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NCT ID: NCT03063177 Completed - Back Pain Clinical Trials

Evaluation of How Different Dosages of Spinal Manipulation Modulate Spinal Stiffness in Participants With Back Pain

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of three different spinal manipulative therapy dosages based on their group assignment and preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will include spinal stiffness measurement and clinical status evaluation through questionnaires.

NCT ID: NCT03062787 Completed - Clinical trials for Osteoarthritis, Knee

Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee

EEFFEK
Start date: April 5, 2017
Phase: N/A
Study type: Interventional

It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).

NCT ID: NCT03062644 Completed - Acute Pain Clinical Trials

Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.

STARDOM2
Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).

NCT ID: NCT03062618 Completed - Psoriasis Clinical Trials

A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis

Start date: February 20, 2017
Phase: Phase 1
Study type: Interventional

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

NCT ID: NCT03062254 Completed - Prostate Cancer Clinical Trials

Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Start date: March 22, 2018
Phase: Phase 2
Study type: Interventional

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.

NCT ID: NCT03061903 Completed - Wound Complication Clinical Trials

Closed Incision Negative Pressure Therapy vs Standard of Care

Prevena
Start date: May 14, 2018
Phase: N/A
Study type: Interventional

High risk patients who receive direct anterior approach total hip arthroplasty are more likely to experience wound complications. The purpose of this study is to determine whether the usage of closed incision negative pressure dressings decreases the risk of wound complication compared to standard dressings. Patients who decide to participate in the study will be randomized to one of the two dressing prior to surgery and will leave the operating room with one of the treating dressings. Patient will be monitored 90 days after surgery for wound complications and pictures of the wounds will be taken. The patients course of treatment besides being randomized to one of the two dressings will be identical to any other patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA). The primary outcome measure will be uneventful wound healing (requiring no intervention) versus the occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound). Secondary outcome measures will include duration of wound healing delay, length of hospital stay, number of days of antibiotic therapy, and direct and estimated indirect costs.

NCT ID: NCT03061825 Completed - Clinical trials for Aorto-iliac Aneurysm

Zenith Alpha™ Abdominal Endovascular Graft

Start date: May 24, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

NCT ID: NCT03061812 Completed - Clinical trials for Small Cell Lung Cancer

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

TAHOE
Start date: April 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

NCT ID: NCT03061578 Completed - Dry Eye Clinical Trials

Evaluation of Dry Eye by Tear Film Imager in a Low Humidity Environmental Exposure Chamber (TFI-LH16)

TFI-LH16
Start date: January 26, 2017
Phase: N/A
Study type: Observational

The study consists of 3 study visits to the clinic over at least 9 days. Visit 1 - the medical screening visit: subjects will undergo informed consent and will be tested for signs and symptoms of Dry Eye Syndrome (DES) including measurements by the TFI. Upon conclusion of the screening for DES, the subjects will be divided to the different categories: NDE, LDDE and ADDE. For ADDE and LDDE subjects the eye fitting the worst DES inclusion criteria will be designated as the study eye. For the NDE subjects the best eye will be designated as the study eye. During Visit 2 and 3, the TFI measurement and other clinical study endpoint procedures will be only conducted on the study eye. The safety endpoint procedures will still be conducted on both eyes individually throughout the study. Subjects will be queried for adverse events (AEs) at all visits. Visit 2 - after two days washout period subject will return for the LH-EEC test. Signs and symptoms of dry eye will be recorded before entering the LH-EEC, during the 120 min stay in the LH-EEC and at the conclusion of the day. Visit 3 - after 7 days washout period subject will return for the last test. The third day procedure is identical to the second day, with the addition of: following LH-EEC exit, subjects will have a health check and study check out procedures conducted. Statistical Analysis: Data will be summarized with respect to baseline characteristics, efficacy variables and safety variables. Summary statistics will include the number of observations (N), mean, standard deviation (SD), median, minimum and maximum values for continuous variables and frequencies and percentages for categorical variables. Missing values will not be replaced or imputed, i.e., no interpolation or extrapolation will be applied to missing values. Safety data will be listed and summarized by group (NDE, ADDE, and LDDE).

NCT ID: NCT03060577 Completed - Type2 Diabetes Clinical Trials

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

ORION-3
Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).