louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06333236: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
Official title: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: ASST Santi Paolo e Carlo
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.

Detailed description: Prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution Kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression.

Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms:

1. Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)
2. Control group (CG): 10 patients will be evaluated as control

Once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. The following examinations will be done in the following sequence:

* Visual acuity
* Slit lamp evaluation
* PERG
* PEV pattern
* Tonometry
* Visual field
* Optical Coherence Tomography
* Dilated Fundus examination

Eligibility criteria: Inclusion Criteria:

* glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression
* controlled intraocular pressure
* at least 3 previous visual field examinations.

Exclusion Criteria:

* angle closure glaucoma and secondary open angle glaucoma
* refractive error outside +2D and -6D
* ophthalmic surgery 6 months before the recruitment
* presence of cataract or other conditions that could affect results of perimetry or electroretinography
* treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months
* presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.

Primary outcomes:
measure: Electrofunctional evaluation
timeFrame: 3 months
Secondary outcomes:
measure: VF and SD-OCT
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01857336: G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation
Official title: Infusion of Recombinant Human Granulocyte Colony Stimulating Factor Mobilized Peripheral Harvest for Poor Engraftment After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Graft Function
Stem Cell Transplantation
Graft Versus Host Disease
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.

Detailed description: Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study.The peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor. Hematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil \> 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.

Eligibility criteria: Inclusion Criteria:

* patients received allogeneic stem cell transplantation;diagnosis of PGF after HSCT; without concurent GVHD,RELAPSE of underlying disease.

Exclusion Criteria:

* age\<14 years;active GVHD;relapse of underlying disease

Primary outcomes:
measure: hematological response
timeFrame: 30 days after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
References:
Clinical trial NCT05258136: Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of PTLD in Patients With EBV-HLH/CAEBV
Official title: Clinical Study on the Efficacy and Safety of Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of Lymphoproliferative Diseases After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With EBV-HLH/CAEBV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTLD
CAEBV
HLH
Keywords: preemptive therapy, CD20 monoclonal antibody
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 20
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical study on the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV

Detailed description: Purpose: To comprehend the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV Study subjects: PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) \> 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists \> 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.

Therapeutic regimen: CD20 monoclonal antibody injection 100 mg/m2 was intravenously infused once a week. It can be discontinued after EBV-DNA negative for 2 consecutive times. Total dose≤ 4 applications per patient

Eligibility criteria: Inclusion Criteria:

* PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) \> 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists \> 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.

Exclusion Criteria:

* Patients with active infection except for EBV; Active hepatitis B or C (positive HBV-DNA or HCV-RNA) ; Known life-threatening allergic reactions to CD20 Monoclonal Antibody Injection or its preparation ingredients; Participate in other clinical studies.

Primary outcomes:
measure: EBV-DNA
timeFrame: 4 weeks
measure: PTLD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Yan Cui
role: STUDY_DIRECTOR
References:
Clinical trial NCT03487536: Nutritional Prognostic Factors in ALS
Official title: Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Deficiency
Neuro-Degenerative Disease
Gastrostomy
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included 47 consecutive patients referring to the Neurological ALS Tertiary Centre, Department of Basic Medical Sciences, Neurosciences and Sense Organs, who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit, Department of Emergency and Organ Transplantation, of the same University Hospital. All patients fulfilled revised El Escorial criteria for probable or definite classical ALS.

Brief summary: Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease \[body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels\], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

Detailed description: Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

Eligibility criteria: Inclusion Criteria:

* ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

Exclusion Criteria:

* ALS patients without PEG

Primary outcomes:
measure: nutritional assessment
timeFrame: at the time of PEG placement (one day)
measure: biochemical nutritional assessment
timeFrame: only at the time of PEG placement (one day)
Secondary outcomes:
measure: body composition assessment
timeFrame: within 2 months from the PEG implantation (one day)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinic Hospital
Study officials:
affiliation: University of Bari
name: Michele Barone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00416936: Bacterial Contamination of Anaesthetists' Hands by Personal Mobile Phones Used in the Operating Theatre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental Microbiology
Equipment Contamination
Personnel, Hospital
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2006-12-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The use of mobile phones in the operating room (OR) has become widespread, because of the lack of reports on serious problems. Since mobile phones are used in close body contact and since, as for most non-medical electronic equipment, there are no cleaning guidelines that meet hospital standards, the hygiene risk involved in using mobile phones in the OR has not yet been determined.


Eligibility criteria: Inclusion Criteria:

* Anaesthetist working in the OR

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
Study officials:
affiliation: Medical University Innsbruck
name: Arnulf Benzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Innsbruck
name: Arnulf Benzer, MD
role: STUDY_DIRECTOR
References:
citation: Klein AA, Djaiani GN. Mobile phones in the hospital--past, present and future. Anaesthesia. 2003 Apr;58(4):353-7. doi: 10.1046/j.1365-2044.2003.03079.x.
citation: Soto RG, Chu LF, Goldman JM, Rampil IJ, Ruskin KJ. Communication in critical care environments: mobile telephones improve patient care. Anesth Analg. 2006 Feb;102(2):535-41. doi: 10.1213/01.ane.0000194506.79408.79.
citation: Smith MA, Mathewson JJ, Ulert IA, Scerpella EG, Ericsson CD. Contaminated stethoscopes revisited. Arch Intern Med. 1996 Jan 8;156(1):82-4.
Clinical trial NCT06545136: Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)
Official title: A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT201) in Subjects With Gaucher Disease (GALILEO-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gaucher Disease, Type 1
Lead sponsor: Spur Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, long-term, follow-up trial of participants with Gaucher disease type 1 who received FLT201 treatment in a preceding clinical trial. Participants will be followed for 5 years post-treatment.


Eligibility criteria: Inclusion Criteria:

* 1. Participants who have previously received FLT201 (including those who may have required recommencement or initiation of ERT/substrate reduction therapy \[SRT\]).
* 2. Participants able to give full informed consent and able to comply with all requirements of the trial.

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) (including DLTs)
timeFrame: Week 38 to Month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Lysosomal Rare Disorders Research and Treatment Center
state: Virginia
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA)
city: Zaragoza
country: Spain
facility: Hospital Quironsalud Zaragoza
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
References:
Clinical trial NCT03171636: Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients
Official title: Analysis of the Types and Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients at Erasto Gaertner Hospital, Curitiba, Brazil.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
KRAS Gene Mutation
EGFR Gene Mutation
Lead sponsor: Hospital Erasto Gaertner
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2017-05-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From 237 patients with NSCLC treated at Erasto Gaertner Cancer Hospital, the largest reference cancer hospital in the Southern Brazil, from January 2005 to January 2017, we could select 130 FFPE specimens stored at the Pathology Department.

Brief summary: The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed description: Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility criteria: Inclusion Criteria:

* Brazilian patients with metastatic non-small cell lung cancer.

Exclusion Criteria:

* Small cell lung cancer and non-metastatic patients.

Primary outcomes:
measure: EGRF mutation status
timeFrame: 3 years
measure: KRAS mutation status
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Parana
Study officials:
affiliation: Liga Paranaense de Combate ao Cancer
name: Thais A Almeida, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02686918: Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse
Official title: Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse - TIPA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.


Eligibility criteria: Inclusion Criteria:

* Patient care at the Cancer Institute Lucien Neuwirth
* Patient aged over 18 years
* Patient with breast cancer overexpressing HER2 adjuvant
* Patient having finished their chemotherapy treatment with IV followed the oncologist day hospital
* Patient under Trastzumab subcutaneously
* Patient affiliated or entitled to a social security scheme (mandatory requirement for all studies)

Exclusion Criteria:

* Refusal to participate, most patient protected under guardianship.
* Patient in inability to understand the course of the study
* Patient with documented history of cognitive or psychiatric disorders.
* Patients pregnant or lactating
* Patients under guardianship or curatorship

Primary outcomes:
measure: Percentage of consultation requiring a medical advice between IPA and oncologist
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of consultations delegated to the IPA
timeFrame: 1 year
measure: Physician satisfaction questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01925118: Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2
Official title: Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Malignant Melanoma and Renal Cell Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignant melanoma or renal cell carcinoma
* At stage IV or relapse
* At least one prior chemotherapy including targeted agents
* At least one haploidential or partially matched-HLA donor
* ECOG performance status 0-1
* Age 18-75 years
* Measurable lesion
* Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

* Chemotherapy within 4 weeks
* Stem cell transplantation
* Active CNS metastasis
* Hypersensitivity to IL-2

Primary outcomes:
measure: 12-week modified immune-related response rate
timeFrame: 12-week
Secondary outcomes:
measure: 6-week modified immune-related response rate
timeFrame: 6-week
measure: Overall response rate based on RECIST v1.1
timeFrame: 6/12-week
measure: Progression-free survival
timeFrame: 6-month
measure: Overall survival
timeFrame: 1-year
measure: Immune-related adverse events
timeFrame: 12-week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: