louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06171204: The Use of Stromal Vascular Fraction for Knee Arthrosis
Official title: Gebruik Van Stromale Vasculaire Fractie Uit Vetweefsel Na Invriezing Voor Knie Arthrose
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A trial to investigate the safety and efficacy of SVF for the treatment of knee arthrosis.

Patients will undergo a single liposuction to obtain the SVF. The SVF will then be isolated and frozen in our laboratory. The SVF will then be injected up to 2 times into the fat pad of the patient's knee.

Detailed description: Stromal Vascular Fraction (SVF) from adipose tissue is increasingly being used in the clinic for a variety of conditions (skin disorders, joint pain, etc.). SVF is a collective term for cells that can be obtained from liposuction fat. These cells can be separated from the fat by mechanical processing of the liposuction fat combined with an additional centrifugation.

Despite the fact that enough SVF can be isolated after such a liposuction for multiple treatments (\>3), our research group has found a way to safely freeze SVF without significant loss of SVF cells. In this way, a patient would only have to undergo one liposuction and associated anesthesia to be able to obtain multiple SVF treatments.

Eligibility criteria: Inclusion Criteria:

* Legal capacity
* Osteochondral lesions
* Inflammatory complaints
* (Peri)tendinitis or tendinopathies and ligamentous injuries
* Impingement complaints
* Arthrofibrosis
* Anterior knee pain

Primary outcomes:
measure: Evaluation of the safety of SVF injections after cryo preservation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ GENT
state: Oost-Vlaanderen
Study officials:
References:
Clinical trial NCT06809504: To Assess the Effectiveness of Structured Occupational Therapy (OT) Interventions on Patients With SUD in Inpatient Department (IPD) Settings, Focusing on Improvements in Cognitive, Physical, and Functional Domains
Official title: Restoring Functionality: Occupational Therapy Interventions in Substance Use Drug Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Disorder
Lead sponsor: Foundation of Medical Research and Laboratories, Pakistan
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 12
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 sessions over 4 weeks, 45-minute sessions divided into:

* 15 minutes for physical exercises
* 15 minutes for psychoeducation
* 15 minutes for cognitive tasks and routine planning
Primary purpose: TREATMENT

Brief summary: OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.


Eligibility criteria: Inclusion Criteria:

* Substance abused disorder
* Admitted in rehabilitation center

Exclusion Criteria:

* Severe cognitive impairment
* Physical disability

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA):
timeFrame: baseline and after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: FMRL
state: Sindh
Study officials:
References:
Clinical trial NCT04273204: Relationships Between OLST, GMFM and Pedobarographic Values in CP
Official title: Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy,
gait,
Gross Motor Function Measurement,
stability,
foot pressure
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2020-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.

The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.

Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.


Eligibility criteria: Inclusion Criteria (for experimental group):

* diagnosed unilateral cerebral palsy
* be able to stand on the affected leg for 0 to 30 seconds

Exclusion Criteria:

* Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
* Lower limb surgeries
* Mental disorders

Primary outcomes:
measure: One leg standing test (OLST)
timeFrame: 1 time, baseline of the study
measure: Gross Motor Function Measurement (GMFM)
timeFrame: 1 time, baseline of the study
measure: Pedobarographic Measurement
timeFrame: 1 time, baseline of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kültür University
Study officials:
References:
Clinical trial NCT02501304: Feasibility Study of the ReVENT Sleep Apnea System
Official title: Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Revent Medical International B.V.
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OSA with AHI 15-40
* Body Mass Index (BMI) ≤ 32
* Refused or failed Continuous Positive Airway Pressure (CPAP)
* Evidence of airway collapse at soft palate and/or base of tongue

Exclusion Criteria:

* Prior OSA surgery
* Anatomy unable to accommodate implants
* Chronic immunosuppressive therapy or known problems with wound healing
* Type I or II diabetes
* Active systemic infection
* Pregnancy
* Other major medical conditions that could confound outcome measures or interfere with study completion

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 24 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06029504: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Official title: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulvar Cancer
Sentinel Lymph Node
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-09-08
Enrollment: 115
Sex: FEMALE
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: Patients with primary or recurrent vulva cancer

Brief summary: The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \< 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \< 4 cm.


Eligibility criteria: Inclusion Criteria:

* Patients with primary vulva cancer, FIGO stage IB (tumor \< 4 cm)
* Patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin

Exclusion Criteria:

* Prior irradiation of the vulva or groins
* Prior SNB or inguinal lymphadenectomy in the relevant groin
* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)

Primary outcomes:
measure: Sentinel Node detection rate
timeFrame: Three years
Secondary outcomes:
measure: Sensitivity, specificity, PPV and NPV
timeFrame: Three years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
References:
Clinical trial NCT04014504: Pethidine Analgesia and Neonatal Hearing Screening Test
Official title: Effect of Pethidine Analgesia on False Positivity in Neonatal Hearing Screening Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Newborn Complication
Keywords: Newborn Hearing Screening
Otoacoustic emissions
Pethidine
False positive
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal disease,Pregnant women were included in the study.

Brief summary: Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.

Detailed description: The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.

Eligibility criteria: Inclusion Criteria:

* term singleton pregnancy,
* Gave birth at 37-41 weeks of gestation,
* without chronic internal disease,
* Pregnant women were included in the study.

Exclusion Criteria:

* Newborn hospitalized in intensive care,
* congenital / chromosomal anomaly,
* congenital CMV infection,
* facial / ear deformities,
* family with hearing problems,
* those with hyperbilirunemia,
* tested at \<12 hours after birth,
* maternal infection,
* Diabetes mellitus, recurrent abortion,
* smoking,
* plesanta previa,
* prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and
* newborns who were at risk of asphyxia hypoxia were excluded from the study.

Primary outcomes:
measure: Neonatal Hearing Screening Test
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT02119104: Prevenar (13v) Infant Drug Use Investigation
Official title: Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infants
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 1087
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation.

Brief summary: The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.

Detailed description: The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.

Eligibility criteria: Inclusion Criteria:

* Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
* Infants aged 2 months, inclusive, to 7 months, exclusive
* Infants with no history of administration of pneumococcal vaccines including Prevenar 13
* Infants expected to receive 4 vaccinations

Exclusion Criteria:

* Vaccines must not be performed if the vaccinee corresponds to any of the following:
* Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
* Persons with evident pyrexia
* Persons who evidently have serious acute diseases
* Besides the persons listed above, persons who are in a status inappropriate for immunization

Primary outcomes:
measure: Number of Participants With Adverse Reactions
timeFrame: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01474304: Intravenous Acetaminophen for Craniotomy Patients
Official title: Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Craniotomy
Keywords: craniotomy
tumor resection
aneurysm
revascularization
opioid
nausea
vomiting
acetaminophen
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2011-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Weigh at least 50 kg (110.23 lbs)
* Undergoing open, elective intracranial procedure for

  * tumor resection
  * aneurysm clipping
  * revascularization
* Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
* Able to provide written informed consent

Exclusion Criteria:

* Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
* Unable to communicate symptoms
* Current daily opioid use (\>40 mg morphine equivalent)
* Tramadol use
* Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
* Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
* Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
* Pregnancy
* Impaired liver function
* Participation in interventional clinical study within the last 30 days
* Known or suspected history of alcohol or drug abuse
* Surgery for resection of acoustic neuroma
* Transphenoidal tumor resection

Primary outcomes:
measure: Total narcotic dose administered over the first 12 hours of postoperative recovery.
timeFrame: 12 hours
Secondary outcomes:
measure: Incidence of nausea during postoperative recovery
timeFrame: 12 hours
measure: Incidence of vomiting during postoperative recovery
timeFrame: 12 hours
measure: Severity of nausea during postoperative recovery
timeFrame: 12 hours
measure: Severity of vomiting during postoperative recovery
timeFrame: 12 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill Campus
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Arthur Lam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646904: Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
Official title: Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.


Eligibility criteria: Inclusion Criteria:

* children 6-16 years of age with a history of AR in the previous year
* T5SS: ≥5 in the last week before enrollment

Exclusion Criteria:

* asthma symptoms
* acute upper respiratory infections
* anatomic nasal defects (ie, septum deviation), or nasal polyps
* use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.

Primary outcomes:
measure: Nasal patency evaluated by acoustic rhinometry.
timeFrame: 21 days
Secondary outcomes:
measure: Efficacy of Beclometasone nasal spray on subjective nasal symptoms
timeFrame: 21 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology, IBIM
Study officials:
References:
Clinical trial NCT04538404: Mortality Score in Elderly Patients With Colon Cancer
Official title: Score for the Prediction of Mortality Risk After Surgery for Colon Cancer in a Case Series of Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Surgery
Colon Cancer
Keywords: colon cancer
surgery
mortality
elderly
scoring system
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 385
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.

Brief summary: CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.

Detailed description: Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score \[Mortality in Elderly patients with Colon Cancer\] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.

Eligibility criteria: Inclusion Criteria:

* Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches

Exclusion Criteria:

* Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies

Primary outcomes:
measure: New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population
timeFrame: Up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Bruno Nardo
city: Bologna
country: Italy
facility: Marialuisa Lugaresi
Study officials:
affiliation: University of Bologna
name: Bruno Nardo, MD,PhD
role: STUDY_DIRECTOR
References: