louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01585376: Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma
Official title: Study Recurrency Testing of Mutations Identified in WGS of Pediatric Rhabdomyosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-25
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with rhabdomyosarcoma

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions.
* To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma.

OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of particular genetic lesions
measure: Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Alberto S. Pappo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03539276: An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia
Official title: The OptimaMed Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia: Results From a Quasi-experimental Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Inappropriate Prescribing
Keywords: quality improvement
long term care
polypharmacy
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: McGill University
name: Université de Montréal
name: Université de Sherbrooke
name: Fonds de la Recherche en Santé du Québec
First posted: 2018-05-29
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre-post study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia

Detailed description: A quasi-experimental study in three long-term care facilities. The intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents

Eligibility criteria: Inclusion Criteria:

* diagnosis of dementia of any etiology
* severe dementia

Exclusion Criteria:

* admission less than 2 months before intervention

Primary outcomes:
measure: Medication regimen
timeFrame: Four months post intervention
Secondary outcomes:
measure: Level of pain
timeFrame: Four months post intervention
measure: Level of agitation
timeFrame: Four months post intervention
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
Study officials:
affiliation: Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
name: Edeltraut Kröger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroger E, Wilchesky M, Marcotte M, Voyer P, Morin M, Champoux N, Monette J, Aubin M, Durand PJ, Verreault R, Arcand M. Medication Use Among Nursing Home Residents With Severe Dementia: Identifying Categories of Appropriateness and Elements of a Successful Intervention. J Am Med Dir Assoc. 2015 Jul 1;16(7):629.e1-17. doi: 10.1016/j.jamda.2015.04.002. Epub 2015 May 13.
Clinical trial NCT01598376: A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
Official title: A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Eyelid Entropion
Keywords: entropion
suture
granuloma
tissue reaction
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Objective

To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response.

Design

A prospective, double blind, randomized clinical trial using a novel ethical study design. Both the patient and clinician analyzing the histology were blinded to the suture gauge used.

Participants

A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study.

Intervention

Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. After 28 days, entropion correction was achieved by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture.

Main outcome measure

Defined histological parameters of suture-related granulomas were measured at multiple levels. Data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients
* Involutional lower eyelid entropion
* Horizontal eyelid laxity associated
* Informed consent

Exclusion Criteria:

* Inability to provide informed consent
* Previous eyelid surgery
* Poorly controlled diabetes
* Oral steroid use
* Addisons disease

Primary outcomes:
measure: Suture associated granuloma outer diameter
timeFrame: 28 days
measure: Suture associated granuloma central cellular element diameter
timeFrame: 28 days
measure: Suture associated granuloma fibrous coat area
timeFrame: 28 days
measure: Suture associated granuloma giant cell number
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: Royal Bournemouth Hospital
name: Ben Parkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587376: Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)
Official title: Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-16
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

Detailed description: This is an exploratory Phase 0 study in participants who previously participated in studies (54861911ALZ2002 \[NCT02260674\], 54861911ALZ2003 \[NCT02569398\], or 54861911ALZ2004 \[NCT02406027\]) with atabecestat. In this study, participants will only have blood drawn. The primary hypotheses for this study is that adverse event of elevated liver enzymes observed in some participants is caused by a T-cell dependent inflammatory response. Participants will be monitored for adverse events and will be called 1 day after the blood draw to assess for any adverse events.

Eligibility criteria: Inclusion Criteria:

* Participant who received and discontinued atabecestat in one of the following prior trials (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Willing and able to adhere to the prohibitions and restrictions specified for this study

Exclusion Criteria:

* Anemic based on the last blood draw in the prior atabecestat trial
* Donated more than (\>) 450 milliliter (mL) of blood in the past 3 months
* Currently participating in an atabecestat study (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)

Primary outcomes:
measure: Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response
timeFrame: Day 1
Secondary outcomes:
measure: Participants T-cell Receptor (TCR) Sequencing
timeFrame: Day 1
Other outcomes:
Locations:
city: Hoboken
country: Belgium
facility: Ziekenhuis Hoge Beuken
city: Paris
country: France
facility: Hôpital Fernand Widal
city: Hamburg
country: Germany
facility: CTC North GmbH & Co. KG
city: Barcelona
country: Spain
facility: Fundacion Ace
city: Stockholm
country: Sweden
facility: Minnesmottagningen, M51
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03284476: Post Surgically Treated Peritonitis Complications
Official title: A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Peritonitis
Keywords: Nosocomial Peritonitis
Community-acquired Peritonitis
Post-operative Peritonitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for peritonitis surgically treated

Brief summary: The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis.

Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed description: Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Eligibility criteria: Inclusion Criteria:

* Nosocomial surgically treated Peritonitis
* Or Community-Acquired surgically treated Peritonitis
* Or Post-operative surgically treated Peritonitis

Exclusion Criteria:

* Consent withdrawal

Primary outcomes:
measure: In ICU stay main complications
timeFrame: Within the first 28 days after ICU admission date
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: In ICU (up to 90 days)
measure: ICU length of stay
timeFrame: In ICU (up to 90 days)
Other outcomes:
measure: Death
timeFrame: In ICU (up to 90 days)
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Non Affiliated
name: Karim Asehnoune, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00705276: Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III;
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation;
* Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History or photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: 5 weeks
measure: The sensibility will be evaluated according the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03864276: The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Official title: The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
Primary purpose: OTHER

Brief summary: Prolonged corrected QT interval (QTc) has been observed in about half of patients with liver cirrhosis. Marked prolongation of QTc (ie, 500 msec) has been considered to be a risk factor for fatal ventricular arrhythmia, such as torsade de pointes,7,8 which has been reported in liver transplantation (LT) surgery. In a previous study, prolonged QTc interval ( 500 msec) was frequently observed throughout the procedure of LT, even among patients with baseline QTc 440 msec. Therefore, it is important to optimize electrolyte balance and hemodynamic status to reduce greater risk of perioperative arrhythmias.

The investigators hypothesized that the change of QTc interval might be differ according to method of general anesthesia (inhalation agent vs. intravenous agent).


Eligibility criteria: Inclusion Criteria:

* patients with liver cirrhosis who will undergo planned liver transplantation

Exclusion Criteria:

* 1. emergent liver transplantation
* 2. unstable angina
* 3. recent MI(Myocardial Infarction)
* 4. uncontrolled hypertension (diastolic BP \> 110mmHg)
* 5. implantable cardiac defibrillator
* 6. severe obesity (BMI\>30kg/m2)
* 7. allergy to propofol

Primary outcomes:
measure: QTc interval
timeFrame: 3 minutes after liver reperfusion
Secondary outcomes:
measure: QTc interval
timeFrame: at the end of the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05766176: Study of the Effectiveness of The COVID-19 Vaccine
Official title: Study of the Effectiveness of The COVID-19 Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19 Vaccine, Health Worker
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Health worker in Universitas Sebelas Maret Hospital, Surakarta, Indonesia

Brief summary: This descriptive study examines neutralizing antibody levels against COVID-19 in health workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia.

Detailed description: This research is a cross-sectional study with a descriptive-analytic design, community-based, of adults who live in Surakarta (age 18 years and over) using the Google form. The inclusion criteria were health workers receiving the third or second dose of the COVID-19 vaccine. Quantitative antibody titers are checked at Prodia's laboratory. Other variables examined were the number and date of vaccination, age, sex, comorbid diseases, body mass index, AEFI symptoms after the vaccine, and history of being infected with COVID-19. In the statistical analysis using the different and regression correlation tests, the significance level of P is less than 0.05.

Eligibility criteria: Inclusion Criteria:

* Health workers who receive the second booster of COVID-19 vaccination

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: quantitative anti-sars-cov-2 titers
timeFrame: Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after
Secondary outcomes:
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: Universitas Sebelas Maret Hospital
state: Central Java
Study officials:
affiliation: Universitas Sebelas Maret
name: Nurhasan Agung Prabowo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
citation: Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
Clinical trial NCT05656976: Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women
Official title: Efficacy of Offering a Self-sampling Device by the General Practitioner to Reach Women Underscreened in the Routine Cervical Cancer Screening Program Compared to Sending Reminder Letters by the Screening Organization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Prevention
Screening
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
name: Sciensano
name: Centrum voor Kankeropsporing
name: Belgian Cancer Registry
name: KU Leuven
name: Vrije Universiteit Brussel
name: Universiteit Antwerpen
First posted: 2022-12-20
Enrollment: 3375
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT)
Primary purpose: SCREENING

Brief summary: The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 65 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".


Eligibility criteria: Inclusion Criteria:

* women between 31-64 years old
* living in Flanders
* eligible for the Flemish actions with regard to population screening
* without a smear registered in the Belgian Cancer Registry in the last 6 years
* registered as GMD patient in one of the participating GP practices

Exclusion Criteria:

* hysterectomy
* pregnancy
* (past) diagnosis of cervical cancer

Primary outcomes:
measure: Response rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Participation rate
timeFrame: Up to 9 months
measure: Cost-effectiveness analysis
timeFrame: Up to 15 months
measure: Feasibility analysis (semi-structured interviews with GP's)
timeFrame: Up to 4 months after the intervention in their practice
measure: Response rate (follow-up cytology test)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Kaatje Van Roy
role: PRINCIPAL_INVESTIGATOR
References: