louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06609304: Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Official title: Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lymphoma, B-Cell
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 20
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: The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are:

* Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?
* What medical problems do participants have when receiving axi-cel treatment?

In this investigator-initiated, single-arm clinical trial, participants will:

* Receive atezolizumab treatment at 2.0×10\^6 cells/Kg as a one-time therapy.
* Visit the clinic as instructed for checkups and tests.


Eligibility criteria: Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form;
2. 18-70 years of age (inclusive);
3. Previously untreated CD19-positive large B-cell lymphoma;
4. Anticipated survival ≥12 weeks;
5. Adequate bone marrow reserve prior to apheresis
6. Appropriate organ function:
7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;

9. Negative blood/urine pregnancy test in women of childbearing age.

Exclusion Criteria:

1. History of allergy to any of the components of the cell product;
2. History of stem cell transplantation;
3. History of organ transplantation;
4. Presence of active infections;
5. Current or history of central nervous system disorders;
6. Previous treatment with other modified T-cell therapy;
7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
8. Malignancies other than those indicated for this trial;
9. History of any prior systemic immune checkpoint therapy;
10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
11. History of a live vaccine within 3 months prior to screening;.

Primary outcomes:
measure: one year PFS
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University, Department of Oncology
state: Henan
Study officials:
References:
Clinical trial NCT04877704: Symprove (Probiotic) as an add-on to COVID-19 Management
Official title: The Effect of Symprove, a Multi-strain Probiotic, as an Adjuvant in the Management of COVID-19 in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The major impact of COVID-19 has been that the severity of respiratory symptoms require intensive hospital treatment. There is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation.

COVID-19 is a multi-systemic disease in which different mechanisms within the body are affected; including the 'Gut microbiome'. 'Gut microbiome' refers to the bacteria living in intestines. While some bacteria is harmful, many are extremely beneficial and necessary for a healthy body. Many patients have gastrointestinal symptoms and there is a major change in the gut micro flora (microbiome), which may have an adverse effect on the respiratory symptoms. The probiotic, Sivomix, was given to hospitalized COVID-19 patients was associated with a more rapid recovery in gastrointestinal symptoms on day 3 and 7, and an eight fold reduction in the requirement for mechanical ventilation in an open trial.

This is a randomized clinical trial, with a recruitment target of 60 patients admitted with COVID-19 symptoms to the general medical wards. Patients will be randomized to receive the probiotic, Symprove, or placebo in addition to their standard of care treatment. Patients will need take either probiotic/placebo daily for 3 months. All follow-up will be whilst they are an inpatient or as a telephone follow-up; they will not need to attend at the hospital to participate.

There is a biological sub-study incorporated into the protocol, but participation is optional. If patients consent to this, they will also need to provide blood, faecal and saliva samples at baseline, Day 7 and final visit (3 months after randomisation). Patients who consent to providing biological samples will need to visit the hospital at Day 7 and final visit.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients who are hospitalised with respiratory COVID-19
* Ability to give informed consent
* Aged 20-85

Exclusion Criteria:

* Patients not meeting the inclusion criteria that have COVID-19
* Inability to consent
* Pregnancy
* Severe pre-existing mental health disorders or addictions

Primary outcomes:
measure: Length of hospital stay
timeFrame: 12 months
Secondary outcomes:
measure: Clinical symptoms
timeFrame: 7 days
measure: Intestinal inflammation
timeFrame: 3 months
measure: Symptom recovery
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Liver Studies
Study officials:
References:
Clinical trial NCT05449704: Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with allergy or drug hypersensitivity
* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~72 hours post-dose
measure: Cmax
timeFrame: pre-dose~72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
Study officials:
References:
Clinical trial NCT00557804: Monitoring in Congestive Heart Failure Study
Official title: Multi-Sensor Monitoring in Congestive Heart Failure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Lead sponsor: Corventis, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care and heart failure clinics

Brief summary: This is a multi-center, non-randomized study designed to develop an external monitor for CHF patients.

Detailed description: Heart failure patients will be externally monitored. The collected information will be used to assess patient status.

Eligibility criteria: Inclusion Criteria:

18 years of age or older

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Corventis, Inc.
name: Imad Libbus, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00158704: Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
Official title: An Open-Label, Continued Access Study of Adefovir Dipivoxil for Patients With Chronic HBV Infection Who Have Completed a Gilead-Sponsored Study of Adefovir Dipivoxil.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatitis B
Keywords: Chronic Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.

Detailed description: The objective of this study is to provide adefovir dipivoxil 10 mg once daily to patients with chronic hepatitis B virus(HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil. The secondary objective of this study is to evaluate the safety of chronic therapy with adefovir dipivoxil 10 mg.

Eligibility criteria: Inclusion Criteria:

* Must have completed one of the following Gilead-sponsored studies as indicated: GS-96-412, GS-98-437, GS-98-438, GS-00-461 and GS-00-481. If the patient has participated in another Gilead-sponsored study, the CRO or Sponsor's Medical Monitor will evaluate for participation in this study on a case by case basis.

Exclusion Criteria:

* Any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements.
* Currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil.
* Currently receiving investigational agents with activity against hepatitis B virus.
* Hypersensitivity to any of the components of the drug product.
* Pregnant or lactating females.
* Inability to comply with study requirements.
* Experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.

Primary outcomes:
measure: To provide adefovir dipivoxil (ADV) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study and require continued access to ADV.
Secondary outcomes:
measure: To evaluate the safety of chronic therapy with ADV 10 mg.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03980301: Screening Hepatitis Positive Women for Congenital Anomalies
Official title: Screening Hepatitis Positive Women for Congenital Anomalies During Pregnancy and Assessment of Liver Status of Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2019-06-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with hepatitis C virus received treatment during first trimester

Brief summary: Hepatitis C virus is one of the virulent viruses

Detailed description: Hepatitius positive women should be screened for congenital anomalies

Eligibility criteria: Inclusion Criteria:

* Pregnant women with hepatitis C virus received treatment during first trimester

Exclusion Criteria:

* pregnant women with hepatitis C virus who didnot receive treatment during first trimester

Primary outcomes:
measure: the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: STUDY_CHAIR
References:
Clinical trial NCT03423901: Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation
Official title: Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: Complications
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.

Detailed description: The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).

Eligibility criteria: Inclusion Criteria:

* Patient receiving a KT and followed at least one year in Toulouse Hospital
* Patient who have signed informed consent
* \> 18 years old

Exclusion Criteria:

* Patient under protective measures
* Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers.
* Immunosuppressive treatments withdrawal - Patient in chronic dialysis
* Ongoing pregnancy or pregnancy in the past year
* Past of splenectomy

Primary outcomes:
measure: Gene expression related to antibody mediated rejection
timeFrame: 1 year posttransplantation
Secondary outcomes:
measure: description of T subsets cells
timeFrame: 1 to 5 years posttransplantation
measure: description of B subsets cells
timeFrame: 1 to 5 years posttransplantation
measure: description of lymphocytes rates
timeFrame: 1 to 5 years posttransplantation
measure: Evolution of creatinine clearance
timeFrame: 1 to 5 years posttransplantation
measure: Evolution of systematic annual kidney biopsies
timeFrame: 1 to 5 years posttransplantation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Arnaud DEL BELLO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812901: Tolerance of Myocardium to Ischemia Injury
Official title: Morning / Afternoon Variation in Myocardial Ischemia Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Injury
Myocardial Ischemia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 88
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: This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation
* Patient in sinus rhythm at the time of surgery
* Patient older than 18
* Patient able to understand the information and consent forms

Exclusion Criteria:

* Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug
* left ventricle ejection fraction \< 40%
* Pregnancy
* Patient in emergency condition

Primary outcomes:
measure: ischemia reperfusion injury in ex vivo conditions
timeFrame: the day of the myocardial biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: Lille University Hospital
name: David Montaigne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbalpha antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.
Clinical trial NCT04248101: Double Ligation and Topical Silver Nitrate
Official title: Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Umbilical Granuloma
Keywords: Double Ligation, Topical Silver Nitrate
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 176
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas

Detailed description: The patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly

Eligibility criteria: Inclusion Criteria:

1. Patients of Umbilical Granuloma, less than 1 year age

Exclusion Criteria:

1. Patients who already had any treatment
2. Parents refused to give consent for enrollment
3. Patients lost in follow up

Primary outcomes:
measure: Frequency of Success/Failure of treatment
timeFrame: 3 weeks
measure: Frequency of complications in both groups
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Paediatric Surgery
name: Nadeem Akhtar, MS Paediatric Surgery
role: STUDY_DIRECTOR
References:
Clinical trial NCT03715101: A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly
Official title: A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elderly
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 20
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects aged 65 - 85 years
* A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2.
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin
timeFrame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
measure: Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin
timeFrame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
measure: Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin
timeFrame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Secondary outcomes:
measure: lipid panel (low-density lipoprotein cholesterol in mg/dL)
timeFrame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
measure: lipid panel (high-density lipoprotein cholesterol in mg/dL)
timeFrame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
measure: lipid panel (Triglyceride in mg/dL)
timeFrame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
measure: lipid panel (Total cholesterol in units of mg/dL)
timeFrame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
measure: lipid metabolites
timeFrame: Day -1 0 hour, Day 21 0 hour
Other outcomes:
Locations:
Study officials:
affiliation: South Korea Seoul National University Bundang Hospital
name: Jae-Yong Chung
role: PRINCIPAL_INVESTIGATOR
References: