louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02218437: Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells（Umbilical Cord Derived）
Official title: Child With Severe Aplastic Anemia (SAA) Therapy: the Injection of Umbilical Cord Derived Mesenchymal Stem Cells.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Complications of Organ Transplant Stem Cells Umbilical Cord
Keywords: Mesenchymal Stem Cells (MSC)
Umbilical Cord
thymocyte globulin (ATG)
Severe Aplastic Anemia (SAA)
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and takes part in the bone marrow microenvironment. The response rate of early treatment on Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG treatment) is associated with long-term effect. The injection of Umbilical Cord Derived Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.

Detailed description: 1. Mesenchymal Stem Cells were prepared by in vitro separation, screening, and culture from healthy human umbilical cord tissue; The " injection of mesenchymal stem cells (umbilical) manufacturing and verification regulation " was also formulated.
2. The starting dose of Umbilical Cord Derived MSC was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; And the maximum tolerated dose was 1 \* 107 cells /kg
3. The response and complete remission rate, relapse rate of the injection of Umbilical Cord Derived Mesenchymal Stem Cells (or combined with ATG ) for Child with SAA were determined.

Eligibility criteria: Inclusion Criteria:

* Non-Severe Aplastic Anemia (NSAA)atients

Exclusion Criteria:

* Severe Aplastic Anemia (SAA) patients

Primary outcomes:
measure: The response and complete remission rate with different doses of Umbilical Cord Derived MSC to treat child with SAA
timeFrame: 1 year
Secondary outcomes:
measure: The relapse rate with different doses of MSC to treat child with SAA
timeFrame: 3-10 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Xiaofan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lan Y, Liu F, Chang L, Liu L, Zhang Y, Yi M, Cai Y, Feng J, Han Z, Han Z, Zhu X. Combination of umbilical cord mesenchymal stem cells and standard immunosuppressive regimen for pediatric patients with severe aplastic anemia. BMC Pediatr. 2021 Feb 27;21(1):102. doi: 10.1186/s12887-021-02562-x.
Clinical trial NCT03245437: Target Engagement and Response to Oxytocin
Official title: Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Social Cognition
Oxytocin
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

Detailed description: The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* stable on an antipsychotic medication

Exclusion Criteria:

* positive pregnancy test history of head injury

Primary outcomes:
measure: Social Cognition Composite Score
timeFrame: 16 weeks
Secondary outcomes:
measure: Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Stephen Marder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04341337: Link of Interest and Training Model
Official title: Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Carcinomatosis
Lead sponsor: Centre de l'arthrose, Paris
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: expert working in academic tertiary center

Brief summary: * The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view.
* Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation.
* But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

Detailed description: * Objective: Using the example of Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC), the investigators analyze the development model of this procedure and provide an ethical analysis of the involvement of the industry in this development.
* Summary Background Data: In the case of breakthrough innovation, medical training is essential for safe use of the new procedure. Pharmaceutical companies may organize this training; but when it becomes the only training opportunity to use the device, scientists and clinicians are exposed to a conflict of interest.
* Methods: The investigators performed a literature review of PIPAC publications using the STROBE criteria. Then, the investigators conducted interviews with an expert panel to analyze the ethical impact of involvement of the industry in the development of the PIPAC procedure.

Eligibility criteria: Inclusion Criteria:

* expert in pipac
* more than 30 PIPAC per year

Exclusion Criteria:

-

Primary outcomes:
measure: qualitative analysis of the interviews
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Université de Paris
Study officials:
References:
citation: Martellotto S, Maillot C, Villeneuve L, Eveno C, Sgarbura O, Pocard M. Restricted access to innovative surgical technique related to a specific training, is it ethical? Example of the PIPAC procedure. A systematic review and an experts survey. Int J Surg. 2020 Nov;83:235-245. doi: 10.1016/j.ijsu.2020.07.004. Epub 2020 Jul 29.
Clinical trial NCT05992337: New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
Official title: New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiotoxicity
Chemotherapy Effect
Chemotherapy Induced Systolic Dysfunction
Lead sponsor: Cardiology Prague
Sponsor class: NETWORK
Collaborators: name: BioVendor LM
name: Oncology Center Medicon
First posted: 2023-08-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with breast cancer

Brief summary: Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. The complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. The project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

Detailed description: The most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. The aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria:

* Known cardiovascular disease

Primary outcomes:
measure: Early detection of the cardiotoxic effect of chemotherapy using new biomarkers
timeFrame: one year follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Cardiology Prague Ltd
city: Prague
country: Czechia
facility: Oncology Center Medicon
Study officials:
References:
Clinical trial NCT03756337: Neuro 1 vs. Neuro 2 Sound Processors
Official title: Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Cochlear Hearing Loss
Keywords: cochlear implant
sound processor
upgrade
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

Detailed description: The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* primary implantation
* subject having participated to previous Neuro 1 sound processor study in Canada
* fluent in English, including reading and writing.

Exclusion Criteria:

* psychologically unsuitable
* unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
* non compliant with all investigational requirements.

Primary outcomes:
measure: speech recognition in quiet
timeFrame: Day 1
Secondary outcomes:
measure: speech recognition in noise
timeFrame: Day 1
measure: pure tone threshold
timeFrame: Day 1
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Hearing and Speech centres
Study officials:
affiliation: Dalhousie University, Halifax,NS, Canada
name: David Peter Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040337: Sequencing T-cells in Type I Diabetes Mellitus
Official title: Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2014-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endocrinology clinic patients currently receiving treatment for Type II Diabetes

Brief summary: The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

Detailed description: Using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. This can also be used to guide therapy in advanced disease.

Eligibility criteria: Inclusion Criteria:

* Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited)
* Patients must be ≥ 18 years old and ≤55 years old

Inclusion criteria: patients T2D as controls

* Patients must have a current or previous diagnosis of T2D
* Patients must be ≥ 18 years old and ≤55 years old

Exclusion Criteria:

• \<18 years old; \> 55 years old

Primary outcomes:
measure: Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes
timeFrame: 3 month intervals for 2 years. Time to assess effectiveness is 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas Physicians at Trinity
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Mrinalini Kulkarni-Date, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03573037: Anticoagulation After RFCA
Official title: Duration of Anticoagulation Therapy Following Catheter Ablation of Atrial Fibrillation; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 246
Sex: ALL
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. This study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. Thromboembolic event and adverse event including major or minor bleeding would be compared.

Detailed description: Catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. Recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (RFCA) became popular globally. It is recommended to anticoagulate patients who received RFCA for atrial fibrillation at least two months after the procedure. However, a few reports suggest anticoagulation in selective patients according to CHADS2-Vasc score. Anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. There is controversy in the duration of anticoagulation after RFCA of atrial fibrillation. The investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after RFCA of atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score who are undergoing RFCA are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after RFCA. Any patient with an evidence of intracardiac thrombus is excluded. The primary endpoint is thromboembolic event in 6 months after RFCA and the secondary endpoint is bleeding event in 6 months after RFCA.

Eligibility criteria: Inclusion Criteria:

* Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1

Exclusion Criteria:

* Presence of intracardiac thrombus

Primary outcomes:
measure: Thromboembolic event
timeFrame: 6 months
Secondary outcomes:
measure: Major bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: The Catholic University of Korea
name: Yong-Seog Oh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01437137: The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complication of Anaesthesia
Keywords: elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 54
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and c-LMA in infants.


Eligibility criteria: Inclusion Criteria:

* infants (0-1 year of age)
* who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* patients with an abnormal airway
* with reactive airway disease
* with gastroesophageal reflux disease
* with chronic respiratory disease
* has a history of an upper respiratory tract infection in the preceding 6-week period

Primary outcomes:
measure: airway leak pressure
timeFrame: within 5 min of insertion of each device
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.
Clinical trial NCT01625637: Tobacco Approach Avoidance Training for Adolescent Smokers-2
Official title: Tobacco Approach Avoidance Training for A Smoking Cessation in Adolescent Smokers- Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Nicotine
Smoking
Adolescent
Tobacco
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2012-06-21
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two part study. In Study 2, smokers who want to quit smoking will participate in a 4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach tendencies in the AAT test trials and the Implicit Association Task, when compared to adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have better abstinence rates compared to those who receive placebo AAT training with CBT.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Between ages 13-18 years
* Able to read and write in English.
* Smokers: Smoking 5 or more cigarettes daily for at least 6 months; Baseline urine cotinine levels \> 500 ng/ml
* Nonsmokers: Never smokers; Baseline urine cotinine levels \< 50 ng/ml

Exclusion Criteria:

* Current criteria for dependence on another psychoactive substance
* Current diagnosis of psychosis, major depression or panic disorder
* Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable
* Pregnant or lactating girls, based on self report.

Primary outcomes:
measure: Number of cigarettes smoked
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, School of Medicine, Department of Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: