louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02031263: Efficacy of Bronchial Thermoplasty in Korean
Official title: Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 9
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: The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute exacerbation and improving quality of life for uncontrolled asthma in Korea through this research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was performed in Western countries.

Korean FDA have approved this procedure in 2013. However, no procedure was performed in Korea, and the data is rare in Asian countries. In this study, investigators will examine the efficacy of this procedure in Korean asthmatics.


Eligibility criteria: Inclusion Criteria:

* 1) Eighteen-year-old or older
* 2) Patients whose asthma is not controlled with more than three months of using high dose inhaled steroids and long acting β2-agonists
* 3) Patients with pre-bronchodilator FEV1 is between sixty and eighty-five%
* 4) Patients who do not improve through continuous drug uses.

Exclusion Criteria:

* 1) Presence of a pacemaker, internal defibrillator, or other implantable electronic devices,
* 2) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines.
* 3) Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments.
* 4)Active respiratory infection
* 5) Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days.
* 6) Known coagulopathy.
* 7) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure with physician guidance.

Primary outcomes:
measure: Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
timeFrame: 6 months
measure: Acute exacerbation
timeFrame: 3,and 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Study officials:
affiliation: Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
name: Sei Won Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386563: taVNS on Pupillary Response and Perceptual Learning
Official title: The Effect of Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) on Pupillary Response and Perceptual Learning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pupillary Response
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study has two parts. The study team will evaluate transcutaneous auricular vagal nerve stimulation (taVNS) and two sham settings during a passive task while measuring pupillary response. Second, the study team will assign either taVNS, sham, or no intervention during a go/no-go task and evaluate perceptual learning over three sessions which will also include measuring the pupillary response and electroencephalogram (EEG).


Eligibility criteria: Inclusion Criteria:

* Healthy individuals 18 to 65
* Normal audiometric testing

Exclusion Criteria:

* Co-morbidities including cardiomyopathies, arrhythmias
* Implantable devices including vagal stimulators, pacemakers
* Presence of metallic implants
* Pregnancy

Primary outcomes:
measure: Change in Time It Takes to Reach 90% of Asymptotic Level Performance
timeFrame: Baseline, Month 3
measure: Change in Overall Mean Peak (Pupillary Response)
timeFrame: Baseline, Month 3
measure: Change in Speed of Learning to Perform a Behavioral Task
timeFrame: Baseline, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health - Bellevue Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mario Svirsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084263: Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures
Official title: A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

Detailed description: Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF

Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.

As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.

In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

Eligibility criteria: Inclusion Criteria:

* Closed ankle fractures (44A, 44B, 44C)
* Ages of 18-65
* Men or women, including pregnant women
* Willing to consent

Exclusion Criteria:

* Open fractures
* Other lower extremity injuries/conditions that affects functional outcomes
* Problems maintaining follow up (homeless, not willing to return for follow up)
* Prisoners
* Unable to consent

Primary outcomes:
measure: American Orthopedic Foot and Ankle Score (AOFAS)
timeFrame: 6 month
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 1 year
measure: Rate of Return to Sports
timeFrame: 1 year
Secondary outcomes:
measure: Rates of Complications
timeFrame: 1 year
measure: Pain Scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Kevin Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03899363: Two Treatment for a Mallet Finger of Tendinous Origin
Official title: A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mallet Finger
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 48
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: A randomized clinical trial, with patients treated either by a custom thermoplastic orthosis or by the Kirschner wire with the distal interphalangeal (DIP) joint extended.

Evaluating the treatment efficacy of the operation management compared with a conventional orthosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a mallet finger, with or without fracture;
* Age≥18 years

Exclusion Criteria:

* Open lesions
* Mallet fractures with subluxation of the DIP
* Delays in treatment \>2 weeks
* DM
* RA

Primary outcomes:
measure: Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed
timeFrame: The first visit(Enrolled and completed treatment), 8 weeks after first visit(two weeks after 6 weeks fixation), 16 weeks(4 weeks after six weeks Rehabilitation)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02330263: Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Occlusive Dissease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.


Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo OPCAB

Exclusion Criteria:

* Subjects are ineligible if they have DM(Diabetes Mellitus),
* Gastroesophageal reflux disease or gastric emptying disorder,
* inflammatory bowel disease,
* previous treatment for intra-abdominal cancer,
* entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
* cognitive dysfunction,
* disabling mental change disorder,
* are unable to communicate or speak Korean

Primary outcomes:
measure: postoperative insulin resistance
timeFrame: within 1 hour after surgery
Secondary outcomes:
measure: preoperative discomfort
timeFrame: 24 hours
measure: perioperative hemodynamic effect
timeFrame: 24 hours
measure: postoperative complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637.
Clinical trial NCT05039463: Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis
Official title: Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Hyaluronic Acid
Platelet Rich Plasma
Keywords: platelet rich plasma
hyaluronic acid
Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of PRP, in combination with HA, at the Amiens University Hospital.

Brief summary: The French Society of Rheumatology cannot rule on the value of intra-articular injections of PRP due to the lack of hindsight and insufficient data. In fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. The investigator objective is therefore to evaluate the effectiveness of combined injections of PRP and hyaluronic acid.


Eligibility criteria: Inclusion Criteria:

* age : \> 18 years old
* Patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of PRP, in combination with HA, at the Amiens University Hospital.

Exclusion Criteria:

* Patient refusal to use the data
* Language barrier
* Age less than 18 years old.

Primary outcomes:
measure: change of the visual analogue scale (VAS) from the "PRP + HA" group on the "HA alone" group
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04160663: Arterial Stiffness and Atrial Fibrillation
Official title: Arterial Stiffness and Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.
Primary purpose: PREVENTION

Brief summary: Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* All patients with persistent AF, scheduled for electrical cardioversion

Exclusion Criteria:

* Unable to provide informed consent.
* Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
* Patients with prior carotid stents.

Primary outcomes:
measure: Recurrence of Atrial Fibrillation following cardioversion
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of heart failure
timeFrame: 6 months
measure: Occurrence of stroke
timeFrame: 6 months
measure: Occurrence of hospitalization
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hon-Chi Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362763: The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
Official title: The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibulodynia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

Detailed description: Patients were randomized to five acupuncture sessions designed to treat pain in the vulvar area (study group), or five acupuncture sessions designed for tranquility (controls). Participants and evaluating gynecologists were blinded to randomization. Participants were examined clinically before treatment and one month after completion of assigned treatment; at both visits they completed the Female Sexual Function Index (FSFI) questionnaire.

FSFI scores for pain during intercourse and total score were used to evaluate change. The examining gynecologist evaluated the degree of sensitivity to touch and the degree of local erythema. Response to treatment was evaluated for each group before and after treatment, and for study group compared to the control group.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

* Pregnancy
* Patient who received other treatment for vestibulodynia in the month preceding.

Primary outcomes:
measure: Female Sexual Function Index (FSFI) questionnaire
timeFrame: 1 month after completion of the assigned treatment
Secondary outcomes:
measure: Clinical examination
timeFrame: 1 month after completion of the assigned treatment
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Yaron Hamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981863: Fibrinolysis Before Cardiopulmonary Bypass?
Official title: Fibrinolysis Before Cardiopulmonary Bypass?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pathologic Fibrinolysis
Keywords: cardiac surgery
cardiopulmonary bypass
fibrinolysis
thromboelastography
D-Dimers
antifibrinolytic agents
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.

Detailed description: Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.

Eligibility criteria: Inclusion Criteria:

* All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

Exclusion Criteria:

* Resternotomy, renal insufficiency, deep hypothermia, age \< 18 yrs

Primary outcomes:
measure: Di-Dimer Increase Before Cardiopulmonary Bypass
timeFrame: 6 months
Secondary outcomes:
measure: Value of Thromboelastography as Monitor of Fibrinolysis
timeFrame: 6 months
Other outcomes:
measure: Length of Time Between Incision and Cardiopulmonary Bypass
timeFrame: From incision to bypass, up to 3 hours
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
Study officials:
affiliation: Stanford University
name: Pieter JA Van der Starre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097863: Clinical Validation of the New Print on Focus DAILIES Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate the improvements to the inversion indicator.

Detailed description: This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Eligibility criteria: Inclusion Criteria:

* Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
* Willing and able to wear study lenses in both eyes in the available parameters.
* Light-eyed subjects.
* Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
* Optimal or acceptable fit in each eye at time of dispensing.
* Willing to wear the study lenses at least 8 hours a day, 5 days a week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* RGP contact lens wearer.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: