louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01472900: 2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
Official title: A Randomized Split-Face Controlled Trial Comparing Efficacy of 2940 Nanometer Er:YAG Laser to 2.5% BP Gel for the Treatment of Inflammatory Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acne is one of the most common conditions that patients seek for help in dermatological clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.


Eligibility criteria: Inclusion Criteria:

* Age 18 year-old to 45 year-old
* Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face
* Fitzpatrick skin phototype I-IV

Exclusion Criteria:

* History or clinical presentation of hypertrophic scar or keloid
* Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria
* Oral isotretinoin taken within the last 6 months prior to enrollment
* Topical retinoid within 4 weeks prior to enrollment
* Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment

Primary outcomes:
measure: percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
timeFrame: 6 week
Secondary outcomes:
measure: Safety
timeFrame: week0,2,4
measure: Photographic clinical improvement
timeFrame: week 2,4,6 and 10
measure: Patient satisfaction
timeFrame: week 6
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
References:
Clinical trial NCT03222700: The Recovery Profiles After Robotic or Open Thyroidectomy
Official title: The Recovery Profiles After Robotic or Open Thyroidectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Sorethroat
Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing robotic thyroidectomy or open conventional thyroidectomy

Brief summary: In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
2. Adults 19 to 70 years of age
3. American Society of Anesthesiologists Physical grade 1-2

Exclusion Criteria:

1. Patients who underwent surgery on the neck and in the laryngeal area before
2. Patients who do not understand or can not express pain scale
3. Patients with sore throat and cough before surgery
4. If intubation is difficult or repeated intubation is performed
5. Patients who are using opioids or analgesics as chronic agents.

Primary outcomes:
measure: postoperative sore throat
timeFrame: postoperative 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Ah-young Oh
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00861900: Immune Mechanisms of Rejection in Human Lung Allografts
Official title: Immune Mechanisms of Rejection in Human Lung Allografts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-03-16
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who is a candidate for a lung transplant.

Brief summary: The investigators have obtained compelling evidence that the development of anti-human leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag period between the development of anti-HLA antibodies and the onset of BOS gives us an opportunity to intervene to delay and/or prevent the development of BOS.


Eligibility criteria: Inclusion Criteria:

* Lung transplant recipient.

Exclusion Criteria:

* Pregnant women,
* Prisoners, AND
* Anyone who is unable or unwilling to consent to this study.

Primary outcomes:
measure: The primary efficacy event is the change in pulmonary function testing values (FEV1).
timeFrame: Lung function is monitored at regular intervals. Patients will be followed for five years.
Secondary outcomes:
measure: Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis.
timeFrame: The subjects are monitored at regular intervals. Patients will be followed for five years.
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Thalachallour Mohanakumar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883400: Spironolactone After Liver Transplant
Official title: Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transplant, Liver
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

Detailed description: The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Eligibility criteria: Inclusion Criteria:

* liver transplant

Exclusion Criteria:

* dual organ transplant

Primary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: CHS
state: North Carolina
Study officials:
affiliation: Charolinas Healthcare System
name: Mark W. Russo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russo MW, Krista Bossi, Gale Groseclose, Levi DM, Lon Eskind, Bennett Noell, Anderson WE, Zamor PJ, Vincent Casingal. Estimates of Glomerular filtration rate in liver transplant recipients are not accurate: A role for 24 hour urine creatinine clearance. Archives of Transplantation 2018:2:1-5.
Clinical trial NCT01614600: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Official title: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Myopia
Keywords: contact lens
dry eye syndrome
symptomatic
daily disposable
myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 88
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 purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).


Eligibility criteria: Inclusion Criteria:

* Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
* Identified as symptomatic using a baseline screening questionnaire.
* Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers \</= 0.75D and no ADD correction.
* Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
* Willing and able to follow instructions and maintain the appointment schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Neophytes and current wearers of daily disposable contact lenses.
* Requires monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* A history of ocular surgery/trauma within the last 6 months.
* Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
timeFrame: Baseline, Week 1, Week 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, MBA, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03434600: Comparison of Oxford UKA and Sigma UKA With RSA.
Official title: Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Knee Replacement
RSA
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.

Hypothesis:

H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.

H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.

H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.

H4: BMD of the proximal tibia does not influence migration of the tibial component


Eligibility criteria: Inclusion Criteria:

* All eligable patients with medial osteoarthritis of the knee.

Exclusion Criteria:

* - Inflammatory arthritis.
* Patients who are not able to participate in the fast-track surgery program.
* Patients with a contralateral knee arthroplasty.
* Patients who are unable to provide informed consent.
* Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
* Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
* On-going case involving work injury of the knee.
* Female patients with a wish of becoming pregnant in the study period.

Primary outcomes:
measure: Migration of prosthesis
timeFrame: 2 years follow-up
Secondary outcomes:
measure: Bone mineral density
timeFrame: 2 years follow-up
measure: Polyethylene wear
timeFrame: 5 years follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Unit Vest
name: Daan Koppens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387100: A Modified Rehabilitation Intervention for Working Persons With Arthritis
Official title: Efficacy of a Modified Vocational Rehabilitation Intervention for Work Disability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis
Keywords: supportive employment
vocational rehabilitation
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2011-07-04
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the effects of a brief vocational rehabilitation intervention on individuals with arthritis who are concerned about their ability to remain employed.


Eligibility criteria: Inclusion Criteria:

* Live or work in eastern Massachusetts
* Age 25-63 years
* Risk of work loss due to arthritis
* Arthritis
* Chronic back pain
* Currently employed

Exclusion Criteria:

* Unemployed
* No arthritis

Primary outcomes:
measure: Change in work status
timeFrame: Baseline, 6, 12, 24 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University, Sargent College of Health and Rehabilitation Sciences
state: Massachusetts
Study officials:
affiliation: Boston University
name: Julie Keysor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: AlHeresh R, Vaughan MW, Brenner IH, Keysor J. Recruitment cost and outcomes for an arthritis work disability prevention randomized clinical trial: The Work It study. Contemp Clin Trials Commun. 2021 Nov 12;24:100862. doi: 10.1016/j.conctc.2021.100862. eCollection 2021 Dec.
citation: Keysor JJ, LaValley MP, Brown C, Felson DT, AlHeresh RA, Vaughan MW, Yood R, Reed JI, Allaire SJ. Efficacy of a Work Disability Prevention Program for People with Rheumatic and Musculoskeletal Conditions: A Single-Blind Parallel-Arm Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Jul;70(7):1022-1029. doi: 10.1002/acr.23423. Epub 2018 Apr 25.
Clinical trial NCT03096600: Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis
Official title: Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rehabilitation
Keywords: spine
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indications for transforaminal lumbar interbody fusion

Brief summary: Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases.

So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.


Eligibility criteria: Inclusion Criteria:

* patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion
* age \>18 hears

Exclusion Criteria:

* Age \>75
* ASA score \>2
* long distance between house and hôpital
* socially isolantes
* pathology needed conventional hospitalisation
* psychiatric pathology

Primary outcomes:
measure: Percentage of passage to conventional hospitalization
timeFrame: week 1
Secondary outcomes:
measure: Assessment of percentage of patients accepting fast track rehabilitation
timeFrame: day1
measure: Early complication rate
timeFrame: day 30
Other outcomes:
Locations:
Study officials:
affiliation: GHPSJ
name: Pomme JOUFROY, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03962400: Reinforcement Learning for Warfarin Dosing
Official title: Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Clotting Disorder
Keywords: warfarin
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial of 2 groups. Subjects in the Control group will receive warfarin with dose adjustment guided by standard protocol. Subjects in the Treatment group will receive warfarin with dose adjustment guided by personalized protocol.
Primary purpose: TREATMENT

Brief summary: This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range.

Detailed description: This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.

Eligibility criteria: Inclusion Criteria:

* Receiving anticoagulation treatment with warfarin.

Exclusion Criteria:

* Pregnancy.

  * History of hemorrhagic cerebrovascular incident.
  * Acquired or inherited hemophilia.
  * Thrombocytopenia (\<100,000 platelets per mm3) on 2 occasions separated by 2 days.
  * Anemia with hemoglobin concentration \< 10 g/dL.
  * Active cancer excluding non-melanoma skin cancers.
  * Active liver disease as documented by prolonged baseline INR ≥ 1.6.
  * Uncontrolled hypertension with 2 readings \>180/110.
  * Recent (\< 2 weeks) neurosurgical procedure.
  * Enrollment in hospice program for any diagnosis.

Primary outcomes:
measure: Percent in Range
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01309100: Product Feasibility of a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction

Exclusion Criteria:

* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

Primary outcomes:
measure: Visual Acuity (Investigational vs Air Optix Aqua Lens)
timeFrame: 1 week
measure: Visual Acuity (Investigational vs Acuvue Oasys Lens)
timeFrame: 1 week
Secondary outcomes:
measure: Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
timeFrame: 1 week
measure: Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
timeFrame: 1 week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tara Vaz, OD
role: PRINCIPAL_INVESTIGATOR
References: