louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03723603: An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Official title: A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.


Eligibility criteria: Inclusion Criteria:

* Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
* Wound has failed at least one wound care treatment
* Wound size is between 1 and 100 square centimeters
* Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is confirmed as being free of infection and absence of osteomyelitis

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Unable or unwilling to receive porcine collagen
* Wound is infected or presence of osteomyelitis
* Allergy or sensitivity to collagen
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol

Primary outcomes:
measure: Change in Wound Size Over Twelve Week Period
timeFrame: Baseline to 84 days
Secondary outcomes:
measure: Change in Bates-Jensen Wound Assessment Tool
timeFrame: Baseline to 84 days
measure: Change in Reported Pain Level
timeFrame: Baseline to 84 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Foot and Ankle Clinic
state: Ohio
Study officials:
affiliation: Cleveland Foot and Ankle Clinic
name: Windy Cole
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05534503: Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?
Official title: Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eventration of the Abdominal Wall
Keywords: Eventration of the abdominal wall
Hernia
Drainage
Retromuscular position
Digestive surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) operated on at HUS between 01/01/2018 and 12/31/2020

Brief summary: Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Patient operated on at HUS between 01/01/2018 and 12/31/2020
* Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position.
* Patient not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Patient who has expressed opposition to the reuse of his or her data for scientific research purposes.
* Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis)
* Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position

Primary outcomes:
measure: infection after drainage in contact with a retromuscular prosthesis
timeFrame: 1 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de chirurgie générale et digestive - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05444803: Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
Official title: Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Analgesia
Hip Fractures
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia

Detailed description: Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.

Eligibility criteria: Inclusion Criteria:

* patients with hip fracture scheduled for surgery under spinal anesthesia.

Exclusion Criteria:

* hemorrhagic diathesis,
* peripheral neuropathy,
* allergy to local anesthetics,
* mental disorders,
* use of analgesics for 8 h before the performance of spinal block

Primary outcomes:
measure: Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
timeFrame: 30 minutes
Secondary outcomes:
measure: Rate of pain scores at rest
timeFrame: 30 min
measure: Rate of pain scores on passive limb lifting
timeFrame: 30 min
measure: rate of postoperative pain scores
timeFrame: 24 hours
measure: Amount of postoperative analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Traning and Research Hospital
name: Safa Eroglu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145103: Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses
Official title: Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation


Eligibility criteria: Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the IOLMaster evaluation;
* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
* Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

* BCVA not available preoperatively or better than 0.3 logMAR pre-op
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Concurrent participation in another drug or device investigation -

Primary outcomes:
measure: Visual acuity
timeFrame: 12 to 18 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Ophthalmology
Study officials:
References:
citation: Johansson B, Daniel ACS, Herbers C, Gerl M, Kretz FTA. Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study. BMC Ophthalmol. 2020 Jun 11;20(1):224. doi: 10.1186/s12886-020-01493-y.
Clinical trial NCT02539303: Delivery of Yamani-15/5 Chemical Solution for PAD
Official title: In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).


Eligibility criteria: Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).

Exclusion:

* Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
* Patients with chronic kidney disease stage V (unless on dialysis).
* Patients with liver cirrhosis.
* Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
* Patients with history of stroke in the last 3 months.
* Patients with unstable angina or history of myocardial infarction in the last 3 months.
* Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
* Women who are pregnant or nursing.

Primary outcomes:
measure: Feasibility
timeFrame: Change from baseline
Secondary outcomes:
measure: Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
timeFrame: Compared to baseline
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Houssam Farres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278703: Opioids Following ACL
Official title: The Utilization of Opioid Medication Following ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 192
Standard ages: CHILD
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 effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).


Eligibility criteria: Inclusion Criteria:

- All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

Exclusion Criteria:

* Concomitant procedure other than meniscectomy or meniscal repair.
* ACL revision
* History of chronic pre-operative opioid use
* History of substance abuse
* Workmen's compensation claims
* Pregnancy

Primary outcomes:
measure: Post-operative pain
timeFrame: 14 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Orthopaedics at Egg Harbor Township
state: New Jersey
Study officials:
References:
Clinical trial NCT06012903: Lower Urinary Tract Symptoms and School Functioning in Children
Official title: Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Urinary Tract Symptoms
Neurodevelopmental Disorders
Incontinence, Urinary
ADHD
ASD
Developmental Coordination Disorder
Child Development
Quality of Life
Keywords: lower urinary tract symptoms
Quality of life
Pediatrics
neurodevelopmental disorders
VSSDES
DCD-Q
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2023-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children following education in recruited primary, regular education schools and their respective parents/guardians and teachers

Brief summary: Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs) can adversely affect children as well and can cause restrictions in their daily life, especially in their school-environment.

The goal of this observational study is to identify the prevalence of LUTS in Flemish primary school children.The main questions it aims to answer are:

* How prevalent are LUTS in regular primary education?
* Is there a relation with well-being in school environment?
* Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked to fill in questionnaires related to this research question.


Eligibility criteria: Inclusion Criteria:

* Children in 4th-6th grade
* Parents whose children are in grades 1-6
* Teachers responsible for teaching children in grades 1-6
* Children who attend regular primary education
* Capable of speaking \& comprehending Dutch

Exclusion Criteria:

* High school students
* home-schooled children
* children who attend special needs education
* Language barrier to understanding Dutch

Primary outcomes:
measure: Bladder and bowel dysfunction
timeFrame: through study completion from the parent-group, 25 minutes
measure: School functioning
timeFrame: through study completion from the children-group, 30 minutes
Secondary outcomes:
measure: Influencing factors on school functioning
timeFrame: through study completion from the parent-, children- and teacher-group, 30 minutes
measure: Perception of treatment characteristics
timeFrame: through study completion of the parent-group, 25 minutes
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital/Ghent University
state: East Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Ellen Vandamme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Bieke Samijn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04816903: Gyni™ Study With Leumit Health Services
Official title: Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginitis
Keywords: gynecology
IVD
Lead sponsor: GynTools Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Leumit Health Services
First posted: 2021-03-25
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Group-A Blinded Group-B Unblinded
Primary purpose: DIAGNOSTIC

Brief summary: About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.

Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes.

The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.


Eligibility criteria: Inclusion Criteria:

* Female ≥18 years old
* Able to read, understand and sign an informed consent form
* At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.

Exclusion Criteria:

* Patients under the age of 18 years
* Patient is unfit to provide an informed consent
* Patient with vaginal bleeding, including menstruation within past 24 hours21
* Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
* Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)

Primary outcomes:
measure: Comparison parameter
timeFrame: 12 months
measure: Comparison parameter
timeFrame: 12 months
measure: Comparison parameter
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Netanya Women's health center, Leumit Health services (HMO)
state: Central
city: Kfar Yasif
country: Israel
facility: Kfar Yasif clinic
state: North
city: Kiryat Bialik
country: Israel
facility: Kiryat Bialik, Leumit health services (HMO) Women's health clinic
state: North
city: Jerusalem
country: Israel
facility: Leumit women's health
Study officials:
References:
Clinical trial NCT00412503: Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Official title: Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory Tumors
Malignant Tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2006-12-18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.


Eligibility criteria: Inclusion Criteria:

* histologically documented malignant tumor
* refractory or relapsing after conventional treatments and for which there is no curative treatment available
* life expectancy \> 8 weeks
* no significant co-morbidity (NCI-CTC \< 2)
* No organ toxicity
* no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy

Exclusion Criteria:

* Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds
* Hypersensibility to Dacarbazine (DTIC)
* Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase

Primary outcomes:
measure: - To determine MTD and DLT of each drug
Secondary outcomes:
measure: To assess safety profile
measure: To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
measure: To assess the efficacy of the association
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Ille de France
Study officials:
affiliation: CHU Toulouse
name: Herve Rubie, MD
role: STUDY_CHAIR
References: