louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03743727: Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir
Official title: The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C Genotype 4
Lead sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.


Eligibility criteria: Inclusion Criteria:

* HCV chronic infection
* Treatment naive and treatment experienced (previous interferon treatment)
* No cirrhosis or compensated cirrhosis

Exclusion Criteria:

* Co-infection with Hepatitis B (HBV)
* Other associated chronic liver illness
* Patients with history of hematemesis (non-cirrhotic portal hypertension)
* Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
* Patients on drugs known to interact unfavorably (Amioidarone, ..)

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: During the 12 weeks of treatment.
measure: Sustained Viral Clearance
timeFrame: At Week 12 after end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Nasr City
country: Egypt
facility: Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
state: Cairo
Study officials:
affiliation: Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
name: Tawhida Y. Abdel Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00791427: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Official title: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Retina Center, Minnesota
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will have AMD with choroidal neovascularization and above age 55 years.

Brief summary: This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>55 years
* Patients to be included in the study must have AMD with choroidal neovascularization
* BCVA between 20/20 - 20/400
* Lesion size less than or equal to 12 MPS disc areas

Exclusion Criteria:

* Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
* Pregnancy (positive pregnancy test)
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Media insufficient to obtain a view
* Other causes of CNV not related to AMD
* Active ocular or peri-ocular infection
* Ocular surgery within 1 month prior to the study

Primary outcomes:
measure: ERG/EOG
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: The Retina Center
state: Minnesota
Study officials:
References:
Clinical trial NCT06168227: A Multicenter and Real-world Analysis of RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer
Official title: A Multicenter and Real-world Analysis of Clinical Outcomes and Safety of the Novel Recombinant Humanized Anti-HER2 Therapeutic Antibody RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: HER2-positive
HER2-low
ADC
RC48
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer were eligible and received RC48 2.5 mg/kg every two weeks alone or combined with drugs with different anti-tumor mechanisms, such as immune checkpoint inhibitors (ICIs), tyrosine kinase inhibitors (TKIs) and antiangiogenic compounds.

Brief summary: Evaluate the efficacy and safety of Disitamb Vedotin in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer

Detailed description: The main goal of this clinical trial is to examinie the utilization of RC48 in different HER2 statuses, elucidating its clinical outcomes and safety, and investigating the factors that influence its clinical efficacy. The primary endpoint was the objective response rate (ORR) assessed by the primary researcher. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), time to progression, and safety.

Eligibility criteria: Inclusion Criteria:

1. histopathologically or imaging-confirmedlocally advanced or metastatic breast cancer ;
2. HER2-positive or low status;
3. the function of major organswas normal, no treatmentcontraindications , andthe estimated survival time was more than 2 months;
4. at least one extracranialmeasurable lesion or osteolytic or mixed bone metastases inaccordance with the Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1);
5. the clinical data were complete and traceable.

Exclusion Criteria:

1. age \<18 ye ars old;
2. other concurrent cancers;
3. patients who rece ived RC48 as a neoadjuvant or adjuvant regimen；
4. Incomplete medical data.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05150327: Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Official title: Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Keywords: Fungal Infection
Immunodeficiency
Fungal filamentous
Liver transplant
Organ transplant
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
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 liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021

Brief summary: Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections


Eligibility criteria: Inclusion Criteria

* Age: from birth
* Subject with a liver transplant in one of the centers participating in the study
* Invasive fungal infection with filamentous fungus between 2007-2021
* Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:

  * Invasive aspergillosis
  * Mucormycosis
  * Fusariosis
  * Scedosporiosis
  * Other infection with filamentous fungus
* Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria

* Subject or (legal representative for minors) who has expressed his opposition to participating in the study
* Subject not with a liver transplant
* Subject under guardianship, curatorship or legal protection

Primary outcomes:
measure: Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients.
timeFrame: Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg
name: François DANION, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04279327: Cell Block Immunohistochemistry in Effusion Cytology
Official title: Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effusion Pleural
Ascites
Pericardial Effusion
Keywords: immunohistochemistry
cytology
moc 31 monoclonal antibody, human
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all cases that have serous effusion of undiagnosed underlying aetiology.

Brief summary: Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.

Detailed description: This is a prospective study that will be conducted at the pathology lab of Assiut University Hospital. The study will include effusion specimens (pleural, peritoneal \& pericardial) and the aspirated fluid will be examined for physical characters e.g. color and appearance.

The sample will be divided into 2 equal parts: one for conventional smear preparation, and the other for cell block. A minimum of 2 thin smears will be prepared and stained with Papanicolou stain.

Cell block sections of 4-6 μ thickness will be prepared and stained with the hematoxylin and eosin stain (H\&E).

For immunohistochemistry, cell blocks will be used. Expression of claudin 4, EZH2, and MOC-31 will be evaluated in benign and malignant cells by using immunoperoxidase technique.

Eligibility criteria: Inclusion Criteria:

* all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.

Exclusion Criteria:

* No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.

Primary outcomes:
measure: Diagnostic performance of EZH2
timeFrame: within 48 hours
measure: Diagnostic performance of claudin4
timeFrame: within 48 hours
measure: Diagnostic performance of MOC-31
timeFrame: within 48 hours
Secondary outcomes:
measure: Prevalence of malignancy among cases presenting with effusion
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Aliaa EM Mahmoud, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundling KE, Cibas ES. Ancillary studies in pleural, pericardial, and peritoneal effusion cytology. Cancer Cytopathol. 2018 Aug;126 Suppl 8:590-598. doi: 10.1002/cncy.22021.
Clinical trial NCT06855927: The Effect of Guided Imagery on Activity-Specific Balance Confidence, Pain, and Psychological Well-Being
Official title: The Effect of Guided Imagery on Activity-Specific Balance Confidence, Pain, and Psychological Well-Being in Elderly Orthopedic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Guided Imagery
Keywords: Orthopedics
Guided Imagery
pain
Psychological Well-Being
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this clinical trial is to evaluate the effect of guided imagery on activity-specific balance confidence, pain, and psychological well-being in elderly orthopedic patients. In the study, guided imagery will be applied by the researchers and will be applied over 2 days for a total of 3 repetitions. The study will be conducted in the postoperative period of the patients.


Eligibility criteria: Inclusion Criteria:

* Patients who are open to communication and collaboration,
* Those who are over 65 years old,
* Those who have a mini-mental test score of 24 and above,
* Those who have the same type of analgesic protocol,
* Those who have a numerical pain score of at least 4 will be included.

Exclusion Criteria:

* Patients who have developed any complications,
* Patients who have hearing, vision and perception problems,
* Patients who have been diagnosed with any psychiatric disease,
* Patients who have developed any complications after surgery will be excluded.

Primary outcomes:
measure: Guided imagery applied to elderly orthopedic patients increases activity-specific balance confidence.
timeFrame: 100 minutes
measure: Guided imagery applied to elderly orthopedic patients reduces pain levels.
timeFrame: 100 minutes
measure: Guided imagery applied to elderly orthopedic patients increases psychological well-being.
timeFrame: 100 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Osmaniye Korkut Ata University
name: Adile Bozkurt Tonguç, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02155127: Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
Official title: Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
physical function
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-04
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million individuals. Impairments in physical function and mobility limitations have been reported in older Chronic Kidney Disease patients, however the consequences of impaired functioning on participation in daily life and quality of life have not been studied. Early identification and interventions to mitigate deterioration in physical function and mobility should lead to improved health and quality of life outcomes in older patients with Chronic Kidney Disease. Although older individuals with Chronic Kidney Disease have reduced survival expectancy, maintaining physical function and mobility may contribute to longer active life expectancy, and higher quality of life despite their diagnosis.


Eligibility criteria: Inclusion Criteria:

* Male and female patients over the age of 60 years
* Diagnosed with moderate to severe CKD (stage 2-4)
* Ambulatory (with or without use of an assistive device such as a cane or walker)
* Living in the community, cognitively able to provide consent and understand directions for the tests
* Cognitive ability to understand and carry out an independent home walking program
* Access and ability to communicate with study staff on a weekly basis and available for follow-up testing.

Exclusion Criteria:

* Inability to carry out a program of walking independently at home
* Unavailable for follow-up testing, estimated GFR \>60 ml/minx1.73m2 and \< 15 ml/minx1.73 m2
* Recent cardiac event (within the past 6 months)
* Uncontrolled hypertension
* Uncontrolled diabetes
* Pulmonary disease that may limit the ability to progress with walking
* Progressive neuromuscular disease
* Any orthopedic or neuromuscular condition that may be exacerbated by increased walking activity
* diabetic foot ulcer.

Primary outcomes:
measure: walking speed
timeFrame: baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Patricia L Painter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05384327: Development and Validation of a Theoretical Test for Chest Tube Insertion
Official title: Development and Validation of a Theoretical Test for Chest Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tubes
Cognitive Skill
Keywords: Chest Tube
Assessment
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:

* The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
* The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.


Eligibility criteria: Inclusion Criteria:

* Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
* The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
* The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
* The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.

Exclusion Criteria:

* For the novice and intermediate group: having to much experience in CTI.

Primary outcomes:
measure: Validity evidence for the theoretical test
timeFrame: Participants are assessed once: the score of each participant is recorded immediately after completion of the test.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Wouter Willaert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05178927: UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
Official title: UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Breast Cancer Foundation
First posted: 2022-01-05
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.


Eligibility criteria: Inclusion Criteria:

* Targets adult patients who are planning to undergo photon or proton radiation therapy at UFHPTI for treatment of the breast or chest wall. As this type of treatment is rare in men, the study will focus on female patients only.

Exclusion Criteria:

* Male subjects

Primary outcomes:
measure: Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process.
timeFrame: The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Perry Johnson
role: PRINCIPAL_INVESTIGATOR
References: