louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04991532: Dasatinib Down-regulates the Expression of PD-1 and Enhances Killing pH + Leukemia Stem Cells
Official title: Research on the Mechanism of Dasatinib Down-regulates the Expression of PD-1 in CMV-activated NKG2C+NK Cells and Enhances Killing pH + Leukemia Stem Cells.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CML-CP patients treated with TKIs

Brief summary: Research on the mechanism of dasatinib down-regulates the expression of PD-1 in CMV-activated NKG2C+NK cells and enhances killing pH + leukemia stem cells.

Detailed description: Some patients with CML can withdraw from TKIs after treatment, and the mechanism might be related to the effect of memory NK cells on anti-Ph+ leukemic stem cells (LSCs). Dasatinib affects immune through several pathways including the expression of PD1 in immune cells. Our previous work showed increased NKG2C+ NK cells were found in cases with CMV-DNA+ who suffered Ph+ leukemia and received Dasatinib, and these memory NK cells have anti-LSCs activity. We hypothesize that: CMV infection activates NKG2C+ memory NK cells proliferation; Dasatinib down-regulates the expression of PD1 in PD1+NKG2C+ NK cell subsets and then enhances anti-LSCs activity of these cells. In this study, the effect of Dasatinib on CMV-activated NKG2C+ cell subsets and its mechanism will be studies. Besides, the different NKG2C+ cell subsets on LSCs will be compared. This study might be helpful to clarify the mechanism of TKI withdrawal and to offer foundation for CMV and Ph+ ALL treatment strategies

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years old, gender is not limited
2. CML-CP patients treated with TKIs
3. No pregnancy was planned during the treatment

Exclusion Criteria:

1.The researcher judged that it was not suitable to participate in this study

Primary outcomes:
measure: NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Dan Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380532: Tableted COVID-19 Therapeutic Vaccine
Official title: Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: COVID-19
SARS-CoV-2
coronavirus
respiratory disease
SARS
ARDS
pneumonia
pandemic
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
Collaborators: name: Immunitor Inc.
First posted: 2020-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers
Primary purpose: TREATMENT

Brief summary: Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

Detailed description: Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.

Eligibility criteria: Inclusion Criteria:

* Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
* Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria:

* Unable to take oral medication,
* Immunocompromised
* Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
* BMI less than 18
* Smoking history (more than one pack per day)

Primary outcomes:
measure: Effect on CBC as per CTCAE v4.0
timeFrame: 15 Days
measure: Effect on biochemistry parameters as per CTCAE v4.0
timeFrame: 15 Days
Secondary outcomes:
measure: Lack of adverse events as per CTCAE v4.0
timeFrame: 15 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Immunitor Inc
state: BC - British Columbia
city: Ulaanbaatar
country: Mongolia
facility: Aldar Bourinbayar
state: BZD, 3-khoroo
Study officials:
affiliation: Immunitor LLC
name: Aldar Bourinbayar, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silin DS, Lyubomska OV, Jirathitikal V, Bourinbaiar AS. Oral vaccination: where we are? Expert Opin Drug Deliv. 2007 Jul;4(4):323-40. doi: 10.1517/17425247.4.4.323.
Clinical trial NCT06964932: Probiotics in Obesity Management
Official title: Efficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.


Eligibility criteria: Inclusion Criteria:

1. A body mass index (BMI) of 25 kg/m² or above;
2. Voluntarily signing an informed consent form to take part in the study;
3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.

Exclusion Criteria:

1. Intake of products akin to the test product in the recent period that might sway the outcomes;
2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
3. Being pregnant, breastfeeding, or planning to conceive;
4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
5. Use of antibiotics in the preceding three months;
6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
7. Smoking in excess of 10 cigarettes daily;
8. Hypersensitivity to probiotic products;
9. Any other participants deemed unsuitable for the research by the investigator.

Primary outcomes:
measure: Change in body weight before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The School of Food and Bioengineering, Henan University of Science and Technolog
state: He Nan
Study officials:
References:
Clinical trial NCT00500032: Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Official title: Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Adult
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine or placebo was administered, will be approached for inclusion into this study which is purely for blood draw. The sera will be used for assay development.

Detailed description: The purpose of this protocol is to analyze the collection of blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As such, the inclusion and exclusion criteria are consistent with the Australian Red Cross guidelines for blood donation.

The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized, placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086 with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon completion of participation in the 6108A1-500 study, subjects will be approached to participate in this blood sampling study. The sites participating in this blood sampling study are the same sites participating in the 6108A1-500 study.

Eligibility criteria: Main Inclusion Criteria:

1. Completed study 6108A1-500.
2. Hemoglobin level ≥12.0 and ≤16.5 g/dL for female subjects and ≥13.0 and ≤18.5 g/dL for male subjects.
3. Body weight ≥45 and ≤120 kg.
4. Systolic blood pressure \>90 and \<180 mm Hg.
5. Diastolic blood pressure \>60 and \<100 mm Hg.
6. Able to be contacted by telephone.
7. For all female subjects: have a negative urine pregnancy test unless the subject is surgically sterile.

Main Exclusion Criteria:

1. Bleeding diathesis or condition associated with prolonged bleeding time.
2. Prior antibiotic use (within 14 days).
3. Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.

Primary outcomes:
measure: Primary objective is to obtain blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500, for use in serological assay development.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Herson
country: Australia
state: Queensland
city: North Adealaide
country: Australia
state: South Australia
city: Perth
country: Australia
state: Western Australia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547532: Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Official title: Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alpha-1 Antitrypsin Deficiency
Keywords: COPD
alpha-1 antitrypsin deficiency
microbioma
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Grifols Biologicals, LLC
First posted: 2015-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD

Brief summary: In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.


Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.

For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.

. Exclusion Criteria:

* The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.

Primary outcomes:
measure: composition of microbioma in sputa
timeFrame: 2 years
Secondary outcomes:
measure: correlation with clinical and physiological parameters
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Pantaleo Giannuzzi, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06870032: Pulmonary Rehabilitation and Quality of Life in Children With Chronic Lung Diseases: A Multidisciplinary Approach
Official title: The Impact of Pulmonary Rehabilitation on Respiratory Function and Quality of Life in Pediatric Patients With Chronic Lung Diseases: A Multidisciplinary Approach in Damietta Governorate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lung Disease
Quality of Life
Respiratory Function Impaired
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Chronic lung diseases (CLDs) such as asthma, cystic fibrosis, and bronchopulmonary dysplasia significantly impact pediatric patients' respiratory function and overall well-being. Pulmonary rehabilitation (PR) has been shown to improve lung function, exercise tolerance, and quality of life in affected individuals. However, limited research has been conducted on PR implementation in Egypt.

Detailed description: Pulmonary rehabilitation significantly enhances respiratory function, exercise capacity, and quality of life in pediatric patients with CLDs while reducing healthcare utilization. These findings highlight the necessity of integrating structured PR programs into pediatric respiratory care in Egypt.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of CLDs, stable clinical condition, and ability to participate in rehabilitation.

Exclusion Criteria:

* Severe comorbidities, recent respiratory infections, or contraindications to physical activity.

Primary outcomes:
measure: Forced Expiratory Volume in One Second
timeFrame: at basline and after 12-weeks of intervention
measure: Forced Vital Capacity
timeFrame: at basline and after 12-weeks of intervention
measure: Peak Expiratory Flow Rate
timeFrame: at basline and after 12-weeks of intervention
Secondary outcomes:
measure: Hospitalization Frequency
timeFrame: at basline and after 12-weeks of intervention
measure: Medication Dependency
timeFrame: at basline and after 12-weeks of intervention
measure: Parental Satisfaction with Treatment
timeFrame: at basline and after 12-weeks of intervention
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Out-patient Clinic, Faculty of Physical Therapy, Horus University
Study officials:
affiliation: Horus University in Egypt
name: Mohamed El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06069232: Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction
Official title: Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease
Keywords: aortic stenosis
aortic valve insufficiency
risk factor
prediction model
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Affiliated Hospital of Guangdong Medical University
name: Second Affiliated Hospital of Shantou University Medical College
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: Zhongshan People's Hospital, Guangdong, China
name: Jieyang People's Hospital
First posted: 2023-10-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participant included in this study were patients with aortic valve disease diagnosed during hospitalization, and these patients were followed up for a long time after discharge.

Brief summary: This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18
* diagnosed as aortic valve disease

Exclusion Criteria:

* aortic valve replacement at baseline

Primary outcomes:
measure: all-cause mortality
timeFrame: from baseline to death or end of follow-up
Secondary outcomes:
measure: Cardiovascular death
timeFrame: from baseline to death or end of follow-up
measure: Aortic valve replacement
timeFrame: from baseline to aortic valve replacement
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-Sun University
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Eighth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: xiaodong zhuang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06121232: Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
Official title: Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy;Peripheral
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Foundation for Anesthesia Education and Research
First posted: 2023-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To learn if a process called neuromodulation can help to improve pain due to CIP

Detailed description: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
* Patients seen at Pain Management Center at MD Anderson Cancer Center
* Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria:

* Patients with cognitive dysfunction
* Patient with recent history (\<6 months) of drug or alcohol abuse
* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
* Patients seen at Pain Management Center at MD Anderson Cancer Center
* Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria

* Patients with cognitive dysfunction
* Patient with recent history (\<6 months) of drug or alcohol abuse
* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Saba Javed, M D
role: PRINCIPAL_INVESTIGATOR
References: