louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03847805: Scapulothoracic and Glenohumeral Stabilization Exercises in Boulderers
Official title: Effectiveness of a Program of Scapulothoracic and Glenohumeral Stabilization Exercises in Boulderers. A Randomized Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Bouldering
Exercise
Shoulder
Stability
Performance
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction. In the block climbing, the fluidity with which the athlete climbs a certain route is fundamental. The speed with which the movements are executed and the number of grippers of upper limbs is related to sports performance. Shoulder injuries are very prevalent in this sport. The inhibition of the stabilizing musculature can alter joint positioning and its normal biomechanics.

Objective. To evaluate the efficacy of a program of stability exercises, scapulothoracic and glenohumeral, in the improvement of shoulder stability and sports performance, in boulder climbers.

Material and method. Forty randomized subjects will be recruit into two groups: experimental (scapulothoracic and glenohumeral stability exercises) and control (glenohumeral stabilization). The stability of the shoulder (Closed Kinetic Chain Upper Extremity Stability Test) and the sports performance (Climbing Test) will be evaluated. The intervention last 6 weeks, with two weekly sessions of 30 minutes each. Differences between evaluations will be analyzed with the t-sudent for related samples and the intra- and intersubject effect with the repeated measures ANOVA test.


Eligibility criteria: Inclusion Criteria:

* Being climbers
* Between the ages of 18 and 40 years
* Belonging to the Boulder Madrid Climbing Gym
* Who climbed at least twice a week
* Having at least 6 months of experience

Exclusion Criteria:

* Were participating in competitions at the time
* Presented pathologies of the upper limb
* Used any type of ergogenic aid
* Had not signed the informed consent document.

Primary outcomes:
measure: Change from baseline stability of the shoulder after treatment and at 6 weeks
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Change from baseline time need to complete a given climbing route and number of grips during climbing after treatment and at 6 weeks
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Real Fundación Victoria Eugenia
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01272505: Conventional SILS vs Harmonic Scalpel SILS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gallbladde Stones
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 137
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* patients with symptomatic gallbladder stones

Exclusion Criteria:

* acute cholecystitis cbd stones contraindications for laparoscopy

Primary outcomes:
measure: operative time
Secondary outcomes:
measure: complications
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Gastroenterology Surgical Center
state: Dakahlia
Study officials:
References:
Clinical trial NCT03331705: Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
Official title: Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Tumor
Lead sponsor: UroSee Corporation
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females requiring a diagnostic cystoscopic procedure

Brief summary: This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.

Detailed description: A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.

This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.

Eligibility criteria: Inclusion Criteria:

1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.

Exclusion Criteria:

1. History of prior bladder/urethral surgery other than TURBT; or
2. History of interstitial cystitis; or
3. Presence of urinary tract infection (UTI); or
4. Gross hematuria; or
5. History of pelvic radiation therapy; or
6. Procidentia; or
7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
8. Unable or unwilling to provide consent to participation in the study.

Primary outcomes:
measure: Assessment of the utility and performance of the cystoscope by the physician
timeFrame: during the procedure
Secondary outcomes:
measure: Patient tolerance of the procedure
timeFrame: during and within 5 days after the procedure
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Las Vegas Urology
state: Nevada
Study officials:
affiliation: UroSee Corporation
name: Bela Denes, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02484105: Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction
Official title: Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.

Detailed description: Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Colonoscopy
* Written informed content

Exclusion Criteria:

* ASA Class 4 or higher
* BMI 40 or higher
* Analgesics taken prior to procedure
* Pregnancy or breast feeding
* Allergy to Fentanyl/Midazolam
* Daily consumption of opioids
* Unable to complete questionnaire

Primary outcomes:
measure: Patient Satisfaction
timeFrame: on average 20 minutes after completed colonoscopy.
Secondary outcomes:
measure: Per-procedural Pain management
timeFrame: From inclusion to completed procedure. On average 45 minutes from first to last measurement.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Endoscopy, Gastrounit, Herlev Hospital
state: Region H
Study officials:
References:
Clinical trial NCT00755105: Measurements of Body Iron Excretion of Healthy Adults
Official title: Body Iron Excretion of Healthy Adults as Measured by Isotope Dilution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: body iron excretion
Iron isotopes
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2008-09-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult men and women who previously participated in iron absorption studies using iron-55 isotope.

Brief summary: This is an observation study of subjects who previously had iron-55 isotope administered in studies of iron absorption. By determining the retention of the isotope in blood during a 3-year period, body iron excretion can be measured.

Detailed description: One year following initial administration of iron-55 as a part of other related studies, subjects provide blood samples every 6 months for 3 years.

Eligibility criteria: Inclusion Criteria:

* Must have taken iron-55 in previous study conducted by USDA Grand Forks Human Nutrition Research Center

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of Iron Excretion.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Janet R Hunt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunt JR, Zito CA, Johnson LK. Body iron excretion by healthy men and women. Am J Clin Nutr. 2009 Jun;89(6):1792-8. doi: 10.3945/ajcn.2009.27439. Epub 2009 Apr 22.
Clinical trial NCT06862505: Histological Analysis of Peri-implant Soft Tissue
Official title: Histological Analysis of Collagen Fibers Around Screw-less, Morse Taper Implant-abutment Connection 8 and 16 Weeks After Implant Uncovering: a Split-mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implant Therapy
Biological Width
Keywords: Dental implants
Biological width
Istological analysis
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.


Eligibility criteria: Inclusion Criteria:

* 18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
* able to understand a sign an informed consent

Exclusion Criteria:

* Peapole having a systemic or local contraindications for implant placement;
* Untreated periodontal disease;
* smokers;
* osteoporosis;
* uncontrolled diabetes;
* refusal to implant rehabilitation;
* refusal to biopsy collection;
* systemic pathologies that could compromise the healing of peri-implant tissues.

Primary outcomes:
measure: Histological analisys
timeFrame: 8 and 16 weeks
Secondary outcomes:
measure: Histomorphometry
timeFrame: 8 and 16 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome
Study officials:
References:
Clinical trial NCT06255405: The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial
Official title: The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Well-Being
Keywords: psychological well-being; self-compassion; children
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Suboptimal psychological well-being in children can have substantial negative effects on their physical health, academic performance, and lifelong health. Preliminary evidence supports that self-compassion have positive impacts on psychological well-being in elderly, adults, and adolescents, but there is apparently lack of this kind of evidence in children. Involvement of parents in the program potentially optimize the effects, this study thus designs a dyadic parent-child self-compassion program (DPC-SC) and aim to examine its effects on children's psychological well-being.


Eligibility criteria: Inclusion Criteria: (Child)

* Study in Primary three or four.
* Can communicate in Cantonese.

Exclusion Criteria: (Child)

* Have emotional dysregulation
* Have past history of mental illness
* Recently experience trauma
* Are in an acute health crisis

Inclusion Criteria: (Parents)

* Is the primary caretaker of the children
* Is willing to interact and do the practices with their children
* Can communicate in Cantonese
* Commit to attend all sessions

Exclusion Criteria: (Parents)

* Have emotional dysregulation
* Have past history of mental illness
* Recently experience trauma
* Are in an acute health crisis

Primary outcomes:
measure: Psychological well-being (child)
timeFrame: Baseline, immediately after intervention
Secondary outcomes:
measure: Perceived stress levels (Child)
timeFrame: Baseline, immediately after intervention
measure: Self-compassion levels (Child)
timeFrame: Baseline, immediately after intervention
measure: Self-compassion levels (parents)
timeFrame: Baseline, immediately after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Metropolitan University
name: Wai Man Sin, MN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06705205: Short, Animated Storytelling (SAS) for Addiction Stigma Reduction
Official title: Short, Animated Storytelling Video to Reduce Addiction Stigma: Protocol for a Multi-country, Online, Randomized, Controlled Trial With 13,500 Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Stigma Towards People With Addiction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Alexander von Humboldt Association
name: Stanford Center for Digital Health
First posted: 2024-11-26
Enrollment: 13500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stigma towards people with addiction is a well-documented problem that negatively impacts help-seeking, treatment and recovery. Social contact with people recovering from addiction can promote empathy and reduce stigma, but social contact is difficult to scale. Short, animated storytelling (SAS) is a novel health communication approach that scales easily because it can leapfrog barriers associated with language, culture, literacy and education levels. This study will investigate if a SAS video intervention can be used to reduce stigma, boost optimism and hope, and increasing empathy towards people with addiction. The study will also explore mechanisms of action of SAS interventions, by measuring the contribution of sound design to the effect of the intervention.


Eligibility criteria: Inclusion Criteria:

* Adults with basic English proficiency between the ages of 18-49

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Addiction Stigma Scale Score as measured by the Attribution Questionnaire (AQ)
timeFrame: Immediately post-intervention on Day 1 and after two weeks
Secondary outcomes:
measure: Change in Optimism Scale Score
timeFrame: Immediately post-intervention on Day 1 and after two weeks
measure: Change in Attitude Thermometer Score
timeFrame: Immediately post-intervention on Day 1 and after two weeks
measure: Change in Levels of Hope using a visual analogue scale (VAS)
timeFrame: Immediately post-intervention on Day 1 and after two weeks
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Maya Adam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328705: D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Official title: D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Sensing
Capture Management
Heart Failure
ICD Indication
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-05-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Detailed description: The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
* Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.

Exclusion Criteria:

* Patients who have 3rd degree heart block, as assessed by the investigator
* Patients who have a mechanical tricuspid heart valve
* Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device

Primary outcomes:
measure: Ventricular fibrillation (VF) detection time
measure: Ventricular Capture Management accuracy
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Coon Rapids
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Charlotte
country: United States
state: North Carolina
Study officials:
affiliation: Medtronic CRDM
name: Cole Hannon
role: STUDY_DIRECTOR
References:
Clinical trial NCT02443805: Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
House Dust Mite Allergy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 1607
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

Detailed description: This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year.

The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.

Eligibility criteria: Main Inclusion Criteria:

* Patients with HDM-associated allergic rhinitis (AR) for at least 1 year
* Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE

Main Exclusion Criteria:

* A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the evaluation periods
* Partly controlled or uncontrolled asthma
* Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5

Primary outcomes:
measure: Total Combined Score
timeFrame: 12 months
Secondary outcomes:
measure: Average Rhinitis Total Symptom Score (RTSS)
timeFrame: 12 months
measure: Average Rescue Medication Score (RMS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South of Florida
state: Florida
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
Study officials:
affiliation: CHU Arnaud de Villeneuve, Montpellier, France
name: Pascal Demoly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South of Florida, Tampa, USA
name: Tom Casale, MD
role: PRINCIPAL_INVESTIGATOR
References: