louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02044627: Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
Official title: A Phase 1, Open-Label,Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of \[14C\]-ETC-1002


Eligibility criteria: Inclusion Criteria:

* Healthy Male Volunteers
* BMI 10-35 kg/m2

Exclusion Criteria:

* Hx of CV, renal, hepatic, chronic respiratory or GI disease
* Hx of drug or alcohol abuse
* smoking within 12 mos of screening

Primary outcomes:
measure: Level of [14C]-ETC-1002 in urine and feces after a single dose
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK
name: Stuart Mair, MBChB, DRCOG, DCPSA, MFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01938027: The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Official title: A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal Neoplasms
Colorectal Neoplasms
transanal surgery
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Detailed description: Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria: Inclusion Criteria:

* age: 20-80 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging, (T1 or T2 or T3) with N0M0
* Rectal cancer located 4-12 cm from the anal verge
* ECOG performance status 2 or less

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer or inflammatory bowel disease
* BMI \> 30
* T3 rectal cancer not treated preoperatively with full-course chemoradiation

Primary outcomes:
measure: Total Mesorectal Excision(TME) quality
timeFrame: 1-5 years
Secondary outcomes:
measure: 30-day postoperative complications, No. of harvested LN
timeFrame: 1-5 years
Other outcomes:
measure: Oncologic outcome(2-year local recurrence free survival, 5-year survival)
timeFrame: 1-5 years
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Jae Hwan Oh
state: Gyeonggi-do
Study officials:
affiliation: NCC,Korea
name: Jae Hwan Oh, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh JH, Park SC, Kim MJ, Park BK, Hyun JH, Chang HJ, Han KS, Sohn DK. Feasibility of transanal endoscopic total mesorectal excision for rectal cancer: results of a pilot study. Ann Surg Treat Res. 2016 Oct;91(4):187-194. doi: 10.4174/astr.2016.91.4.187. Epub 2016 Sep 30.
Clinical trial NCT02599727: Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure
Official title: Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise, Isometric
Keywords: balance, postural
postural equilibrium
heart rate
blood pressure
pulse oxygenation
mental speed
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Determine the effects repeated isometric exercises have on balance, blood pressure, heart rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a subject can process information and make decisions based upon that information).

Detailed description: Subjects will complete a mental speed test and will undergo Computerized Dynamic Posturography (CDP) testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. Immediately prior to the CDP testing, subjects will have their heart rate, blood pressure and pulse Ox measured. These will constitute the baseline information.

Subjects will then be divided into two groups: the isometric exercise group (they will be instructed to perform specific isometric exercises three times a week, for the next 8 weeks) and the control group (no exercises will be prescribe to them).

The same testing procedure indicated above will be followed at the end of the 8 weeks. The mental speed test, CDP testing, heart rate, blood pressure and pulse Ox will constitute the follow-up information.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)

Primary outcomes:
measure: Changes in Heart Rate
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: Changes in Stability Score
timeFrame: Baseline and at 8 weeks
measure: Changes in Blood Pressure
timeFrame: Baseline and at 8 weeks
measure: Changes in Mental Speed
timeFrame: Baseline and at 8 weeks
Other outcomes:
Locations:
city: Cape Canaveral
country: United States
facility: Carrick Institute for Graduate Studies
state: Florida
Study officials:
affiliation: Carrick Institute for Graduate Studies
name: Frederick R Carrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604927: Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines. Previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity. In line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups. Although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.


Eligibility criteria: Inclusion Criteria:

* Paralympian training for any exercise modality for at least one year;
* A weekly training volume of 6 hours or more;
* Have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year;
* Available for carrying out the experimental procedures.

Exclusion Criteria:

* Use of creatine or beta-alanine for at least 3 and 6 months before the trial;
* Cardiovascular or respiratory disease;
* Clinical condition that result in malabsorption of nutrients;
* Any other medical condition that prevents the realization of experimental procedures.

Primary outcomes:
measure: Exercise performance (Time to exhaustion test)
timeFrame: 28 days
measure: Muscle carnosine content before and after supplementation
timeFrame: 28 days
Secondary outcomes:
measure: Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles
timeFrame: 28 days
measure: Blood pH.
timeFrame: 5 minutes after performance tests
measure: Safety of beta-alanine supplementation measured by complete hemogram analysis
timeFrame: 28 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Physical Education and Sports, University of Sao Paulo
Study officials:
References:
Clinical trial NCT04573127: Gender Dysphoria: Epidemiological Data
Official title: Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the outpatient clinic at our department of endocrinology

Brief summary: Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy


Eligibility criteria: Retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. All measurements were made at the time of the routine follow-up visits

Primary outcomes:
measure: Incdience rate of cardiovascular diseases
timeFrame: 2004-2020
measure: Incidence rate of dyslipidemia
timeFrame: 2004-2020
Secondary outcomes:
measure: Incidence rate of oncological diseases
timeFrame: 2004-2020
measure: Incidence rate of psychiatric diseases
timeFrame: 2004-2020
measure: Overall mortality rate
timeFrame: 2004-2020
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT00908427: Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia
Official title: Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia
KTP laser
transurethral resection of prostate
urinary bladder neck obstruction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 86
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.


Eligibility criteria: Inclusion Criteria:

* Symptomatic BPH
* International Score Prostate Symptom (IPSS) of 13 or greater
* prostate volume of 30 to 100 ML
* Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of \>125 mL and a PVR \<350mL
* Able to give fully informed consent

Exclusion Criteria:

* Subjects with histological diagnosis of prostate cancer
* Subjects with history of chronic urinary retention
* Subjects with urethral stricture,
* Subjects with bladder neck contracture
* Subjects with urinary tract infection
* Subjects with prostate volume on TRUS of \>100 mL
* Subjects with suspected neurogenic bladder dysfunction
* Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Primary outcomes:
measure: The changes of bladder outlet obstruction index (BOOI)
timeFrame: 6months
Secondary outcomes:
measure: The changes of Quality of Life (QoL) parameters
timeFrame: 6, 12 months
measure: The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
timeFrame: 6, 12 months
measure: The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
timeFrame: 6months
measure: The changes of International Prostatic Symptom Scores (IPSS)
timeFrame: 6, 12 months
measure: The changes of Schafer obstruction grade parameters
timeFrame: 6months
measure: The changes of prostate volume
timeFrame: 6, 12 months
measure: postoperative catheterization days
timeFrame: immediate postoperative period
measure: Complications
timeFrame: During all study periods
measure: The changes of the hemoglobin and the serum sodium and the serum PSA
timeFrame: immediate postoperative period
measure: The change of IIEF score
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sung-Won Lee, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082427: Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain
Official title: Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Virtual reality hypnosis
Radiofrequency thermocoagulation
Chronic pain
Anxiety
Complementary approach
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Liege
First posted: 2023-10-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.


Eligibility criteria: Inclusion Criteria:

* suffering from chronic pain
* \>18 years old
* French speaking
* no claustrophobia
* no head or face wounds
* sufficient auditory and visual acuity for an effective use of the VRH technique

Primary outcomes:
measure: Anxiety
timeFrame: One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency
Secondary outcomes:
measure: Anxiety trait
timeFrame: One week before the Radiofrquency
measure: Pain intensity
timeFrame: One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency
measure: Immersive tendencies
timeFrame: On the day of the radiofrequency before the VRH/Ctr
measure: Sens of presence
timeFrame: Right after the VRH/Ctr
measure: Satisfaction
timeFrame: After the radiofrequency, Average 1 hour
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
Study officials:
References:
Clinical trial NCT03452527: Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Official title: A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Wet Macular Degeneration
Lead sponsor: Iconic Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Males or females of any race, ≥50 years of age
* Active primary CNV secondary to AMD in the study eye

Exclusion Criteria:

* Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
* Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
* Vitrectomy in the study eye

Primary outcomes:
measure: Change in Choroidal Neovascularization (CNV) Over Time
timeFrame: Month 9
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) Over Time
timeFrame: Month 9
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Site 2
state: California
city: Santa Ana
country: United States
facility: Site 8
state: California
city: Syracuse
country: United States
facility: Site 7
state: New York
city: Ashland
country: United States
facility: Site 3
state: Oregon
city: Philadelphia
country: United States
facility: Site 6
state: Pennsylvania
city: Austin
country: United States
facility: Site 1
state: Texas
city: McAllen
country: United States
facility: Site 4
state: Texas
city: San Antonio
country: United States
facility: Site 5
state: Texas
Study officials:
affiliation: Iconic Therapeutics, Inc.
name: Gabriela Burian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00277927: Mild Valvar Pulmonary Stenosis
Official title: Clinical Management of Children With Mild Valvar Pulmonary Stenosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: Pediatric
Cardiac
Valvar Pulmonary Stenosis
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 146
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children at Children's Healthecare of Atlanta between the dates of 1984 and 2003 with mild valvar pulmonary stenosis that were less than 2 years old

Brief summary: Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data suggested that most of these patients do well. Nonetheless, the majority of these patients is followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic studies to follow the gradient. Such follow-up can be costly and it is not know if there is any benefit to periodic evaluation.

Detailed description: Young children (less than or equal to 2 years of age) with mild valvar pulmonary stenosis are unlikely to develop worsening stenosis with age and periodic cardiac evaluation is not warranted.

To describe the clinical course of children with mild valvar pulmonary stenosis diagnosed in early childhood. To examine the clinical practice patterns of cardiologists caring for these patients.

Retrospective chart review of all children diagnosed with mild valvar pulmonary stenosis born between 1984 and 2003 and followed by Sibley Heart Center Cardiology. Patient variables will include: pulmonary valve gradient, need for catheterization, exercise intolerance and endocarditis. Practice variables will include: frequency of follow-up, number of echocardiographic studies, exercise limitations.

Eligibility criteria: Inclusion Criteria:

* Children's Healthcare of Atlanta medical charts 1984 to 2003 diagnosed with mild valvar pulmonary stenosis Patients less than or equal to two years of age

Exclusion Criteria:

* Those who do no meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
name: William T. Mahle, MD
role: PRINCIPAL_INVESTIGATOR
References: