cyrilzakka/clinical-trials huggingface dataset:
Effect of Allopurinol on Markers of Mineral and Bone Metabolism

Hyperuricemia is a common condition in patients with chronic kidney disease (CKD) in the glomerular filtration rate. Recently, it has been suggested that uric acid is related to a mineral and bone disease of CKD (CKD-MBD) since the high concentration of uric acid is associated with the harmful effect of vitamin D. The proof of concept of the association between acid uric acid and CKD-MBD is based on a prospective study (sample size 6) that observed, after 1 week of use of allopurinol, an increase in the concentration of 1,25(2D, a result independent of the concentration of calcium, phosphorus, 25(OH)D and PTH. An experimental study found that hyperuricemia could modify the expression of the 1α-hydroxylase enzyme, consequently reducing 1,25(OH). The current study aims to evaluate the action of allopurinol on CKD-MBD biomarkers (25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus). We hypothesize that allopurinol can improve serum levels of 1,25(OH) 2D and PTH. This is a controlled, randomized, double-blind study, defined as a filtration rate \< 60ml/1.73 m², according to the CKD-EPI equation. Inclusion criteria: patients with stages III, IV and V CKD who are not on dialysis with a serum level of 25(OH)-vitamin D \>20 ng/ml. Exclusion criteria: Patients diagnosed with gout, undergoing treatment with allopurinol, patients already in use and drugs with sensitivity to the drug. Based on a previous study, we calculated a sample for 2 groups (placebo and drug) with pre and post-measurements (a total of 4). Considering a standard deviation of 4 and a difference of 7 in the treated group, 3 in the placebo group, and an alpha error of 5%, we calculated a sample of 25 patients in each arm.

In this randomized double-blind study, patients receive allopurinol or a placebo for 3 months.

Dependent variables: 25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus Population: stage 3, 4 or 5 CKD on conservative management at the Nephrology Service of Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil.

The same physician will follow patients. Adverse effects will be recorded.

Eligibility Criteria:
Inclusion Criteria: stage 3, 4 or 5 CKD on conservative management

-

Exclusion Criteria:

* allergy to allopurinol
* current treatment with allopurinol
* Gout
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery

There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.

Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.

As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial neuromuscular blockade is usually maintained during general anesthesia for MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.

Eligibility Criteria:
Inclusion Criteria:

* Those who undergo microvascular decompression with sevoflurane anesthesia by diagnosis of hemifacial spasm in our institution

Exclusion Criteria:

* Patients were excluded from the study if they had any of following: severe cardiopulmonary disorder with hemodynamic unstability (pulmonary hypertension, cardiomyopathy, mechanical ventilation, American Society of Anesthesiologists physical status III or more), severe hepatic or renal disease.
* Those who can not undergo MEP monitoring due to central or peripheral neuromuscular disease, e.g. cerebral palsy, myasthenia gravis, acute spinal injury, neurologic shock
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters

This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and above
* Self-reporting Stress
* Able to provide informed consent
* Agree not to change current diet and exercise program while enrolled in this trial
* Agree not to undertake another clinical trial while enrolled in this trial

Exclusion Criteria:

* Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)\*
* Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* Receiving treatment for anxiety, or taking supplements# for anxiety or sleep conditions such as saffron, valerian, etc.
* Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Known pregnant or lactating woman
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other related clinical study during the past 1 month
* History of infection in the month prior to the study

  * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

    * Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
Rhabdomyolysis and Robot-assisted Radical Prostatectomy

In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.

In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.

Fifty-two ASA I-II patients aged 50-80 years, BMI \>25 kg/m2 scheduled for an elective RARP were enrolled to the study.

In all patients, pre-anesthetic evaluations including laboratory tests and Charlson Comorbidity Index (CCI) were performed one week before surgery in anesthesia clinic. Comorbid diseases were rated based on CCI. A 4-points scale was used to rate comorbid conditions \[1 mild; 4 severe\]. Comorbidity grading was performed by adding scores given for each comorbid disease. Based on the grading, patients were stratified into 4 groups as follows: grade 0, 1-2, 3-4 and ≥ 5

In the operation room, intubation was performed after standard anesthesia For surgery, patients were placed in low lithotomy position. All patients were placed on a soft sponge mattress and soft padding gel pads were provided above the shoulders. The patients were placed in a 30-degree STP after achieving pneumoperitoneum at an intra-abdominal pressure level of 15 mmHg. After placing patient to desired position (T0), blood samples were drawn for measurements of ABG, Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB and CPK.

During the operation, normal saline (1 m/kg/hr) and 6% HES 200/05 (1 ml/kg/hr) infusions were applied. Operation time (OT) and Trendelenburg time (TT) were recorded in all patients.

Blood samples were repeated on the hours 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery. Hydration with 2000 ml crystalloid solution was given until hour 24 after surgery. In all patients, urine output was monitored.

Rhabdomyolysis was defined as postoperative serum CPK level exceeding 5,000 IU/L. It was planned to manage these patients with hypervolemic therapy, correction of acidosis by using IV sodium bicarbonate and stimulation of diuresis by IV furosemide with a goal of maintaining minimal diuresis of 60 ml/hr at pH level of 7.

Postoperative RF was defined as an increase in serum creatinine of 1mg/dl/day (or 90 mmol/l/day) for 2 consecutive days beyond the baseline.

Patients were discharged with control laboratory tests, including the same parameters, on the hour 48 (T48) postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged 50-80 years,
* BMI \>25 kg/m2
* Patients scheduled for an elective RARP

Exclusion Criteria:

* Patients with ASA III-IV risk status,
* Patients with comorbid diseases that can cause increased muscular activity such as severe dystonia or status asthmaticus,
* Patients with renal or hepatic failure and patients on statin or steroid therapy were excluded.
* Patients converted to laparotomy during surgery.
Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver

The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients.

Criteria:

* Breast cancer
* Clinical evidence of metastatic disease in the liver
* Performance status (0-2)
* Not pregnant
* Laboratory values received after any prior chemotherapy
* Normal Pt/PTT
* recovered from any chemotherapy side-effects
* No prior radiation therapy to the liver
* No other MAJOR site of cancer such as lungs or brain
* No uncontrolled infections
* a candidate for surgical resection or ablation therapy

Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.

Eligibility Criteria:
Inclusion Criteria:

* Documented breast cancer
* Clinical evidence of mets to the liver
* Performance status of 0-2
* Life expectancy of greater equal to 3 months
* Not pregnant
* 4 weeks or more since last radiation therapy
* Recovered from all side effects of prior chemotherapy
* Not needing concurrent chemotherapy
* recovered laboratory values
* Bilirubin \< 2.0

Exclusion Criteria:

* Candidate for surgical resection or ablation of liver lesion/s
* Prior radiation therapy to the liver
* Co-Morbid disease
* pulmonary insufficiency
* Portal vein thrombosis
* Contraindications to angiography
* \> 20 % lung shunting on MAA
* Diffuse extra-hepatic disease
* Concurrent chemotherapy OR capecitabine with 8 weeks
* Failed MAA
* Uncontrolled active infection
* Severe liver dysfunction
Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.

OBJECTIVES:

Primary

* Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.

Secondary

* Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm.

OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers

To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age and diagnosed with mild to moderate Alzheimer's disease or healthy volunteers
* fluent in reading and speaking English
* AD patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements
* AD patients who have received AChEIs or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug

Exclusion Criteria:

* Have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years
* Have serious or uncontrolled health problems or laboratory tests
* Multiple or severe drug allergies
* Prior participation in an active immunization study
Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy

The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Microbiological samples were taken from the retainers at the baseline, after 1 and after 2 months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test.

The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients who wear essix retainers for contention therapy are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Periodontal evaluation and microbiological samples are conducted at the baseline, after 1 and after 2 months.

Bacterial loads are collected from essix retainers, whereas Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test are assessed from the patients' mouth.

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed orthodontic treatment and under Essix retainers phase.

Exclusion Criteria:

* Patients under orthodontic treatment with fixed appliances or clear aligners.
* Non-orthodontic patients.
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
* Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
* Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

Exclusion Criteria:

* Has a very severe luminal disease activity
* History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
* Any medical contraindications preventing study participation
* Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation

Central venous catheterization is commonly applied in patients undergoing cardiac surgery. The subclavian vein has lower risk of infection and provides more patients comfort. However central venous catheterization may results in complications such as pneumothorax, hemothorax or arterial puncture. It has been suggested that ultrasound (US) guidance could improve the success rate, reduce the number of needle passes and decrease complications. Two different real-time 2-dimensional US techniques can be employed in the insertion of central venous catheters. The first technique involves real-time US-guided cannulation of subclavian vein using a long axis/in-plane approach. The second one involves real-time US-guided using a short axis/out-off-plane approach. However to date no studies have compared their efficacy and safety. The purpose of this study was to compare the US-guided long-axis versus short-axis approach for the SCV catheterization in adult critical care patients.

The two techniques used for vessel visualization are far different:

The Short-Axis (SA) approach attempts to view the vessel in cross-section while venous access is obtained. The strength of the SA approach is that the vein is centered under the transducer and that the midpoint of the transducer becomes a reference point for the insertion of the needle, and that at the same time is possible to visualize SC artery and the pleural line. SA approach is easy to learn by novice sonologists.

The Long-Axis (LA) approach employs a technique that views the length of the vessel during cannulation.For this reason, with LA approach is possible to visualize the needle advance during the entire procedure from the soft tissues until the lumen of the vein, but SC artery and pleural line are not visualized in the same scan. For LA approach, practice is required to keep the needle precisely within the image and care must be taken to avoid the probe inadvertently moving away from the target structure.

Eligibility Criteria:
Inclusion Criteria:

* aged =\>18 years
* patients who needed central venous catheter for clinical reasons

Exclusion Criteria:

* aged \<18a years
DE-CT in Lung Cancer Proton Therapy

Dose distribution calculations for proton therapy are more accurate when based on DE-CT than on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations is for lung cancer patients.

In order to calculate the dose distribution of protons adequately, accurate estimations of the stopping power ratio (SPR) medium to water, are required. Using a conversion from single energy CT (SE-CT) images results in an uncertainty in the SPR of at least 3-4%. This uncertainty results in in the use of larger margins around the clinical target volume (CTV) and hence more dose to the organs at risk (OAR). It also effects in the conservative use of beam directions, which are often sub-optimal, to avoid irradiating normal tissues.

Dual energy CT (DE-CT) improves the accuracy of the SPR and therefore the proton range estimation.

An evaluation of the proton range for several tissues using SE-CT and DE-CT as input to Monte Carlo (MC) simulations showed on average improvements in range prediction from 0.1% to 2.1% when using DECT instead of SECT, but in several phantoms and also versus proton-CT, the errors on SE-CT based proton stopping power ratios are reported to be more than 7 %.

A limitation of these studies is that most of them were performed in phantoms. In the first clinical data set on five patients with base of skull tumours, it was reported that although the SPR estimation was indeed better for DE-CT than for SE-CT, its clinical relevance was unclear. However, in the same study, phantom measurements showed a large uncertainty of the SPR in the lung. This is due to the large heterogeneity of the lungs and the huge difference in the density of the lungs compared to the mediastinum, the tumour and the chest cavity.

It is therefore important to study the SPR differences of SE-CT compared to DE-CT in lung cancer patients and the impact on the dose distribution especially in the context of adaptive radiotherapy. As during the course of concurrent chemotherapy and radiotherapy, which is the standard treatment in the majority of stage III lung cancer patients, important anatomical changes may occur, it is also of clinical relevance to determine the influence of repeated dose calculations on DE-CT.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
* Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
* Able to give written informed consent
* Able to have adequate contraception in woman with child bearing potential

Exclusion Criteria:

* Not able to give written informed consent
* Not able to comply with adequate contraception in woman with child bearing potential