louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05881798: Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Official title: Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Vein Thrombosis
Venous Thromboembolism
Pulmonary Embolism
Keywords: Celect Platinum Vena Cava Filter
Gunther Tulip Vena Cava Filter Retrieval Set
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter

Brief summary: This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.


Eligibility criteria: Inclusion Criteria:

* A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
* Subject has not previously participated in the Cook MDR-2126 study.

Exclusion Criteria:

* Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.

Primary outcomes:
measure: Filter-related primary endpoint (safety)
timeFrame: Index procedure through 12-months post procedure
measure: Filter-related primary endpoint (performance)
timeFrame: 12-months post procedure
measure: Filter Retrieval-related primary endpoint
timeFrame: Through 30-days post procedure
measure: Filter Retrieval-related primary endpoint
timeFrame: At the time of retrieval procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
Study officials:
References:
Clinical trial NCT06643598: Virtual A2 Study for At Risk Children
Official title: Virtual Abecedarian Approach (A2) For IPNH-NDCP (Infants With Perinatal Neurological Histories - At Risk for Neurodevelopmental Disabilities or Cerebral Palsy)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxic Ischaemic Encephalopathy (HIE)
Premature Birth
Cerebral Palsy
Neurological Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 100
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.


Eligibility criteria: Inclusion Criteria:

1. IPNH-NDCP patients, including:

   * Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
   * premature children (born at less than 28 weeks gestational age).
2. Parent or legal guardian will also be enrolled as a participant
3. Parents must be English-speaking (able to provide consent and complete questionnaires).

Exclusion Criteria:

1. Not suitable for study participation due to other reasons at the discretion of the investigator.
2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
4. For parents or legal guardians, there are no exclusion criteria.

Primary outcomes:
measure: Parent Satisfaction Questionnaire
timeFrame: Assessed at end of treatment (up to 60 months)
measure: Number of Sessions Attended
timeFrame: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)
Secondary outcomes:
measure: Bayley Assessment
timeFrame: Data collected at 12, 24, 36, 48 and 60 month time points
measure: Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: Data collected at the 24, 36, 48 and 60 month time points
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Data collected at 24, 36, 48 and 60 month time points
measure: Early Executive Functions Questionnaire (EEFQ)
timeFrame: Data collected at 12 and 24 month time points
measure: NIH Baby/Infant and NIH Pediatric Toolbox
timeFrame: Data collected at 12, 24, 36, 48 and 60-month time points
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Melisa Carrasco McCaul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00703898: Durability of Nevirapine-Based Antiretroviral Regimen
Official title: Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
nevirapine
durability
AIDS
Treatment Naïve
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
First posted: 2008-06-24
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.


Eligibility criteria: Inclusion Criteria:

* HIV-infected individuals ≥15 years of age
* CD4 cell count \<350 cells/mm3
* Willing to participate and give consent form

Exclusion Criteria:

* previous antiretroviral therapy
* pregnancy
* receiving a medication that has drug-drug interactions with NVP or RFP
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>5 times of upper limit of normal range

Primary outcomes:
measure: number of patients with undetectable plasma HIV-1 viral load
timeFrame: 240 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Department of Medicine, Bamrasnaradura Infectious Diseases Institute
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute
name: Weerawat Manosuthi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manosuthi W, Tantanathip P, Prasithisirikul W, Likanonsakul S, Sungkanuparph S. Durability of stavudine, lamivudine and nevirapine among advanced HIV-1 infected patients with/without prior co-administration of rifampicin: a 144-week prospective study. BMC Infect Dis. 2008 Oct 14;8:136. doi: 10.1186/1471-2334-8-136.
Clinical trial NCT06683898: The Role of Focus Strategies on Pilates
Official title: The Role of Focus Strategies on Pilates Performance and Reaction Time: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reaction Time
Humans
Exercise Therapy
Exercise Movement Techniques
Pilates
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims of the randomized controlled study is compare to the effects of external and internal focus strategies, commonly used in Pilates, on participants' reaction time and performance metrics. Conducted over an 8-week Pilates program at Alanya Alaaddin Keykubat University, we plan to include 25 participants in each focus group. Participants in the external focus group will use equipment to perform exercises, while the internal focus group will perform exercises with attention to body positioning.

Detailed description: The primary aim of this study is to examine the difference in effects between 8-week internally and externally focused Pilates exercises on the performance of young sedentary individuals. A secondary aim is to investigate the effects of internally and externally focused Pilates exercises on the physical characteristics and reaction time of young sedentary individuals.

Eligibility criteria: Inclusion Criteria:

* Volunteers aged between 18 and 30 years who have no musculoskeletal disabilities and are willing to exercise were included in the study.

Exclusion Criteria:

* Had any cardiovascular or musculoskeletal condition that would prevent them from exercising,
* Had an acute pain history of 5 or more on the visual analog scale in the past week,
* Had a systemic disease that would prevent exercise,
* Had a BMI of 30 or above,
* Had any issues that would hinder their ability to perceive or understand verbal commands, or had hearing problems.

Primary outcomes:
measure: Multiple Jump Test
timeFrame: Baseline - right after the intervention
measure: BFS Vertical Jump Test
timeFrame: Baseline - right after the intervention
measure: Squat Jump Test
timeFrame: Baseline - right after the intervention
measure: Acoustic Reaction Test
timeFrame: Baseline - right after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaaddin Keykubat Üniversity
state: Alanya
Study officials:
References:
Clinical trial NCT03533998: Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT
Official title: Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 30
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutualiste Montsouris).

Brief summary: The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.

Detailed description: Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.

Eligibility criteria: Inclusion Criteria:

* Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies

Exclusion Criteria:

* Primary radiotherapy, brachytherapy and whole-gland treatments

Primary outcomes:
measure: ability of genomic biomarkers to Measuring tumour aggressiveness
timeFrame: molecular analyses
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Qusay Mandoorah, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00511498: Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy
Official title: Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Laparoscopic Radical Prostatectomy
Nightly sildenafil
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-08-06
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

1. Male sex
2. Age \< 65
3. IIEF erectile function domain score \> 26 (out of 30 points possible for this subscale)
4. Steady sexual partner
5. Untreated prostate cancer TNM stage \< cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade \< 8.
6. Willingness to participate in a clinical trial as manifested by informed consent
7. Actually undergo nerve-sparing LRP surgery

Exclusion Criteria:

1. Not fulfilling all of the criteria for entry above
2. Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
3. Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
4. Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively
5. Obstructive sleep apnea

Primary outcomes:
measure: IIEF score
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Christian P Pavlovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06835998: The Effect of Stress Ball Use on Stress, Sleep Quality and Comfort Levels
Official title: The Effect of Stress Ball Use on Stress, Sleep Quality, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Stress Ball
Sleep Quality
Comfort Levels
Hemodialysis Patients
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled, parellel
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.

Detailed description: The study population consisted of patients undergoing hemodialysis treatment in the hemodialysis unit of a training and research hospital located in western Türkiye between February 19, 2024, and April 19, 2024 (N=90). The study sample included a total of 60 patients (30 in the experimental group and 30 in the control group), selected through randomization from those who met the research criteria and agreed to participate. During the study, two patients from the experimental group and one patient from the control group were excluded from the study due to health issues that prevented them from using the stress ball. The study was conducted with a total of 57 patients (28 in the experimental group and 29 in the control group).

Eligibility criteria: Inclusion Criteria:

* participants had to be volunteers
* aged 18 years and older,
* undergoing hemodialysis treatment for at least six months,
* attending hemodialysis sessions three times a week,
* not having any conditions that would impede the use of a stress ball.

Exclusion Criteria:

* individuals who refused to participate in the study,
* those undergoing hemodialysis for less than six months,
* patients attending hemodialysis sessions twice a week,
* individuals with health problems that prevented them from using a stress ball.

Primary outcomes:
measure: Stress evaluated using the Perceived Stress Scale
timeFrame: Change from before implementation and 4th week of practice
measure: Sleep quality ewaluated the Pittsburgh Sleep Quality Index
timeFrame: Change from before implementation and 4th week of practice
measure: Comfort evaluated using Hemodialysis Comfort Scale Version II
timeFrame: Change from before implementation and 4th week of practice
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Turkey, Muğla Sıtkı Koçman University
Study officials:
affiliation: Muğla Sıtkı Koçman Universty
name: Ayse Kacaroglu Vicdan, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman Universty
name: Dilek Dilek Gibyeli Genek, Assisstant Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06744998: Hemopatch Implication After Axillary Dissection for Breast Cancer
Official title: Hemopatch Implication After Axillary Dissection for Breast Cancer: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Primary breast cancer
Axillary dissection
Axillary seroma
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective monocentric controlled randomized surgical trial
Primary purpose: PREVENTION

Brief summary: Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

Detailed description: With the de-escalation of axillary lymph node dissection (ALND) to sentinel lymph node biopsy as a surgical procedure staging in breast cancer (BC), the physical and psychological morbidity has been improved significantly. However, ALND is still considered in a relevant number of BC patients as treatment for controlling locoregional axillary disease, and these patients present still important complications related to ALND, such as neuropathy, limitation of shoulder movement, arm lymphedema, and most commonly seroma evolution.

Multiple surgical devices with the intent to improve sealing of lymphatic and blood vessels have demonstrated contrasting results in the incidence of seroma formation after ALND and are no utilized routinary. Non-surgical devices, such as chemical medications, sealing small vessels by stimulating collagen and fibrinogen syntheses, also could improve to sealing of the lymphatic vessels. Additionally, fibrin glue-coated collagen patches and fibrin glue application to the surgical cavity were already tested in ALND patients with contrasting benefit in term of seroma prevention. Unfortunately, none of these studies provided a good solution to eliminate or reduce the incidence of seroma after ALND in BC treatment.

Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

Eligibility criteria: Inclusion Criteria:

* Patients with primary breast cancer
* Mastectomy or breast conserving surgery
* Patients eligible for axillary dissection
* Male or female
* Any age
* Previous (or not) neoadjuvant treatments
* Any breast histotypes

Exclusion Criteria:

* Previous axillary surgery

Primary outcomes:
measure: Axillary seroma evaluation
timeFrame: 1 week
Secondary outcomes:
measure: Hospital access evaluation
timeFrame: 1 month
measure: Drain duration evaluation
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Giovanni Corso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982098: Prevention of Urinary Incontinence After Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Prostatectomy
Prostatic cancer
Urinary incontinence
Exercise
Electric stimulation therapy
Counseling
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.

The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* men who will undergo radical prostatectomy for prostatic cancer

Exclusion Criteria:

* previous urinary and/or faecal incontinence
* neurologic bladder
* previous pelvic surgery

Primary outcomes:
measure: Complete continence (PAD test 24 hours <10 cc)
timeFrame: 12 months
Secondary outcomes:
measure: PAD test 24 hours
timeFrame: 12 months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"
Study officials:
affiliation: AUO "Maggiore della Carità" - Novara
name: Carlo Cisari, prof.
role: STUDY_DIRECTOR
affiliation: AUO "Maggiore della Carità" - Novara
name: Carlo Terrone, prof.
role: STUDY_CHAIR
References: