cyrilzakka/clinical-trials huggingface dataset:
Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis

The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.

The aim of the present study is to determine whether or not the adjunction of Pentoxifylline to corticosteroids would improve 6-month survival of patients with severe alcoholic hepatitis. This multicenter, randomized, double-blinded, controlled, phase 3 trial was conducted in 24 centers located in France and Belgium. Alcoholic hepatitis was biopsy-proven. All eligible patients were randomly assigned in a 1:1 ratio to receive corticosteroids + Pentoxifylline or corticosteroids + Placebo. The primary outcome of the study was 6-month survival. Assuming a two-sided type I error of 0.05, a randomization ratio of 1:1 between the 2 groups, 6-month survival of 64% in the Placebo and Corticosteroids group and of 78 % in the Pentoxifylline and Corticosteroids group, we estimated that with 268 randomized patients (134 in each group), the study would have a power of 80% to detect this increase in 6-month survival in the Pentoxifylline and Corticosteroid group.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol consumption more than 40 gram/day for women and 50 gram/day for men
* Maddrey discriminant function higher than 32
* Onset of jaundice within the 3 previous months
* Biopsy-proven alcoholic hepatitis

Exclusion Criteria:

* Hypersensitivity to pentoxifylline
* Any severe disease that may potential affect survival such as cardiac failure, ischemic cardiopathy, respiratory failure
* Any neoplasm that occurred within the 2 previous years
* Hepatocellular carcinoma or any previous diagnosis of hepatocellular carcinoma
* Portal thrombosis
* Severe gastrointestinal bleeding
* Uncontrolled sepsis within the 7 previous days
* Hepatorenal syndrome type I
* Viral and fungal infection
* Acute pancreatitis
* Any tuberculosis that occurred within the 5 previous years
* Psychiatric disorders that contraindicate the use of corticosteroids
* Infection related to virus of the hepatites B or C
* HIV infection (Human immunodeficiency virus)
* Any treatment with corticosteroids, immunosuppressive agents, budesonide, thalidomide or pentoxifylline that was given within the previous year
* Pregnancy or breast feeding
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy


Eligibility Criteria:
Inclusion Criteria:between 3 and 12 years of age

* ASA 1 or 2

Exclusion Criteria:

* did not consent
Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion

Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.

Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample.

Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions.

However, EUS-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results, with an estimated negative predictive value not higher than 70-80%.

ROSE could improve the diagnostic yeld of this procedure. Data about the utility of rapid on-site evalutation (ROSE) are still controversial. Without ROSE, current guidelines suggest performance of three to four needle passes with an fine needle aspiration (FNA) needle or two to three passes with a fine needle biopsy (FNB) needle.

Potential drawbacks of ROSE are the considerable time commitment, costs and logistical and personnel issues that arise because of the "on demand" nature of these procedures with the need to have available technologists.

Ex-vivo fluorescence confocal laser microscopy (FCM) is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation.

FCM involves no damage or cell/tissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded (FFPE) for permanent histology. FCM allows both cellular and architectural details to be visualized, similar to standard histological analysis of paraffin-embedded or frozen samples. With FCM, multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylin/eosin (H\&E)- stained sections directly from native tissues.

Recently, the feasibility of FCM with MAVIG VivaScope® 2500M-G4 in EUS-FNB sample of pancreatic solid lesions has been investigated . This previous single-center study demonstrated good concordance between the FCM image-based evaluation and the final FFPE histology.

However in this first study, a single type of FNB needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease. Therefore it might be not representative of the everyday clinical practice. In addition the first study was mainly focused on the adequacy assessment of the samples.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic solid lesions

Exclusion Criteria:

* cystic lesions
* not suitable acoustic window for needle biopsy
* decline to give informed consent.
Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75 years
* OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
* Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
* For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
* Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent

Exclusion Criteria:

* Stenosis \>30% or renal artery aneurysm in either renal artery
* Fibromuscular dysplasia (FMD)
* Known causes of secondary HTN
* Type 1 diabetes mellitus
* eGFR \<40 mL/min/1.73m2
* Known ejection fraction of \<30% or heart failure that required hospitalization in the previous 6 months
* Severe valvular heart disease
* ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority between the detection rate of clinically significant PCa with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI + systematic biopsy.

II. To compare the positive yield of targeted biopsy cores based on mp-US + systematic biopsy with targeted biopsy based on mp-MRI + systematic biopsy, for detection of clinically significant PCa.

SECONDARY OBJECTIVES:

I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically significant PCa.

II. To construct an optimal logistic regression model to predict the presence of clinically significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA), PSA velocity and any other biological variables (e.g., age).

OUTLINE:

Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US and prostate biopsies on study.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be scheduled for a prostate biopsy, based on an elevated PSA (\> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (\> 0.75ng/ml/year), or abnormal digital rectal examination
* Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies
* Subject must be a male at least 18 years of age when informed consent is obtained

Exclusion Criteria:

* Participant in a clinical trial involving an investigational drug within the past 30 days
* Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity
* Previous treatment for prostate cancer, including hormone therapy
* Clinically unstable, severely ill, or moribund as per treating physician
Effects of Mindfulness Training on Emotional Care Strategies

Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to investigate 1) the effects of mindfulness training on teachers' well-being (i.e. general health, positive affect, stress, negative affect); 2) whether decentering strategy (vs. cognitive reappraisal strategy) is nurtured by mindfulness practice; and 3) whether decentering instead of cognitive reappraisal is the mediator that explains the impact of mindfulness on well-being. Participants will be randomized to either intervention (8-week .b Foundations course) or waiting-list control condition.

All the participants will complete an online survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention. A subset of participants (N = 30) will complete an electroencephalography (EEG) experiment.

Prior to the experiment, participants will complete an online questionnaire writing down eight recent autobiographical situations: four reflecting a neutral experience, two reflecting events that triggered anxiety, and two reflecting events that triggered sadness. After writing about each situation, participants will be asked to identify five keywords that are both unique and tightly linked to each situation.

During the experiment, participants will be reminded of the autobiographical situations in the computerized task. Participants will be asked to view the keywords (i.e. control condition); step back and view the keywords like an impartial observer, allowing whatever thoughts or emotions arise to come and go (i.e. decentering condition); and think about the keywords from different perspective to minimize negative emotions (i.e. reappraisal condition). EEG will be recorded while participants complete the task. Participants will receive $200 Hong Kong dollars each time as a remuneration for the time to participate in the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or above
* Working in local schools or education institutions
* Willing to participate in mindfulness training voluntarily

Exclusion Criteria:

* Have history of neurological or psychiatric disorder, brain injury, birth complications, or significant sensory impairment
* Currently under medications that are known to affect the brain (e.g. anti-depressants, epileptica, tranquilizer, sleep medication, psychotropics, ritalin, concerta, etc.)
* Experiencing severe or unstable mental health condition currently
* Completed 8-week mindfulness training previously
* Unwilling to go by random assignment
Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease

The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is older than 18 years
2. Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure
3. Patient must be compliant with all follow-up visits
4. Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5)
5. Patient's life expectancy is more than 2 years
6. Patient has iliac atherosclerotic de novo lesion(s) type A, B, C \& D according to TASC-II classification
7. Target vessel diameter is between 5 and 9 mm
8. Target lesion has a baseline diameter stenosis of more than 50%
9. Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both \<50% stenosis)

Exclusion Criteria:

1. Patient has a life expectancy of less than 2 years
2. Patient is refusing to be compliant with all follow-up visits
3. Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
4. Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy
5. Patient has already been treated with a stent in the ipsilateral target vessel
6. Patient suffered tissue loss in the target extremities, defined as Rutherford 6
7. Patient is already enrolled in this or another investigational device study
8. Patient had a coronary intervention within the last 60 days before enrolment into this study or there is a planned coronary intervention within 60 days of enrolment into this study
9. Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure
10. Any planned surgical intervention within 30 days of the index-procedure
11. Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years.
12. Patient has no sufficient infra-inguinal run-off (\>50% stenosis). Patient inclusion is only possible if revascularization (endovascular or surgical) is performed in the same procedure with a peroperative angiographic control yielding \<30% stenosis.
13. Target lesion is a restenotic lesion.
14. Target lesion is adjacent an aneurysm.
15. Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.
C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.


Eligibility Criteria:
Key Inclusion Criteria:

* Use of adequate contraception for females of childbearing potential
* Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
* Documented medical history compatible with chronic HCV
* Either no liver cirrhosis or with compensated liver cirrhosis
* If HIV-1-positive, must meet the following 2 criteria:

  1. Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and an undetectable plasma HIV-1 RNA level
  2. Suitable ARV treatment and not taking any contraindicated medications

Key Exclusion Criteria:

* Pregnant or breastfeeding
* Co-infected with hepatitis B virus
* Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
* Requirement of any prohibited medications
* Use of other investigational drugs within 30 days of dosing
* History or signs of decompensated liver disease (decompensated cirrhosis)
* History of hepatocellular carcinoma (HCC)
* Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas

This is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.

A total of no more than 20 people are expected to participate in this study at the Medical College of Wisconsin/Froedtert Hospital. Patients will be followed for three years.

The usual treatment for sarcomas that spread to the lungs is to remove the cancer with surgery. Patients who cannot have surgery or prefer not to have surgery, can receive radiation therapy. Standard radiation therapy involves several weeks of daily treatment sessions, although it is not as effective as surgery and may seriously damage normal surrounding lung tissue. Stereotactic body radiation therapy (SBRT) is a radiation treatment that gives fewer but higher doses of radiation than standard radiation. SBRT is used to treat metastases to the lung from many types of cancer but has not been used very often with patients who have metastatic disease to their lungs from sarcomas.

The purpose of this study is to test the possibility of SBRT to the lung for metastatic disease to the lung. This information will be used to find out if there are factors that can predict recovery or outcome of patients with metastatic disease to the lung from sarcoma. SBRT will consist of 1 to 3 treatments per week for a total of 3 to 5 treatments to each tumor until therapy is complete. After SBRT is completed, follow-up exams will occur 4-6 weeks from the completion of radiation treatment, every 3 months in year 1 and every 6 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease
* No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study
* 1-5 pulmonary lesions all ≤5 cm in size
* Medically inoperable or declines surgery
* Patients may have had previous treatment for pulmonary metastases

Exclusion Criteria:

* Patients who have uncontrolled extra-pulmonary disease
* Pregnant women
* Patients who have greater than 5 pulmonary lesions at the time of study enrollment
* Patients who have disease progression outside the lungs within 3 months of enrollment on the study
* Disease pathology other than sarcoma subtypes
* Patients with a history of metastatic disease from a primary other than sarcoma
Safety Profile of Psilocybin for Cocaine Use Disorder

The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.


Eligibility Criteria:
Inclusion Criteria:

* Have a Body Mass Index from 18.5 - 34kg/m\^2
* Score of at least 3 on the Severity of Dependence Scale
* Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
* At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
* 0 use of a classical psychedelic in the last year

Exclusion Criteria:

* History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
* Abnormal electrocardiogram based on testing at study entrance
* A resting heart rate greater than 90 bpm
* Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
* Current use of antidepressants or other serotonergic-affecting substances
* History of cardiac conditions
* History of hepatic or renal impairments
* History of stroke or Transient Ischemic Attack
* Epilepsy or history of seizures
* Immediate family or personal history of psychosis, bipolar disorder, or schizophrenia
* Anxiety or mood disorders determined by the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V)
* Must not meet DSM-V criteria for any substance use disorders other than cocaine, caffeine, or nicotine
* Must not meet DSM-V criteria for borderline personality or dissociative disorders
* Current suicidal ideation or lifetime history of suicide attempts
* Arrest for a violent offense
* Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
* Women will not be eligible if trying to get pregnant, pregnant, or lactating