cyrilzakka/clinical-trials huggingface dataset:
Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation can modulate corticomotor excitability and therefore has great rehabilitative potential for individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In particular, intermittent theta burst stimulation (iTBS) can increase corticomotor excitability and may be a useful adjunct to physical rehabilitation to promote motor re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant or less important function to perform a more critical function. Upper limb reconstruction is intended to help individuals achieve their goals related to activities of daily living and independence in the community. Outcomes after reconstruction are variable and depend largely on the efficacy of motor re-education of the transferred muscle to perform a new function. The long-term goal of our research is to determine whether iTBS combined with physical rehabilitation can improve motor re-education after reconstruction. As a first step, the purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia: individuals with and without upper limb reconstruction.


Eligibility Criteria:
Inclusion Criteria for all subjects with tetraplegia:

* Injury to the lower cervical spinal cord at least one year prior to the date of participation
* Motor function classified according to the American Spinal Injury Association International Standards for Neurological Classification of Spinal Cord Injury at levels ranging from C5-C8

Inclusion criteria for the subjects with tetraplegia and upper limb reconstruction:

• At least one year post-operative from tendon or nerve transfer surgery of the upper limb

Exclusion criteria for all subjects with tetraplegia:

* Presence of concurrent severe medical illness, including unhealed decubiti, use of baclofen pumps, existing infection, cardiovascular disease, significant osteoporosis, or a history of pulmonary complications.
* Metal implant near head or neck
* Risk of seizure of history of seizures
Sleep Disturbance in Deployed Soldiers

Hypotheses:

* Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.
* Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention group will more closely approximate normal as compared to sleep measures of Soldiers randomized to the control group.


Eligibility Criteria:
Inclusion Criteria:

* All study participants must be on Active Duty, or be Reserve or National Guard Service Members notified of impending deployment.
* Recruited prior to deployment in order to obtain baseline measures before deployment.
* Have been stateside at least one full year.
* Able to read and speak English and consent themselves.

Exclusion Criteria:

* Subjects with self-identified sleep disorder (for example restless leg syndrome or sleep apnea)
* Pregnancy. Pregnant women will be excluded from the study since pregnancy places women in a non-deployable status and pregnant Soldiers will not be deploying.
S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx

RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy and laser surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx.

OBJECTIVES: I. Assess the feasibility of treating untreated stage I, II and selected stage III squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and irradiation. II. Estimate the 3 year progression free survival and describe the location of disease progression.

OUTLINE: Patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration. Patients with N1 disease may undergo an optional neck dissection ipsilateral to the neck mass. Neck dissection includes complete removal of at least lymph node levels 2-4. Radiation therapy begins 14 days following laser surgery. Patients are followed every 3 months for the first year, every 6 months for the second year, and every 12 months thereafter until death.

PROJECTED ACCRUAL: There will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed, untreated stage I, II, or selected stage III (T1-T2, N1, M0) squamous cell carcinoma of the supraglottic larynx Bidimensionally measurable disease No metastatic or stage III T3 disease No immediate life-threatening complications of the disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 50,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Not specified Renal: Not specified Cardiovascular: At least 3 months since prior myocardial infarction No uncontrolled congestive heart failure No unstable or uncontrolled angina Other: No prior malignancy except for the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Other cancer for which the patient has been disease-free for at least five years No history of prior laryngeal cancer No history of primary tumors of any aerodigestive tract site except disease site All fertile patients must use an effective contraceptive method Must be medically able to undergo general anesthesia No psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with study protocol No other unstable or pre-existing major medical condition

PRIOR CONCURRENT THERAPY: No prior treatment for squamous cell carcinoma of the supraglottic larynx
ESP Block in Robotic Cardiac Surgery

Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic.

At 3 months the patients will be contacted to assess for pain and ask them for they life quality.

Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire.

The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description.

Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed.

Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours.

The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane.

An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room.

Both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. After the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously.

The pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. After acute phase of postoperative pain and typically until chest drainages are retired, the ESP catheter and the IV morphine will be withdrawn. After discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. Quality of life, pain and if present, its characteristics will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Robotic Cardiac Surgery
* Accepts to participate

Exclusion Criteria:

* Use of other regional anesthesia technics
* Presence of chronic Pain
* Psychiatric pathology, drug abuse
* Allergy or intolerance to local anesthetics
Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.


Eligibility Criteria:
Inclusion Criteria:

* Admission because of congestive heart failure
* Elevated NT-proBNP levels on admission

Exclusion Criteria:

* Life-threatening cardiac arrhythmias
* Urgent intervention
* Severe lung disease
* Presence of life threatening disease
* Signed informed consent for other study
* Mental or physical status not allowing written informed consent.
* Unwillingness to give informed consent
* Patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery

The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.

MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between the ages of 18 and 65 years
2. Subject scheduled to undergo bilateral endoscopic sinus surgery
3. Subject signs IRB-approved informed consent form
4. Subject agrees to comply with all study-related procedures

Exclusion Criteria:

1. History of removal of one or both middle turbinates
2. Significant sinonasal polyps
3. Presence of marked septal asymmetry
4. Presence of significant concha bullosa, which requires surgical excision
5. Presence of non-viable tissue at the implantation site
6. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
7. Known or suspected allergy to device components
8. Participating in another clinical trial which could affect the healing of the middle turbinate
9. Uncontrolled diabetes
10. Known or suspected use of illicit drugs
11. Known or suspected alcoholism
12. Other medical illness that could prevent follow-up or increase the risk of surgery
13. Pregnant or unwilling to take pregnancy prevention measures
14. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ

This is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasiaⅠwithout invasion.

HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer. The important roles of E6 and E7 playing in HPV-driven carcinogenesis make them attractive targets for therapeutic interventions. Previous evidences showed that using designated TALEN and CRISPR/Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth.

This study will evaluate the safety and efficacy of TALEN-HPV E6/E7 and CRISPR/Cas9-HPV E6/E7 in treating HPV Persistency and HPV-related Cervical Intraepithelial NeoplasiaⅠ

Eligibility Criteria:
Inclusion Criteria:

* Documented HPV16 or HPV18 infection.
* Married and fertile, no fertility requirements.
* Without administration of hormone in the last six months.
* Subjects must be meet the ethical requirements and have signed informed consent.

Exclusion Criteria:

* Pregnancy and breast feeding
* Any bacterial vaginitis
* Any Fungal vaginitis
* Any sexually transmitted diseases
* Active drug or alcohol abuse
* Any HPV medications within the past 12 weeks
* Allergy to active or non active ingredients in the study of drugs
* Cardiac insufficiency
* Liver and renal insufficiency
* Hypertension and severe complications
* Serious illness in past 30 days
* Currently participating in another clinical trial or any prior gene therapy
Parent Engagement Package: Comparing Strategies for Engaging Parents Into Parenting Programs

This study tests the effectiveness of different strategies for engaging parents into an evidence-based parenting skills intervention, the Triple P Positive Parenting Program, offered universally to parents of children attending one of six public elementary schools.

Parenting skills programs have been shown to help prevent youth substance use and mental health disorders. Unfortunately, few parents participate in parenting programs when given the opportunity. Thus, developing effective strategies to increase engagement in effective preventive parenting interventions is essential for these programs to have a significant public health impact. The purpose of this study is to identify parent engagement strategies that increase participation in effective parenting programs and consequently improve parenting practices and children's well-being.

Eligibility Criteria:
Inclusion Criteria:

* Is a caregiver of a child in kindergarten, 1st, 2nd or 3rd grade at a participating school (i.e.,"target child");
* The target child lives with the caregiver at least half of the time;
* The caregiver speaks English or Spanish;
* The caregiver is listed as one of the target child's parents/guardians in the school's records.

Exclusion Criteria:

* The target child is in a self-contained classroom due to cognitive or emotional disabilities;
* The caregiver is a kindergarten, 1st, 2nd or 3rd grade teacher at a participating school;
* The target child attended one of the participating schools during a previous cohort of the study;
* The caregiver is participating in a competing parenting program at the school, the "Intensive Family Literacy program".
Pediatric Liver Database

The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.

In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Under 18 years of age
* newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated
* receive a liver transplant prior to their eighteenth birthday

Exclusion Criteria:

* Patients decline participation.
* Patients have no liver diseases.
Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.

Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective CABG over age 18

Exclusion Criteria:

* Under age 18
* Emergent CABG
* Prior exposure to nephrotoxic drug
* Dialysis patients
* Uncontrolled hypertension
Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

Studies have shown that tele-nursing practice is effective in children with Type 1 Diabetes Mellitus, but the number of studies conducted is very few. No study examining the concepts of metabolic control, self-efficacy, quality of life and anxiety together was found in the literature review. With this study, it is aimed that diabetes education given by tele-nursing has an effect on metabolic control, self-efficacy, quality of life and anxiety level of adolescents with type 1 diabetes, and that diabetic adolescents can easily obtain the information they need about nursing care when they cannot come to the clinic.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* The child is between the ages of 12-18,
* After the information, the adolescent agrees to participate in the study, and the parent gives written consent,
* The child can understand and speak Turkish,
* Parent's ability to understand and speak Turkish,
* Having a smart phone and having access to the internet,
* Having been diagnosed with T1DM at least 1 year ago,
* Being on insulin therapy by the subcutaneous route,
* Coming to the outpatient clinic at least once every 3 months.

Exclusion Criteria:

Exclusion Criteria:

* Age younger than 12 or older than 18,
* Having another chronic disease,
* Using an insulin pump
* Having vision and hearing problems,
* Using the Continuous Glucose Tracking System,
* Having a physical or mental disability.
The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals

In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood pressure was investigated.

Recent studies have shown that dark chocolate consumption may have a positive effect on cardiovascular risk markers.The aim of this study is to investigate the effect of regular consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy individuals. A total of 37 healthy individuals completed the study conducted in this direction. Participants were randomly divided into two groups as dark chocolate group (n=17) and control group (n=20). While the dark chocolate group consumed 36 g/day (400 mg/day flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. At the end of the study, the anthropometric measurements of the individuals were evaluated. Blood lipid profile, fasting blood glucose, HbA1c, CRP levels, systolic blood pressure and diastolic blood pressure measurements were investigated.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/m2
* Systolic blood pressure \<140 mmHg and/or diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Individuals with any diagnosed chronic or acute illness
* Individuals diagnosed or in contact with Covid-19
* Individuals with allergies to cocoa/chocolate products
* Individuals in the process of losing weight
* Individuals with smoking and alcohol consumption
* Individuals taking medication or vitamin/mineral supplements
* Individuals doing heavy physical activity
* Individuals who regularly consume cocoa/chocolate products for the last 1 month (\> 3 days a week)
* Pregnant or lactating women were excluded from the study.
Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Fibrosis due to surgical trauma is a common problem with cochlear implants. Fibrosis limits the effectiveness of implant and increases the power consumption. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.

The most common problem with cochlear implants is that their effectiveness decreases over time and they are not functional enough mainly due to fibrosis.

Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.

Cochlear implant application will be performed under general anesthesia. After the postauricular incision and mastoidectomy, posterior tympanotomy will find the middle ear and from there the round window, and platelet fibrin prepared with the i-prf technique will be locally applied to the round window during the operation, and then implantation will be performed.

The points where the electrode enters the cochlea will be covered with fascia.

Intraoperative NRT and impedances will be measured on all electrodes in all patients, and NRT and impedance measurements will be repeated in the 1st week, 1st month, 3rd and 6th months postoperatively.

Custom Sound EP 5.0 (5.0.4.136) program provided by Cochlear company will be used for these measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sensorineural hearing loss
* Patients who will have cochlear implant surgery with CI422 electrode

Exclusion Criteria:

* Patients with cochlear abnormality
* Patients with auditory neuropathy
Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy

The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
* \> or = to 21 years of age

Exclusion Criteria:

* Patients who are not candidates for an esophagectomy as determined by the treating surgeon
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.

To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17 Consultant Chest Physicians. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.

Exclusion Criteria:

* Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.