louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06027580: Orthosis to Improve Trunk Control in Infants Age 6-18 Months
Official title: Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: abnormal muscle tone
cerebral palsy
hypotonia
muscle tone
spasticity
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: SPIO
First posted: 2023-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.

Brief summary: The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.

Detailed description: This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.

Eligibility criteria: Inclusion Criteria:

* Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone
* No previous use of SPIO® or similar Lycra/compression garments
* Assessed by provider as likely to benefit from use of compression garment

Exclusion Criteria:

* Non-English speaking
* Inability for family to bring study subject to assessments
* Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period
* Botulinum toxin injections within 3 months, or during study participation
* Having prior orthopedic or neurosurgery surgeries within one year

Primary outcomes:
measure: Change in head and trunk position from centerline at baseline, 3-months and 6-months.
timeFrame: Through study completion, an average of 2 years
measure: Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Children's Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mitchell O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485780: Botulinum Toxin Injection in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
Official title: The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control
Keywords: hemorrhoidectomy
botulinum toxin
pain
wound healing
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized study, which anticipatedly recruited 60 patients in the outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After obtaining those patients' consent in the clinic, they were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.


Eligibility criteria: Inclusion Criteria:

* patients with age over 20 but under 80, who need to undergo hemorrhoidectomy

Exclusion Criteria:

* patients under the age of 20
* patients with nonsteroidal anti-inflammatory drugs (NSAIDs) allergy or sensitivity
* patients with Botulinum toxin allergy or sensitivity
* patients with dialysis or renal insufficiency
* pregnant and breastfeeding women
* vulnerable population

Primary outcomes:
measure: one week after operation
timeFrame: 1 weel
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
References:
citation: Cheng YC, Beh JY, Wu PH, Tsai NY, Jao SW. Early botulinum toxin injection reduces pain after hemorrhoidectomy: a pilot study. Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27.
Clinical trial NCT01017380: Preemptive Analgesia in Cruciate Reconstruction
Official title: Comparing Etoricoxib and Celecoxib for Preemptive Analgesia for Acute Postoperative Pain in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Injury
Keywords: preemptive analgesia
cruciate ligament
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.


Eligibility criteria: Inclusion Criteria:

* patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria:

* previous knee surgery

Primary outcomes:
measure: VAS score
timeFrame: 6,12,24,48 hour postoperative
Secondary outcomes:
measure: number of analgesic used
timeFrame: 48 hour postoperative
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Boonsin Tangtrakulwanich, MD.,Ph.D
role: STUDY_DIRECTOR
References:
citation: Boonriong T, Tangtrakulwanich B, Glabglay P, Nimmaanrat S. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:246. doi: 10.1186/1471-2474-11-246.
Clinical trial NCT06721780: AR Vs VR in Burns Dressing Changes
Official title: AR Vs VR in Burns Dressing Changes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns Multiple
Lead sponsor: Buckinghamshire Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. This process is not only distressing for the children but also for their parents and the healthcare professionals involved. Current methods to reduce this trauma include the use of play therapists, but such resources are often limited. There is good evidence that Augmented Reality (AR) and Virtual Reality (VR) can help by providing a distracting and immersive environment that eases pain and fear. However, no studies have yet compared these two modern technologies to see which is more effective


Eligibility criteria: Inclusion Criteria:

* • Participants presenting with guardians with parental responsibility, who are willing and able to consent to recruitment.

  * Aged 4-17 years
  * Presenting with burns requiring a dressing change, on their first attendance to the burns clinic.
  * Participating child is able to complete the FACES Pain Scale

Exclusion Criteria:

* • Children aged 4 or below

  * Those with severe cognitive impairment, visual disorders, facial burns or other conditions preventing the safe use of VR/AR technology.
  * Previous 'cybersickness' symptoms (nausea, dizziness).

Primary outcomes:
measure: determine the relative performance
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02163980: Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Orchipexy
Keywords: dexmedetomidine
caudal block
children
children (1-6 years) undergoing ambulatory orchipexy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 80
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.


Eligibility criteria: Inclusion Criteria:

* children undergoing ambulatory orchiopexy,
* ASA status I

Exclusion Criteria:

* mental retardation,
* developmental delay,
* neurological or psychiatric illness,
* coagulation disorder,
* spinal anomalies

Primary outcomes:
measure: vital sign
timeFrame: up to 180 min after surgery
Secondary outcomes:
measure: inhalation anesthetics requirements
timeFrame: up to 180 min after surgery
Other outcomes:
measure: incidence of agitation
timeFrame: up to 180 min after surgery
measure: sedation score
timeFrame: up to 180 min after surgery
measure: pain scores
timeFrame: up to 180 min after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Univ. College of Medicine Dep. Of Anesthesiology
Study officials:
References:
citation: Cho JE, Kim JY, Park SJ, Kil HK. The Effect of 1 microg/kg Dexmedetomidine Combined with High-Volume/Low-Concentration Caudal Ropivacaine in Children Undergoing Ambulatory Orchiopexy. Biol Pharm Bull. 2015;38(7):1020-5. doi: 10.1248/bpb.b15-00086.
Clinical trial NCT02774980: Cognitive Markers of Response to Treatment in Resistant Depression
Official title: Cognitive Markers of Response to Treatment in Resistant Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a major depressive episode diagnosis

Brief summary: Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.

The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).

To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.


Eligibility criteria: Inclusion Criteria:

* Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.

Exclusion Criteria:

* Patients with major depressive episode during more of 12 months
* Alzheimer dementia or related disease (CIM 10)
* Score Hamilton Depression Rating Scale (HDRS) \< 18

Primary outcomes:
measure: Clinic assessments: Score BDI - II
timeFrame: Change from the baseline score BDI-II at 12 months after introducing the new therapy
measure: Functional assessments : Score Sheehan Disability Scale (SDS)
timeFrame: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
measure: Neuropsychologic assessments: M.M.S.E. (Mini Mental Score Evaluation)
timeFrame: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopital Pasteur
Study officials:
affiliation: CHU of Nice
name: Nelly Darmon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937780: Anal Cancer Radiotherapy Study
Official title: Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anal Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 75
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: Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy

Brief summary: This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.


Eligibility criteria: Inclusion Criteria:

* Histologically verified anal squamous cell carcinoma
* Radiotherapy or chemoradiotherapy planned
* ECOG performance status 0-2
* \>= 18 years of age
* Signed informed consent and expected cooperation of the patients for treatment and follow up

Exclusion Criteria:

- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Prediction of local recurrence
timeFrame: 2 years
measure: Biomarker ability to predict local recurrence rate
timeFrame: 5 years
measure: Improvement of faecal incontinence
timeFrame: 5 years
measure: Pain relief of palliative radiotherapy
timeFrame: 5 years
Other outcomes:
measure: Tumor regression
timeFrame: 5 years
measure: PET and MRI prediction of local tumor control
timeFrame: 5 years
measure: To identify biomarkers predictive of treatment response or late effects
timeFrame: 5 years
measure: Prevalence and severity of late effects in follow-up; fatigue, faecal incontinence, sexual dysfunction, health-related quality of life. Effect of intervention.
timeFrame: 5 years
measure: Duration of symptom relief of palliative radiotherapy
timeFrame: 5 years
measure: Local recurrence rate
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Marianne G Guren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429580: Prophylactic Tranexamic Acid Use After Vaginal Delivery
Official title: Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Vaginal Delivery
Prophylactic Tranexamic Acid Use
Keywords: tranexamic acid
vaginal delivery
postpartum hemorrhage
active management of vaginal delivery
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Sisli Hamidiye Etfal Training and Research Hospital
First posted: 2022-06-23
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.

Detailed description: It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.

Eligibility criteria: Inclusion Criteria:

* singleton pregnant women
* woman between the ages of 18-45 years
* woman who gave birth at 34 weeks and above

Exclusion Criteria:

* Pregnancies with less than 1 hour period between hospitalization and delivery
* Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
* Women with previous uterine surgery or cesarean section
* Women with a history of thromboembolism
* women with serious illness

Primary outcomes:
measure: The loss of blood at the 3rd and 4th stages of labor
timeFrame: 6 month
Secondary outcomes:
measure: The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT05811780: The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry
Official title: The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medical Condition Requiring Extracorporeal Organ Support
Keywords: Acute Respiratory Distress Syndrome
acute respiratory failure
severe respiratory failure
cardiogenic shock
cardiac arrest
extracorporeal cardiopulmonary resuscitation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving extracorporeal organ support and being treated in the Department of Interdisciplinary Medical Intensive Care of the Freiburg University Medical Center

Brief summary: A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.


Eligibility criteria: Inclusion Criteria:

* Treatment with any kind of extracorporeal organ support

Exclusion Criteria:

* none

Primary outcomes:
measure: Hospital survival
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Mesenteric ischemia
timeFrame: 30 days
measure: Fluid balance
timeFrame: 7 days
measure: ECMO run-time
timeFrame: 60 days
Locations:
city: Freiburg
country: Germany
facility: University of Freiburg Medical Center
Study officials:
affiliation: University of Freiburg
name: Tobias Wengenmayer, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Freiburg
name: Dawid L Staudacher, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Paul M Biever, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Jonathan Rilinger, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Alexander Supady, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: