louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06272084: Analysis of TPE Treatments With multiFiltratePRO
Official title: Analysis of TPE Treatments With multiFiltratePRO
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Keywords: Therapeutical Plasma Exchange
ASFA Guideline
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: X-act Cologne Clinical Research GmbH
First posted: 2024-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.

Brief summary: Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.

Detailed description: The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the TPE mode of the multiFiltratePRO system.

The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.

Eligibility criteria: Inclusion Criteria:

* Body weight ≥40kg irrespective of the age
* Patients with indication for TPE treatment according to ASFA guideline
* Patients have been treated with TPE between January 2019 and October 2023
* Availability of at least 50% of the parameters to be documented for the patient

Exclusion Criteria:

* Participation in an interventional clinical study during the retrospectively collected TPE treatment data
* Previous documentation within this study
* Simultaneous use of another filter for additional therapy form

Primary outcomes:
measure: Total amount of exchange plasma (prescribed vs achieved exchange volume)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
state: Bavaria
Study officials:
affiliation: Klinikum Aschaffenburg-Alzenau
name: Stefan Büttner, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587884: Anti-recurrence Treatment of Postresection on HCC Patients With MVI Presence and Over-expression of ASPH
Official title: Anti-recurrence Treatment of Postresection on Hepatocellular Carcinoma Patients With Microvascular Invasion Presence and Over-expression of Aspartate Beta-hydroxylase: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Recurrence
Microvascular Invasion
Aspartate beta-hydroxylase
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 180
Sex: ALL
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: The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on the prognosis of patients with microvascular invasion presence(MVI) and overexpression of Aspartate-β-hydroxylase(ASPH).


Eligibility criteria: Inclusion Criteria:

1. Via clinical diagnosis and confirm it is primary liver cancer
2. Pathological evidence of HCC
3. Confirm presence of MVI and over-expression of ASPH after opreation
4. Within Milan criteria
5. Estimate tumor can gain treatment of curing operation
6. No evidence for extrahepatic metestasis
7. liver function ：Child-Pugh A/B

Exclusion Criteria:

1. Reject to attend
2. Impossible to come to our hospital for physical examination regularly
3. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction
4. Female with pregnancy or during the lactation period

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Time to recurrence
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Shen Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434584: Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
Official title: Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: include 40 patient cases and 8 doctors (4 senior and 4 junior)

Brief summary: The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.


Eligibility criteria: Case:

Inclusion Criteria:

* Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
* Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.

Exclusion Criteria:

- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).

Doctor

Inclusion Criteria:

licensed medical practitioner.

Primary outcomes:
measure: Doctors' decision-making accuracy
timeFrame: up to 2 months
measure: Doctors' decision-making confidence
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaoying Li
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaoying Li, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00154284: Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Official title: A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Organ Transplantation, Renal Transplantation
Keywords: Renal transplantation,
everolimus,
immunosuppressants,
basiliximab,
cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 114
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: The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Detailed description: This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Eligibility criteria: Inclusion Criteria:

* Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
* Renal cold ischemic time \< 36 hours.
* Age of donor \< 65 years.

Exclusion Criteria:

* Patients who have received an investigational drug within 4 weeks of baseline period.
* Patients who are recipients of multiple organ transplants, including any organ other than kidney.
* Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
timeFrame: At Month 3 and Month 12
Secondary outcomes:
measure: Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
timeFrame: Month 12
measure: Serum Creatinine at Month 6 and 12
timeFrame: 6 month and 12 months
measure: Calculated Creatinine Clearance at 6 Month and 12 Month
timeFrame: 6 month and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Grinyo JM, Paul J, Novoa P, et al. (2010). Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation, Am J Transplant; 10(Suppl 4): 503: Abstract 1636.
Clinical trial NCT06035484: Effect of Seat Height and Angle on Wheelchair Foot Propulsion
Official title: Effect of Seat Height and Angle on Wheelchair Foot Propulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Manual Wheelchair
Bilateral propulsion
Foot propulsion
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Within-subjects repeated measures design
Primary purpose: OTHER

Brief summary: The purpose of the project is to explore the effect of differences in seat height and seat angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are to determine whether differences in seat height and seat angle impact: a) propulsion speed; b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and d) perceived difficulty with foot propulsion.

A repeated measures designs allows comparison between 5 different seat height conditions and 4 different seat angle conditions to determine whether there are significant differences in outcome, and if so, which conditions provide better outcomes. Participants will propel a customized MWC through a standardized course using each seat configuration; the sequence will be randomized to reduce any learning effects.


Eligibility criteria: Inclusion Criteria:

* student in College of Rehabilitation Sciences enrolled in Master of Occupational Therapy, Master of Physical Therapy, or Bachelor of Respiratory Therapy program at the University of Manitoba.
* Able-bodied individuals

Exclusion Criteria:

* Students whose hip width exceeds 21 inches or lower leg length is shorter than 16 inches will be excluded as the test manual wheelchair will not accommodate these dimensions.

Primary outcomes:
measure: Propulsion speed
timeFrame: ~30-60 seconds
measure: Knee range of motion
timeFrame: ~30-60 seconds
measure: Effectiveness of foot propulsion gait
timeFrame: ~30-60 seconds
measure: Perceived difficulty with foot propulsion
timeFrame: ~30-60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
citation: Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
citation: Heinrichs ND, Kirby RL, Smith C, Russell KFJ, Theriault CJ, Doucette SP. Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 1 - wheeling forward on a smooth level surface. Disabil Rehabil Assist Technol. 2021 Nov;16(8):831-839. doi: 10.1080/17483107.2020.1741036. Epub 2020 Apr 2.
Clinical trial NCT04033484: Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
Official title: Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineal Wound Complications After ELAPE
Keywords: extralevator abdominoperineal excision
Perineal wound healing
negative pressure wound therapy
biological mesh
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. A systematic review suggested a significant decrease in perineal wound complications when using incisional negative pressure wound therapy was demonstrated, with surgical site infection rates as low as 9% (vs 41% in control groups). The review suggested that incisional negative pressure wound therapy decreases perineal wound complications after abdominoperineal resection. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.


Eligibility criteria: Inclusion Criteria:

1. Rectal cancer within 4 cm of the anal verge
2. T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy
3. Absence of distant metastases
4. Absence of intestinal obstruction

Exclusion Criteria:

1. T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy
2. Distant metastases
3. Intestinal obstruction
4. Pregnancy or lactating
5. Contraindications to surgery
6. A mental disorder

Primary outcomes:
measure: perineal wound complications
timeFrame: 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhen Jun. Wang
Study officials:
References:
Clinical trial NCT04580784: Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer
Official title: Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Radiotherapy Side Effect
Keywords: Breast cancer
Radiotherapy
Hypofractionation
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2020-10-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

Detailed description: Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.

Eligibility criteria: Inclusion Criteria:

1. Histologically proven diagnosis of invasive breast adenocarcinoma.
2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
3. No macroscopic evidence of distant metastases at diagnosis.

Exclusion Criteria:

1. Prior radiation to the thoracic region.
2. Pregnancy.
3. Patients with synchronous or prior malignancy.
4. Positive surgical margins.

Primary outcomes:
measure: Change in cosmetic breast appearance
timeFrame: six months
measure: Acute radiation toxicity assessment
timeFrame: six months
measure: Patient quality of life assessment.
timeFrame: six months
measure: Patient satisfaction.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El AiniH
Study officials:
affiliation: Kasr El AiniH
name: Mona Salem, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418284: Online Learning of Veterinary Anatomy During COVID-19 Pandemic
Official title: Evaluation of the Online Learning of Veterinary Anatomy During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Anatomy
online learning
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 1517
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Veterinary Medical students who are studying anatomy online during the pandemic lockdown

Brief summary: This study aims to analyze the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Detailed description: Analysis of the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Eligibility criteria: Inclusion Criteria:

* Veterinary Medical students who are studying anatomy online during the pandemic lockdown

Exclusion Criteria:

-

Primary outcomes:
measure: Measure the students' interest in studying anatomy on-line.
timeFrame: 05/06/2020-05/07/2020
Secondary outcomes:
measure: Assess the easiness of using technology during studying anatomy online
timeFrame: 05/06/2020-05/07/2020
measure: Assess the student satisfaction regarding the provided study materials
timeFrame: 05/06/2020-05/07/2020
Other outcomes:
measure: Online learning as a substitution for face-to-face teaching
timeFrame: 05/06/2020-05/07/2020
measure: Measure the understanding of anatomy using on-line learning.
timeFrame: 05/06/2020-05/07/2020
measure: Assess the average studying time of anatomy before and during the pandemic lockdown
timeFrame: 05/06/2020-05/07/2020
measure: Assess the common problems during studying anatomy online
timeFrame: 05/06/2020-05/07/2020
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References:
Clinical trial NCT01910584: Quality of Life and Sexual Function of the Novasure Endometrial Ablation in Menorrhagia
Official title: Prospective Study of the Influence on Quality of Life and Sexual Function of the Novasure Endometrial Ablation in the Treatment of Menorrhagia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Sexual Activity
Keywords: quality of life
sexual activity
Novasure endometrial ablation
menorrhagia
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients diagnosed menorrhagia scheduled for Novasure endometrial ablation in The First Affiliated Hospital between November 2012 and November 2015

Brief summary: The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.

Detailed description: patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.

patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of menorrhagia
* family complete
* normal endometrial pathology
* had not been referred specifically for surgery
* with normal uterine cavity

Exclusion Criteria:

* pregnancy or demand to preserve fertility
* acute reproductive tract inflammation or urinary tract inflammation
* pathology demonstrate endometrial cancer or precancerous change
* acute pelvic inflammation
* intrauterine device(IUD) in uterus
* depth of uterine cavity less than 4cm or more than 10cm
* pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)

Primary outcomes:
measure: Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
timeFrame: one year after Novasure Endometrial Ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shu-Zhong Yao, PhD & MD
role: STUDY_DIRECTOR
References: