cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .

The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.


Eligibility Criteria:
Inclusion Criteria:

* physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

* refuse to participate have a body mass index (BMI) \>30 kg/m2 ASA physical status \>II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.
Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

This study is a cross-sectional study that wishes to investigate whether there is an increased incidence of sarcopenia in patients with chronic kidney disease compared to the Danish background population. A possible association between sarcopenia and fall, as well as the incidence of osteoporosis in patients with chronic kidney disease will also be described.

Sarcopenia is a condition diagnosed from different clinical findings such as low muscle mass, low muscle strength and possibly also poor physical performance. In the general population, the risk of fall and bone fracture increases, when sarcopenia is also present.

Sarcopenia is known to occur in patients with chronic kidney disease, but whether, and if so, how this differs from the incidence in patients without kidney disease has not previously been described.

Patients with chronic kidney disease have a 3 times higher risk of bone fracture compared to the Danish background population, and they also have an increased risk of falls.

The association between sarcopenia, risk of falls and osteoporosis in patients with kidney disease is until now sparsely described, and because of this, the investigators want to explore this further in this cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* Chronic kidney disease stage 4-5 not on dialysis (nonD) (corresponding to an estimated glomerular filtration rate (eGFR) ≤30 ml/min based on Kidney Disease Improving Global Outcomes (KDIGO) definition and not on dialysis)

Exclusion Criteria:

* Kidney transplanted
* Immobilized/hospitalized for more than 1 week within the last 6 weeks
* Active treatment with growth hormone or sex hormone
* Known muscle disease
* The lack of ability to speak or understand Danish
* The lack of ability to give an informed consent
* The lack of ability to participate in a clinical study based on the assessment by the local investigator
Effects of Anesthetic Technique on NK Cells

The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years old of either gender
* Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon
* Must be able to have an epidural

Exclusion Criteria:

* ASA IV and above
* Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine.
* Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
* Uncontrolled hypertension (BP \> 140/90)
* Cardiac arrhythmias particularly prolonged QT syndrome
* Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
* Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
* Pregnant or lactating women
* Morbid obesity (BMI \> 40 kg/m2) AND/OR weight \> 150 kg
* Chronic renal failure ( creatinine \> 2.0 mg/dL)
* Liver failure e.g., active cirrhosis
* Alcohol or substance abuse within in the past 3 months
* Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
* Neuropathic pain
* Chronic opioid consumption (\>30mg oxycodone or greater per day)
* Cachexia from any cause
* Systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
* HIV or other immunosuppressive condition
* Preoperative INR \> 1.4 or platelet count \< 100
* Sepsis or overlying skin cellulitis at epidural catheter insertion site
* Inability to tolerate/unwillingness to have an epidural catheter for intraoperative/postoperative pain control for any reason, including prior back surgery resulting in distorted anatomy that precludes neuraxial anesthesia.
* Inability to tolerate an epidural solution of either fentanyl or bupivacaine or needs another form of specialized pain control.
Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)

Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac)

The purpose of the COVID-BioVac study is to establish a biobank of biological samples from subjects who have received the anti-SARS-CoV-2 vaccine, with the ultimate aim (following approval by the EC of specific substudies) to study and characterize the antiviral immune response generated following anti-SARS-CoV-2 vaccination. To this end, the COVID-BioVac Biobank will be officially established for the collection and storage of human biological material, non-profit, to support research activities aimed at advancing scientific knowledge, including in the genetic field, on the immune response. vaccination-induced anti-SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Who have vaccinated for SARS-CoV-2 with Pfizer-BioNTech vaccine or others
* Signing of informed consent from January to March 2021

Exclusion Criteria:

* none
Early External Cephalic Version (ECV) 2 Trial

For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?

Primary Outcomes: Rate of Caesarean section

Secondary Outcomes: Rate of preterm birth

Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.

The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.

Eligibility Criteria:
Inclusion Criteria:

1. Women with any breech presentation
2. A live singleton fetus
3. Gestational age of 33 weeks 0 days to 35 weeks 6 days

Exclusion Criteria:

1. Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
2. Contraindications to early ECV (e.g. increased risk of preterm labour \[such as past history of preterm labour in this or previous pregnancies\], increased risk of abruptio placenta \[such as maternal hypertension\])
3. Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
4. Women planning delivery by CS if the fetus turns to cephalic
5. Women planning a vaginal delivery if the fetus remains breech
6. Women at increased risk of unstable lie (eg. grand multiparity)
7. Previous participation in EECV2 Trial
Assessment Of Shivering With iSeismograph

Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment of shivering has been based on a simple scale using descriptive words rather than actual measurements. We believe that we can assess shivering more scientifically by using a novel method to quantify arm movements during shivering.

This novel method will allow the investigators to quantitatively assess and measure shivering in obstetric parturients undergoing varying procedures under epidural anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy
* epidural in situ

Exclusion Criteria:

* non-cesarean delivery
PET/MR in Radiotherapy for Head and Neck Cancer Pilot

This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art new imaging technique, into the radiotherapy treatment pathway of patients with head and neck cancer. Ultimately the investigators aim to establish appropriate scanning and image registration protocols, to allow progression to a randomized trial of adaptive radiotherapy dose escalation. The latter is thought to potentially improve outcomes in this group.

Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx, planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study participants will have two PET/MRI scans, with the radiotherapy immobilization devices in situ. The first will be done prior to the start of radiotherapy, the second half way through treatment.

Image quality will be assessed by comparing to standard diagnostic scans and different registration methods will be compared to establish the best way of incorporating PET/MR image data into the radiotherapy planning system. Patient tolerability and workflow considerations will also be qualitatively assessed. Furthermore, a planning study will be conducted to establish relevant treatment protocols for a subsequent dose escalation trial.

PET/MRI is an exciting new technology with a lot of potential in the context of adaptive radiotherapy dose escalation. Within this pilot study the investigators aim to address the technical challenges of using it in this context prior to proceeding to a randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Written, voluntary, informed consent
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Life expectancy \> 12 months
* Histologically proven SCC of the oropharynx, hypopharynx and larynx
* Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
* Visible disease (\>1cm) at the primary site on any imaging modality performed within 4 weeks of starting radiotherapy treatment
* Staging PET/CT and diagnostic MRI of the head and neck images need to be available for comparison.
* Adequate organ function and absence of other major concurrent illness, allowing the patient to tolerate scanning regime

Exclusion Criteria:

* Inability to provide informed consent
* Impaired renal function (serum creatinine of \> 200)
* Severely impaired liver function
* Patients with allergies or contra-indications to the radio-tracer and/or contrast agent used in the study
* Severe claustrophobia or inability to tolerate PET or MRI scans
* General contra-indications to MRI, as defined in MRI safety departmental protocols
* Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
* Any patient who has urinary or faecal incontinence
* ECOG Performance Status ≥ 3
* Pregnant or breastfeeding women
Prevalence of COVID-19 in High Altitude : Insights From the Highest City of the World

Since the beginning of 2020, SARS-CoV-2 outbreak spread over the world, conducting in a pandemic state declared by the world health organization in March 2020. Conflicting data have been yet published regarding to the incidence rate of COVID-19 infection in altitude. Mainly based on analysis from national Peru database, some authors argued that COVID-19 disease, as well as case fatality rate was less frequent in altitude. However, epidemiological data are lacking regarding to the prevalence of COVID-19 in altitude, and more specially in high altitude.

Aim of this cross-sectional study is to assess the prevalence of seroconversion for the SARS-CoV-2 in the population of La Rinconada, a mining town at 5,100 m, the highest city in the world.


Eligibility Criteria:
Inclusion Criteria:

- Age \> 18 years.

Exclusion Criteria:

* Age \< 18 years.
* Inability to give informed consent.
Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination

Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.
* Age between 18-74 years

Exclusion Criteria:

* Women undergoing mastectomy due to cancer.
* Age \< 18 years or \> 74 years.
Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia

The goal of this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. The main questions it aims to answer are:

* The distribution of different volumes of ropivacaine after caudal anesthesia
* The blockade level after caudal anesthesia with varying doses
* The minimum effective concentration of ropivacaine among pediatric patients of different age groups Researchers will inject different doses or concentrations of ropivacaine into the caudal canal to observe the drug's spread range, the level of blockade, and the duration of its effect.

Participants will:

* Undergo magnetic resonance imaging (MRI) examinations before and after caudal anesthesia
* Will be detected the blockade level after caudal anesthesia

The activity of CYP1A2 in newborns and infants is lower than in adults, which may result in slower metabolism of ropivacaine. This might necessitate a reduction in the dosage or concentration of ropivacaine to prevent drug accumulation and toxicity. Additionally, since the nervous system in children is still developing, excessively high concentrations of ropivacaine could have adverse effects. Therefore, the lowest effective concentration of ropivacaine should be chosen to minimize the risk of adverse reactions. Generally, the dosage of ropivacaine should be determined based on the patient's age, weight, and the type of surgery. However, there are currently no definitive dosage recommendations, and further research is needed to determine these guidelines.

The goal of this clinical trial is to exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. Using MRI to investigate the distribution of different doses of ropivacaine after caudal anesthesia, and employing infrared imaging technology to detect the blockade level after caudal anesthesia with varying doses.

Participants will receive 0.5ml/Kg, 1ml/Kg and 1.5ml/Kg ropivacaine, then undergo magnetic resonance imaging (MRI) examinations to detect the distribution and optic nerve sheath diameter (ONSD) before and after caudal injection. Also, the blockade level will be detected 15min and 30 min after caudal anesthesia

Eligibility Criteria:
Inclusion Criteria:

BMI ≤ 30 kg/m²; lower limbs surgery; lower abdomen surgery; perineal region surgery; Normal liver and kidney function; Normal coagulation function; Hemoglobin \> 70 g/L.

Exclusion Criteria:

Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
Clinical Evaluation of Giomer and Resin-based Fissure Sealants

The objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (FPMs) affected by MIH.

One-hundred FPMs with MIH which were indicated for non-invasive fissure sealant were selected in 39 children (between 6-12 years). Using a split mouth design, the FPMs were randomized into two groups; Group 1: resin sealant (Conceal F); Group 2: giomer sealant (BeautiSealant) and dental isolation device was used during the procedure (Mr. Thursty). Clinical evaluation was performed by two blinded examiners using the United States Public Health Service (USPHS) criteria to assess anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months. Statistical analysis was performed using SPSS 20.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p\<0.05. The association between independent variable (groups) and dependent variable (USPHS scores) was evaluated with Fisher's exact test. The crosstabulation of the categorical data regarding the groups were analyzed with chi-square test or Fisher's exact test. The Log-rank test and Kaplan-Meier analysis were used to calculate and compare the cumulative survival rates of the sealants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination
* Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
* Presenting at least two FPMs that were fully erupted and indicated for non-invasive fissure sealant.
* The FPMs with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk

Exclusion Criteria:

* Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
* Enamel defect due to a condition other than MIH
The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis

The acute respiratory distress syndrome (ARDS) remains a common and morbid complication of critical illness. Sepsis contribute to a lot of ARDS cases, but mechanisms by which non-pulmonary insults such as extrapulmonary sepsis propagate lung injury remain unclear. Most eukaryotic cells release small anuclear membrane-bound vesicles into the extracellular environment in either physiological or pathophysiological conditions, often called extracellular vesicles (EVs) .Through their cargo containing bioactive molecules such as proteins, mRNAs, and microRNAs and their interaction with target cells, EVs are recognized as important mediators of cellular communication. Mitochondrial contents are clearly present in EVs, and mitochondrial cargo within EVs have been shown to stimulate the production of proinﬂammatory cytokines, further enhancing LPS-induced inﬂammation. Among the mitochondrial contents, mtDNA was present at higher levels in EVs.Therefore, we hypothesis, EVs containing mtDNA play an important role in the occurrence and development of ARDS caused by extrapulmonary sepsis.

Inclusion criteria: Patients with ARDS caused by abdominal infection Exclusion criteria: age \<18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor The pathological information of the patients was collected on 24h, 48h after admission including demographic data, Acute Physiology and Chronic Health Evaluation (APACHE) II score , number of organ failures included in the Sequential Organ Failure Assessment (SOFA) score. The levels of lactate and inflammatory mediators (i.e., plasma C-reactive protein and procalcitonin) were detected on 24h and 48h after admission. All patients were followed up for 28 days, and all-cause mortality was recorded. The durations of mechanical ventilation and ICU stay were also recorded. The primary outcome was mortality on Day 28. Secondary outcomes included the ventilator days and ICU length of stay.

Peripheral blood samples (2 mL) were collected on 24h and 48h after admission to the ICU. EVs were isolated from the plasma, and mtDNA concentration of plasma DNA was evaluated by RT-qPCR.

Eligibility Criteria:
Inclusion Criteria:

Patients with ARDS caused by abdominal infection

Exclusion Criteria:

age \<18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor
A Trial of Vitamin D Therapy in Patients With Heart Failure

The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.

A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients \> 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) class II-IV
* Able to walk
* Serum 25OHD level 37.5 ng/ml or less
* Fully titrated on heart failure medications

Exclusion Criteria:

* Osteoporosis
* Primary hyperparathyroidism or hypercalcemia.
* Nephrolithiasis
* Hemo or peritoneal dialysis and/or creatinine of \> 2.5
* Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
* Current illicit drug user or \> 3 alcoholic drinks a day
* Metastatic or advanced cancer
* Myocardial infarction in the preceding 6 months
* Medications which can lower vitamin D levels or bioavailability