louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00557973: A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Official title: Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Spasticity
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury

Detailed description: This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.

Eligibility criteria: Inclusion Criteria:

* Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit

Exclusion Criteria:

* Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures

Primary outcomes:
measure: Maximum Ashworth score
timeFrame: Day 17
Secondary outcomes:
measure: Average Ashworth score
timeFrame: Day 17
measure: Two Highest Ashworth scores
timeFrame: Day 17
measure: Average Non-zero Ashworth Scores
timeFrame: Day 17
Other outcomes:
Locations:
city: Downey
country: United States
state: California
city: Gilroy
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Jose
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
Study officials:
affiliation: XenoPort, Inc.
name: Michael Leong, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02705573: Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Official title: Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation, Mannitol
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect of mannitol on perioperative redox status in patients receiving renal transplantation using the oxidation-reduction potentials assessed with the RedoxSYS®system.

We are planning to perform a double-blind randomized controlled trial. In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined befor induction of anesthesia and 24 hours after administration of study medication: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18.

Furthermore we want to perform sORP and cORP before induction of anesthesia, just before bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery room.

Data will be collected, compared and published at the end of the study. It is planned to include a total of 34 patients in the study.


Eligibility criteria: Inclusion Criteria: all patients with end stage renal diseases -

Exclusion Criteria: Patients younger than 18 years of age or older than 80, alergy to mannitol, Pregnancy, Breast-feed

-

Primary outcomes:
measure: renal biomark
timeFrame: 24 hours
Secondary outcomes:
measure: renal function parameter
timeFrame: 24 hours
measure: oxidation-reduction potential (ORP) of mannitol
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
citation: Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kabon B. The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):162-168. doi: 10.1111/aas.13713. Epub 2020 Oct 15.
citation: Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kainz A, Kabon B. Mannitol and renal graft injury in patients undergoing deceased donor renal transplantation - a randomized controlled clinical trial. BMC Nephrol. 2020 Jul 28;21(1):307. doi: 10.1186/s12882-020-01961-z.
Clinical trial NCT02978573: Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe
Official title: A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of First Metatarsalphalangeal Joint
Keywords: First MTP Joint
Hallux Rigidus
Hallux Limitus
Cartilage Replacement
Osteoarthritis
First MTP Joint Osteoarthritis
Big Toe Pain
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-01
Enrollment: 135
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: Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.

Detailed description: As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva

Eligibility criteria: Inclusion Criteria:

* Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.

Exclusion Criteria:

* Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.

Primary outcomes:
measure: Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
timeFrame: 5 year
Secondary outcomes:
measure: Pain Scale (VAS)
timeFrame: 5 year
measure: Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
timeFrame: 5 year
measure: Foot and Ankle Ability Measure (FAAM) Sports
timeFrame: 5 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Judith Baumhauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02753673: Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy
Official title: Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Conserving Therapy
Reported Outcomes Instrument
16-325
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Hospital for Special Surgery, New York
name: McMaster University
First posted: 2016-04-28
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: The purpose of this study is to develop a questionnaire to measure patient expectations of breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will assist both surgeons and patients by helping provide valuable information to patients about what to expect during and after surgery.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-75
* Patients who are scheduled to undergo lumpectomy at MSKCC as part of breast conserving therapy for invasive breast cancer OR who have completed BCT (lumpectomy and radiation) at least 6 months prior to recruitment

Exclusion Criteria:

* Inability to speak or understand English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
* Patients undergoing lumpectomy without radiation

Primary outcomes:
measure: measure patient expectations of breast-conserving therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea L Pusic, MD, MHS,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192073: Analysis of Suprapectoral and Subpectoral Biceps Tenodesis
Official title: Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Biceps Tendonitis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder).

Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo biceps tenodesis
* Pain at intertubercular groove
* Anterior Humeral pain
* Patient agrees to follow up and consent

Exclusion Criteria:

* Biceps Tenotomy
* Revision biceps procedure
* Prior SLAP or labral repair
* Concomitant subscapularis repair
* More than 1 rotator cuff repair at time of surgery
* Concomitant arthroplasty
* Prior infection

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: 1 year
Secondary outcomes:
measure: Constant Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush Univeristy Medical Center
name: Nikhil N Verma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forsythe B, Berlinberg EJ, Diaz CC, Korrapati A, Agarwalla A, Patel HH, Cole BJ, Cvetanovich GL, Yanke AB, Romeo AA, Verma NN. No Difference in Clinical Outcomes for Arthroscopic Suprapectoral Versus Open Subpectoral Biceps Tenodesis at Midterm Follow-up: A Randomized Prospective Analysis. Am J Sports Med. 2022 May;50(6):1486-1494. doi: 10.1177/03635465221084731.
Clinical trial NCT04936373: Quality of Life of Patients With Pregnancy Related VTE
Official title: Pregnancy-related VTE; Quality of Patients' Lives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health, Subjective
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were identified by searching the hospital database. Those who meet the inclusion criteria

Brief summary: A retrospective study of the quality of life and problems experienced by patients who developed pregnancy related VTE. It involves patients seen at JUH in 2012-2020. A questionnaire will be filled by those patients and any other patients in Jordan. It was translated to an Arabic form from EQ-5D, VEINES-QOL/SYM questionnaire and PEmb-QoL. The quality of their lives will be assessed and the problems encountered are going to be analyzed to try to find some solutions. This project is going to be a national research project with the efforts to try to find common platforms for those patients and nidus to establish a national support group.

Detailed description: Retrospective study and analysis using a questionnaire which will be distributed to patients. The patients' data and contact details (phone numbers, whatsApp, email address...) will be collected from their clinical records at the JUH hospital. The period 2012-2020 will be covered. The questionnaire link is; file:///C:/Users/user/Downloads/QoL-post-VTE-during-pregnancy-5.pdf and file:///C:/Users/user/Downloads/arabic%20questionnaire%20last%201.pdf

Eligibility criteria: Inclusion Criteria:

* pregnancy related event
* confirmed diagnosis by an objective diagnostic tool (Duplex ultrasonography, CT pulmonary angiography, spiral CT scan or ventilation perfusion scan)
* consent (acceptance) to participate was obtained
* alive patients

Exclusion Criteria:

* death
* an objective diagnostic tool could not be found to confirm the diagnosis
* their event was not related to pregnancy
* refusal to participate

Primary outcomes:
measure: leg pain
timeFrame: 6 months
measure: Breathlessness
timeFrame: 6 months
measure: difficulties completing duties at work
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Al-Husban University Naser
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
References:
Clinical trial NCT03744273: Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Mammaplasty
Acellular Dermis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-11-16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions.

This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.


Eligibility criteria: Inclusion Criteria:

* age between 20 and 70
* planning 2-stage expander-implant breast reconstruction using acellular dermal matrix
* with no medical history such as diabetes, hypertension, or smoking
* no surgical history

Exclusion Criteria:

* pregnant
* newly detected medical or surgical condition
* acellular dermal matrix loss due to allergic reaction or prosthetic infection
* breast cancer recurrence
* transfer to other institution
* reconstruction give-up due to patient's wish
* no biopsy score

Primary outcomes:
measure: histology scoring
timeFrame: immediate after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jai-Kyong Pyon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05093127: CArotid Robotic Procedure Evaluation
Official title: CArotid Robotic Procedure Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Diseases
Lead sponsor: Robocath
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2021-10-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 8 Patients with carotid artery disease, including patients with web diaphragm, who qualify for Carotid Artery Stenting.

Brief summary: This study aims to evaluate the use of R-One in the peripheral vasculature.

Detailed description: This is a prospective, single-arm, monocenter study to evaluate the R-one use in carotid artery stenting procedures. Up to 8 patients will be included and followed at 30 days.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Candidate for CAS
3. Presence of a WEB-diaphragm lesion at carotid artery ostium, proved by non-invasive imaging (CTA or MRA)
4. No minimum delay between previous stroke therapy (IMT) is required
5. Double antiplatelet therapy the day before the procedure and 1 month after the procedure is required
6. The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.
7. The patient is affiliated with a social security scheme

Exclusion Criteria:

1. Target lesion has atherosclerotic or dissection stenosis or occlusion;
2. Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
3. CAS performed at the end of intracranial mechanical thrombectomy
4. Contra-indications of double antiplatelet therapy the day before the procedure and 1 month after the procedure
5. Patients under judicial protection, tutorship or curatorship
6. Any patient participating in another clinical study valuating a drug or a medical device (except registries for which the primary endpoint has not been evaluated);
7. Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Primary outcomes:
measure: Procedure technical success
timeFrame: Index Procedure : Day 0
Secondary outcomes:
measure: Absence of intra-procedural complications
timeFrame: At Day 0 and at Day 30 +/- 7 days
measure: Reduction in primary operator radiation exposure
timeFrame: Index Procedure : At Day 0
measure: Radiation exposure for the patient
timeFrame: Index Procedure: At Day 0
measure: Overall Procedure Time
timeFrame: Index Procedure : At Day 0
measure: Overall contrast volume
timeFrame: Index Procedure : At Day 0
measure: Contrast volume during Robotic Procedure
timeFrame: Index Procedure : At Day 0
Other outcomes:
Locations:
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: François EUGENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06489327: Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Official title: Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Keywords: preoperative anxiety
general anesthesia
major surgery
oral melatonin
placebo
premedication
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Al-Ayen Iraqi University
First posted: 2024-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.

In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.

Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex
* age from 4 to 14 years
* Patients with American society Anesthesiologist physical status I and II
* Patients undergoing elective surgeries

Exclusion Criteria:

* ASA more than III
* Drug allergy.
* Gastrointestinal disorders.

Primary outcomes:
measure: preoperative anxiety
timeFrame: 24 hours
Secondary outcomes:
measure: preoperative sedation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Facualty of Pharmacy, Al Azhar University
city: Madīnat Bābil
country: Iraq
facility: Al-Ayen Univerisity
state: Babel
Study officials:
affiliation: Al-Azhar University
name: Neveen Kohaf, ph.d
role: PRINCIPAL_INVESTIGATOR
References: