louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01219465: Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Mesenchymal Stem Cells
Umbilical Cord
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 1
mesenchymal stem cells
Umbilical cord
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Detailed description: Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
* Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

* diabetic ketoacidosis.
* evidence of retinopathy at baseline.
* Body Mass Index \>30.
* Severe or acute organ damage.
* Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
* Severe psychiatric disorder.
* Presence of malignancy.

Primary outcomes:
measure: C peptide release test
timeFrame: 3 months
Secondary outcomes:
measure: Exogenous insulin dose
timeFrame: 3 months
measure: blood glucose
timeFrame: 3 months
measure: glycosylated Hemoglobin A1c
timeFrame: 3 months
measure: Number of severe and documented hypoglycemic events
timeFrame: 3 months
measure: Immunologic reconstitution parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem Cell Research Center of Medical School Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yangang Wang, MD Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03182465: Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia
Official title: Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia According to the MASCC Score: a Prospective, Monocentric Observational Study (CALIF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Febrile Neutropenia, Drug-Induced
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CALIF study is a monocentric observational study which aim is to analyse the value of adding procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the management of chemo-induced febrile neutropenia occurring in patient with solid tumour. Febrile neutropenia will be managed according to international guidelines. PCT will be dosed at initial presentation. Primary objective is to determine the optimal value of PCT for the detection of septicaemia in low risk (according to MASCC score). The investigators plan also to compare two risk stratification scores: the validated MASCC score and a recently developed score which includes PCT and other more objective items.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* Patients with solid malignant tumor treated by chemotherapy (neoadjuvant, concomittant, adjuvant or metastatic)
* Febrile neutropenia chemo-induced (fever \> 38°C, neutrophils \< 500 /microliter or nadir \< 500 /microliter)
* Patients non hospitalized at the event (when he presented febrile neutropenia)
* Informed consent signed

Exclusion Criteria:

* Thyroid medullar carcinoma
* Patient not able to understand protocol (mental retardation, psychiatric disorders, .... )

Primary outcomes:
measure: Minimum level of ProCalcitonin
timeFrame: at day 0
Secondary outcomes:
measure: Compare the MASCC score and the Anh & al score
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: jean-Pascal Machiels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008265: Fascial Dehiscence and Mortality
Official title: Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Wound Breakdown
Keywords: Fascial dehiscence
Mortality
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent open colonic resection for carcinoma in the period 2001-2008 in Denmark.

Brief summary: Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence.

The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent open colonic resection identified in the DCCG

Exclusion Criteria:

* None

Primary outcomes:
measure: 3-year mortality
timeFrame: Three years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Digestive Disease Center, Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Digestive Disease Center, Bispebjerg Hospital
name: Kristian K Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04779931: Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
Official title: The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Conditions, Multiple
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-03-03
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Feasibility will be assessed by recruitment, attrition, and data collection on measures of quality of life and social support. Usability will be captured by self-report usability scales and actual back end utilization data.


Eligibility criteria: Inclusion Criteria:

* ≥65 years of age
* self-report diagnosis of heart failure (HF)
* have multiple chronic conditions (MCC) based on the Disease Burden/Morbidity Assessment by Self-Report (Individuals will be eligible if they self-report the number of diagnosis \> 2 and a disease burden score \>2 indicating the presence of at least two chronic conditions that limit activities of daily of living)
* community dwelling in the United States
* English speaking

Exclusion Criteria:

* Self-reported diagnosis of Alzheimer's disease or dementia
* Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
* Participation in community-based palliative care in the last 12 months

Primary outcomes:
measure: User Mobile Application Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Jennifer D Portz, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986531: The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
Official title: A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: schizophrenia
early phase trials
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* ECT in the last 6 months
* Substance abuse or dependence
* History of claustrophobia

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: 1 fMRI on Day 4; 1 fMRI on Day 21
measure: Computerized neurocognitive tests
timeFrame: 1 on Day -1; 1 on Day 1 and on Day 21
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Day-1; Day 4; Day 17; Day 21
measure: Electroencephalography (EEG)
timeFrame: Day 4; Day 21
measure: Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,
timeFrame: Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35
measure: Suicidality assessment, collection of adverse events
timeFrame: Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section
name: Raquel Gur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05233631: Therapeutic EUS Registry
Official title: Therapeutic Endoscopic Ultrasound (EUS) Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastrointestinal Disease
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures

Brief summary: The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Detailed description: This study is a prospective, observational, medical chart review. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - May 2019. Those subjects will undergo no additional tests and procedures as part of this study.

In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of T-EUS procedures.

Eligibility criteria: Inclusion Criteria:

* Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - May 2019
* Any patient who will undergo clinically indicated and/or standard of care T-EUS procedures from June 2019 - June 2027

Exclusion Criteria:

* Any patient who has not undergone endoscopic ultrasound would be excluded from the study.
* Below 18 years of age

Primary outcomes:
measure: clinical success rates
timeFrame: October 2014 - June 2022
measure: Documentation of Safety
timeFrame: October 2014 - June 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177631: Proteomic Analysis of Human Hepatocellular Carcinoma
Official title: Proteomic Analysis of Human Hepatocellular Carcinoma Associated With Portal Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, hepatocellular
Portal vein
Proteomics
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

Arm A: Hepatocellular carcinoma with vessel invasion:

* hepatocellular carcionoma, pathologic diagnosed.
* image documented vessel invasion, including portal vein thrombosis
* eligible for surgical intervension.

Arm B: hepatocellular carcinoma without vessel invasion:

* hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria.
* no vessel invasion on image.

Arm C: Healthy hepatitis carrier:

* patients age \>18 years old with hepatitis B or C
* normal liver function.

Primary outcomes:
measure: Recurrence
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT03210831: Early Predictors of Necrotizing Enterocolitis in Neonates
Official title: Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Necrotizing Enterocolitis
Keywords: NEC, tissue oxygenation, gut inflammation
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 450
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: low birth weight, preterm infants

Brief summary: The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants.

Detailed description: The study will enroll premature, low birth weight infants in the Neonatal Intensive Care Units (NICU). Potential study subjects will be identified upon delivery, or transfer to the NICU, and notification by the neonatology service. Infants born at less than 30 weeks gestational age, birth weight less than or equal to 1500 grams will be eligible for enrollment in the study. The purpose of the study designed is to compare the splanchnic tissue oxygenation index and gut inflammatory biomarkers of patients with any stage of NEC with healthy controls. Since we will not be able to determine which patients will develop NEC a priori, we will anticipate enrolling up to 450 neonates to identify 15 neonates with NEC.

Eligibility criteria: Inclusion Criteria:

* Infants born at ≤30 weeks gestational age and/or
* Infants with a birth weight ≤1500 grams

Exclusion Criteria:

* gestational age at birth greater than 30 weeks
* obvious dysmorphic syndromes
* any abdominal wall defect including omphalocele or gastroschisis
* any known intestinal atresia
* complex cardiac abnormalities
* any known lethal chromosomal abnormalities

Primary outcomes:
measure: splanchnic tissue oxygenation in population at high risk for NEC
timeFrame: 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Oluyinka Olutoye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04870931: Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer
Official title: Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative and Long-term Outcomes of TEM and TEM-ESD
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We analysed all patients who underwent TEM or TEM-ESD in our centers between 2007 and 2021

Brief summary: We retrospectively analysed all TEM and TEM-ESD procedures that took place in Surgical Clinic of the Municipal Hospital of Karlsruhe and the Surgery Department of the University Hospital of Mannheim from 2007 to 2021. We evaluated the periopüerative and long-term outcomes of both procedures for adenomas, adenocarcinomas and other tumours seperately and we compared the results between the two techniques.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent TEM or TEM-ESD

Exclusion Criteria:

-

Primary outcomes:
measure: Local recurrence
timeFrame: 5 years
Secondary outcomes:
measure: en bloc resection
timeFrame: 5 years
measure: complete en bloc resection
timeFrame: 5 years
measure: procedure time
timeFrame: 5 years
measure: perioperative morbidity
timeFrame: 5 years
measure: long-term adverse events
timeFrame: 5 years
measure: survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital of Mannheim
state: BW
Study officials:
References:
citation: Kouladouros K, Baral J. Transanal endoscopic microsurgical submucosal dissection (TEM-ESD) for rectal adenomas: a retrospective cohort study of 145 consecutive cases. Langenbecks Arch Surg. 2022 Sep;407(6):2423-2430. doi: 10.1007/s00423-022-02562-0. Epub 2022 Jun 2.
Clinical trial NCT06290531: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain
Official title: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Local Anesthesia
Buzzy
Topical Anesthesia
Pain
precooling
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.

The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.

Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.

Detailed description: The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.

Eligibility criteria: Inclusion Criteria:

* Children in the mixed dentition stage,
* Age range 6-12 years old,
* Need extraction to a maxillary molar,
* Cooperative and medically free.

Exclusion Criteria:

* Exclusion will be performed if the parent refused the participation of their children in the research.

Primary outcomes:
measure: Patient reported pain during needle injection
timeFrame: Immediately post injection
Secondary outcomes:
measure: Child behaviour during needle injection
timeFrame: Immediately during injection
measure: Heart rate
timeFrame: Immediately post injection
measure: Oxygen saturation
timeFrame: Immediately post injection
measure: Child and parent satisfaction
timeFrame: Immediately post injection
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Study officials:
affiliation: Associate Professor
name: Fatma KI Abdelgawad, PhD
role: PRINCIPAL_INVESTIGATOR
References: