louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06101979: A Prospective Study of Fortiva in Hernia Repair
Official title: A Prospective Study of Fortiva in Hernia Repair
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventral Hernia
Incisional Hernia
Abdominal Wall Reconstruction
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be candidates for hernia surgery recruited from the participating Investigator's population

Brief summary: The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

Detailed description: This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.

Eligibility criteria: Inclusion Criteria:

* 18 years of age at time of consent
* Undergoing hernia surgery in which Fortiva Tissue Matrix will be used
* Have no contraindications to the test material (s)
* Able to provide informed consent
* Able to read, understand and complete study questionnaires
* Able and willing to return for scheduled study visits

Exclusion Criteria:

* \<18 years of age
* American Society of Anesthesiologists (ASA) physical class of 4,5 or 6
* Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
* Hernia repairs involving active infection

Primary outcomes:
measure: Type of adverse events
timeFrame: 6 weeks, 6 months, 12 months and 24 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks, 6 months, 12 months and 24 months
measure: Pain measured using the visual analog scale for pain
timeFrame: 6 weeks, 6 months, 12 months and 24 months
measure: Implant failure
timeFrame: 6 weeks, 6 months, 12 months and 24 months
measure: Hernia recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
Study officials:
References:
Clinical trial NCT05714579: Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
Official title: Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Stenosis, Severe
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

Detailed description: The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.

The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.

This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.

Eligibility criteria: Inclusion Criteria:

* Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
* Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
* Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
* Patient having signed a consent.

Exclusion Criteria:

* Contraindication to Transcatheter Aortic Valve Implantation ;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Implantation of a Pacemaker at 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital Privé Médipôle
Study officials:
References:
Clinical trial NCT00943579: Open-Label Extension Study of Kuvan for Autism
Official title: Kuvan® (Sapropterin) as a Treatment for Autistic Disorder: An Open Label Extension Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autistic Disorder
Keywords: autism
autistic disorder
tetrahydrobiopterin
sapropterin
treatment
Lead sponsor: The Children's Health Council
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2009-07-22
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.

Detailed description: This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. During this protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. The purpose of the study primarily is to gather additional information on safety and efficacy in this population.

Eligibility criteria: Inclusion Criteria:

* All subjects must have completed earlier trial, CHC 0901 (NCT00850070)
* Parents must be willing and able to sign informed consent

Exclusion Criteria:

* Child failed to complete CHC 0901 (NCT00850070)

Primary outcomes:
measure: Clinical Global Impressions Scale
timeFrame: 16 weeks
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale, 2nd Edition
timeFrame: Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).
measure: Children's Yale Brown Obsessive Compulsive Scale
timeFrame: Weeks 8 & 16
measure: Parental Global Assessment
timeFrame: Weeks 8 & 16
measure: Preschool Language Scale, 4th Edition (PLS-4)
timeFrame: Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).
measure: Connor's Preschool ADHD Questionnaire
timeFrame: Weeks 8 & 16
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).
measure: Adverse Events Reporting
timeFrame: Cummulative throughout study
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: The Children's Health Council
state: California
Study officials:
affiliation: The Children's Health Council
name: Glen R Elliott, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697379: Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories
Official title: Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Biosafety Protection
Infectious Diseases
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
First posted: 2024-11-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Brief summary: Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

Detailed description: In high-level biosafety laboratories, the National Center for Infectious Disease Medicine, medical consortiums and other national platforms, systematic assessment of the project developed individual physical protection equipment in different scenarios of the safety performance, the intelligent application of the effect and the use of experience, the assessment of the indicators covering the protection performance, safety, stability, comfort, environmental protection, intelligence, ease of operation, including but not limited to local breakage protection performance, Aerosol protection performance, airtightness, liquid penetration performance, differential pressure stability, noise value, air supply flow, ease of wear and removal, ease of movement, ease of operation, degradability, degree of intelligence, etc., and ultimately determine the technical indicators and testing methods of individual physical protective equipment, and establish evaluation technical standards. Based on the determined technical indexes and testing methods of individual physical protective equipment, we will carry out parallel comparative evaluation of similar foreign imported equipment, and form a technical research report on the evaluation of the performance of relevant protective equipment. Optimise the quantitative performance indexes of PPE for domestic shortcomings and weaknesses. Prepare standard operation norms and technical standards for individual physical protective equipment.

Eligibility criteria: Inclusion Criteria:

* Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Exclusion Criteria:

* NA

Primary outcomes:
measure: Performance evaluation of medical protective clothing
timeFrame: 3 years
Secondary outcomes:
measure: Protective headgear performance evaluation
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital medical university
state: Beijing
Study officials:
References:
Clinical trial NCT06794879: Survey for Parental Perception of Procedural Analgosedation in Pediatric Age.
Official title: Survey of Parental Perception of Procedural Analgosedation in Pediatric Age.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Analgesia
Sensation, Hyperalgesic
Keywords: procedural analgosedation
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic of the U.O. Urgent Pediatrician, Emergency Department and Short and Intensive Observation of IRCCS - Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola.

Brief summary: The conduction of this study may provide useful information about how much parents know and understand about procedural sedation, helping to identify any gaps. In addition, expectations and concerns about procedural sedation may be highlighted so that strategies aimed at improving communication by health care personnel can be developed. The results may guide the development of training programs for health care personnel so as to improve the management of procedural sedation and interaction with parents.

Detailed description: The study involves the completion of a survey by Parents/Guardians, the remaining interventions will be performed following the normal care procedure outpatient regimen, according to normal clinical practice.

Eligibility criteria: Inclusion Criteria:

* Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: Identify the parent's degree of agreement/disagreement with pediatric procedural analgosedation practices and factors that may influence it
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Laura Andreozzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368379: Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Official title: Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prader Willi Syndrome
Adrenal Insufficiency
Keywords: Metyrapone
ACTH stimulation test
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.


Eligibility criteria: Inclusion Criteria:

* Individuals with Prader Willi Syndrome ages 2 years and older

Exclusion Criteria:

* Individuals who are ill at the time of study
* Individuals who are pregnant at the time of study
* Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).

Primary outcomes:
measure: Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
timeFrame: 40 minutes
measure: Prescence of central adrenal insufficiency using overnight metyrapone test
timeFrame: 8 hours
Secondary outcomes:
measure: Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity.
timeFrame: 0
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01142479: Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Official title: The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Radiotherapy
Chinese Herbal Medicine
Keywords: Breast Cancer
Radiotherapy
Chinese herbal medicine
TPE-1
Leukopenia
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Taipei Medical University Shuang Ho Hospital
First posted: 2010-06-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.

Detailed description: TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.

Eligibility criteria: Inclusion Criteria:

* breast cancer
* age between 18 to 70 yrs
* finished chemotherapy (adriamycin ), will receiving radiotherapy
* Chinese population
* KP$ between 40-100
* ECOG \< 2
* WBC \>4X10(9)／L and Hb \> 10g/dl
* Assigned informed concent.

Exclusion Criteria:

* receiving operation during 14 days
* blood transfusion during one month.
* ALT \>100mg/dL
* Creatinine \>2.0mg/dL
* Total bilirubin \>2.0mg/dL
* Infection
* prolation
* Taking anti-seizure , psychological drugs or any drugs not suitable patients
* AIDS or any disease diagnosed by physician and not suitable patients.

Primary outcomes:
measure: the % change of white blood cell(WBC) count
timeFrame: 6 weeks
Secondary outcomes:
measure: Hemoglobin (Hb)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shuang Ho Hospital
Study officials:
References:
Clinical trial NCT03187379: Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Official title: Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain Management
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 102
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 will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.

Detailed description: The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.

Eligibility criteria: Inclusion Criteria:

* bariatric surgery patients
* laparoscopic roux-en-y gastric bypass
* use of EEA stapler anastomosis

Exclusion Criteria:

* age \<18 years
* previous history of roux-en-y gastric bypass
* patients undergoing other bariatric procedures
* pre-operative opioid analgesics

Primary outcomes:
measure: Post-Operative Pain
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Post-Operative Pain
timeFrame: 48 hours post-surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Staff
name: Alisan Fathalizadeh, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827579: Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)
Official title: Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Haematological Malignancies
Keywords: Transplant
CD25/71 allodepleted donor T cells
Infection
Acute Myeloid Leukaemia
Acute Lymphoblastic Leukaemia
Adult
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2013-04-09
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.


Eligibility criteria: Inclusion Criteria:

* Age ≥16 years
* Underlying haematological malignancy
* Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
* Written Informed consent

Exclusion Criteria:

* Life expectancy \< 6 weeks
* Female patients who are pregnant and lactating
* Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Primary outcomes:
measure: Circulating CD3+ve T cell count at 4 months post-SCT
timeFrame: 4 months post transplant
Secondary outcomes:
measure: Incidence of grade II-IV acute and chronic GVHD
timeFrame: 1 year post transplant
measure: Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping
timeFrame: 1 year post transplant
measure: In vitro anti-viral responses of circulating PBMC
timeFrame: 1 year post transplant
measure: Transplant related mortality at 1 year post-SCT
timeFrame: 1 year post transplant
measure: Disease-free survival at 1 year post-SCT
timeFrame: 1 year post transplant
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Persis Amrolia
role: STUDY_CHAIR
References: