cyrilzakka/clinical-trials huggingface dataset:
Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair

The study compares the effect of thigh high compression stockings on cerebral desaturation events in patients undergoing shoulder arthroscopy in the beach chair position with a BMI greater than or equal to 30.

On the day of surgery, enrolled patients whom have signed consent for participation in the study will be randomized to receive thigh high compression stockings with SCDs or SCDs alone. The importance of the investigation, proposed methodology, and potential risks of participation will be addressed. In the pre-operative holding area, a cerebral oximeter (INVOS 5100C, Covidien) will be placed on the skull as directed by the manufacturer. The sensors will be placed on the skull bilaterally in order to assess perfusion in both hemispheres. Cerebral oximeter is a non-invasive, transcutaneous tool that can be used to measure cerebral tissue oxygenation. The tool uses nearinfrared spectroscopy to measure the percentage of hemoglobin saturated with oxygen in the microcirculation of tissue within approximately 2-3cm below the skin. The technology is approved by the FDA in the anesthesia setting to monitor cerebral oxygenation and is commonly used in cardiothoracic surgery and its use has been validated in the surgical setting.11 A baseline cerebral tissue oxygen saturation (rSO2) will be recorded. All patients will be anesthetized using a standardized protocol. Once anesthesia has been induced, thigh high compression stockings will be applied to the appropriate group followed by SCDs. All patients in the study will wear sequential compression devices on both legs for thrombosis prophylaxis regardless of randomization. The patient will then be raised into the beach chair position and secured in the normal fashion and the planned surgery will begin. Intraoperative rSO2 data will be continuously recorded throughout the case. The system will be set to alarm when the rSO2 decreases greater than 20% from baseline. These events will be recorded throughout the case as CDEs. To avoid cerebral vascular injury, these events will be treated with a protocol by anesthesia including ephedrine, phenylephrine, and the patient may be returned to the supine position if needed. When surgery is complete, patients will be recovered in the post-anesthesia care unit. The study will be conducted at three facilities within the Loyola system: the Loyola Ambulatory Surgery Center at Oakbrook (LASCO), the Ambulatory Surgery Center at Loyola (ASC), and at Gottlieb Memorial Hospital (GMH). Personnel will include the attending surgeon, orthopaedic surgery residents, and anesthesia staff assigned to each case, all of whom will be fully educated on the study and protocols.

Eligibility Criteria:
Inclusion Criteria:

* • All patient over age 18

  * BMI \> 30
  * Undergoing shoulder arthroscopy in beach chair position

Exclusion Criteria:

* • Age \< 18 years

  * BMI \< 30
  * Known and documented \>90% occlusion of carotid artery
  * Prior neck surgery
  * Women who are pregnant
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?

The purpose of this prospective study is to investigate the degree of association between the volume of important pain-relevant structures in the brain and the size of the areas of secondary hyperalgesia.

The healthy study participants will be included from the cohort of a previous study (NCT02527395) where areas of secondary hyperalgesia, heat pain detection thresholds, pain during 1 min. thermal stimulation and test results from the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Score will be retrieved. The study consists of 1 study day. The study day will be conducted at a maximum of 2 months and a minimum of 2 weeks after the completion of the previous study (NCT02527395).The results of the previous study (NCT02527395) will be blinded until all participants have completed the study day.

All study participants will complete a MRI-scan of the brain.

The MRI scans will be performed with a Siemens MAGNETOM Verio 3 tesla, with b17 software, and a 32-channel head coil. The MRI-scan sequence is as follows:

* 3D Localiser
* 3D T1 weighted iso
* AX Diffusion tensor imaging
* AX Epi resting state fMRI
* AX Gre field map
* AX Epi ASL
* AX T2-weighted blade
* AX T2-weighted flair
* AX T2-weighted\* Gre

Total MRI-scan time is estimated to approximately 40 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<35 years
* Speak and understand Danish
* Male sex
* Study participants who have understood and signed the informed consent
* No prescription medicine during the last 30 days.
* Have participated and completed the study with the identifier: NCT02527395.

Exclusion Criteria:

* Study participants that cannot cooperate to the test.
* Study participants who have a weekly intake of \>21 units of alcohol, or a have consumed \>3 units of alcohol within 24 hours before experimental day.
* Study participants with a substance abuse, assessed by the investigator.
* Study participants, who have consumed analgesics less than 3 days before experimental day.
* Study participants, who have consumed antihistamines less than 48 hours before experimental day.
* Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
* Study participants with chronic pain.
* Study participants with neurological illnesses.
* Study participants with psychiatric diagnoses.
* Study participants with a Body Mass Index of \>30 kg/m2 or \<18 kg/m2
* Study participants with Contraindications to MRI
* Study participants that decline information regarding potential pathological findings in relation to the MRI.
* Study participants that have any kind of trauma resulting in pain and administration of analgesics in the period between experimental pain testing and MRI-scan.
* Study participant that experience a head trauma in the period between the experimental pain testing and the MRI-scan.
Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section

Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries.

With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section.

We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.

Postpartum hemorrhage (PPH) is still among the leading causes of maternal morbidity and mortality. The incidence of PPH is reduced by active management of the third stage of labor which includes the use of uterotonics for pharmacological prophylaxis. However, there is an on-going debate about the optimal drug selection since uterotonics such as oxytocin and methylergometrine are liable for specific side effects and complications when administered within a dose range needed to be effective for PPH. In the search for an alternative to these conventional standard uterotonics, misoprostol (prostaglandin E1) has turned out to be an effective therapeutic option and has been implemented in actual treatment regimens. The objective of this study was to compare the effectiveness of oral applicated misoprostol versus intravenous oxytocin in reducing blood loss in low risk obstetric patients undergoing non-scheduled cesarean section (CS) under spinal anesthesia.

Comparison:

In this prospective, double blind study, parturients undergoing CS were randomized to receive either a) oral misoprostol and an infusion of normal saline supplemented with placebo, or b) an oral placebo and an infusion of normal saline, supplemented with oxytocin subsequently to intravenous oxytocin after cord clamping in both groups.

The primary outcomes were the amount of intra- and postoperative blood loss and the occurrence of drug-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation

Exclusion Criteria:

* Emergency CS
* Fetal distress
* Fetal malformations
* Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome)
* Hypersensitivity to prostaglandins
* Coagulopathy
* Severe systemic disorders
* An American Society of Anesthesiologists (ASA) physical status \>/= 3
* Severe asthma
* Prior myomectomy
* Maternal fever (\> 38.5 °C)
Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)

This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

Most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. It has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and HbA1c level, improve lipid profile, and decrease blood pressure. Based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. Further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of prediabetes according to the American Diabetes Association (ADA) guidelines
* level 4 of muscle strength
* willingness to accept exercise intervention
* provision of written informed consent.

Exclusion Criteria:

* type 2 or other types of diabetes
* women who are pregnant
* hepatic dysfunction, as evidenced by alanine aminotransferase (ALT) or alkaline phosphatase (ALP) levels greater than 2.5-fold the upper limits of normal
* crucial organ failure or other severe diseases, including myocardial infarction
* malignancy
A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin .

This is a Phase 3 double-blind study. KS patients are randomized to 1 of 2 treatment arms. They receive either ALRT1057 gel or placebo for 12 weeks. If progressive disease for KS is noted before Week 12, patients are switched to the other blinded treatment arm. If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. After that time or after 12 weeks of treatment, open-label ALRT1057 may be received.

Eligibility Criteria:
Information not available
Accuracy of Computer Guided Free Gingival Graft

A patient specific surgical guide for harvesting of free gingival graft from the palate


Eligibility Criteria:
Inclusion Criteria:

* patients with intraoral alveolar defect requiring soft tissue augmentation

Exclusion Criteria:

1. - patients with systemic diseases interfering with surgical interventions
2. - Poor oral hygiene
Depression ,Anxiety and Stress Disorders Among Diabetic Patients in Assuit University Hospitals

1. Assessment the prevalence of psychiatric disorders in diabetic patient in Assuit University Hospital.
2. Determine the associated factors with the psychiatric disorders.

Across the world, both Diabetes and Psychiatric disorders are on rise. Diabetes strongly affects disability, mortality, and global health expenditure. Diabetes mellitus is a disabling long-term health condition that is common and growing. Globally, it affects 10.5% of the population and is the leading cause of lost disability-adjusted life years Type 1 diabetes is a lifelong autoimmune disease characterized by insulin deficiency and resultant hyperglycemia. It constitutes around 10% of all diagnosed cases of diabetes and its incidence is increasing globally. Type 2 diabetes mellitus (DM2) is a chronic metabolic disease characterized by an increase in normal serum glucose levels (hyperglycemia).

Psychological disorders can occur in people with diabetes of all ages. Type 1 diabetes seems to have a higher prevalence of psychological disorders than type 2 diabetes.

About 15%-20% of people with diabetes are suffering from depression. the exact cause of depression in people with diabetes is unknown, it is likely complex due to a combination of genetic, physiological, and psychological factors. Depression and anxiety could worsen the prognosis of diabetes by reducing the patients' ability to self-care and increasing non-compliance to treatments while increasing the risk of serious short-term and long-term complications such as blindness, amputations, stroke, and even premature death.

Eligibility Criteria:
Inclusion Criteria:

Age between 18 and 70 years Diagnosed according to criteria of the American Diabetes Association fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher or A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT).

Exclusion Criteria:

* Patient with cognitive difficulties
* To be very sick and unable to give consent
* Women who were pregnant or had given birth in the last 6 months
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma

A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy

Objective to evaluate the efficacy and safety of maintenance therapy with Chidamide in patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma（DLBCL） with complete response after completion of prior chemotherapy, so as to provide the basis for the application of Chidamide in HBV positive DLBCL

Eligibility Criteria:
Inclusion Criteria:

* histopathology confirmed DLBCL，with chronic hepatitis B before treatment
* After systemic treatment, complete response has been achieved and complete response lasted within 1year before enrollment
* The expected chemotherapy was completed and the laboratory indexes returned to normal
* The absolute value of neutrophil ≥ 1.5 × 10 9 / L, platelet count≥ 90 × 10 9 / L, hemoglobin level≥ 90 g / L
* Patients who cannot undergo hematopoietic stem cell transplantation for various reasons
* 18-75 years old, both male and female
* ECOG PS 0-1
* Body weight: male 67 ± 20 kg (47-87 kg), female 55 ± 20 kg (35-75 kg)
* expected survival time ≥3 months
* Voluntary written informed consent prior to trail screening

Exclusion Criteria:

* Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures
* Patients with prolonged QTc interval (male \> 450ms, female \> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and coronary heart disease with symptoms requiring drug treatment
* B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period
* Patients with previous or planned organ transplantation
* Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment
* HBV nucleic acid quantitation \> 103 IU / ml
* Patients with active bleeding
* Patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other this kind of diseases or medical history
* Patients with active infection or persistent fever within 14 days before enrollment
* less than 6 weeks after major organ surgery
* Abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; ALT / AST \> 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST \> 5 times of upper limit of normal value for patients with liver metastasis \], abnormal renal function (serum creatinine \> 1.5 times of upper limit of normal value)
* Mental disorders/Those who cannot obtain informed consent
* Patients with drug abuse and long-term alcohol abuse that affect evaluation
* The investigator determined not suitable to participate in this study
Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?

RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.

A standard general anesthesia protocol is given to all patients by the same anesthesiologist. A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The MV will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to 6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via randomization software before the surgery. According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. A high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy and safety of RIRS.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent RIRS with kidney stones older than18 y.o

Exclusion Criteria:

Patients younger than 18 years old Patients with a known respiratory disease Patients with a renal anomaly Proximal ureteral stones, or stones with multiple locations The patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.
Stair Instead of Elevator Use at Work: Cardiovascular Primary Preventive Effects on Hospital Employees.

This is an intervention study which evaluates the cardiovascular primary preventive effects of using stairs instead of elevators at the worksite during a 12-weeks period. We hypothesize that stair-climbing during working hours can meet the daily amount of physical activity recommended by current public health guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* No or little stair-use at work (\< 5 stories/day)
* Sedentary lifestyle

Exclusion Criteria:

* Positive answers to the health screening physical activity readiness questionnaire (PAR-Q)
* Part-time employment \< 80%
* Absence of more than 2 weeks during the intervention period
* Intention to begin a weight control program
* Medication changes which may influence blood pressure, lipid or glucose metabolism
The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy

Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care.

Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Several studies suggest that nutritional intake increases when the patient is satisfied about the quality of the meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care. Also, the investigators expect that this strategy will have a positive effect on patient satisfaction, other nutrition-related issues, including nausea and vomiting, on nutritional intake per se and hence, on the nutritional status. Additional benefits might include reduced use of medication, especially anti-emetics.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* diagnosed with cancer
* receiving chemotherapy according to a minimum schedule of every 2 weeks
* living within a 40 km radius around the Radboud University Nijmegen Medical Centre
* written informed consent

Exclusion Criteria:

* renal insufficiency (MDRD-GFR (glomerular filtration rate) \< 60ml/min and/or proteinuria)\*
* dementia or any other condition which makes it impossible to fill out questionnaires correctly
* unable to understand or speak Dutch
* depending on artificial nutrition in the form of Oral Nutritional Supplements, tube feeding or total parenteral nutrition
* swallowing or passage problems

  * proteinuria is defined in case of a protein creatinine ratio \> 0.5g/10mmol or an albuminuria \> 300mg/day. This is checked by default before the start of chemotherapy by the treating physician to decide whether or not the patient is eligible for receiving chemotherapy.
Valved Graft PMCF Study

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.


Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement

Exclusion Criteria:

* anticoagulation therapy intolerant
* active endocarditis
* anatomical or medical, surgical, psychological or social contraindications