cyrilzakka/clinical-trials huggingface dataset:
Safety And Tolerability Study Of BID Titration Scheme With PF-05089771

The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.
Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population.

Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects. The effect size of analgesia from these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not covered.

The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint, suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. This study also identified the relevant landmarks for those articular branches. The high articular branches from FN and AON are consistently found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE), whereas the ON , close to the inferomedial acetabulum. Using this information, the investigator developed an ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the investigator will examine the efficacy of PENG block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)

Exclusion Criteria:

* Coagulopathy
* infection at the injection site
* allergy to local anesthetics
* severe cardiopulmonary disease (≥ASA IV)
* diabetic or other neuropathies
* patients receiving opioids for chronic analgesic therapy
* contraindication to spinal anesthesia
* inability to comprehend visual analog scale (VAS).
Validation Study on the Impact of Decipher® Testing - VANDAAM Study

The primary purpose of this study is to determine whether a tumor test recently developed by GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher® test was developed from samples derived mainly from men of European origins and little is known about its performance in AAM. It is important to study whether this test can be used in AAM who are known to experience the highest rates of prostate cancer as well as death from prostate cancer. The use of the Decipher® test result to predict how well a patient will do before treatment may make it possible for doctors to distinguish aggressive disease from low risk prostate cancer and modify treatment accordingly. Thus, patients that do not need additional therapies may be spared from unnecessary side effects and those that are at risk may be provided with more aggressive therapy to improve survival. This study is being done to learn whether the Decipher test can really affect these outcomes.

This is a multisite, prospective validation trial. Based on a population consisting of 25% AAM and 75% NAAM, investigators will actively recruit participants and aim to achieve a 1:1 enrollment ratio of AAM to NAAM. To achieve this, low risk AAM will be accrued first and then matching NAAM will be enrolled. NAAM men will be matched to AAM on prostate specific antigen (PSA) at diagnosis.

There will be no treatment intervention beyond standard of care (SOC), and therefore participants will be allowed to choose their definitive treatment option. The intent is to enroll low risk and high volume disease (burden) patients to limit the accrual of patients that would select active surveillance (AS).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Karnofsky Performance Status \>70
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Pathologically (histologically) proven diagnosis of prostate cancer (PCa) undergoing their first line of treatment
* Meet National Comprehensive Cancer Network (NCCN) criteria for either: Low risk PCa (defined as Gleason score 6 in ≥ 3 cores; T-stage T1c- T2a); Intermediate risk PCa (defined as Gleason score 7, or prostatic specific antigen (PSA) ≥ 10 ng/ml \& \< 20 ng/ml, or T-stage ≤ T2c)
* Eligible for either radical prostatectomy (RP) or definitive radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT))
* Age \> 18 years
* Biopsy specimen available

Exclusion Criteria:

* Inability to acquire biopsy or prostatectomy tissue
* History of prior PCa directed chemotherapy or pelvic irradiation (prior to study enrollment)
* Documented distant metastatic disease or pelvic lymphadenopathy
* Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral orchiectomy
* Targeted for active surveillance after diagnostic biopsy
* Selecting ADT alone after diagnostic biopsy
* On active surveillance for \> 6 months after diagnosis
Scapular Mobilization With Arm Movement in Patients With Adhesive Capsulitis.

50 patients with shoulder adhesive capsulitis were admitted. the patients will receive scapular mobilization (downward or upward mobilization) associated with arm movements. The percentage of improvement in shoulder ROM of flexion, abduction, and external rotation; and decrease in shoulder pain and disability index (SPADI).


Eligibility Criteria:
Inclusion Criteria:

* The existence of unilateral adhesive capsulitis (stage II) with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula

Exclusion Criteria:

* The presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries near the shoulder region.
Rifaximin Versus Lactulose in Renal Failure

The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.


Eligibility Criteria:
Inclusion Criteria:

* cirrhosis of liver of any etiology
* progressive renal failure
* stage 0-2 hepatic encephalopathy

Exclusion Criteria:

* pregnant women
Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications

The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 60 years of age ASAI and ASA II were included

Exclusion Criteria:

* history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases.
Prospective Cohort Study of Intravenous Lipid Emulsion for Resuscitating Critically-ill Poisoned Patients

The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. A secondary objective is to determine the mortality in this critically ill population of individuals.

Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Eligibility Criteria:
Inclusion Criteria:

* receiving intravenous lipid emulsion for treatment of a drug toxicity
* Evaluation of a medical toxicologist as part of the ToxIC registry consortium

Exclusion Criteria:

* not evaluated by a medical toxicologist participating in ToxIC
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.

Neonatal respiratory distress syndrome (RDS) is caused by lung immaturity and surfactant deficiency in preterm newborns and is an important cause of morbidity and mortality.

Surfactant therapy plays an essential role in the management of RDS as it reduces lung injury and improves survival, While surfactant alone is very effective, some studies showed that its combination with budesonide significantly reduces BPD and inflammatory markers.

Neutrophils extracellular traps (NETs) are a defense mechanism where neutrophils are the reaction to microbial infection and cast a net-like structure. NETs are composed of chromatin decondensed and some 30 enzymes and peptides. Many components such as Neutrophil elastase (NE) and Myeloperoxidase enzyme (MPO) have antimicrobial, but also a cytotoxic property that causes tissue injury. The immune regulatory abilities of the pulmonary surfactant are known to alter the function of the adaptive and innate immune cells.

So, in this study, The Investigator will Assess the immunomodulatory effect of low and high doses of Alveofact with or without Budesonide.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤ 35 weeks with

  1. Respiratory distress syndrome.
  2. Need surfactant administration based on European RDS consensus: (Sweet et al., 2019)
  3. If intubation is required as part of stabilization.
  4. Clinically presenting with increased work of breathing including (tachypnea, nasal flaring, grunting, retractions, and cyanosis, with decreased air entry on auscultation.
  5. Babies who are worsening when FiO2 \>0.30 on CPAP pressure of at least 6 cm H2O to maintain normal saturations.

Exclusion Criteria:

Preterm neonates with evidence of any of the following will be excluded:

1. Chromosomal anomaly or Congenital heart defect
2. Hemodynamically significant patent ductus arteriosus.
3. Early-onset sepsis or bacterial infection
4. Congenital pneumonia
5. Intra ventricular hemorrhage (IVH)
6. Parenteral refusal to participate.
Study to Evaluate D-1553 in Subjects With Solid Tumors

This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation.


Eligibility Criteria:
Inclusion criteria

* Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available, or the subject is refractory to or intolerant of existing standard treatment.
* Subject has KRasG12C mutation in tumor tissue or other bio-specimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
* Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
* Subject has measurable disease according to RECIST, v1.1.

Exclusion Criteria:

* Subject with unstable or progressive central nervous system (CNS) metastases.
* Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
* Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is \> 480 msec based on triplicate measurements of electrocardiogram (ECG).
* Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
* Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
* Subject has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results.
* Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
* Subject has unresolved toxicities from prior anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, v5.0, Grade ≤ 1 (Grade ≤ 2 for peripheral neuropathy).
* Subject had major surgery within 4 weeks prior to study intervention administration or last dose of palliative radiation therapy within 2 weeks prior to study intervention administration.
* Subject is pregnant or lactating.
Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia

Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due to lack of stereoscopic vision, this traditional method sometimes cannot meet the requirement on identifying the existence and details of NVC, especially when the aberrant vessels turn out to be delicate veins. The three-dimensional analytic techniques, such as curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic views, so as to assist to design the surgical plan.

Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve may correlate with the severity of facial pain due to atrophy of the nerve in most cases of ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss, demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of ITN.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis according to the International Classification of Headache Disorders criteria (3rd edition); 1 year disease duration at least.

Exclusion Criteria:

* Secondary causes of ITN; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.
Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock

This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (LVEF ≤ 40%) in sinus rhythm, baseline HR ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the Cardiological Intensive Care Unit.
* Pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion.
* Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure \> 90 mm Hg.
* Patient's signature on the consent form.

Exclusion Criteria:

* Previous treatment with ivabradine (\< 48 hours).
* Known hypersensitivity to ivabradine.
* Cardiac rhythm different from sinus rhythm.
* Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (AV) block.
* Severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis.
* QT interval higher than 450 ms.
* Sepsis as a probable mechanism of tachycardia and hypotension.
* Need for urgent cardiac surgery, planned within 72 hours of possible inclusion.
* Severe aortic stenosis or severe valvular disease that requires surgical correction.
* Patient must not have received an IV bolus of furosemide immediately before the baseline hemodynamic assessment.
* Severe hepatic insufficiency.
* Patient must not be participating in another clinical trial.
* Concomitant use of potent CYP3A4 inhibitors.
* Acute anemia or hypovolemia uncorrected.
* Pregnancy.
Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CIDP
* on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

* myelopathy or evidence of central demyelination
* persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
* evidence of systemic disease that might cause neuropathy
* heart diseases (congestive heart failure or arrhythmia)
* pulmonary conditions (asthma or CIPD)
* rheumatoid conditions (such as rheumatoid arthritis)
* renal failure
A Pilot Study to Explore the Role of Gut Flora in Gout

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Gout

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of Gout by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition