louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06985498: CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Official title: Safety and Efficacy of CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Lymphobkastic Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 15
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: Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. We conducted CD22/CD19 CAR T-cells and blinatumoab combined with auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.


Eligibility criteria: Inclusion Criteria:

1. subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT;
2. positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry;
3. cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation;
4. subjects aged 15-65 years (including 15 and 65 years), regardless of gender;
5. T-cell amplification test pass;
6. expected survival \> 3 months.

Exclusion Criteria:

1. patients with recurrence of only isolated extramedullary lesions;
2. combination of other malignant tumors;
3. previously treated with anti-CD19 or/and CD22 or/and CD3 therapies;
4. immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent;
5. uncontrolled active infections;
6. HIV infection;
7. active hepatitis B or hepatitis C infection;
8. history of severe tachyphylaxis to aminoglycoside antibiotics;
9. history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: leukemia free survival
timeFrame: 2 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01166698: Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Safety
Tolerability
Keywords: Safety
tolerability
healthy
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication

Primary outcomes:
measure: Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: Frequent safety measurements during the study from screening period to follow-up
Secondary outcomes:
measure: Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma
timeFrame: Multiple PK blood samples from pre-dose until 96 hours post last dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
References:
Clinical trial NCT01469598: Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer
Official title: Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Carcinoma
Recurrent Esophageal Squamous Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 24
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: Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule depolymerization.

In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with G-CSF support every 3 week.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
* Age \> 18 years
* ECOG performance status 0 - 2
* At least one measurable lesion(s) by RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed)
* Prior radiotherapy must be completed 2 weeks before study entry.
* Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
* Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
* Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
* Written informed consent

Exclusion Criteria:

* Evidence of serious gastrointestinal bleeding
* Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
* Serious metabolic disease such as severe non-compensated diabetes mellitus
* History of significant neurologic or psychiatric disorders
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* Pregnant or lactating woman

Primary outcomes:
measure: Response rate
timeFrame: 1years
Secondary outcomes:
measure: progression free survival
timeFrame: 1years
measure: overall survival
timeFrame: 1years
measure: Number of Adverse Events
timeFrame: 1years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical Center
Study officials:
References:
Clinical trial NCT00320398: Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Elective Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombosis, Venous
Keywords: Fondaparinux
Hip Replacement Arthroplasty
VTE
THR
MOSLL
pentasaccharide
Xa factor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.

Exclusion Criteria:

* Active, clinically significant bleeding (excluding drainage).

Primary outcomes:
measure: Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period
timeFrame: Up to Day 17
measure: Percentage of Participants With Major Bleeding
timeFrame: Up to Day 17
Secondary outcomes:
measure: Percentage of Participants With Minor Bleeding
timeFrame: Up to Day 17
measure: Percentage of Participants With All Deep Vein Thrombosis (DVT)
timeFrame: Up to Day 17
measure: Percentage of Participants With Proximal DVT
timeFrame: Up to Day 17
measure: Percentage of Participants With Distal Only DVT
timeFrame: Up to Day 17
measure: Percentage of Participants With Symptomatic DVT During Main Efficacy Period
timeFrame: Up to Day 17
measure: Percentage of Participants With Pulmonary Embolism During Efficacy Period
timeFrame: Up to Day 17
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
timeFrame: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.
measure: Number of Transfused Participants
timeFrame: Up to Day 17.
measure: Volume of Transfusion
timeFrame: Up to Day 17
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06980298: Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders
Official title: Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders in Sohag Governorate, Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Toxoplasmosis in Neuropsychiatric Disorders
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 90
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 children will be collected from children ,45 of them have either epilepsy or ADHD and another matched 45 children for age and gender, served as control.

Brief summary: Toxoplasma gondii is recognized as being involved in the etiology of various psychotic disorders including epilepsy and ADHD (Markovitz et al.,2015).

There are many explanations for such associations between toxoplasmosis and neurological disorders which include many anatomical and neurotransmitter-related changes. Toxoplasmosis may cause alterations in neurotransmitter levels like serotonin, noradrenaline, glutamate, nitric oxide and gamma aminobutyric acid, increase in the levels of proinflammatory cytokines and modulate the dopaminergic signaling (Babaie et al., 2017). The behavioral changes produced by the cyst formation in the brain tissue may also related to the localization of the cyst within specific parts of the brain and this is assumed to be one of the main causes of epilepsy in toxoplasmosis. Moreover, tachyzoites may invade the brain tissues and excite brain cells especially neurons, microglia and astrocytes. Additionally, the presence of Toxoplasma in brain evokes inflammatory response and stimulate immune system to produce antibodies with increase in proinflammatory cytokines. Interestingly, some studies described that many host genes and proteins could be affected by Toxoplasma, signifying its involvement in many genetic disorders including neuropsychiatric diseases.The current study aimed to assess the seroprevalence of anti-Toxoplasma IgM and IgG antibodies among children with some neuropsychiatric disorders (Epilepsy and ADHD) in Sohag governorate, Egypt.


Eligibility criteria: Inclusion criteria: Children with neuropsychiatric disorders (epilepsy,ADHD). Exclusion criteria: Children with history of neurosurgery, head injury or trauma, neoplastic or autoimmune diseases, or receiving immunosuppressant or systemic corticosteroid, and those with possible neurological infection.

Primary outcomes:
measure: Comparison between incidence of Toxoplasma gondii in children with neuropsychiatric disorders and children without neuropsychiatric disorders
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence of Toxoplasma gondii in children with neuropsychiatric disorders
timeFrame: 4 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT05758298: Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
Official title: Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Betel Nut Cessation
Keywords: replacement therapy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Commonwealth Healthcare Corporation
First posted: 2023-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.

Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:

* non-medicated regular chewing gum
* nicotine 2 mg gum
* nicotine 4 mg gum

Detailed description: Objectives include:

A. Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.

B. Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.

C. Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.

Eligibility criteria: Inclusion Criteria:

* Daily betel nut chewers who use betel nut and tobacco in their chews.
* Interested in betel nut reduction or cessation when they are informed of the study.
* Must chew greater than or equal to 4 times a day.
* Must have an appointment with a provider at the Commonwealth Healthcare Corporation

Exclusion Criteria:

* Tobacco smokers
* Under the age of 18 years old
* Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more)
* Pregnant patients
* Established diagnosis of oropharyngeal cancer

Primary outcomes:
measure: Change in average "betel nut chews per day" at 3 months
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: Mary Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831998: In-vivo Efficacy of Patient Preoperative Prep
Official title: Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Skin Preparation
Lead sponsor: Zurex Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Detailed description: The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good health
* Minimum skin flora baseline requirements on abdomen and groin
* Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
* Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
* Subjects who are pregnant, attempting pregnancy or nursing.

Primary outcomes:
measure: Bacterial Reduction
timeFrame: 10 minutes post product application
measure: Bacterial Reduction - Abdomen
timeFrame: 10 minutes post product application
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: MicroBioTest Laboratories
state: Virginia
Study officials:
affiliation: Microbac Laboratories, Inc.
name: Muhammad H Bashir
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.
Clinical trial NCT02434198: Falling in Patients With COPD Referred to Pulmonary Rehabilitation: Incidence, Risk Factors and Prediction Tools
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pulmonary rehabilitation
balance assessment
Chronic Obstructive Pulmonary Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the outpatient pulmonary rehabilitation (PR) program in the Gasthuisberg University Hospital (Leuven, Belgium) will be screened for eligibility.

Brief summary: The primary aim of this study is to investigate the incidence of falling in a cohort of patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary rehabilitation program and to verify the risk factors. The secondary aim is to verify whether available balance assessment tools are feasible in clinical practice and which tools and values can best predict falls in people with COPD.


Eligibility criteria: Inclusion Criteria:

* Patients with a primary diagnosis of COPD according to internationally accepted guidelines
* All patients referred to the outpatient PR program of Gasthuisberg University Hospital (Leuven, Belgium).

Exclusion Criteria:

* None

Primary outcomes:
measure: incidence of falling
timeFrame: 6 months
Secondary outcomes:
measure: association between falling status and the score in balance tests
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospitals Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04152798: Approach to Hiatal Hernia Repair Based on Collagen Study
Official title: Approach to Hiatal Hernia Repair Based on Collagen Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiatal Hernia
Gastroesophageal Reflux Disease
Lead sponsor: Odessa National Medical University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

Detailed description: The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques.

Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery.

Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.

Eligibility criteria: Inclusion Criteria:

* Age older than 20 years
* Initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity)
* Performance of laparoscopic hiatal hernia repair
* Informed Consent as documented by signature

Exclusion Criteria:

* Cases of conversion to open surgery
* Age \< 20 years and \> 80 years
* History of oesophageal/gastric/duodenal surgery including vagotomy

Primary outcomes:
measure: Recurrence rate of hiatal hernia
timeFrame: 36 months
Secondary outcomes:
measure: Quality of life and satisfaction
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
References: