehringer Ingelheim Investigational Site
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04069377: Mechanical Versus Manual Chest Compression
Official title: Mechanical Versus Manual Chest Compression: A Retrospective Study in Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Cardiopulmonary Resuscitation
Keywords: Cardiopulmonary Resuscitation
Chest compression
Manuel
Mechanical
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
Collaborators: name: Ankara Training and Research Hospital
First posted: 2019-08-28
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data of out-of-hospital cardiac arrest cases undergoing cardiopulmonary resuscitation in the emergency department were analyzed retrospectively.

Brief summary: In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases.

Detailed description: In this study, the investigators retrospectively analyzed resuscitations performed over a 2-year period and compared manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge parameters.

Eligibility criteria: Inclusion Criteria:

Over 18 age Cardiac arrest cases Out-of-hospital arrest

Exclusion Criteria:

\<18 age

Primary outcomes:
measure: Rate of the mortality on the 30th day
timeFrame: 30 days
measure: Rate of the return of spontaneous circulation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
state: Çankaya
Study officials:
References:
citation: Brodal Syversen K, Souvannasacd E, Renger R. Validating the LUCAS(R) mechanical chest compression fit specifications. Am J Emerg Med. 2019 Feb;37(2):371-373. doi: 10.1016/j.ajem.2018.06.069. Epub 2018 Jun 30. No abstract available.
citation: Bonnes JL, Brouwer MA, Navarese EP, Verhaert DV, Verheugt FW, Smeets JL, de Boer MJ. Manual Cardiopulmonary Resuscitation Versus CPR Including a Mechanical Chest Compression Device in Out-of-Hospital Cardiac Arrest: A Comprehensive Meta-analysis From Randomized and Observational Studies. Ann Emerg Med. 2016 Mar;67(3):349-360.e3. doi: 10.1016/j.annemergmed.2015.09.023. Epub 2015 Nov 19.
citation: Gates S, Quinn T, Deakin CD, Blair L, Couper K, Perkins GD. Mechanical chest compression for out of hospital cardiac arrest: Systematic review and meta-analysis. Resuscitation. 2015 Sep;94:91-7. doi: 10.1016/j.resuscitation.2015.07.002. Epub 2015 Jul 17.
Clinical trial NCT04161677: MIST3: Active Patient Safety Reporting
Official title: Mitigation Investigation for Spinal Manipulation Treatments (MIST) - Part 3: Continued Assessment & Feasibility of an Electronic Active Surveillance Reporting System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: Adverse event
Electronic reporting system
Chiropractic
Spinal manipulation
Lead sponsor: Parker University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of all patients at the Parker University Wellness clinic will be invited to participate in the study.

Brief summary: This study will seek to describe and understand adverse events (AE) severity ratings.

Detailed description: Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.

Eligibility criteria: Inclusion Criteria:

* Health patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Pre-screening questionnaire
timeFrame: 5-10 minute
measure: Post-survey
timeFrame: Immediately after visit
measure: follow-up questionnaire
timeFrame: 7-10 days after visit
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker University
state: Texas
Study officials:
References:
Clinical trial NCT02228577: Safety and Performance Study of the CyPass System Applier Model 241
Official title: A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma (OAG)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 172
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with OAG who underwent combination cataract/glaucoma surgery and received the CyPass Micro-Stent using the CyPass Applier Model 241

Brief summary: This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of OAG
2. CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation

Exclusion Criteria:

1. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
2. Prior incisional glaucoma surgery

Primary outcomes:
measure: Ocular adverse events in the study eye
timeFrame: Intraoperatively though the first 3 postoperative months
Secondary outcomes:
Other outcomes:
Locations:
city: Neubrandenburg
country: Germany
facility: Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum
Study officials:
References:
Clinical trial NCT00642577: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Official title: A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 214
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 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
* \>=1 measurable lesion;
* ECOG performance status of \<=1.

Exclusion Criteria:

* prior systemic therapy for advanced or metastatic disease;
* adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
* other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* clinically significant cardiovascular disease in past 6 months.

Primary outcomes:
measure: Progression-free survival.
timeFrame: 6 months
Secondary outcomes:
measure: Overall response rate, time to response, duration of response, overall survival.
timeFrame: Event driven
measure: AEs, laboratory tests
timeFrame: Throughout study
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Guangdong
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Qingdao
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Wuhan
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02562677: TNS for Treating Major Depressive Disorder in the Elderly
Official title: Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Elderly
Lead sponsor: Santa Casa Medical School
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.


Eligibility criteria: Inclusion Criteria:

1. patients between 65 and 99 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria:

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Primary outcomes:
measure: Hamilton Depressive Rating Scale version 17 items (HDRS-17)
timeFrame: Change from baseline in depressive symptoms at 2 weeks ]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
citation: Shiozawa P, Silva ME, Carvalho TC, Cordeiro Q, Brunoni AR, Fregni F. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. 2014 Jul;72(7):542-7. doi: 10.1590/0004-282x20140061.
Clinical trial NCT05869877: The PIV5Rights Safety and Quality Bundle
Official title: The PIV5Rights Safety and Quality Bundle
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Catheter Complications
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Vygon GmbH & Co. KG
First posted: 2023-05-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled trial evaluating a peripheral intravenous catheter (PIVC) inserting using a bundled approach. Will evaluate the for extended dwell time and less complications compared to a PIVC using a non-bundled approach
Primary purpose: OTHER

Brief summary: Purpose of this study is to see if a Peripheral Intravenous Catheter PIVC will last longer if inserted by a Registered Nurse (RN) who specializes in inserting PIVCs. Main question it aims to answer:

1. We believe that the use of the ultrasound, an RN who specializes in PIVC placement with the use of ultrasound and the use of best of class medical technology, may improve first stick success with PIVC insertion and the length of time the PIVC stays in place without showing any related complications

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent, patients will be randomized using Research Randomizer. At that time, the IV Therapist will insert a PIVC using standard of care medical equipment (control) or use ultrasound guidance, if needed, to insert a PIVC using the bundle with the best of class medical devices. Daily, a research RN will round, assess the site and take a picture. When therapy is complete or the PIVC malfunctions, the research RN will document the reason why the PIVC failed and that patient will no longer remain in the study.

Eligibility criteria: Inclusion Criteria:

* 18 years or older with not upper limit
* requires an IV for fluid and or medication administration
* able to read and write English and willing to complete written, informed consent

Exclusion Criteria:

* Unable to speak and read English
* Vulnerable populations such as minors (under age of 18)
* Incompetent or mentally challenged
* Prisoners
* Pregnant women or the unborn
* presented in the hospital prior to study start date

Primary outcomes:
measure: 1 PIVC Per Patient Stay
timeFrame: 1 year
Secondary outcomes:
measure: Dwell Time
timeFrame: 1 year
measure: Cost Impact
timeFrame: 1 year
measure: Outcome Analysis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hartford Hospital
name: Lee J Steere, ADN
role: PRINCIPAL_INVESTIGATOR
References: