Treatment Trials

102 Clinical Trials for Various Conditions

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COMPLETED
Tension in Posterior Component Separation for Abdominal Wall Reconstruction
Description

The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.

COMPLETED
Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product
Description

The primary hypothesis of the present study is that supplementation with the Tension Relief test product will reduce the severity of symptoms of a tension headache.

Conditions
WITHDRAWN
A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
Description

The study aims to compare outcomes in patient comfort, cosmetic appearance, and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic.

RECRUITING
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
Description

This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.

RECRUITING
The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure
Description

This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.

COMPLETED
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
Description

The goal of this clinical trial is to determine the clinical impact of restoring the anatomic-tension relationship of the long head of the biceps (LHB) when performing a biceps tenotomy and tenodesis. The main question it aims to answer is whether anatomic tensioning will improve functional outcome scores and decrease postoperative complications. The investigators hypothesize that through a standardized method of anatomically tensioning the LHB tendon during tenodesis, patient outcomes will improve. Researchers will compare these outcomes to a control group receiving the traditional tensioning technique. Participants will be randomized to either the anatomic tensioning treatment group or the traditional tensioning control group.

RECRUITING
Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
Description

The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation. 1. What is the abdominal wall tension for hernias repaired without a component separation? 2. What patient factors contribute to greater abdominal wall tension? 3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes? Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.

NOT_YET_RECRUITING
Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
Description

The purpose of this research study is to learn more about the relationship between Obstructive Sleep Apnea (OSA) and Normal Tension Glaucoma (NTG). OSA is a nighttime disorder of the upper airway that causes an intermittent lack of oxygen while sleeping. NTG is a type of glaucoma that occurs despite the normal intraocular pressure levels, making its detection more difficult. Left untreated, irreversible optic nerve damage and extensive vision loss can result. Previous research has shown some evidence between OSA and the development of NTG. The investigators are researching whether undergoing treatment for OSA would help to improve the vascular health to the retina, and in effect, improve the early signs of visual dysfunction seen with diagnostic testing.

COMPLETED
Change in Fascial Tension in Open Abdomens
Description

The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

ACTIVE_NOT_RECRUITING
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
Description

Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

COMPLETED
Physiologic Tension of the Abdominal Wall
Description

Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.

UNKNOWN
Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma
Description

Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH. Hypotheses * Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG. * Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG. * Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.

ACTIVE_NOT_RECRUITING
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
Description

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

TERMINATED
Progressive Tension Sutures in Gender Affirming Mastectomy
Description

50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.

Conditions
ACTIVE_NOT_RECRUITING
Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax
Description

Intrapleural pressures have been shown to be a useful clinical predictor in pleural effusions, however it's utility has not been described in pneumothorax. Data on intrapleural pressures in pneumothorax are limited. Furthermore, the pleural pressure in tension pneumothorax is theorized to be greater than atmospheric pressure, though this has never been verified. Pneumothorax is primarily treated with a tube thoracostomy. This observational study will record intrapleural pressures in participants with pneumothorax undergoing a tube thoracostomy. Clinical outcomes of participants will then be monitored for need for pleurodesis, intrabronchial valve placement, and video assisted thoracoscopic surgery (VATS) to identify a correlation with intrapleural pressure.

RECRUITING
HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches
Description

The purpose of this research is to compare two different approaches for treating patients with tension-type headaches: thrust Manipulation, electric dry Needling and exercise Vs. non-thrust mobilization, soft-tissue mobilization, exercise and TENS. Physical therapists commonly use all of these techniques to treat tension-type headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

TERMINATED
Capsular Tension Rings in Intraocular Lens Rotation
Description

To investigate whether implantation of a capsular tension ring device will affect the degree of rotation of an implanted toric intraocular lens following cataract surgery.

RECRUITING
Tension Versus no Tension With Foley Bulb Induction
Description

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

UNKNOWN
Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
Description

The hypothesis of the study is that sub-dissociative dose ketamine will prove to be superior to or as standard therapy, ketorolac, in the treatment of acute tension type headache (TTH) as measured by the 10 point Numerical Rating Scale (NRS. The aim of the study is to compare the safety \& efficacy of intravenous sub-dissociative dose ketamine versus ketorolac for acute treatment of migraines in the Emergency Department (ED) The primary endpoints are: Patient perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes. The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at 15, 30, 45, 60, 75, 90 min, Number of emergency department re-visits for acute migraine one month post discharge, incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams) during study period, incidence of nausea, vomiting, or worsening headache, Incidence of bad taste, Incidence of burning sensations in the nostrils, incidence of hypertension, time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale.

Conditions
COMPLETED
Tension Tamer Randomized Control Trial
Description

This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. After informed consent is obtained, subjects will complete baseline visit consisting of a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining 4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.

UNKNOWN
Yoga for Pediatric Tension-Type Headache
Description

This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment response, including experimental pain sensitivity, chronic stress, and negative cognitions linked to chronic pain.

Conditions
COMPLETED
Tension of THERABAND® Kinesiology Tape on Shoulder Pain
Description

The purpose of this study is to determine the effectiveness of standard tension of Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain, disability, and recovery speed during an in-office rehabilitative program. A convenience sample size of 38 new patients with current shoulder pain will be recruited for this study. The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder Score (PENN). After completing the initial paperwork, patients will be randomized into two groups, control (0% tension) and intervention(increasing tension). At the beginning of each week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4 weeks patients will complete the PENN.

Conditions
COMPLETED
The Role of Therapy for Muscle Tension Dysphagia
Description

Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing function as evidenced by videofluoroscopic swallow study. These patients also demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the unloading of the supraglottic muscle tension has been shown to be highly effective in symptom resolution per the investigators' clinical experience. The study is designed to answer efficacy of treatment being offered to patients with muscle tension dysphagia.

UNKNOWN
Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.
Description

The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.

COMPLETED
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
Description

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a single qualifying Tension-Type-Headache (TTH).

RECRUITING
EyeKon Medical Inc. Capsular Tension Ring Study
Description

This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation to give added support in order to keep the intraocular lens well centered, especially in eyes with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to be successfully implanted into an eye which otherwise could not have supported an intraocular lens.

COMPLETED
Inguinal Hernia Management: Watchful Waiting vs. Tension-Free Open Repair
Description

Purpose: To determine if observation (watchful waiting is a safe alternative to routine repair of asymptomatic inguinal hernias in adult males. Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at diagnosis to prevent the life threatening complications of bowel obstruction or incarceration with strangulation and that operation becomes more difficult the longer a hernia is left un-repaired.

TERMINATED
Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Description

This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

COMPLETED
A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration
Description

The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event. The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.

TERMINATED
Efficacy of a Single Dose of Aspirin vs. Acetaminophen in Tension Type Headache
Description

The purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache pain.

Conditions