louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04100421: Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients
Official title: Study on the Level of Bisphenol Compounds in Patients With Chronic Kidney Disease and Renal Replacement Therapy and Relationship Between Bisphenols and Dialyzer Membrane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Hemodialysis Complication
Keywords: bisphenol
human exposure
chronic kidney disease
blood purification
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD, on dialysis in one center, and age- and gender- matched healthy volunteers were enrolled from Shanghai Ninth People's Hospital affiliated to Shanghai JiaoTong University.

Brief summary: In this retrospective study, the serum levels of Bisphenol A (BPA) and three BPA analogs, namely, bisphenol B (BPB), bisphenol S (BPS), and bisphenol F (BPF), in patients with CKD, patients on dialysis therapy and healthy control were investigated to find out if BPA and BPA analogs accumulates in patients with chronic kidney disease (CKD), and if hemodialysis filters contribute to bisphenol burden in patients on hemodialysis (HD).


Eligibility criteria: Inclusion Criteria:

* age 18; informed consent

Exclusion Criteria:

* absence of active inflammatory, infectious, malignant diseases, acute chronic kidney disease, or pregnancy at the initiation or during the study

Primary outcomes:
measure: Death
timeFrame: 2017.01-2018.06
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References:
Clinical trial NCT02537821: HLA Sensitization in Severely Burned Patients
Official title: HLA Sensitization in Severely Burned Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severely Burned Patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 50
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: Severely burned patients

Brief summary: Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin) and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in severely burned patients.


Eligibility criteria: Inclusion Criteria:

* severely burned patients in need for hospitalization

Exclusion Criteria:

* hematologic diseases
* Cancer

Primary outcomes:
measure: HLA antibody formation (HLA Sensitization) (Unit: PRA in %)
timeFrame: Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Raemistrasse 100, 8091
name: Jan Plock, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572021: A Comparison of the Outcomes in Fortiva and Strattice Mesh
Official title: A Comparison of the Outcomes in Fortiva and Strattice Mesh
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Keywords: ventral hernia
surgical biologic mesh
hernia complications
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of prospective group to retrospective group
Primary purpose: TREATMENT

Brief summary: A comparison of ventral hernia repair with Strattice and Fortiva mesh.Primary The study team aims to determine the hernia recurrence rates for RTI Surgical biologic mesh (Fortiva) compared to Strattice. Also the study team aims to determine the mesh related complications for RTI Surgical biologic mesh (Fortiva) compared to Strattice

Detailed description: This study will be a prospective, matched study of patients using Fortiva biologic mesh to determine the rates of hernia recurrence and mesh related complication compared to Strattice mesh. Patients who meet the inclusion and exclusion criteria will be prospectively enrolled to receive a Ventral Hernia Repair (VHR) using Fortiva biologic mesh and will be compared to a retrospective cohort of patients with a VHR that utilized Strattice mesh. Patients will be propensity matched in a 1:3 (Fortiva : Strattice) fashion based on age, sex, and hernia defect size.

Eligibility criteria: Inclusion Criteria:

* Ventral Hernia requiring surgical repair

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Frequency of participants with a Hernia recurrence
timeFrame: 1 year follow up post surgical repair
measure: Percent of participants with a Hernia recurrence
timeFrame: 1 year follow up post surgical repair
Secondary outcomes:
measure: Frequency of participants with a Mesh related complication
timeFrame: 1 year follow up post surgical repair
measure: Percent of participants with a Mesh related complication
timeFrame: 1 year follow up post surgical repair
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Todd Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03553121: Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.
Official title: Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Bowel Functions
Keywords: gynecologic cancer
postoperative bowel function
walking
debulking
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2018-06-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: walking preoperatively not walking preoperatively
Primary purpose: PREVENTION

Brief summary: Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.


Eligibility criteria: Inclusion Criteria:

* patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy

Exclusion Criteria:

* ASA score \>2 orthopedic problems ileostomy or colostomy \>24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)

Primary outcomes:
measure: the time to the first passage of flatus after surgery
timeFrame: 6 hours- 5 days
Secondary outcomes:
measure: the time to first defecation
timeFrame: 6 hours- 7 day
measure: time to first bowel movement
timeFrame: 6 hours- 5 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Study officials:
References:
citation: Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.
citation: Ozdemir IA, Comba C, Demirayak G, Gulseren V, Erdogan SV, Aslanova F, Afsar S, Gungorduk K. Impact of pre-operative walking on post-operative bowel function in patients with gynecologic cancer. Int J Gynecol Cancer. 2019 Oct;29(8):1311-1316. doi: 10.1136/ijgc-2019-000633. Epub 2019 Jul 19.
Clinical trial NCT01141621: The Dallas Hereditary Spherocytosis Cohort Study
Official title: The Dallas Hereditary Spherocytosis Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hereditary Spherocytosis
Keywords: HS
congenital hemolytic anemia
splenectomy
quality of life
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 55
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Center for Cancer and Blood Disorders outpatient clinics

Brief summary: The purpose of this study is to

1. better characterize the short term and long term natural history of hereditary spherocytosis (HS) including diagnosis, complications, and indications for and response to splenectomy
2. evaluate and describe the health-related quality of life in children with HS.

Detailed description: Patients with a new or established diagnosis of HS seen at Children's Medical Center will be asked to enroll in the study. Previous and current medical records will be reviewed to systematically catalogue their history of HS, including diagnosis, complications, hospitalizations, medications and laboratory data. Health-related quality of life questionnaires will be given to the patients and their parents at enrollment and periodically during the follow-up. Those who agree will have up to three small samples of blood collected and frozen for future laboratory studies of complications associated with HS and/or splenectomy.

We anticipate enrolling approximately 200 children and young adults with HS in this study and following them until adulthood (age 18-21 years).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of HS with or without prior splenectomy
* Age 0 - 21 years
* Spanish-speaking subjects are eligible to participate

Exclusion Criteria:

* Unable to provide contact information for follow-up

Primary outcomes:
measure: Health related quality of life
timeFrame: Approximately at 5 years
Secondary outcomes:
measure: Primary indications for splenectomy
timeFrame: Approximately at 5 years
measure: Complications of HS
timeFrame: Approximately at 5 years and at 10 years
measure: Complications of splenectomy
timeFrame: Approximately at 5 years
measure: Diagnosis of HS
timeFrame: At enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04385121: Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
Official title: Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Stress Disorders, Post-Traumatic
Anxiety
Depression
Keywords: COVID-19
Psychological impact
Family members
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 88
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: Family members of COVID+ patient

Brief summary: The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.


Eligibility criteria: Inclusion Criteria:

* Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition.
* A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner.
* The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor.

Exclusion Criteria:

* Difficulties in understanding French

Primary outcomes:
measure: Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: CHU de Strasbourg
name: Julie HELMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrie M, Aquin C, Buis G, Gehant E, Granier A, Kercha H, Le Guillou C, Martin G, Roulot K, Meziani F, Putois O, Helms J. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021 Jan 9;9(1):5. doi: 10.1186/s40560-020-00520-w.
Clinical trial NCT03390621: Parental Feeding Styles and Child Dietary Quality
Official title: Parental Feeding Styles and Child Dietary Quality at Dinner Among Low-income Minority Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Quality
Keywords: parent feeding styles
dietary quality
dinner meal
preschool
low-income
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 177
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals from the larger data set of 177 families who had complete dietary and demographic data.

Brief summary: In this study, the investigators will use an existing data set to examine the relationship between parent feeding styles and the quality of the dinner meal using the Healthy Eating Index.

Detailed description: Investigators will use an existing data set collected between 2007 and 2009. The purpose of the larger data set including 177 families was to examine parent - child interactions during dinner meals in low-income Hispanic and African-American families participating in Head Start programs. Data was collected on parent-child interactions and information regarding the food served and consumed by children during dinner meals. The specific aims included: 1) examining the overall diet quality using the Healthy Eating Index of Head Start preschool dinner meals by parent feeding styles, an 2) the diet quality of the dinner meal served to that of the meal consumed and within each of the parent feeding styles.

Eligibility criteria: Inclusion Criteria:

* Parents who were responsible for feeding the child while the child was not in Head Start and their oldest child enrolled in Head Start.

Exclusion Criteria:

* Any children who have dietary restraints or food allergies.

Primary outcomes:
measure: Dietary Quality
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sheryl O Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hughes SO, Power TG, Papaioannou MA, Cross MB, Nicklas TA, Hall SK, Shewchuk RM. Emotional climate, feeding practices, and feeding styles: an observational analysis of the dinner meal in Head Start families. Int J Behav Nutr Phys Act. 2011 Jun 10;8:60. doi: 10.1186/1479-5868-8-60.
Clinical trial NCT02032121: Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Official title: Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Pediatric Cancer
Keywords: Cancer survivors
Long-term cancer survivor
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.


Eligibility criteria: Inclusion Criteria:

* 6-30 years of age
* 2 years from the completion of therapy for cancer
* free of active disease

Exclusion Criteria:

* \<6 or \> 30 years of age
* current cancer treatment or inside of 2 years post treatment
* Active disease/infection

Primary outcomes:
measure: Vascular Inflammation
timeFrame: single time point at initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, MIller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Tracie L Miller, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512421: Navigated EM Total Knee Replacement: Accuracy Study
Official title: Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Total Knee Replacement
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men and women that are candidates for total knee replacement.

Brief summary: The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.

The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.

It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.

Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.

In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.


Eligibility criteria: Inclusion Criteria:

* Signing informed consent

Exclusion Criteria:

* Pregnancy
* Soldiers in active military service

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Orthopedic Department
Study officials:
affiliation: Hadassah Medical Organization
name: Meir Libergall, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994121: Prospective Investigation of Multiple Sclerosis in the Three Rivers Region
Official title: Prospective Investigation of Multiple Sclerosis in the Three Rivers Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 7500
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with multiple sclerosis and related disorders and controls

Brief summary: In this longitudinal prospective natural history study of multiple sclerosis (MS), the overarching goal is to understand the factors that influence individual variation in disease trajectory and treatment response and pave the way for realizing precision medicine in MS. Because MS is a chronic neurological disorder, this observational cohort study will span a 30-year time frame.

Detailed description: Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes, Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis, Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor Inventory, and the COVID19 Response Surveys.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for MS patients include:

  1. willing and able to give consent
  2. age 7 years or older
  3. diagnosis of multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease
* For healthy controls:

  1. Age 7 years or older
  2. Willing and able to provide consent (for \>=18 years) or assent with permission from at least one of the child's parents (for \<18 years)
  3. No known personal history of multiple sclerosis or related disorders
  4. No other chronic diseases
  5. Family members, unrelated household controls, or controls from the general population could be eligible

There is no exclusion criteria.

Primary outcomes:
measure: Establish a prospective cohort of well-characterized MS patients and controls
timeFrame: within 30 years
measure: Investigate the predictors of the variations in disease trajectory and treatment response
timeFrame: within 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Zongqi Xia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: