louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00629720: Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Official title: Four-week, Open-label, Multicenter, Randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder Neurogenic
Keywords: elevated detrusor leak point pressure
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years).

The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

Primary outcomes:
measure: PK parameters
Secondary outcomes:
measure: Safety evaluation
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Sanofi-Aventis Administrative Office
state: Pennsylvania
city: Belgrade
country: Serbia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01983020: Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Official title: Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.


Eligibility criteria: Inclusion Criteria:

Male and Female \>/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study

Exclusion Criteria:

Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

Primary outcomes:
measure: Pain Intensity
timeFrame: postoperative day 1 - 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Ronald Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733420: Biodentine Versus White MTA Pulpotomy
Official title: The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Extensive Decay in Primary Molars
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.

Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.


Eligibility criteria: Inclusion Criteria:

* Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
* Patients without any known medical history of systemic complications contradicting pulp treatment.
* Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
* Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.

Primary outcomes:
measure: Clinical successes after pulpotomy.
timeFrame: at baseline visit
measure: Clinical success after pulpotomy.
timeFrame: 3 months after pulpotomy.
measure: Clinical successes after pulpotomy.
timeFrame: 6 months after pulpotomy.
measure: Clinical successes after pulpotomy.
timeFrame: 12 months after pulpotomy.
measure: Radiographic successes after pulpotomy.
timeFrame: at baseline visit
measure: Radiographic successes after pulpotomy.
timeFrame: 6 months after pulpotomy.
measure: Radiographic successes after pulpotomy.
timeFrame: 12 months after pulpotomy.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Ghent
name: Luc Martens, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04372420: Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
Official title: Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation
Primary purpose: TREATMENT

Brief summary: The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

Detailed description: 44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using ImageJ® software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to PRF. From this trial conducted over a period of 6 months, the unique properties associated with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material for Grade II furcation defects.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients of age group 20-55 yrs
* grade II furcation involvement and probing pocket depth of ≥5mm

Exclusion Criteria:

* Medically compromised patients
* subjects who underwent radiotherapy or chemotherapy in the past 12 months
* patients having uncontrolled periodontal disease and
* subjects smoking ≥10 cigarettes per day were excluded

Primary outcomes:
measure: BONE FILL
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: RV Chandra
state: Telangana
Study officials:
References:
Clinical trial NCT03717220: Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Official title: Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Finger Injuries
Keywords: soft-tissue defects
dorsal branch of the digital artery
regional flap
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2018-10-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.

Detailed description: For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Eligibility criteria: Inclusion Criteria:

* the separate soft tissue defects with exposed bone or tendon in different digits
* the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
* necessity to preserve digit length
* local tissue near the defect can be used as the donor
* a patient between 15 and 60 years of age

Exclusion Criteria:

* concomitant injuries to the dorsum of the injured finger
* a defect \< 1.5 cm and\>3.5 cm in length
* a finger degloving injury
* the defect of the thumb

Primary outcomes:
measure: Static 2PD test
timeFrame: 18 months to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.
Clinical trial NCT02776020: Non-invasive, Real-time Anesthetic Drug-monitoring System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing propofol sedation while undergoing trans vaginal ovum retrieval (TVOR) for in vitro fertilization (IVF).

Brief summary: The aim of this study is to determine efficacy of the "CorrecDose" device to continuously and non-invasively follow the changes in propofol concentrations in the participants' blood.


Eligibility criteria: Inclusion Criteria:

* Women who have signed Informed consent form
* Women undergoing Trans vaginal ovum retrieval (TVOR) for invitro fertilization (IVF) and will be sedated with propofol administered intravenos (IV)

Exclusion Criteria:

* Women with background diseases
* Women with chronic use of drug and medication
* Women with peripheral blood vessels problems
* Women with high blood pressure
* Women with body mass index (BMI) score over 35 or less than 18

Primary outcomes:
measure: Changes in Propofol Blood Levels
timeFrame: Half hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam
name: Philippe Abecassis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429220: Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: deep brain stimulation
monopolar review
motion sensors
tremor
bradykinesia
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease

Brief summary: The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's disease patients.


Eligibility criteria: Inclusion Criteria:

* Hoehn and Yahr stage 2 or worse when off medications
* Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds
* L-dopa responsive with clearly defined "on" periods, UPDRS motor III average tremor and bradykinesia improves by 25%
* Stable on medical therapy for at least one month prior to study enrollment
* Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi
* Available to participate for six months following DBS surgery

Exclusion Criteria:

* "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
* previous Parkinson's Disease surgery
* medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
* contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
* neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery
* intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT06616220: Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
Official title: Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Scoliosis
Scoliosis Idiopathic
Scoliosis; Adolescence
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Detailed description: This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Eligibility criteria: Inclusion Criteria:

* children scheduled for idiopathic scoliosis surgery
* age \>10 and \<18 years

Exclusion Criteria:

* age \< 10 years
* age \< 18 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use

Primary outcomes:
measure: First need of opioid analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours after procedure
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 12 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 24 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 48 hours after surgery
measure: glucose
timeFrame: 12 hours after surgery
measure: glucose
timeFrame: 24 hours after surgery
measure: glucose
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
References:
Clinical trial NCT06783920: MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
Official title: EFFECT of MUSIC in Reducing Pain and Anxiety During Copper T380A Intrauterine Device Insertion in Nulliparous Women.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intrauterine Device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

Detailed description: The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

Eligibility criteria: Inclusion Criteria:

* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.

Exclusion Criteria:

* a prior pregnancy greater than 20 weeks of duration

  * currently pregnant or were pregnant within 6 weeks of study entry
  * had a prior attempted or successful IUD insertion
  * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis
  * undiagnosed abnormal uterine bleeding
  * pelvic inﬂammatory disease within the last 3 months
  * ﬁbroids or other uterine abnormalities distorting the uterine cavity

Primary outcomes:
measure: pain during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: anxiety during IUD insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04220320: The Success of Labor Induction Based on a Modified BISHOP Score.
Official title: The Success of Labor Induction Based on a Modified BISHOP Score Compared to Classic BISHOP Score and Cervical Length in Transvaginal Sonography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 758
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women over 37 weeks' gestation that are candidates for induction of labor for obstetric/other medical indications.

Brief summary: Pregnant women at term will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

Detailed description: Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.

The women will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies.
* Candidates for vaginal delivery.

Exclusion Criteria:

* Multiple pregnancies.
* Candidates for cesarean section.

Primary outcomes:
measure: Time to delivery
timeFrame: Up to 72 hours.
Secondary outcomes:
measure: BISHOP score after primary induction.
timeFrame: Up to 24 hours.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam healthcare campus
Study officials:
affiliation: Rambam Healthcare Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: