cyrilzakka/clinical-trials huggingface dataset:
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. There is controversy about its effectiveness.

The local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic .

There are few studies with administration of tramadol for hernioplasty, Which led to the interest in this study.

The primary objective of the study was to evaluate the analgesic effect of tramadol injected into the surgical incision in patients undergoing hernioplasty.

The study is a prospective, comparative, double covered. The distribution of patients in the groups was randomly drawn prior to starting the project and the groups were identified in envelopes numbered 1-40.

Criteria for inclusion and exclusion After approval by the Ethics Committee of UNIFESP and signature of consent by those responsible, and the term of assent by patients over six years, 40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent hernioplasty.

Children with bleeding disorders, using analgesic or sensitivity to any drug will be excluded.

The patients will be randomly divided into one of two groups. Patients in group 1 will receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure Patients in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline solution and local infiltration with 5 mL of saline solution 0.9% at the end of the surgical procedure.

All patients will undergo general anesthesia, and will receive additional analgesia with dipyrone and morphine as needed in post operative period.

Eligibility Criteria:
Inclusion Criteria:

* children of both sexes
* aged between 3 and 12 years
* underwent hernioplasty

Exclusion Criteria:

* children with bleeding disorders
* using analgesic
* sensitivity to any drug.
Appalachians Together Restoring the Eating Environment

Most of the nation's serious chronic health challenges and causes of death, including diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both poor diets and associated disease are disproportionately common in the Appalachian counties of eastern Kentucky, a region with stark health inequities, including elevated rates of obesity, overweight, and premature mortality. The purpose of this pilot study is to evaluate a multi-component intervention developed through community-based participatory research methods for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The intervention components evaluated in this study consist of a social marketing campaign delivered to middle and high schools to promote healthy snacking and water consumption, and a series of group cooking classes for adults.

This pilot study evaluates two principal components of a community-based intervention to improve dietary habits and access to healthy foods: a school-based healthy snacking campaign and a series of community cooking classes for adults. The primary outcome assessed within each intervention component is dietary intake as measured by self-reported beverage and food consumption in pre-post surveys. Secondary outcome variables include attitudes, preferences, confidence, self-efficacy and other psychosocial variables related to healthy eating behaviors, perceptions of healthy food availability, food purchasing and preparation habits, and perceived barriers to healthy eating.

The school-based intervention component employs a nonequivalent control group research design. A subset of middle- and high-schools within a single county in eastern KY will receive a healthy snacking campaign intervention, and students from randomly selected classrooms within these schools will be invited to enroll in the study. Students from middle- and high-school classrooms in a comparison county that receives no intervention will serve as nonequivalent controls. The investigators specific aims for this component are to improve the availability of healthy snack foods that students may purchase at school, increase student consumption of healthy snacks over unhealthy snacks, and increase the consumption of water over sugar-sweetened beverages. Following baseline, posttest surveys will be administered at 3, 6 and 14 months.

Community cooking classes will be delivered to a non-random sample of adults who will complete pretest-posttest measures at baseline and 8 weeks. The specific aims of this component are to increase the consumption of healthy foods at home, and increase participant knowledge, skills, and self-efficacy around healthy home cooking.

Eligibility Criteria:
Inclusion Criteria:

* For School-Based Component: 6th-12th grade students enrolled in a participating school and classroom in the intervention or comparison county.
* For Cooking Classes: Adults aged 18 years and older residing in intervention county who have at least one juvenile in household.
Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

This study evaluates the addition of occlusive dressings (hydrocolloids) or topical silicone gel in the treatment of shingles (herpes zoster). One third of the participants will receive a hydrocolloid occlusive dressing, one third will receive the topical silicone gel and one third will receive the current treatment of the rash consisting of drying solutions (soaks).

Herpes zoster (HZ), also known shingles, is a viral disease caused by the varicella-zoster virus. It is considered a local reactivation of varicella (chicken pox). The rash of herpes zoster is characterized by vesicles that appear following a single dermatome (the territory that is innervated by one spinal nerve). These vesicles may be very painful and cause discomfort due to draining and crusting. When a person becomes sick with shingles healthcare professionals prescribe systemic (oral) treatment with antivirals (e.g. acyclovir) and pain medication according to the type and severity. To treat the local lesions caused by shingles, over the centuries, patients have been treated with drying solutions and drying powders. This practice has been passed on through the years without any evidence supporting its effectiveness, in all likelihood due to the fact that the rash is self-limited to 2 to 3 weeks. Recently, new evidence has shown that the vesicles that appear with the shingles rash are not superficial but involve deeper areas of the skin and should be considered partial thickness wounds. Since 1962, it has become clear that partial thickness wounds benefit from occlusive therapy (keeping wounds closed and avoiding drying) such as dressings and occlusive gels that keep the wound wet rather than allowing it to dry.

In this clinical trial the investigators believe that given this information, using occlusive therapy with a hydrocolloid dressing or a silicone-based gel may heal the rash of herpes zoster, decrease pain and improve the quality of life, much faster than the treatment currently used of drying the area with powders and solutions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of HZ confirmed by a certified dermatologist
* Patients having maximum 72 hours from the start of the first vesicle
* Older than 18 years

Exclusion Criteria:

* Patients with dimethicone allergy
* Patients with hydrocolloid allergy
* Patients with acetaminophen allergy
* Patients with aluminium sulphate and calcium acetate allergy
* Patients with acyclovir allergy
* Pregnant women
* Breastfeeding women
* Unable to give informed consent
* Patients with signs of infection over the skin rash
* Patients with disseminated HZ
* Patients with hemorrhagic HZ
* Patients with complications such as pneumonia or encephalitis
* Patients unable to apply the treatment to the affected area
* Patients with HZ-associated keratitis
* Patients whose rash is located to hairy areas that may hinder occlusion with the hydrocolloid dressing.
Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary antibiotic use in skilled nursing facilities. The first target of intervention is the tasks carried out by nursing staff after a change in condition and after an antibiotic prescription is initiated. The second target are the management staff who provide feedback to staff. The third target are the administrators who identify and overcome organizational barriers to implementation.

In this study, we will implement two tools that are intended to minimize unnecessary antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility staff assess risk and communicate with prescribers when residents experience a change in health status that may result in the use of antibiotics. The second tool is used after an antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions, narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic therapy.


Eligibility Criteria:
This is an organizational intervention. Outcomes will be evaluated at the population-level by facility.

Nursing home residents:

Inclusion Criteria:

* Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities.

Exclusion Criteria:

* Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
* Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
* measurable and evaluable lesions by ultrasound, computer-tomography or MRI
* Performance status ECOG \< 2 or karnofsky index \> 60%
* normal organ function

Exclusion Criteria:

* more than 1 chemotherapy prior enrollment
* ongoing treatment with epoetin alpha or related drugs
* history of thrombosis or embolism during the past 12 months prior enrollment
* ileus
* left ventricular failure \> NYHA classification \> 2
* Ongoing toxicity of any kind (\> CTC Grad II)
Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients

Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment.

Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Diabetes Mellitus type II
* Patient male or female 18-80 years old
* Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4
* HbA1c \> 8.5%
* Hematocrit \> 30%

Exclusion Criteria:

* Kanofsky performance status \< 60
* Patient with ABI (Ankle Brachial index) \< 0.4
* Patient who receive steroid ,chemotherapeutic drug
* Pregnant or lactating woman
* Patient had a history of organ transplantation, and using immunosuppressive drug
* Patient with end-stage renal disease requiring hemodialysis, or history of G6PD or severe thalassemia, or ischemic heart disease, Congestive heart failure, Heart arrhythmia
* Patient who is participating in another clinical study or have done it in the past 30 days.
Lifestyle Changes in PCOS with OSA and NAFLD

Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended

Forty obese PCOS men with obstructive sleeping apnea and compaint of fatty liver will participate in this trial . Group (study group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes. Group (control group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver . for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake,

Eligibility Criteria:
Inclusion Criteria:

* forty women
* women complaint PCOS
* women complain obstructive sleep apnea
* women are obese
* women complain fatty liver

Exclusion Criteria:

* cardiac insult
* renal insult
* malignacy
* pregnancy
Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma

The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. Patients undergoing deceased donor liver transplantation for the first time.

Exclusion Criteria:

(1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.
Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.

The research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized ICU cohort from 2013 to 2015 in Rigshospitalet (Glostrup).

The overall aim is to understand the pathophysiological mechanism in delirium and septic encephalopathy and its consequences.

For this purpose we will:

1. Provide extensive cognitive testing. These results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients.
2. First, the investigators will examine if the differences in cognitive function is reflected in the ability of the brain to generate high-frequency electrical oscillations that accompany and underlie perception, attention, cognition, memory formation and retrieval. It will be performed by carrying out continuous EEG (cEEG) and by examination of steady-state evoked cognitive EEG responses.
3. Second, the investigations will examine MRI, structural and diffusion tensor imaging sequences. Hippocampal, thalamic, amygdala, lentiform nucleus and cingulate cortex volumes will be determined bilaterally and will be compared between individuals with healthy brain aging and patients that survived delirium.
4. Third, the investigators will assess plasma markers of free radical production.

Eligibility Criteria:
Inclusion Criteria for the ICU cohort:

* Age \>18 years;
* Length of stay \>24 hours in the ICU.

Exclusion Criteria for the ICU cohort:

* Expected death \<24 hours;
* Psychiatric illness; pre-existing delirium; severe dementia; cerebrovascular event \<six months; major surgery \<two months;
* Non-Danish or English speaking.
Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

RATIONALE: Some cancers become resistant to chemotherapy drugs. Combining cyclosporine with chemotherapy may prevent resistance to the drugs and allow the cancer cells to be killed.

PURPOSE: Randomized phase II trial to study the effectiveness of adding cyclosporine to combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.

OBJECTIVES: I. Evaluate whether the addition of cyclosporine (CYSP) to mitoxantrone (DHAD) and etoposide (VP-16) increases the response rate and duration of response in adults with refractory or relapsed acute myelogenous leukemia (AML). II. Correlate response to this treatment with the presence of P-glycoprotein (P-gp) multidrug resistance (MDR) and the degree of in vitro modulation of leukemic blasts, including CD34+ blasts. III. Correlate response with the presence of other resistance mechanisms, such as atypical MDR and non-P-gp phenotype. IV. Evaluate the toxicity of this treatment in AML patients. V. Study the effect of CYSP on DHAD and VP-16 pharmacokinetics and metabolism and, potentially, on intracellular drug accumulation.

OUTLINE: Randomized study. The following acronyms are used: CYSP Cyclosporine, NSC-290193 DHAD Mitoxantrone, NSC-301739 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy. DHAD; VP-16. Arm II: 2-Drug Combination Chemotherapy with Drug Resistance Inhibition. DHAD; VP-16; with CYSP.

PROJECTED ACCRUAL: At least 25 patients/arm will be entered over approximately 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Acute myelogenous leukemia (AML) in the following categories: Refractory to initial standard therapy consisting of idarubicin/cytarabine and amsacrin/cytarabine (on protocol HOVON 29) First or subsequent relapse following complete response to standard chemotherapy (on protocols HOVON 4/4A or 11 or any other protocol) At least 6 months between mitoxantrone/etoposide and relapse No myelodysplasia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 2 x normal Alkaline phosphatase no greater than 2 x normal Renal: Creatinine no greater than 1.7 mg/dl (150 micromoles/liter) OR Creatinine clearance at least 60 ml/min Cardiovascular: No uncontrolled hypertension No other severe cardiac disease Pulmonary: No severe pulmonary disease Other: No known intolerance to any study drug No uncontrolled severe infection Not HIV seropositive No severe neurologic or metabolic disease No concomitant malignancy except: Nonmelanomatous skin cancer In situ cervical carcinoma No pregnant women

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Screening and Intervention of Postextubation Dysphagia

This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is over 20 years old.
* Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.

Exclusion Criteria:

* Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.
* Patient who has preexisting difficulty swallowing.
* Patient who has received a tracheostomy.
* Patient who were unable to follow verbal instructions.
* Patient who were on contact and droplet precautions (e.g., open tuberculosis)
* Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention
Cervical Cord Compression and Hypertension

Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.

It had been reported the cervical spondylotic myelopathy may lead to the development of hypertension. Decompression surgeries ameliorated neurological symptoms as well as the blood pressure. The cause may be the abnormality of autonomic dysfunction developed after myelopathy. However, the evidence was weak. We have noticed a tendency of hypotension during anesthesia in patients undergroing cervical spine surgeries, especially in surgeries of long levels and hypertensive patients. Thus we postulate the autonomic activity is abnormal in patients with cervical myelopathy. Sympathetic hyperactivity developed in order to maintain adequate perfusion to the cervical cord. When patients are under anesthesia, the sympathetic tone is suppressed, thus leading to severe hypotension that require the treatment of inotropic treatment. Heart rate variability (HRV) is a good index of autonomic activity. Thus we plan to Therefore we will measure the HRV (analysis of ECG) and baroreflex activity (analysis of arterial line during the anesthesia) in patients undergoing cervical spine surgeries for decompression of cord compression perioperatively. The primary end-point is the comparison of severity of cord compression between normotensive and hypertensive patients with cervical myelopathy. The secondary end-point is to compare blood pressure and HRV pre- and postoperatively. The third end-point is to elucidate the causative factors for severe hypotension during anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* cervical spine surgery for cord compression

Exclusion Criteria:

* spinal cord injury
* ASA class \>3
* chronic kidney disease
* congestive heart failure
* BMI\>30
* atrial fibrillation/ flutter
* obstructive sleep apnea