cyrilzakka/clinical-trials huggingface dataset:
Outcome Prediction in Patients With Acute Disorders of Consciousness

Prior research has indicated a link between outcomes in patients with disorders of consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree of uncertainty in acute situations, this study plans to record EEG responses and observe microexpressions in DOC patients during exposure to auditory stimuli, with the aim to identify more reliable prognostic indicators. The goal is to uncover potential patterns or signals that can contribute to a more comprehensive understanding of a patient's condition, and thereby provide more accurate prognostication.

This study intends to probe the potential of electroencephalography (EEG) and microexpression analysis for predicting the outcomes of acutely unresponsive patients within the intensive care unit (ICU). Previous research has illuminated a relationship between patients' emotional responses to auditory stimuli and their prognosis. However, the predictive utility of these responses in the context of acute conditions remains largely unexplored.

At the onset of the study, participants will undergo EEG monitoring while exposed to a pre-determined set of emotional auditory stimuli. Additionally, the patients' facial expressions will be captured via video for subsequent microexpression analysis.

Follow-up assessments of the patients' status will be conducted at three, six, and twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these EEG and microexpression responses. This study aims to identify possible correlations between these findings, the patients' diagnoses, and their respective outcomes over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute brain injury (\<28 days) in ICU
* GCS ≤ 8
* ≥ 2 days after sedation
* Normal hearing, with auditory startle reflex

Exclusion Criteria:

• Children under 18
Noradrenalin vs Terlipressin in Hepatorenal Syndrome

The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome

Hepatorenal syndrome (HRS) is a major complication of cirrhosis; it is characterized by functional renal failure and poor prognosis. Arterial dilation is a key pathogenic event of HRS, leading to reduction of the effective blood volume, homeostatic activation of vasoactive systems and renal vasoconstriction with decrease in renal blood flow. The clinical signs of HRS vary depending on the clinical pattern. HRS type 1 is characterized by a rapidly progressive renal failure; HRS type 2 by a moderate and more stable renal failure. HRS type 1 has a very poor short term prognosis, with a median survival of only about 2 weeks; patients with HRS type 2 have a median survival of about 6 months. The management of HRS still constitutes a major challenge. Liver transplantation is the ideal treatment, but it has important inherent drawbacks, such as the organ shortage and the time needed to perform the transplant, that is too long to consent the survival of these patients. The management of HRS has focused on improving renal function, thus extending patients survival and allowing the performance of the liver transplant. In the last years, remarkable results have been obtained using vasoconstrictor drugs. By improving the effective blood volume, vasoconstrictors induce the suppression of homeostatic vasoactive systems and increase renal blood flow and glomerular filtration rate.Among vasoconstrictors, terlipressin, a V1 vasopressin agonist, has currently the best efficacy pedigree. However, it is expensive and is not available in many countries, including North America. More recently, it was suggested that alpha-adrenergic drugs such noradrenalin and midodrine may be also effective in HRS. Noradrenalin would have the potential advantage of wider availability and of lower cost. The current prospective randomized study was undertaken to assess the efficacy and safety of noradrenalin vs terlipressin in patients with HRS.

Eligibility Criteria:
Inclusion Criteria:

* Hepatorenal syndrome
* Age: 18-75 years
* Informed written consent

Exclusion Criteria:

* Multinodular hepatocellular carcinoma (more than 3 nodules)
* Portal vein thrombosis
* Ongoing bacterial infection
* Ongoing or recent (less than one week) bleeding
* Cardio-pulmonary failure
* Coronary artery disease
* Peripheral artery disease
* Arterial hypertension
Intraosseous PRP for Knee Osteoarthritis: Pilot Study

The aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.This study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged 40 to 77 years.
* Predominant internal tibiofemoral knee osteoarthritis.
* Joint pain above 2.5 VAS points.
* Radiographic severity degrees 3 and 4 according to Ahlbäck scale.
* Values of body mass index between 20 and 33.
* Possibility for observation during the follow-up period.

Exclusion Criteria:

* Bilateral knee osteoarthritis which requires infiltration in both knees.
* Values of body mass index \> 33.
* Polyarticular disease diagnosed.
* Severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘).
* Arthroscopy in the last year prior to treatment.
* Intra-articular infiltration of hyaluronic acid in the past 6 months.
* Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
* Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%).
* Blood disorders (thrombopathy, thrombocytopenia, and anemia with Hb \< 9).
* Undergoing immunosuppressive therapy and/or warfarin.
* Treatment with corticosteroids during the 6 months prior to inclusion in the study.
Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.

The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.

The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Signed initial informed consent
* Participant agrees to genetic counseling

Exclusion Criteria:

* Prospective participant unable to sign informed consent based on referring physician recommendation.
* Patient has neuroendocrine pancreatic tumor
The Spanner Prostatic Stent and Patient's Quality of Life

Acute urinary retention is considered one of the most common problems in the older age, especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary retention using the Foley catheter still causes problems at the level of patient movement and the daily exercises. However, with the emergence of a new device, the spanner, investigators believe that many of the above mentioned problems can be resolved. This tool may provide more freedom for the patient.

This research comes up to date with technological innovations in the field of health where investigators want to evaluate the efficacy of a new catheter (The Spanner) to reduce the acute urinary retention and to determine whether they are consistent with the daily life of the patient, compared to the Foley catheter previously used.

The study include all patients with acute urinary retention due to prostatic obstruction. Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral or bladder surgery, or if they were at high risk of developing bladder or kidney stones The study will be national community based study conducted in different hospitals in Saudi Arabia. Investigators will test two different types of stents in patients with acute urinary retention for a short period (not exceeding five days), find out the compatibility of these stents with the daily life of the patient and determine their impact on his quality of life using an appropriate questionnaire after each use.

