louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04072692: Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
Official title: Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts.

The first part is an observational study. The aim of the first part is to attempts to measure the gliding and morphological characteristics of the flexor tendons and median nerve in the longitudinal or cross-sectional directions via the ultrasonographical images incorporating with the motion capture experiment of the wrist and fingers. The gliding and morphological features of the tendons and nerve will be compared under different postures or movement patterns of the wrist and hand.

The second part is an interventional study. The aim of the first part is to establishes a novel hybrid rehabilitation protocol which combines the tendon gliding exercise with nerve mobilization to treat either the trigger digit or the carpal tunnel syndrome. A randomized controlled trial to investigate the short-term treatment effect and the follow-up examination will be carried out as well.

The third part is an observational study. The aim of the first part is to investigate the effects of carpal tunnel release on the hand performances from functional perspectives. In addition, a novel wrist orthosis will be developed to eliminate the bowstringing effect of the flexor tendons after carpal tunnel release.


Eligibility criteria: Inclusion Criteria:

1. Healthy subjects without any history musculoskeletal diseases
2. Patients with carpal tunnel release surgery

Exclusion Criteria:

* Subjects with fracture or surgery in the upper extremity.

Primary outcomes:
measure: Change in the gliding features of tendons
timeFrame: baseline, 1 month, 6 months
measure: Change in the gliding features of median nerve
timeFrame: baseline, 1 month, 6 months
measure: Change in the grip strength
timeFrame: baseline, 1 month, 6 months
measure: Change in the pinch force
timeFrame: baseline, 1 month, 6 months
measure: Change in the threshold value of sensitivity
timeFrame: baseline, 1 month, 6 months
measure: Change in the mechanical properties of the flexor tendons
timeFrame: baseline, 1 month, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References:
Clinical trial NCT04421092: Efficacy of SLN Block for Chronic Cough
Official title: Efficacy of Superior Laryngeal Nerve Block for Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cough
Superior Laryngeal Nerve Block
Neurogenic Cough
Keywords: superior laryngeal nerve block
chronic cough
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.


Eligibility criteria: Inclusion Criteria:

* History consistent with neurogenic cough
* Exclusion of other etiologies (see exclusion criteria)
* Age ≥ 18

Exclusion Criteria:

* Current neuromodulating medication use
* Untreated other etiologies of cough:

Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI \> 13 or RFS \>11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)

Primary outcomes:
measure: Change in cough severity
timeFrame: Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)
Secondary outcomes:
measure: Subjective improvement in cough
timeFrame: Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy
measure: Daily change in subjective cough severity
timeFrame: Daily after each treatment (estimated 3 months total)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Courtney Tipton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713192: Registry for Perioperative Data in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery

Brief summary: The purpose of this registry is to obtain perioperative data in patients undergoing cardiac surgery and find out relations between the data and investigate several causes affecting postoperative complications.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* refused to participate

Primary outcomes:
measure: perioperative data
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Cho YJ, Koo CH, Kim TK, Hong DM, Jeon Y. Comparison of cardiac output measures by transpulmonary thermodilution, pulse contour analysis, and pulmonary artery thermodilution during off-pump coronary artery bypass surgery: a subgroup analysis of the cardiovascular anaesthesia registry at a single tertiary centre. J Clin Monit Comput. 2016 Dec;30(6):771-782. doi: 10.1007/s10877-015-9784-6. Epub 2015 Oct 1.
citation: Kim TK, Cho YJ, Min JJ, Murkin JM, Bahk JH, Hong DM, Jeon Y. Microvascular reactivity and clinical outcomes in cardiac surgery. Crit Care. 2015 Sep 4;19(1):316. doi: 10.1186/s13054-015-1025-3.
Clinical trial NCT05774392: An Observational Study of Patients With Chronic Kidney Disease
Official title: An Observational Study of Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Disease, Chronic
End Stage Kidney Disease
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adults who are being managed for Stage 1-5 CKD or received a transplant for ESKD.

Brief summary: TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).


Eligibility criteria: Disease Cohort

Inclusion Criteria:

* Adult\* patients at the time of enrollment with a diagnosis of CKD/ESKD by ICD-10 code in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* Adult \* patients diagnosed and managed for CKD/ESKD invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Primary outcomes:
measure: To characterize the natural history of disease in patients with CKD/ESKD.
timeFrame: 20 Years
measure: To assess safety and effectiveness of CKD/ESKD treatments and treatments for complications of either condition
timeFrame: 20 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients with CKD/ESKD
timeFrame: 20 Years
measure: To evaluate longitudinal and patient reported outcomes in CKD/ESKD
timeFrame: 20 Years
measure: To select and evaluate quality of care measures for patients with CKD/ESKD
timeFrame: 20 Years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00205192: Optimizing Cardiac Resynchronization
Official title: Optimizing Cardiac Resynchronization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac resynchronization
echocardiography
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.

Brief summary: Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions:

1. in the patient's native rhythm simulated by changing the pacing system to atrial pacing only;
2. in conventional dual chamber pacing (DDD mode); and
3. during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.


Eligibility criteria: Inclusion Criteria:

* All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
* The study is only open to patients as enumerated above, and also patients who have good imaging windows.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Peter S Rahko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978092: Monochromatic Digital-Pupillometry With Two Automated Devices in Comparison to Manual Measurements on Digital Photographs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupil Examination
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of a university eye-hospital which underwent examinations for refractive or cataract surgery

Brief summary: Retrospective, analysis of three different methods to measure patients' pupil diameters


Eligibility criteria: Inclusion Criteria:

* usable measurement values from three different examinations

Exclusion Criteria:

* bad image quality

Primary outcomes:
measure: Pupils' diameter
timeFrame: September 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06118892: MISHA Post-Market Clinical Study
Official title: Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Moximed
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective evaluation of the safety and effectiveness of the MISHA Knee System.

The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.

The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.

This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.

Study subjects will be followed over a five-year post-implant period.


Eligibility criteria: Key Inclusion Criteria:

1. Subjects aged 25 to 65 years at time of index procedure
2. Body Mass Index (BMI) of \< 35
3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
4. WOMAC pain ≥ 40
5. Failed non-operative OA treatment

Key Exclusion Criteria:

1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
3. Ligamentous instability
4. Active or recent knee infection
5. Inflammatory joint disease, including sequalae of viral infections
6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
7. History of keloid, hypertrophic or contracture scaring
8. Propensity for restrictive scar formation or adhesions with prior procedures

Primary outcomes:
measure: Freedom from device- and procedure-related Subsequent Surgical Interventions
timeFrame: 5 years post-implantation
Secondary outcomes:
measure: WOMAC Pain
timeFrame: 5 years
measure: WOMAC Function
timeFrame: 5 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Oregon Health and Science University
name: Dennis Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04596592: Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Official title: Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgenderism
Gender Dysphoria
Insulin Sensitivity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-22
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender and cisgender adolescents

Brief summary: To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.


Eligibility criteria: Inclusion Criteria (transgender females):

* Identify as a transgender female
* Age 13-16 years at the time of enrollment
* If on a gonadotropin releasing hormone analogue, \> 6 months exposure
* Plan to start estradiol clinically in \< 4 months

Inclusion Criteria (cisgender males and females):

* Males and females ages 13-16 years

Exclusion Criteria:

* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Antipsychotic medication use
* Type 1 or 2 diabetes (by medical history)
* Polycystic ovarian syndrome (PCOS for cisgender females)
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight\> 400 lbs
* On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
* Pregnancy (for cisgender females)

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Change from baseline to 12 months
measure: Brachial artery flow mediated dilation
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Large artery stiffness
timeFrame: Change from baseline to 12 months
measure: Cerebrovascular function
timeFrame: Change from baseline to 12 months
measure: VO2 peak
timeFrame: Change from baseline to 12 months
measure: Fat mass
timeFrame: Change from baseline to 12 months
measure: Fat-free mass
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Natalie Nokoff, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06200792: Stress and Anxiety Affect Residents' Performance
Official title: The Impact of Stress in Residents' Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Stress Disorder
Work Related Stress
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 40
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: Anesthesiologists residents

Brief summary: Being an anesthesiologist implies huge dedication and both physical and psychological efforts. None has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions.

Detailed description: During a working day, trainees will have their physiological and psychological data recorded before starting their clinical activity and after them. Electrodermal activity with the eSense device, Executive functions through the TOL-R and all the questionnaires and scales will be sampled at the beginning of the day and at the end of the day the same procedure will be applied again (exclusion for PSS-10 scale, STAY-Y trait anxiety and GAD-7) eSense and TOL-R, are useful tools to understand sympathetic activity and executive functions. The galvanometer it is the gold standard to measure EDA; i.e. electrodermal activity, which is a pure sympathetic index, while Tower of London it is the gold standard to assess planning, monitoring and programming skills, both data are supposed to be heavily involved in an anesthesiologist trainee during the all day.

The aims of the study are to evaluate executive functions at the start and at the end of a working day and to understand theirs relationship with anxiety, perceived stress levels and physiological changes in sympathetic activity.

Eligibility criteria: Inclusion Criteria:

* Being an anesthesiologist residents
* Written informed consent obtained

Exclusion Criteria:

* Psychiatric disorders
* Neurological disorders
* Suffering from high blood pressure

Primary outcomes:
measure: Differences in executive functions overtime
timeFrame: baseline and immediately after intervention
Secondary outcomes:
measure: Differences in dermal activity during working day
timeFrame: baseline and immediately after intervention
measure: Assess the general level of anxiety
timeFrame: baseline and immediately after intervention
measure: General level of anxiety
timeFrame: baseline and immediately after intervention
measure: Evaluating the general levels of perceived stress levels
timeFrame: baseline and immediately after intervention
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Clinica Odontoiatrica
Study officials:
References:
Clinical trial NCT01237392: Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Official title: Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Skin Ulcers
Keywords: wound debridement
requiring debridement
Lead sponsor: Calvary Hospital, Bronx, NY
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.


Eligibility criteria: Inclusion Criteria:

* Chronic wound needing debridement \>3 cm2
* Ulcer history \>4mo
* Adequate arterial blood flow (ABI\>0.7)
* Venous, Inflammatory, Pressure, Diabetic

Exclusion Criteria:

* Bleeding disorder
* ABI\<0.7
* Uncontrolled diabetes
* Taking systemic corticosteroids
* Chemotherapy
* Participating in another study
* Treatment with Apligraft, Dermagraft, or Regranex within 90 days

Primary outcomes:
measure: Time to complete wound closure
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Relative rate of wound healing
timeFrame: 8, 12 and 24 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calvary Hospital Center for Curative and Palliative Wound Care
state: New York
Study officials:
affiliation: Director, Wound care Center, Calvary Hospital
name: Oscar M Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician, Wound Care Center, Calvary Hospital
name: Martin E Wendelken, DPM, RN
role: STUDY_DIRECTOR
References: