louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03506217: Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
Official title: Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Valve Prolapse
Keywords: mitral valve prolaps,
chorda tendinea,
cardiac output
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients who underwent mitral valve repair with Neochord DS1000 system after severe mitral insufficiency in Sakarya University Educational Research Hospital between September-2016 and June-2017

Brief summary: Minimally invasive transapical off-pump chordae implantation includes features such as tachycardia, arrhythmia, hemorrhage, sudden hemodynamic changes caused by the device moving in the left ventricle and the atrium, for anesthetists. In this observational study, the investigators presented the investigators's hemodynamic recuperation and anesthesia experiences revealed by cardiac output measurement after transapical mitral valve repair.

Detailed description: In Sakarya University Educational Research Hospital, perioperative file records of 13 patients who underwent mitral valve repair using the Neochord DS1000 system were retrospectively analyzed. In addition, hemodynamic measurements recorded with the Vigileo Flotrac invasive arterial cardiac output device were evaluated.

Eligibility criteria: Inclusion Criteria:

* All patients that surgical criteria for Neochord implantation with transapical mini-thoracotomy are prolapsus or chordae rupture in posterior, anterior areas or in both leaflets were included.

Exclusion Criteria:

* Exclusion criteria are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction.

Primary outcomes:
measure: invasive arterial cardiac output (CO) measurement
timeFrame: 1 month
measure: systemic vascular resistance (SVR)
timeFrame: 1mounth
measure: stroke volume variance (SVV)
timeFrame: 1 mounth
measure: blood pressure
timeFrame: 1 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Research and Training Hospital
state: Merkez
Study officials:
affiliation: Sakarya University Research and Training Hospital
name: Umit Karadeniz
role: STUDY_CHAIR
References:
citation: Colli A, Zucchetta F, Torregrossa G, Manzan E, Bizzotto E, Besola L, Bellu R, Sarais C, Pittarello D, Gerosa G. Transapical off-pump mitral valve repair with Neochord Implantation (TOP-MINI): step-by-step guide. Ann Cardiothorac Surg. 2015 May;4(3):295-7. doi: 10.3978/j.issn.2225-319X.2015.05.01. No abstract available.
Clinical trial NCT02613117: Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentinal Hypersensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have at least one tooth at risk for hypersensitivity.

Exclusion Criteria:

* any medical condition requiring pre-medication prior to dental procedures
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* a history of kidney stones
* have self-reported pregnancy or nursing
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate

Primary outcomes:
measure: How Satisfied Were Participants With Treatment?
timeFrame: up to 8 weeks
measure: Ease of Treatment at Home
timeFrame: Up to 8 weeks
measure: Did Participants Notice a Difference in the Areas Noted?
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
References:
Clinical trial NCT03046017: Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Official title: Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.


Eligibility criteria: Inclusion Criteria:

* Volunteers 21-60 years of age.
* Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
* At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
* At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
* Complicated back problems (e.g., prior back surgery, medicolegal issues).
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
* Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
* History of medical or psychiatric illness.
* History of substance / alcohol abuse or dependence.

Primary outcomes:
measure: fMRI signal changes
timeFrame: 2 days; Sessions 5 and 7
measure: Gracely Scale pain rating changes
timeFrame: 2 days; Sessions 2 and 7
measure: resting state functional connectivity changes
timeFrame: 2 days; Sessions 5 and 7
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Martinos Center for Biomedical Imagin
state: Massachusetts
Study officials:
References:
Clinical trial NCT06007417: A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
Official title: The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: GHD
Keywords: GHD
growth hormone deficiency
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 162
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.

Detailed description: The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.

Eligibility criteria: Inclusion Criteria:

1. Prepubertal children with GHD in Tanner Stage 1
2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
4. Growth hormone stimulation tests: ≤10 ng/mL
5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
6. Normal 46 XX karyotype for girls.
7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant

Exclusion Criteria:

1. BA≥CA
2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
5. Any reason per investigator's discretion

Primary outcomes:
measure: Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
timeFrame: 52 weeks
Secondary outcomes:
measure: Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Cook Childrens
state: Texas
Study officials:
affiliation: University of Minnesota
name: Bradley Miller
role: STUDY_CHAIR
References:
Clinical trial NCT00222417: Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
Official title: Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Otosclerosis
Tympanic Membrane Perforation
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.

Brief summary: We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

Detailed description: Consecutive patients 12 years or older due for myringoplasty or stapes surgery at the ENT-department, University hospital of Tromsø, in an approximate time span of one year, have been studied with the following audiometric investigations at the preoperative admission, 2, 6 and 12 months postoperatively: Transient otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, speech audiometry using spondaic recognition for air and bone-conduction. Results will be statistically analysed using the Statistical Package for the Social Sciences, with the unoperated ear (paired organ) serving as controls. The goal is to look at alternative methods for analysing the patients' preoperative hearing in order to increase the precision of clinical decision-making. The secondary goal is to elucidate the effects of middle ear surgery on the inner ear.

Eligibility criteria: Inclusion Criteria:

* Tympanic membrane perforation without chronic secretion or cholesteatoma
* Suspected otosclerosis

Exclusion Criteria:

* Below 12 years of age
* Patient not consenting to study
* Perioperative findings suggesting chronic otitis or cholesteatoma
* Patients not fluent in Norwegian or unable to cooperate in audiometry

Primary outcomes:
measure: Post-operative hearing threshold level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: ENT-department, University Hospital of Tromsø
state: Troms
Study officials:
affiliation: ENT-department, University of Tromsø, 9038 Tromsø, Norway
name: Niels C Stenklev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03359317: Jogging in the Change of Osteoporosis
Official title: Jogging in the Change of Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Bone Diseases
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: Wujin People's Hospital
name: Chongqing Zhongshan Hospital
First posted: 2017-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging

Detailed description: Patients in this research are given an entry Bone Densitometry（DEXA）scan and are required to advance from 3-minute jogging a day to 10-minute level in daily practice for 1 year as instructed. After 1 year, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan in the study. Dose-response relationships between the amount of jogging and bone mineral density are sought. Jogging-related fractures and other adverse effects are also noted.

Eligibility criteria: Inclusion Criteria:

Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX

Exclusion Criteria:

Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs, severe heart disease

Primary outcomes:
measure: DEXA T-score
timeFrame: 1 year
Secondary outcomes:
measure: Number of fractures
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Peixun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189317: Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Official title: Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.

Exclusion Criteria:

* Patients with known allergies to local anesthetics
* pregnant patients
* patients with a history of liver disease
* patients undergoing bilateral procedures
* Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques
* Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.

Primary outcomes:
measure: Change in Numerical Rating Scale (NRS) Pain Score
timeFrame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Secondary outcomes:
measure: Change in Home Opioid Use
timeFrame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
measure: Difference in Time to First Opioid Use
timeFrame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Orthopaedic and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: John Xerogeanes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Premkumar A, Samady H, Slone H, Hash R, Karas S, Xerogeanes J. Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1680-6. doi: 10.1177/0363546516640772. Epub 2016 Apr 25.
Clinical trial NCT01302717: Left Ventricular Pacing to Avoid Cardiac Enlargement Study
Official title: Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complete AV Block
Sick Sinus Syndrome
Keywords: Left ventricular pacing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 0
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.

Detailed description: In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.

The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.

Eligibility criteria: Inclusion Criteria:

* Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
* Paced QRS duration ≥185 ms

Exclusion Criteria:

* Left ventricular ejection fraction \< 50 %
* Acute coronary syndrome
* If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
* if they had a life expectancy of less than 1 year
* if they had received a heart transplant

Primary outcomes:
measure: Left ventricular ejection fraction (%) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Left ventricular end-systolic volume (ml) at 12 months
timeFrame: 12 months
measure: Left ventricular end-diastolic volume (ml) at 12 months
timeFrame: 12 months
measure: NYHA functional class
timeFrame: 12 months
measure: Functional capacity
timeFrame: 12 months
measure: NT-proBNP
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seil Oh, MD, PhD
role: STUDY_CHAIR
References: