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Laser Skin Procedure

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3261. Proteomic Profiling for Influenza Vaccination

and after FluMist intranasal attenuated live-virus influenza vaccination to identify surrogate markers reflective of the immune response by using surface-enhanced laser desorption/ionization-time of flight (SELDI-TOF) and matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry proteomic profiling tools reflective of the immune response. Concurrent T-cell activation, cytokine assays, and hemagglutination inhibition (HI) serologic assays will correlate cellular and humoral (...) of enrollment, visit 1(day 0). Provides written informed consent. Subject is judged to be healthy on the basis of verbal medical and concomitant medications history and has been medically stable prior to screening Subject is able to attend scheduled visits and to comply with the study procedures during the entire duration of the study and will be available for 1 month after enrollment. Female is not at risk of pregnancy, based on the following: Utilizing adequate method of birth control and agree

2006 Clinical Trials

3262. Ablation of Intestinal Metaplasia Containing Dysplasia

): Medtronic - MITG Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing Barrett's Esophagus. Condition or disease Intervention/treatment Phase Barrett Esophagus Device: Ablation System plus anti-secretory medication Device: Sham procedure plus anti-secretory medication (...) with this diagnosis. In other disease states, such as colon polyps or premalignant skin lesions, removal of the premalignant tissue results in a reduction in the risk of ultimately developing cancer. This is a logical conclusion when considering the premalignant lesion of Barrett's esophagus (particularly Barrett's esophagus with dysplasia), as the "tissue at risk" can be completely removed by ablation. This premise has been tested in the Barrett's dysplasia population in photoablative trials using PDT

2006 Clinical Trials

3263. Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery

Bile Duct Cancer Recurrent Gallbladder Cancer Drug: porfimer sodium Procedure: adjuvant therapy Procedure: laser therapy Procedure: photodynamic therapy Procedure: phototherapy Phase 3 Detailed Description: OBJECTIVES: Primary Compare the overall survival time in patients with unresectable Bismuth type III or IV, stage III-IV cholangiocarcinoma treated with double plastic endoprostheses insertion with vs without adjuvant photodynamic therapy using porfimer sodium as palliative treatment. Secondary (...) are then randomized to 1 of 2 treatment arms. Arm I: Patients receive porfimer sodium IV on day 1. Patients undergo endoscopic laser light therapy to the tumor site on day 3. Arm II: Patients receive no further treatment. Quality of life is assessed at baseline and then at weeks 2, 13, 26, 39, 52, and 65. After completion of study treatment, patients are followed within 30-90 days. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study. Study Design Go to Layout table

2005 Clinical Trials

3264. Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis

radiation therapy in treating laryngeal cancer of the glottis. PURPOSE: This randomized phase II trial is studying endoscopic surgery to see how well it works compared with radiation therapy in treating patients with stage 0, stage I, or stage II laryngeal cancer of the glottis. Condition or disease Intervention/treatment Phase Head and Neck Cancer Procedure: endoscopic surgery Procedure: laser surgery Radiation: radiation therapy Phase 2 Detailed Description: OBJECTIVES: Determine the feasibility (...) according to participating center and T stage (Tis or T1 vs T2a). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo endoscopic excision via CO_2 laser or cold steel. Arm II: Patients undergo radiotherapy once daily, 5 days a week, for 3-4 weeks. Patients undergo vocal analysis at baseline and at 6 months and 1 and 2 years after randomization. Quality of life is assessed at baseline, at 1 year, and then annually for 5 years. After completion of study treatment, patients

2006 Clinical Trials

3265. Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area. Presence of known or suspected metastatic disease. History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa). Known sensitivity to any of the ingredients in the study drug. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion (...) : January 28, 2016 Sponsor: Peplin Information provided by: Peplin Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses. Condition or disease Intervention/treatment Phase Actinic Keratosis Drug: PEP005 Phase 2 Detailed Description: Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated

2006 Clinical Trials

3266. Study to Assess the Effect Of Alosetron On Mucosal Blood Flow

Measures Go to Primary Outcome Measures : Left Colon Mucosal Blood Flow (MBF) [ Time Frame: Day 6 after each treatment period ] On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period. Secondary (...) Outcome Measures : Rectal Mucosal Blood Flow (MBF) [ Time Frame: Day 6 after each treatment period ] On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period. Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons [ Time

2006 Clinical Trials

3267. Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

: Dexmedetomidine Procedure: Microneurography Procedure: Laser doppler velocimetry Phase 1 Detailed Description: Cocaine abuse has emerged as a major cause of life-threatening cardiovascular emergencies but our understanding of the underlying mechanisms mediating the adverse effects of cocaine is far from complete. Our previous studies in cocaine-naive human subjects have demonstrated that intranasal cocaine acutely stimulates the human cardiovascular system by a novel central mechanism of action.We (...) Masking: Double Primary Purpose: Treatment Official Title: Cocaine and Sympathetic Nerve Activity in Humans Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Blood pressure Heart rate Skin sympathetic nerve activity Skin blood flow Coronary blood flow Secondary Outcome Measures : Sedation status Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate

2006 Clinical Trials

3268. Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment

temperature, leading to destruction of the follicle and disruption of the hair growth mechanism, while leaving the skin undamaged. Both laser and light devices have been proven successful in inducing permanent hair removal, as well as delayed hair growth, while causing minimal discomfort and complications. The light devices are based on the IPL technology, which differs from laser light in various physical aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL delivers (...) a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of this study is to evaluate the safety and efficacy of using Leortec 300 device for hair removal treatment. Condition or disease Intervention/treatment

2006 Clinical Trials

3269. Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

: June 23, 2006 Last Update Posted : December 5, 2014 Sponsor: University Hospital, Ghent Information provided by (Responsible Party): University Hospital, Ghent Study Details Study Description Go to Brief Summary: This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing. Condition or disease Intervention/treatment Phase Burn Wounds - Partial Thickness (2nd Degree) Procedure: aquacel AG hydrofiber versus acticoat (...) : September 2015 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: aquacel AG hydrofiber Procedure: aquacel AG hydrofiber versus acticoat burn dressing Aquacel AG hydrofiber versus acticoat burn dressing will be compared. Experimental: Acticoat burn dressing Procedure: aquacel AG hydrofiber versus acticoat burn dressing Aquacel AG hydrofiber versus acticoat burn dressing will be compared. Outcome Measures Go

2006 Clinical Trials

3270. Photodynamic Therapy for Permanent Hair Removal

Details Study Description Go to Brief Summary: 24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected. Condition or disease Intervention/treatment Phase Hypertrichosis Hirsutism Procedure: application of a dye suspension followed by a laser intervention Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment (...) for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: All Criteria Inclusion Criteria: age 18-60 Exclusion Criteria: anormal behavior pregnancy pathologic skin conditions medication that my interfere with the study allergy against the photosensitizer lack of compliance other reasons considered important by the investigator Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff

2006 Clinical Trials

3271. Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer

: bevacizumab Drug: cisplatin Drug: irinotecan hydrochloride Genetic: proteomic profiling Other: diagnostic laboratory biomarker analysis Other: mass spectrometry Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy Phase 2 Detailed Description: OBJECTIVES: Primary Evaluate the toxicity and safety of bevacizumab when given together with cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgery and adjuvant (...) undergo external beam radiotherapy 5 days a week for 6 weeks beginning on day 43. Surgery: Patients undergo surgery 6-8 weeks after finishing combination therapy and radiotherapy. Maintenance therapy: Approximately 6 weeks after surgery, patients receive bevacizumab IV over 30-90 minutes every 3 weeks for 6 months. Blood samples are obtained at baseline, after finishing chemoradiotherapy, and prior to maintenance therapy and are examined by the matrix-assisted laser-desorption ionization time

2006 Clinical Trials

3272. Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)

-absorbable material in the periorbital region or facial treatment with augmentation material within 12 months prior to screening. Any prior treatment with botulinum toxin (of any serotype). Previous treatment with lasers for skin resurfacing or treatment with deep chemical peels within 12 months prior to screening. Inability to substantially lessen the lateral canthal lines by physically spreading them apart. Facial conditions that could affect safety or efficacy results such as: active infection (...) . In the opinion of the Investigator moderate to severe lateral canthal lines (crow’s feet) during maximum smile on both sides of the face. In the opinion of the Investigator mild to severe lateral canthal lines (crow’s feet) at rest on both sides of the face. Exclusion Criteria: Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results. Previous insertion of any non

2005 Clinical Trials

3274. Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.) History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. History of treated diabetic gastric paresis. New York Heart Association Class III or IV heart failure regardless of therapy (...) with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled

2006 Clinical Trials

3275. Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.) History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. History of treated diabetic gastric paresis. New York Heart Association Class III or IV heart failure regardless of therapy (...) agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled

2006 Clinical Trials

3277. Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

the participant from completing the study Able and willing to provide written informed consent Exclusion Criteria Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the participant may be rescreened within 1 week. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II (...) is allowed.) History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening History of treated diabetic gastric paresis New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated participants who are stable at Class I or II are candidates for the study. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening History of any

2006 Clinical Trials

3278. Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1

of Health Research (CIHR) Information provided by: Ontario Clinical Oncology Group (OCOG) Study Details Study Description Go to Brief Summary: This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses. Condition or disease Intervention/treatment Phase Cervical Intraepithelial Neoplasia Procedure: loop electrosurgical excision procedure (LEEP) Phase 3 Detailed Description: In women who present with biopsy-proven CIN (...) ) Primary Purpose: Treatment Official Title: Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1 Study Start Date : November 2000 Actual Primary Completion Date : September 2007 Actual Study Completion Date : September 2007 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Immediate Treatment - LEEP - Loop electrosurgical excision procedure Procedure: loop

2005 Clinical Trials

3279. Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy

the post treatment prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded. Condition or disease Intervention/treatment Phase Prostate Cancer Procedure: Androgen suppression, radiotherapy Procedure: Androgen suppression, radiotherapy, iodine 125 brachytherapy Phase 3 Detailed Description: Patients will be randomly assigned with equal probability to one or two treatment arms, Arm 1 or Arm 2, where the interventions associated with these Arms are as follows: Arm 1 (...) Procedure: Androgen suppression, radiotherapy Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions). Other Names: Androgen suppression: non-steroidal androgen (any of flutamide, nilutamide or bicalutamide (bicalutamide is almost always used). LHRH monotherapy: buserelin acetate or leuprolide acetate

2005 Clinical Trials

3280. A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery

Operation not performed according to the standard procedures. Any eye condition which urgently requires treatment with NSAIDs or corticosteroids. History of intraocular surgery in the operated eye. Any laser therapy or cryotherapy in the operated eye in the 90 days preceding surgery. Any previous episode of uveitis in the operated eye. Clinically significant trichiasis or other clinically relevant concurrent inflammatory/ infective eye disorders (e.g. conjunctivitis, episcleritis) except mild forms (...) to Outcome Measures Go to Primary Outcome Measures : Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter. Secondary Outcome Measures : The secondary objectives were to demonstrate that two days treatment with 0.5 % prednisolone acetate eye drops: are superior to vehicle regarding corneal edema and bulbar conjunctival hyperemia, are safe regarding intraocular pressure (IOP), visual acuity and frequency of AEs and SAEs, are well tolerated

2005 Clinical Trials

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