cyrilzakka/clinical-trials huggingface dataset:
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

There is a screening period of up to 6 weeks, a variable treatment period for individual participants. In order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants who prematurely discontinued from treatment will be expected to complete the Early Termination (ET) and End of Study (EOS) visits. Such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (LTFU) for cardiovascular events (CV) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this LTFU data collection. Participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
* Anemia qualified by measurements of hemoglobin values during screening
* Additional blood work must be in a safe range for study entry
* Body weight 45 to 160 kilograms (kg)
* Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

* Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
* More than 1 dose of intravenous iron within 12 weeks prior to study participation
* Blood transfusion within 8 weeks prior to study participation
* Active infection
* Chronic liver disease
* Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
* Uncontrolled blood pressure within 2 weeks prior to study participation
* Renal cell carcinoma
* History of malignancy, including multiple myeloma or other myelodysplastic syndrome
* Chronic inflammatory disease that could impact red blood cell production
* Any prior organ transplant or a scheduled organ transplantation
* Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
* Gastrointestinal bleeding
* Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
* Recent use of an investigational drug or treatment, or participation in an investigational study
Ultrasound-Guided Serratus Anterior Plane Block for Additional Pain Relief After Lung Surgery

The purpose of this study is to see if an anesthesia technique called serratus anterior plane block may provide additional pain relief for the chest wall after lung surgery. The study will evaluate the effect the serratus anterior plane block technique has on the need for opioids after surgery,the level of pain during recovery, and other aspects of recovery, like whether the patient has nausea and their ability to breathe deeply. The effects of the serratus anterior plane block will be compared to the effects of an inactive (sham) block.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age who are capable of giving consent. English language proficiency is required.
* Undergoing elective minimally invasive (VATS or RATS) anatomic lung resection (segmentectomy or lobectomy) without an epidural.

Exclusion Criteria:

* Pregnancy (Patients must have a negative pregnancy test within 30 days of the operation)
* History of documented anaphylaxis or contraindication to local anesthetics
* History of ipsilateral thoracic surgery. Ipsilateral thoracic surgery indicates any previous thoracoscopic or open (i.e. via thoracotomy) pleural biopsy, lung resection, esophageal surgery, chest wall resection, or other thoracic surgery within the chest cavity. This does not include image-guided lung biopsy. Note: Mediport placement and other procedures performed by a surgeon/proceduralist NOT within the chest cavity are not excluded. Likewise, patients with a history of ipsilateral breast surgery are also not excluded. The purpose is to exclude patients who may have had injury to the intercostal nerves from previous surgery or who have surgically altered anatomy of the hemithorax.
* Patients undergoing bilateral procedures
* Weight \< 50 kg
* Chronic sustained-release opioid use for \> 2 weeks duration (in the 30 days prior to surgery)
* Significant cognitive impairment or documented psychological impairment
* American Society of Anesthesiologists (ASA) physical status \> 3
* Patients may also be excluded from the study if the block is deemed not technically feasible (this may be determined intraoperatively).
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (\>65 years) and in middle aged group (\<45years) of patients.

We believe that known data regarding the minimum anesthetic volume required for effective US-SCB from middle age population can not be applicable to the elderly population since our preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in abstract form in the European Journal of Anaesthesiology, showed that involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 3 elderly patients (\>65 years) scheduled for hand surgery
* ASA 1-3 middle aged patients (\<45 years)

Exclusion Criteria:

* Cognitive impairment
* Coagulopathy
* Allergy to local anesthetics
* Infection at the puncture site,
* Body mass index \> 35 kg/m2
Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent.
* Patient is willing to be available for each examination scheduled over the study duration.
* Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
* Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
* Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).

Exclusion Criteria:

* Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
* Has presence of active malignancy
* Has a history of severe allergy
* Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
* Pregnant, or may become pregnant within follow-up period of study
* Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
* Spondylolisthesis at the target level
* Has undergone previous lumbar surgery
* Has severe osteoporosis (T-score ≤ -3.5)
* BMI \> 35kg/m2
* Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
* Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
Hypo-fractionated Postoperative IMRT in Prostate Cancer

To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.

To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP) for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous integrated boost (IMRT-SIB).

One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage: 18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Acute and late toxicities were recorded and evaluated according to RTOG (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for Research and Treatment of Cancer) scale, respectively.

Median follow-up was 30 months (13-92).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* prior radical prostatectomy with or without lymphadenectomy
* high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis \> 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value)
* ECOG performance status 0-1
* adequate bone marrow function (hemoglobin concentration \> 8 g/dl, white blood cell count \> 3,000/ mm³, platelet count \> 75,000/ mm³)
* pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis
* bone scan
* informed consent

Exclusion Criteria:

* prior pelvic radiotherapy
* distant metastases
* macroscopic residual tumor
* pelvic or para-aortic nodes at re-evaluation imaging after surgery
* secondary malignancies
* genetic syndromes of hyper-radio-sensitivity
* chronic inflammatory bowel disease
* previously treated with androgen deprivation therapy
* previously treated with chemotherapy for prostate cancer
The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine

Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue. Anatomic studies on posterior epidural space and its contents are few, including semifluid property. In other words, there has not been studied thoroughly regarding the significance and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were free under this layer. The anterior surface of this membrane lay close to the dura mater without any attachment.

To date, the epidural fat has been resected routinely by pituitary forcep and suction drainage during posterior lumbar surgery. However, the investigators focused on the role of epidural fat, which might be associated with postoperative outcome. The investigators thought that this peculiar character, epidural fat, should be caused by certain etiologies. In general, each tissue, such as epidural fat, has its inherited features and significance, thereby the epidural fat has also specific role. However, there has not been fully studies regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural fat on the postoperative outcomes such as pain intensity and functional outcomes by whether the epidural fat would be resected or not during posterior decompressive surgery. The investigators hypothesized that the epidural fat would be associated with postoperative pain intensitive, functional outcomes, and complications of the surgery such as failed back surgery syndrome. In this study, new device for resection of epidural fat was not utilized, but just resected with conventional devices such as pituitary forcep.


Eligibility Criteria:
Inclusion Criteria:

* patients with a lumbar spinal stenosis, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
* patients who underwent one-level posterior decompression
* patients aging between 20 and 80 years
* patients who volunteered for this study with written consent
* patient who were followed-up for one year or more

Exclusion Criteria:

* fractures, infection, or tumors in the lumbar spine
* patients with hemorrhagic disorders such as hemophilia and thrombocythemia
* patient with a follow-up period of less than one year
* patients who are not suitable for this study judged by the principal investigator
Plant Based Diet, Ethnicity, and the Gut Microbiome

Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

To characterize the human gut microbiome under highly controlled dietary intake in healthy normal weight adult participants who differ by ethnicity: White non-Hispanic and Black non-Hispanic adults. Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-40
* BMI 18.5-24.9
* Caucasian or African American

Exclusion Criteria:

* Not weight stable
* Using Medications
* Using Dietary Supplements
* Chronic Disease
* Tobacco Use
* Drug Use
* Pregnant or Lactating
* Diet Restrictions
* Vegetarian or Vegan
Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH

This study compares the bioavailability of IV and PO acetaminophen in both blood and the cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also compare the temperature and levels of inflammatory cytokines in both blood and CSF of patients treated with IV and PO acetaminophen.

In individuals diagnosed with subarachnoid hemorrhage (SAH), fevers have been shown to have detrimental micro and macroscopic effects on the brain that can ultimately cause secondary brain injury. The anti-pyretic effects of oral acetaminophen have been studied in critically ill patients but no study has been able to compare these effects to the IV form of acetaminophen also known as OFIRMEV. The investigators wish to explore the notion that IV acetaminophen will be more effective than enteral acetaminophen in reducing the incidence of non-infectious fevers in critically ill patients. In addition, the investigators propose to study the levels of inflammatory cytokines after administration of IV or enteral acetaminophen, as well as, determine the incidence of vasospasm in SAH patients treated with IV acetaminophen. Currently, external ventricular drain (EVD) placement is the "standard of care" in patients who present with SAH and altered mental status/coma. The presence of an EVD allows for continuous sampling and removal of cerebral spinal fluid (CSF) as necessary to alleviate dangerous elevations in intracranial pressure. This clinical scenario allows for a unique, continuous outlet to access the CSF, without placing patients at risk, and without further invasive procedures (i.e. repeated spinal taps). These samples of CSF can be assayed for levels of acetaminophen, as well as inflammatory markers of fever which include interleukin-1 (IL-1), interleukin-6 (IL-6), and thromboxane-2 (TXA-2), in patients selected to be given enteral or IV acetaminophen.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subarachnoid hemorrhage (must be confirmed by CT, CT angiography, lumbar puncture, or MRI).
* Fisher Grade between 1-3 (subarachnoid blood without signs of intraventricular hemorrhage or parenchymal extension).
* Placement of an external ventricular drain.
* Adults aged 18-100 years.

Exclusion Criteria:

* Anyone under the age of 18 or over the age of 100.
* Adult patients with subarachnoid hemorrhage with interventricular hemorrhage or parenchymal extension (Fisher Grade 4).
* Contraindication to acetaminophen such as a known hypersensitivity, severe hepatic impairment, or severe active liver disease.
* Severe renal impairment (creatinine clearance ≤ 30 mL/min).
Indocyanine Green and Rectosigmoid Endometriosis

Indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue perfusion.

The aim of this study is to evaluate a possible correlation between rectosigmoid vascularization and surgical and clinical data including pre and post-operative bowel symptoms in patients needing surgery for rectosigmoid endometriosis.

Patients with symptomatic rectosigmoid endometriosis requiring laparoscopic surgery are included in the study.

Before surgery, bowel symptoms are assessed using validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index).

Indocyanine green is administered through peripheral line. A near-infrared (NIR) camera-head enables real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. Rectosigmoid tract perfusion is assessed before and after the removal of the nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used.

After complete removal of rectosigmoid nodule, the post-operative follow-up will be the same as usual after intestinal endometriosis surgery. Postoperative bowel symptoms are evaluated using the same questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance
* Patients with indication for removal of endometriosic lesions by laparoscopic surgery
* Obtaining Informed Consent

Exclusion Criteria:

* Known or suspected allergy to iodine
* Previous rectal surgery
* History of active pelvic infection
* Intra-abdominal or pelvic malignancy
* Pelvic radiation therapy
* Hyperthyroidism
* Liver dysfunction
* Serum creatinine \> 2.0 mg/dL
Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery

The purpose of this study is to test whether Botox injection in anterior belly of digastric muscle in BSSO for mandibular advancement surgery could reduce the tendency of postoperative relapse.

Research question:

(P) In patient has skeletal class II mandibular retrognathism, (I) will Botox injection in anterior belly of digastric. (O) Affect the relapse of the mandible after mandibular advancement orthognathic surgery?

Participants will be undergo Botox injection in anterior belly of digastric and bilateral sagittal split surgery

In the intervention group:

Botulinum toxin type A will be first injected into anterior belly of digastric muscles 2-3 days prior to any surgical intervention (for the BTX to be clinically effective). A total of 20 U of Botox will be injected bilaterally by using 25g needle, 1 cc insulin syringe through extra oral approach in 4 point.

Intra-operative procedures:

Access through a vestibular Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.

* The cutting guide of the mandible will be placed onto the exposed bony surface and manipulated to the best fit. Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side.
* Then, a reciprocating saw will be used to perform the planned bilateral sagittal split osteotomy. After adequate mandibular mobilization and removal of bony interferences, the mandible will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws.
* In Bi-max surgery the maxillary cutting guide will be fixed in the same manner and Lefort I osteotomy will be carried out.
* After adequate mobilization, the maxilla will be repositioned by the patient specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws.
* All incisions were closed with 4-0 resorbable sutures.

Eligibility Criteria:
Inclusion Criteria:

* Patients need bilateral sagittal split osteotomy for correction of skeletal class II malocclusion (mandibular retrognathism).
* Age of the patient above 18 years.
* All patients are free from any systemic disease that may affect normal bone healing.

Exclusion Criteria:

* Patient with history of facial bone trauma, cleft lip or palate.
* Intra-bony lesions or infections that may interfere with surgery.
* Previous orthognathic surgeries.
* Patients with relative contraindications to (BTX) injection such as pregnancy, lactation, neuromuscular diseases (e.g., myasthenia gravis), motor neuron disease, allergy to any of the components of (BTX).