cyrilzakka/clinical-trials huggingface dataset:
Innovative Approaches to Assessment of Pain Control and Sedation in the NICU

It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation

This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery.

The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants.

The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.

Eligibility Criteria:
Inclusion Criteria:

* All patients will be admitted to the NICU, and having a post-menstrual age of \>28 weeks. Participants will be divided into four groups according to the following criteria:

Group A

* Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
* Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade

Group B

* Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
* Patients who are not anticipated to receive acute post-surgical neuromuscular blockade

Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);

Group D No plan for surgery

Exclusion Criteria:

* Confirmed or suspected clinical seizures
* Metabolic abnormalities or inborn error of metabolism
* Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes
Effects of Exercise or Taping on Pain, Function, Range of Motion, Strength and Kyphosis in Subacromial Pain Syndrome

Participants with subacromial pain syndrome underwent shoulder exercises. In addition to the exercises, group A received thoracic extension exercise and group B received kinesio taping. All exercises were performed five days per week for three weeks. Thoracic extension exercise was performed once a week and remained in place for 5 days. Evaluations were performed one to three days before and one to three days after the three-week exercise program.

Seventy-five adults with subacromial pain syndrome were randomized into three groups. Group A and Group B received thoracal extension exersice and thoracal kinesiotaping in addition to shoulder exercise, respectively, while Group C received only shoulder exercise. All exercises were performed five days a week for three weeks. Thoracal extension exercise was applied once a week and remained in place for 5 days. Assessments were conducted one to three days before and one to three days after the three-week exercise program. Shoulder pain intensity, pressure pain threshold (PPT) of the upper trapezius and pectoralis major, self-reported function and health status, active range of motion (AROM), and isometric strength of the shoulder were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Having shoulder pain for at least 6 weeks
* Aggravation of shoulder pain with resisted shoulder movements

Exclusion Criteria:

* Those with full-thickness rotator cuff rupture
* Those who have had previous shoulder surgery
* Those who have had cervical or thoracic spine surgery
* Those with a history of inflammatory disease or cancer
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.

The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Minimum age of 18 years
* Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
* Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study.
* Body Mass Index (BMI) ≤ 30
* Visible fat in the thigh / saddlebag area to be treated
* Subject must be able to read, understand and sign the Consent Form
* Subject must adhere to the follow-up schedule and study instructions
* Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment)

Exclusion Criteria:

* Taking weight-loss medications/supplements
* Simultaneous participation in any other clinical study
* Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
* Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
* Arteriosclerosis or weakened blood vessels
* Heart disease
* Thromboembolic disease
* Diagnosed or documented immune system disorders (including Panniculitis)
* Bleeding disorders
* Presence of uncontrolled hypertension
* Taking prescription anticoagulants
* History of keloid formation
* History of malignant tumors in the target area
* Diabetes
* Any disease or condition that could impair wound healing
* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
* Infection in the target area
* Implanted electrical device(s) or metallic implants
* Pregnant or lactating
Enhancing Function in Later Life: Exercise and Functional Network Connectivity

Physiological and neurocognitive changes experienced as a result of increasing age may influence socioemotional functioning and economic behaviors, yet, the mechanisms through which these changes occur are not well understood. Studies have also shown that aerobic exercise may protect against age-related cognitive decline in other domains. This research is designed to test the hypothesis that aerobic exercise will enhance social, emotional and economic functioning in older adults, and that these effects will occur via the effect of exercise on neurocognitive structure and function assessed via magnetic resonance imaging (MRI). Advancing our knowledge of the mechanisms that influence emotional, social and economic functioning could inform the development of targeted treatments and prevention programs for older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age 25-35 for younger adults, and age 60 or over for older adults
* Sedentary (i.e., \< 60 minutes per week of moderate physical activity in the past 6-months)
* Able to make fewer than 3 errors on the Pfeiffer Mental Status192
* Willing to accept random assignment to condition (older adults)
* Physically capable of safely engaging in moderate exercise activity (i.e., no injuries, physical impairments, or pre-existing contraindications) as assessed by a study physician
* Able to successfully complete a maximal exercise test without evidence of cardiac or other abnormalities
* Planning to remain in the Boulder-Denver metro area for the next 4 months (older adults)

Exclusion Criteria:

* Are a heavy smoker (\>20 pack years)
* Are diabetic
* Have a body size exceeding the capacity of the magnetic resonance imaging machine (approximately 23" in diameter)
* Are on antipsychotic medications
* Are currently under treatment for any psychiatric disorder, including clinical depression, Alzheimer's, or dementia
* Are currently pregnant
* Have magnetic resonance imaging contraindications (i.e., non-removable metallic implants, claustrophobia, traumatic brain injury, current pregnancy, etc.)
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Eligibility Criteria:
Inclusion Criteria:

* Male or female gender
* Age\>18 years
* Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
* Able to give informed consent
* Able and willing to participate in follow-up evaluations
* Upper GI with a documented hiatal hernia greater than 5cm
* Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.

Exclusion Criteria:

* Previous surgery of the esophagus and/or the stomach
* Emergent operation for acute gastric volvulus or strangulation
* Biopsy consistent with malignancy
* Body Mass Index (BMI) over 35kg/m2
* Inability to perform primary closure of crura
* Active smoking
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients

The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
* One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
* Eastern Cooperative Oncology Group 0-2
* Expected life span over 6 months.
* No distant metastasis
* Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous history of chemotherapy or radiation
* Hypersensitive reaction to platinum/paclitaxel agent
* History of other cancer
* Concurrent systemic illness not appropriate for chemotherapy
* Active infection requiring antibiotics
* Pregnancy
* Metastasis to paraaortic lymph node
The Effect of Therapeutic Touch on Exam Anxiety

Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.

Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups.

Test anxiety is a condition that has cognitive, emotional and physiological aspects and causes unwanted and disturbing emotions during the exam. It can inhibit the mental perception needed to do well on an exam, as well as the clear thinking skills and memory needed to study effectively.The person may feel anxious, worthless or disorganized, experience rapid heartbeat, headaches and stress; They may compare themselves with their peers due to test anxiety. Test anxiety can hinder educational success and negatively impact students' skill development and academic performance. Nursing education is a highly stressful process that includes theoretical and practical learning and teaching experiences. This situation further increases students' anxiety levels. Studies have found that nursing students' test anxiety is higher than other university students.I t is known that many complementary methods are used to reduce anxiety. Therapeutic touch, which is one of the energy-based practices, is one of them.

When the literature is examined, it can be seen that therapeutic touch has been studied on symptoms such as anxiety, fatigue, sleep quality, comfort and pain in different sample groups, but there is no study on test anxiety.Therefore, this study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.

Eligibility Criteria:
Inclusion Criteria:

* To be over 18 years of age,
* To know Turkish and to agree to participate in the research
* Being a fourth year nursing student
* Not having received any energy therapy (reiki, therapeutic touch) before

Exclusion Criteria:

* Presence of existing psychiatric illness,
* Using anxiolytic and antidepressant medications
Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study.

In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 \<1.03 (11%) (P=0.004).

This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study.

HYPOTHESES:

PRIMARY:

1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
2. The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD.

SECONDARY:

1. A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA.
2. Serial measurement of R2I2 will produce consistent values.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* History of ischaemic cardiomyopathy

Exclusion Criteria:

* Unable to give informed consent
* \<28 days since cardiac surgery or acute coronary syndrome
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma

This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
* Are currently treated with topical PGA for ocular hypertension in both eyes.
* Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.

Exclusion Criteria:

* Eye surgery (including cataract surgery) within the past 3 months.
* History of glaucoma related surgery.
T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs. the suprapatellar approach. Subjects will be randomized to one or the other standard care surgical approaches.


Eligibility Criteria:
Inclusion Criteria:

1. Isolated tibial shaft fractures indicated for intramedullary nailing,
2. Acute tibia fractures,
3. Closed or open tibia fractures,
4. Skeletally mature patient between the ages of 21 and 50,
5. No prior history of knee surgery,
6. No prior history of knee pain,
7. No history of degenerative joint disease or inflammatory arthropathy
8. Not pregnant or known to be under the jurisdiction of the Department of Corrections
9. Able to provide informed consent.
10. Qualifies for standard care tibial IM nailing using either a suprapatellar or infrapatellar approach with no physician preference or definitive clinical indication for one or the other approach
11. Ability to communicate, read, and write in English
12. Intent of subject to receive follow up fracture care at the PI's institution.

Exclusion Criteria:

1. Tibial fractures requiring articular reconstruction (tibial plateau fractures and pilon fractures),
2. Periprosthetic fractures,
3. Nonunions or malunions,
4. History of previous knee surgery,
5. History of preexisting knee pain,
6. History of degenerative arthritis or inflammatory arthropathy, any evidence of degenerative changes of pre-operative knee radiographs, and any concomitant injury to that limb.
7. Any contraindication to MRI imaging
8. Retained stainless steel hardware proximal to the knee joint including, but not limited to prior knee replacement.
9. Under age 18 at the time of presentation, pregnant or planning to become pregnant within the study period, or under the jurisdiction of the Department of Corrections.
10. Inability to provide informed consent
11. Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
12. Insurance or other circumstantial restriction that would prohibit or interfere with the subject's ability to receive follow up care at the PI's institution.
13. Any condition, acute or chronic, that in the opinion of the attending physician or the Principal Investigator, would contraindicate participation in this study.
Sensory Symptoms in Tourette Syndrome

Patients with tics will be asked to complete a series of validated questionnaires (in electronic and/or paper format) regarding symptoms and conditions often associated with Tourette syndrome, including premonitory urges, sensory experiences, inattention, obsessive-compulsive tendencies, anxiety, and depression. Participants will also be asked to complete a quality of life assessment. This series of questionnaires will be administered annually.

Patients with tics will be recruited to participate in an observational study assessing extent and variation in non-motor features of Tourette syndrome over time. Each participant will complete a battery of validated questionnaires and scales online or in paper format (per patient preference), including the Premonitory Urge to Tic Scale (PUTS), the Sensory Gating Inventory (SGI), the Sensory Perception Quotient, the ADHD Self-Report Screening Scale, and others. These questionnaires will be administered annually to patients. For the analysis, participants will be stratified by age into late adolescents (18-25 years old) and adults (older than 25 years) since adolescent development ends at approximately age 25.

Eligibility Criteria:
Inclusion criteria:

* 18 years of age or older
* Ability to provide informed consent and answer self-report questionnaires independently in English
* Diagnosis of Tourette syndrome (TS), chronic motor tic disorder, or chronic vocal tic disorder

Exclusion criteria:

* History of psychotic disorder
* History of significant neurologic disorder (e.g., stroke) other than TS or another chronic tic disorder