Eligibility Criteria:
Inclusion Criteria:

* Acute Urinary retention due to Prostatic Obstruction

Exclusion Criteria:

* Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral or bladder surgery, or if they were at high risk of developing bladder or kidney stones
Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine

Succinylcholine is an important component of rapid sequential induction of general anesthesia because of its rapid onset and short duration of action. However, myofibrillation is a common complication after succinylcholine injection and may lead to persistent postoperative myalgia, increased intraocular, intragastric and intracranial pressure in patients. Increased risk of peri-induction and postoperative patient discomfort. The effectiveness of rocuronium bromide pretreatment in reducing succinylcholine-induced myalgias has been demonstrated in several recent studies. However, the half effective amount of rocuronium pretreatment for small doses is not well known. Therefore, this study applied the Dixon sequential method to investigate the ED50 of preemptive intravenous rocuronium bromide for the prevention of succinylcholine-induced myofibrillation and to investigate the effect of age factor on the ED50 of rocuronium bromide for the prevention of succinylcholine-induced myofibrillation to provide a reference for the rational clinical selection of rocuronium bromide dose.


Eligibility Criteria:
Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA grade I-II

Exclusion Criteria:

1. Possible airway difficulties,
2. allergies or contraindications to rocuronium and succincholine ，
3. cardiac insufficiency,
4. hepatic or renal dysfunction,
5. neuromuscular disease,
6. surgery lasting more than 2 hours,
7. taking any known drug that has interaction with neuromuscular blockers.
Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 89 years of age.
* Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
* Ability of participant to understand and the willingness to sign a written informed consent document.
* Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.

Exclusion Criteria:

* Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
* Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
* Patients meeting the above enrollment criteria who have had CancerNext performed previously.
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.

The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT.

The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy.

The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA \< 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or three consecutive rises will be included.

All eligible patients will be randomized to one of the following two treatment arms:

Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks.

Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks.

The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate adenocarcinoma treated with radical prostatectomy;
* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
* No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
* PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
* PSA at inclusion \< 1.0 ng/mL;
* WHO performance status 0-2 at inclusion;
* Age at inclusion between 18 and 80 years;
* Written (signed and dated) informed consent prior to registration.

Exclusion Criteria:

* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
* Double-sided metallic hip prosthesis;
* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
Estimation of the Carrier Frequency and Incidence of Smith-Lemli-Opitz Syndrome in African Americans

RSH/Smith-Lemli-Opitz syndrome (SLOS) is one that causes mental retardation. It is common in the Caucasian population but rare in African American and African black populations. It has been shown that SLOS is caused by a specific defect in DHCR7, an enzyme used in cholesterol metabolism. Studies have already been done to determine the frequency of the SLOS-causing mutations in various geographic Caucasian populations. This study will investigate the frequency of the DHCR7 mutations in the African American population. If the frequency observed suggests that SLOS cases are not being identified in this ethnic group, the study will provide the rationale for future studies to identify these patients.

The sample size will be 1,600. The study population will consist of archived biological specimens in the form of newborn screening blood spots from two newborn screening centers, one in Maryland and one in Pennsylvania. Subjects will be of African American ethnicity, including blacks of African, Caribbean, and Central American descent.

Genomic DNA will be extracted from blood spots and screened for the six common SLOS mutations. If SLOS syndrome is found, followup will be attempted for the Maryland samples (the Pennsylvania samples will be totally anonymous).

RSH/Smith-Lemli-Opitz syndrome (SLOS) is a multiple congenital anomaly/mental retardation syndrome caused by inborn error of cholesterol metabolism (Tint et al. 1994; Opitz 1999; Kelley 2000). Recent studies have shown SLOS to be one of the most common inherited metabolic defects in the Caucasian population. SLOS is believed to be rare in people of Chinese, Japanese, Indian, and Korean origin as well as in the African American and African Black population (Tsukahara et al. 1998; Yu et al 2000a; Witsch-Baumgartner et al. 2000; Witsch-Baumgartner et al. 2001, Battaile et al. 2001). The frequency spectra of DHCR7 mutations have been established for American Caucasians (Yu et al. 2000b, Battaile et al. 2001), mixed American Caucasian collection of patients (Witsch-Baumgartner et al 2000), for European ethnic groups from Poland, German/Austria, Great Britain (Witsch-Baumgartner et al. 2001) and from Italy (De Brasi et al. 1999). In these Caucasian populations, the most common mutations (IVS8-1G\>C, W151X, V326L, R352W, R404C and T93M) account for 60% of SLOS mutant alleles. These suggest that frequent SLOS-causing mutations have different geographic origins and histories. This project will investigate the frequency gradient of DHCR7 mutations in the African American population.

Eligibility Criteria:
INCLUSION CRITERIA:

These will be newborn screening blood spots from African American babies. Samples from Blacks of African, Caribbean and Central American descent will be included. The classification of the infants will be based on the maternal identification as Black or African American by blood spot submission card.

EXCLUSION CRITERIA:

Newborn screening blood spots from non-African American or non-Black babies.
Pivotal Study of a Percutaneous Mitral Valve Repair System

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Eligibility Criteria:
Key Inclusion/Exclusion Criteria:

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:

* Are 18 years or older.
* Symptomatic
* If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
* Are candidates for mitral valve surgery
* Are candidates for transseptal catheterization
* Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
* Appropriate valve anatomy for MitraClip
* Does not need other cardiac surgery or any emergency surgery
* Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
* Mitral valve orifice area ≥ 4 cm2
* Do not have renal insufficiency
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation