louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06210243: C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
Official title: A Single-arm, Open-label Clinical Study to Assess the Safety and Efficacy of the C752 CAR-T Cells for Patients With CD19+ Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma, B-Cell
CAR-T
Lead sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sponsor class: OTHER
Collaborators: name: Shanghai PerHum Therapeutics Co., Ltd.
First posted: 2024-01-18
Enrollment: 2
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: It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.


Eligibility criteria: Inclusion Criteria:

* Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
* Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
* Have progression by least one systemic treatment and no available standard of care treatment.
* At least one measurable lesion by Lugano 2014
* Expected survival ≥ 12 weeks
* Have an ECOG performance status of 0 or 1
* Adequate organ function
* Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
* Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial

Exclusion Criteria:

* Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
* Central nervous system involvement
* HBV/HCV
* HIV infection
* Concurrent use of systemic steroids or immunosuppression
* Uncontrolled active infection
* Wash-out period of from the last anti-cancer treatment
* Active second malignancy
* Have not recovered from the effects of previous therapy
* Have psychological or physical conditions that do not permit compliance with the protocol
* Pregnant or nursing (lactating) women

Primary outcomes:
measure: The incidence and severity of adverse events (AEs)
timeFrame: 1 year
measure: Dose Limiting Toxicities
timeFrame: First 28 days s after C752 injection
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 1 year
measure: PFS
timeFrame: 1 year
measure: Pharmacokinetic - AUC
timeFrame: 1 year
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th Hospital of Joint LogisticsSupport Force of People's Liberation
state: Yunnan
Study officials:
affiliation: 920th Hospital
name: Sanbin Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02463643: To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
Official title: A Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophagitis, Reflux
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 503
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.


Eligibility criteria: Inclusion Criteria:

* In observation period, the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 20% (96 participants) or more of the total participants.
* Outpatient (including inpatient for examination)

Exclusion Criteria:

* Participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, Barrett's esophagus ( columnar epithelium metaplasia\>=3 cm ) or high-grade dysplasia.However, participants with Schatzki's ring ( \>=20mm ) are allowed to be included.
* Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating\>=3mm) within 28 days prior to observation period . Participants with above disease at endoscopy during the observation period.
* Participants with Zollinger-Ellison syndrome.Participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others.
* Participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .

Primary outcomes:
measure: Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
timeFrame: 8 weeks
Secondary outcomes:
measure: Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT00585143: Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly
Official title: Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia, Renal Insufficiency
Keywords: Dyslipidemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-01-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly


Eligibility criteria: Inclusion Criteria

Body Mass Index (BMI) 19 to 33, inclusive

Either normal kidney function, or mild or moderate kidney impairment

Exclusion Criteria

Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease.

History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Primary outcomes:
measure: Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin
timeFrame: Days 1, 8, 9, and 10
Secondary outcomes:
measure: Safety and tolerability of the study drugs
timeFrame: Study duration
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 6610
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 6738
state: Florida
city: Minneapolis
country: United States
facility: Site Reference ID/Investigator# 7723
state: Minnesota
city: Knoxville
country: United States
facility: Site Reference ID/Investigator# 7319
state: Tennessee
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 6928
state: Texas
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 8280
state: Virginia
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04962243: Whether Patients With Achilles Tendon Tears Have Different Lipid Levels Than Healthy People: a Retrospective Study
Official title: Whether Patients With Achilles Tendon Tears Have Different Lipid Levels Than Healthy People: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 10662
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Yang Yuping, Deputy Chief Physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017 in Peking University Third Hospital of Sports Medicine for patients with Achilles tendon rupture repair surgery

Brief summary: To explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism.

Detailed description: Data were collected from 287 patients with Achilles tendon rupture repaired by Yang Yuping, deputy chief physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017. A total of 10,375 subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period were selected as the control group, and 9,193 subjects were selected as the control group after excluding patients without blood lipid test results, professional athletes, hypertension and diabetes patients. The general data, blood glucose, blood lipid, blood uric acid, smoking and alcohol consumption of the subjects were collected through the hospital information system. The blood glucose, blood lipid, uric acid and other data of the control group and the Achilles tendon rupture group were detected, and it was concluded that the blood lipid level of the patients with Achilles tendon rupture group was higher than that of the control group.

Eligibility criteria: Inclusion Criteria:

* Rupture of Achilles tendon repair surgery experience

Exclusion Criteria:

* hypertension
* diabetes
* Professional athlete
* No blood lipid test results

Primary outcomes:
measure: Blood glucose levels
timeFrame: a month after the surgery
measure: blood lipid levels
timeFrame: a month after the surgery
measure: uric acid levels
timeFrame: a month after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univerisity Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06419543: Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy
Official title: Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy, Gastrointestinal
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 333
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

Detailed description: Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.

Eligibility criteria: Inclusion Criteria:

* Age 1-12 years old
* ASA I-II level
* Sign an informed consent form

Exclusion Criteria:

* Developmental delay or neurological and psychiatric disorders
* Severe malnutrition or severe obesity
* High risk of stomach fullness and reflux aspiration
* Allergic to benzodiazepines and opioids
* Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
* Severe sleep apnea
* Abnormal liver and kidney function
* Recently participated in other clinical studies

Primary outcomes:
measure: incidence of paradoxical reaction
timeFrame: 2 minutes after first infusion of remimazolam
Secondary outcomes:
measure: performance and duration of paradoxical reaction
timeFrame: 2 minutes after first infusion of remimazolam
measure: dosage of sedative drugs
timeFrame: First infusion until end of remimazolam administration
measure: time records
timeFrame: 1 day
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 1 day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospita
name: aihua Du, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02847143: Ocytocine and Cerebral Activation in Relation With Attachement
Official title: A Cross Over Randomized Controlled Trial of the Effect of Nasal Ocytocine on Cerebral Activations in Relation With Attachement in the General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attachement Style
Keywords: Attachement
Oxytocin
fMRI
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.

Detailed description: Healthy adult male will be recruited. Their attachement style will be assessed through the Attachement scale interview (ASI).

They will have 2 fMRI sessions, during which emotional images will be presented.

One session will be preceded by a nasal administration of oxytocin and the other session will be preceded by a placebo nasal administration. The order of both administrations will be randomized.

Eligibility criteria: Inclusion Criteria:

* comprehension of french
* having signed the informed consent

Exclusion Criteria:

* chronic disease (liver failure, kidney failure) and cardiovascular disease
* hypertensive treatment
* treatment wich increases QT
* current hospitalisation
* fMRI contraindication
* legal protection

Primary outcomes:
measure: BOLD signal intensity
timeFrame: 45 min after intranasal administration of oxytocin or placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Lauriane VULLIEZ-COADY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Comte A, Szymanska M, Monnin J, Moulin T, Nezelof S, Magnin E, Jardri R, Vulliez-Coady L. Neural correlates of distress and comfort in individuals with avoidant, anxious and secure attachment style: an fMRI study. Attach Hum Dev. 2024 Oct;26(5):423-445. doi: 10.1080/14616734.2024.2384393. Epub 2024 Aug 2.
Clinical trial NCT00474643: Correlation of Hyperghrelinemia With Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader Willi Syndrome
Obesity
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-05-17
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Detailed description: Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.

Eligibility criteria: Inclusion Criteria:

* Prader Willi syndrome
* Children with obesity

Exclusion Criteria:

* Acute illness
* On regular medications except growth hormone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Kyung Hoon Paik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500743: Role of Suppression of Endometriosis With Progestins Before IVF-ET
Official title: Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
Endometriosis
Pregnancy Rate
Progestins
GnRH-analogue
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 134
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of endometriosis
* body mass index \< 35 Kg/m2

Exclusion Criteria:

* if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
* liver or kidney disease
* evidence of diminished ovarian reserve (e.g. high FSH level \>12 IU/L or low AMH level \<1 ng/ml).

Primary outcomes:
measure: the number of retrieved oocytes
timeFrame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Secondary outcomes:
measure: the fertilization rate
timeFrame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
measure: the number of transferrable embryos
timeFrame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
measure: the cost of the treatment
timeFrame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
measure: pregnancy rate per cycle started
timeFrame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
measure: the clinical pregnancy rate per cycle started
timeFrame: after women have postive pregnancy test (2 weeks after after the embryo transfer)
measure: the miscarriage rate
timeFrame: After occurence of the clinical pregnancy (5 months after after the embryo transfer)
measure: patient's quality of life
timeFrame: throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months"
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia Infertility research unit
Study officials:
References:
citation: Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.
Clinical trial NCT04225143: Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders
Official title: Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurogenic Urinary Bladder, Spastic
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 50
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: This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

Detailed description: Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.

The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.

They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.

Eligibility criteria: Inclusion Criteria:

* Individuals who received research information
* Individuals affiliated to a social security scheme
* Individuals over 18 years of age
* Individuals with non-serious neurological bladder hyperactivity

Exclusion Criteria:

-

Primary outcomes:
measure: Urinary symptom profile score (USP score)
timeFrame: 3 months
Secondary outcomes:
measure: mictional calendar
timeFrame: 3 months
measure: Patient global impression of improvement (PGI-I)
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: