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NCT ID: NCT04221113 Completed - Clinical trials for Injury of Extensor Tendon of Hand (Disorder)

Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Functional recovery measurement : Comparing early active mobilization versus immobilization after extensor tendon repair in zones IV to VIII. Immobilization for six weeks has been the postoperative protocol for the patients with hand's extensor tendon repair in our institute. In this study early mobilization of the hand i.e. also an internationally followed way, is compared with the aforementioned immobilization protocol to see which turns out to be a better option in the interest of the patient.

NCT ID: NCT04220866 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)

Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.

NCT ID: NCT04220775 Completed - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

Start date: March 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and how well bintrafusp alfa and stereotactic body radiation therapy work in treating patients with head and neck squamous cell cancer that has come back (recurrent) or has occurred after having cancer in the past (second primary). Immunotherapy with bintrafusp alfa may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving bintrafusp alfa and stereotactic body radiation therapy may help to control recurrent head and neck squamous cell cancer.

NCT ID: NCT04220541 Completed - Clinical trials for Proprioceptive Disorders

Investigation of the Effects of Exercise on Patients With Chiari Malformation

Start date: July 6, 2020
Phase: N/A
Study type: Interventional

Chiari Malformation (CM) is a posterior brain anomaly caused by the displacement of the brain stem and cerebellum into the cervical spinal canal. There are 8 types of Chiari malformations described today that vary according to the severity of the anomaly. In CM Type 1, cerebrospinal fluid (CSF) circulation deteriorated along with the foramen magnum and the cerebellar tonsillar decreased to at least 5 mm below the foramen magnum. Depending on this situation, headache, cerebellar findings, muscle strength, and sensory loss and so on. and adversely affect the daily life of the patient. When establishing an exercise program for the symptoms of CM type 1, it should be taken into consideration that somatosensory, visual, vestibular system and cerebellum are in close relationship with each other and balance and coordination result from this close relationship. When the literature is reviewed for exercise programs aimed at reducing instability in the cervical region, it is seen that 80% of the stability of the cervical spine originates from the muscular system and its importance in the treatment process is being investigated more and more day by day. However, no randomized controlled study was performed on these subjects. This study was planned to investigate the effects of two different exercise programs on pain, balance, coordination, proprioception, functional capacity, body posture, daily life activities and quality of life. The study was planned to involve at least 20 individuals with CM Type 1 who were not surgical indications in the 18-65 age range. The study was designed as a randomized, self-controlled study. Demographic data and characteristics of the subjects who meet the inclusion criteria and agree to participate in the study will be recorded at the beginning of the study. Patients will be evaluated in two different time periods. The first evaluations will be performed on the first day when patients are referred to rehabilitation by the physician. Following this assessment, all patients will be assigned numbers, which will be divided into two groups using a simple randomization method in the form of drawing lots. A total of 18 sessions 3 times a week for six weeks, the first group will receive symptomatic exercise program and the second group will focus on the deep muscles in the cervical region, especially the stabilizer, and a "Motor learning-based" exercise program that includes gradual control of these muscles. After 6 weeks, the first evaluations will be repeated in both groups.

NCT ID: NCT04220320 Completed - Clinical trials for Induction of Labor Affected Fetus / Newborn

The Success of Labor Induction Based on a Modified BISHOP Score.

Start date: March 1, 2020
Phase:
Study type: Observational

Pregnant women at term will be divided randomly into 3 groups: 1. Gynecological evaluation based on classic BISHOP score. 2. Gynecological evaluation based on a modified BISHOP score. 3. Gynecological evaluation based on cervical length as measured by transvaginal sonography. After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

NCT ID: NCT04219826 Completed - Clinical trials for Hypertrophic Cardiomyopathy (HCM)

Dose-finding Study to Evaluate the Safety, Tolerability, PK, and PD of CK-3773274 in Adults With HCM

REDWOOD-HCM
Start date: January 10, 2020
Phase: Phase 2
Study type: Interventional

This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).

NCT ID: NCT04219566 Completed - Insomnia Clinical Trials

Vestibular Nerve Stimulation to Improve Sleep

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).

NCT ID: NCT04219436 Completed - Clinical trials for Altered Passive Eruption of Teeth

The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability

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

Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors. Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width. Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues. In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group periosteal suturing technique was done in the second figure of eight (modified interrupted) suturing technique was. Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery. The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue. Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.

NCT ID: NCT04217863 Completed - Clinical trials for Traumatic Stress, Post-Traumatic Growth

To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).

NCT ID: NCT04217226 Completed - Hypotension Clinical Trials

Perfusion Index-derived Parameters as Predictors Post-induction Hypotension.

Start date: January 20, 2020
Phase:
Study type: Observational

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension. This study aims to evaluate the ability of preoperative plethysmographic variability index, perfusion index and the Dicrotic Plethysmography to predict post-induction hypotension.