louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04872582: Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study
Official title: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Nasopharyngeal Carcinoma
Chemotherapy Effect
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

Detailed description: To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
* Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
* Previously diagnosed WHO classification type II or III by histological pathology.
* At least one measurable lesion (according to RECIST1.1).
* Age between 18 and 70.
* Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
* Enough blood test.
* Participate voluntarily and sign the informed consent.

Exclusion Criteria:

* Previously diagnosed WHO classification type I by histological pathology.
* Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
* Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
* A history of interstitial pneumonia or other autoimmune diseases.
* Sever infection.
* Sever heart disease.
* HIV infection.
* Allogeneic organ transplantation
* Malignancy other than nasopharyngeal carcinoma.
* Pregnancy or breast feeding.
* Received other test drugs.

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 years
measure: progression-free survival (PFS)
timeFrame: 2 years
measure: duration of response (DOR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yanqun Xiang
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanqun Xiang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00744120: Lymphoma Follow-up
Official title: Lymphoma Follow-up Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2008-08-29
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, previously entered on NIH study who may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis

Brief summary: This follow-up protocol is designed to evaluate participants who have previously been lymphoma patients treated on approved clinical studies of the National Institutes of Health.

Detailed description: The intent of this protocol is to accrue up to 800 volunteers who are interested in participating in NIA research studies as part of follow-up for previous cancer treatment at NIH. Participants will be asked to answer questions regarding their general health status, diagnoses, and admissions to hospital, and to provide possible documentation. They may be asked to come to the NIA Clinical Research Unit at Harbor Hospital to participate in a follow-up evaluation. They will have the opportunity to obtain additional information about studies in which they may wish to participate and to discuss eligibility issues with NIA staff members. Any identified clinical problems in need of care will also be discussed. Volunteers may be referred, with their permission, to their private medical doctor for follow-up. They may be re-evaluated within a year for further follow-up.

The follow-up evaluation may include history and physical, blood and urine tests, questionnaire, MRI or CT.

Eligibility criteria: Inclusion Criteria:

* Previously treated on an approved NCI/NIH protocols
* Willing and able to provide informed consent for current NIA protocol
* Rare, unusual, interesting or unknown condition that requires diagnosis

Exclusion Criteria:

* Does not meet the criteria of any previously-approved NIH Protocol.

Primary outcomes:
measure: Long-term survival following treatment for lymphoma
timeFrame: Annually
Secondary outcomes:
measure: Long-term toxicity possibly attributable to lymphoma or treatment for lymphoma
timeFrame: Annually
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: NIA Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Patricia L. Duffey, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927420: Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
Official title: Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
adherence
treatment
real life practice
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings

Brief summary: The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bipolar disorder I or II DSM-IV
* Patients treated with at least one oral antipsychotic
* Subjects able to read and write

Exclusion Criteria:

* Patients participating in clinical trials

Primary outcomes:
measure: Morisky-Green Scale
timeFrame: Once, at the visit moment
measure: Drug Attitude Inventory Scale (DAI-10)
timeFrame: Once, at the visit moment
Secondary outcomes:
measure: Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M)
timeFrame: Once, at the visit moment
measure: Functioning Assessment Short Test (FAST)
timeFrame: Once, at the visit moment
Other outcomes:
Locations:
city: Langreo
country: Spain
facility: Research Site
state: Asturias
city: Las Palmas
country: Spain
facility: Research Site
state: Gran Canarias
city: Calahorra
country: Spain
facility: Research Site
state: La Rioja
city: La Laguna
country: Spain
facility: Research Site
state: Tenerife
city: Alicante
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Elche
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Lerida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Orense
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca Spain EpidemiologyValue Demonstration Unit
name: Elisa Gil
role: STUDY_DIRECTOR
References:
Clinical trial NCT01279720: Gene Therapy ADA Deficiency
Official title: Phase I Gene Therapy Protocol for Adenosine Deaminase Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adenosine Deaminase Deficiency
Keywords: Adenosine deaminase deficiency
Gene therapy
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 8
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adenosine deaminase deficiency is an inherited disorder that results in severe abnormalities of the immune system and leaves children unable to fight infection. This trial aims to treat adenosine deaminase deficiency patients using gene therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients who lack a human leukocyte antigen (HLA)-genotypically identical bone marrow donor OR phenotypically matched family or unrelated donor AND who show incomplete immune reconstitution on Polyethylene glycol-modified adenosine deaminase (PEG-ADA) enzyme replacement therapy (defined by absolute CD4+ count \<300 cell/mm3 and who remain on immunoglobulin replacement therapy)
2. Diagnosis of ADA-SCID (Severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA)confirmed by DNA sequencing OR by confirmed absence of \<3% of ADA enzymatic activity in peripheral blood or (for neonates) in umbilical cord blood erythrocytes and/or leukocytes or in cultured fetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of PEG-ADA replacement therapy
3. Parental/guardian/patient signed informed consent

Primary outcomes:
measure: Immunological reconstitution
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: 5 years
measure: Molecular characterisation of gene transfer
timeFrame: 5 years
measure: Normalisation of nutritional status, growth, and development
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust
Study officials:
References:
citation: Aiuti A, Slavin S, Aker M, Ficara F, Deola S, Mortellaro A, Morecki S, Andolfi G, Tabucchi A, Carlucci F, Marinello E, Cattaneo F, Vai S, Servida P, Miniero R, Roncarolo MG, Bordignon C. Correction of ADA-SCID by stem cell gene therapy combined with nonmyeloablative conditioning. Science. 2002 Jun 28;296(5577):2410-3. doi: 10.1126/science.1070104.
citation: Hoogerbrugge PM, van Beusechem VW, Fischer A, Debree M, le Deist F, Perignon JL, Morgan G, Gaspar B, Fairbanks LD, Skeoch CH, Moseley A, Harvey M, Levinsky RJ, Valerio D. Bone marrow gene transfer in three patients with adenosine deaminase deficiency. Gene Ther. 1996 Feb;3(2):179-83.
citation: Hershfield MS. PEG-ADA: an alternative to haploidentical bone marrow transplantation and an adjunct to gene therapy for adenosine deaminase deficiency. Hum Mutat. 1995;5(2):107-12. doi: 10.1002/humu.1380050202.
Clinical trial NCT03957720: The Individual Therapy for Patients With Wilson's Disease
Official title: The Individual Therapy for Patients With Wilson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Wilson's Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Based on the genotype characteristics and genotype-phenotype-treatment prognosis data of Chinese WD patients, this study intends to further optimize the treatment regimen of Chinese WD patients and formulate individualized treatment regimens for each genotype, so as to further improve the prognosis of patients.

Detailed description: The purpose of the study is to evaluate treatment regimen efficacy based on different mutations, and Zinc treatment in presymptomatic WD patients.

Eligibility criteria: Inclusion Criteria:

* Genetic diagnosis of Wilson's disease
* Presymptomatic patients with Wilson's disease

Exclusion Criteria:

* Movement disorder due to other definite causes instead of Wilson's disease
* Severe Lung, kidney or liver disease
* Neoplastic Disease

Primary outcomes:
measure: Serum ceruloplasmin
timeFrame: Five years
measure: 24-hour urine copper
timeFrame: Five years
measure: serum copper
timeFrame: Five years
measure: White blood cell
timeFrame: Five years
measure: Platelet count
timeFrame: Five years
measure: urine protein level
timeFrame: Five years
measure: Alanine transaminase
timeFrame: Five years
measure: blood creatinine
timeFrame: Five years
measure: international normalized ratio
timeFrame: Five years
measure: hepatic fibrosis markers test
timeFrame: Five years
measure: bone mineral density test
timeFrame: Five years
measure: Abdominal ultrasound
timeFrame: Five years
measure: Urinary ultrasound
timeFrame: Five years
measure: Cranial MRI scan
timeFrame: Five years
measure: Unified Wilson's disease rating scale
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: econd Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Zhi-Ying Wu, MD&PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650020: The Impact of Synchronous Online Learning on the Theoretical Training of New Paediatric Nurses
Official title: The Impact of Synchronous Online Learning on the Theoretical Training of New Paediatric Nurses: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Keywords: Synchronous online learning
Randomized controlled trial
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To examine the impact of synchronous online learning on the effectiveness of theoretical training and self-efficacy among newly graduated pediatric nurses.We carried out a Prospective randomized controlled trial.The sample comprised 45 newly graduated pediatric nurses randomly assigned to an experimental cohort group or a cohort group.The control group underwent traditional face-to-face teaching, whereas the experimental group engaged in synchronous online learning.Comparative analysis encompassed the test score from post-session 10-minute assessments, evaluations conducted after one week, and those after one month, alongside their academic self-efficacy scores.

Detailed description: Aims To examine the impact of synchronous online learning on the effectiveness of theoretical training and self-efficacy among newly graduated pediatric nurses.

Design Prospective randomized controlled trial. Methods The sample comprised 45 newly graduated pediatric nurses randomly assigned to an experimental cohort group or a cohort group.The control group underwent traditional face-to-face teaching, whereas the experimental group engaged in synchronous online learning.Comparative analysis encompassed the test score from post-session 10-minute assessments, evaluations conducted after one week, and those after one month, alongside their academic self-efficacy scores.

Eligibility criteria: Inclusion Criteria:

1. Novice pediatric nurses
2. Continued engagement in full-time nursing studies;
3. Successful completion of pre-employment training evaluation at the hospital.

Exclusion Criteria:

1. Inability to complete all specified training modules;
2. Unwillingness to participate in the study.

Primary outcomes:
measure: Theoretical Evaluation Scores
timeFrame: The assessment occurred across multiple stages: the pre-class test, the 10-minute post-class test, one week, and one month.
Secondary outcomes:
measure: Scores of Academic Self-efficacy
timeFrame: one month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaojing Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965120: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
Official title: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Diseases
Keywords: Ischaemia reperfusion
Bradykinin
Platelet activation
Endothelial function
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: University of Oxford
First posted: 2009-08-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility criteria: Inclusion Criteria:

* healthy males between 18-65 years of ages
* non-smokers

Exclusion Criteria:

* any concurrent illness or chronic medical condition
* concurrent use of vasoactive medication
* smoking history

Primary outcomes:
measure: Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion
timeFrame: 20 fixed timepoints during each study visit (3hrs)
Secondary outcomes:
measure: Change in platelet-monocyte-binding after ischaemia reperfusion
timeFrame: 4 fixed timepoints during each study visit (3hrs)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh, 49 Little France Crescent
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD, FRCP
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Rajesh K Kharbanda, PhD, FRCP
role: STUDY_DIRECTOR
References:
citation: Pedersen CM, Schmidt MR, Barnes G, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Bradykinin does not mediate remote ischaemic preconditioning or ischaemia-reperfusion injury in vivo in man. Heart. 2011 Nov;97(22):1857-61. doi: 10.1136/heartjnl-2011-300323. Epub 2011 Aug 26.
Clinical trial NCT06928220: The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit
Official title: A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Anastomosis; Complications
Ileus Paralytic
Keywords: bladder Cancer
Cystectomy
hand sewn anastamosis
stapled anastamosis
intestinal complications
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 120
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: Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.

Detailed description: Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.

At Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.

Currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique

Eligibility criteria: Inclusion Criteria:

* Patient who consents to participate and signs the informed consent.
* Patient candidate for radical open cystectomy and ileal conduit.

Exclusion Criteria:

* Patient who is unable to complete the study questionnaires.
* Patient who has a life expectancy of less than 1 year.
* Candidate patients for other urinary diversions other than ileal conduit as a first option
* Candidate patients for laparoscopic or robotic cystectomy..

Primary outcomes:
measure: Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the predictive factors of postoperative complications.
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Puigvert
Study officials:
References: