cyrilzakka/clinical-trials huggingface dataset:
Early Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE

Pretransplant hepatoencephalopathy (HE) markedly impacts recipient outcomes after liver transplantation. Intraoperative CRRT showed benefits but feasibility was much concerned. This study aims to observe the effect on consciousness recovery when initiating CRRT early in the post-transplant period in recipients with ACLF and overt HE.

Hepatoencephalopathy (HE) is a common severe decompensation in end stage liver diseases and resulted to the need of liver transplantation (LT). Pretransplant HE markedly impacts recipient outcomes after liver transplantation. HE in acute on chronic liver failure (ACLF) is categorized to type C HE. Hyperammonemia and systemic inflammation have been reported to contribute its development. Continuous renal replacement therapy (CRRT) has been shown great benefits in ACLF patients with HE. Intraoperative CRRT in LT also showed benefits but feasibility was much concerned. Our preliminary retrospective data showed that early CRRT (eCRRT) after LT reduced consciousness recovery time, ventilation days and post-transplant infection rate.

This open label, parallel randomized trial will observe the effect on consciousness recovery when initiating CRRT early (eCRRT) in the post-transplant period in recipients with ACLF and overt HE.

The CRRT safety and ventilation days, infection, mortality and ICU stay will also be measured.

Eligibility Criteria:
Inclusion Criteria: Liver transplant recipients who meet all of the following criteria will be enrolled

1. Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity (PTA)\<40%;
2. Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven classification;
3. HE associated with acute liver failure (Type A) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (Type C)

Exclusion Criteria:

1. Patients with a previous history of kidney-related diseases and glomerular filtration rate \<30 millilitre per minute;
2. Patients with acute renal failure need CRRT before transplantation;
3. Patients newly developed acute renal failure need CRRT at the time of randomization;
4. Retransplantation or multiple-organs transplantation;
5. Any ischemic or hemorrhagic stroke co-morbidity;
6. Hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors;
7. Extremely moribund patients with an expected life expectancy of less than 24 hours.
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved CD20+ DLBCL;
* relapse or refractory DLBCL#
* previously received systemic chemotherapy with anthracycline#
* not eligible for autologous hematopoietic stem cell transplantation#
* at least one evaluable lesion#
* ECOG PS 0-1;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* double-hit lymphoma;
* previously received treatment of HDAC inhibitor;
* plan to receive autologous stem cell transplantation;
* involvement of central nervous system;
* previously received gemcitabine within the past 6 months;
* patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection

This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18-65 years of old, inclusive
* Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
* HCV treatment naïve or PEG-IFN, IFN, and/or RBV experienced (treatment must have ceased at least 3 months prior to screening). Treatment experienced subjects should not exceed 40% of the subjects enrolled in each cohort
* Mono-infection with HCV genotype 1a for Cohorts 1, 2, 3, 4, and 5 and mono-infection with HCV genotype 1b for Cohort 6 and 7.
* Estimated creatinine clearance ≥ 70 mL/min,
* QTcF interval ≤ 450 msec for males and ≤ 470 msec for females, QRS duration \< 120 msec, PR interval \< 220 msec,
* Body mass index (BMI) of 19.0 to 34.0 kg/m\^2, inclusive.

Exclusion Criteria:

* Urine drug screen positive for illicit/illegal drugs
* ALT and AST levels \> 5 times the upper limit of the normal range (ULN)
* Direct bilirubin \> ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets \< 90,000/mm\^3, prothrombin time ≥ 1.5 × ULN and albumin \< 3.5 g/dL) are not eligible for study participation.
* Subjects with an absolute neutrophil count (ANC) \< 1,000 cells/mm\^3 (\< 750 cells/mm\^3 for black or African-American subjects), hemoglobin (Hb) \< 11 g/dL,
* Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype other than genotype 1a/b are not eligible for study participation.
* Evidence of hepatocellular carcinoma (e.g., a-fetoprotein \> 50 ng/mL or as indicated by recent ultrasound or other standard of care measure)
* History of significant cardiac disease. The following ECG abnormalities at screening are exclusionary: QTcF (QT corrected using Fridericia's formula=QT/RR\^0.333) \> 450 msec for males and \> 470 for females; QRS \> 120 msec (left or right hemiblock is not exclusionary); PR interval \> 220 msec; bradycardia (\< 45 beats per minute); second or third degree heart block.
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Physical Activity During Social Isolation

The aim of the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-50
* Being volunteer

Exclusion Criteria:

* Being unable to communicate in Turkish
* Not knowing read and write in Turkish
Autobiographical Memory Organization in Schizophrenia

The aim of the study is to investigate the temporal organization of autobiographical memory in patients with schizophrenia. Patients and control participants will be invited separately to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an automatic camera around their neck, which is called SenseCam®. Pictures obtained with SenseCam® will be later presented to the participants during the session of test. They will be asked to determine the chronological order of 12 pictures corresponding to 12 particular events of the tour. Then they will be asked to watch the complete sequence of photos from the tour and to determine the beginning and ending of the events that have occurred during the tour. According to the investigators hypotheses, patients should have difficulty to find out the correct chronological order of the photos and to determine the appropriate beginnings and endings of the events


Eligibility Criteria:
Inclusion Criteria:

* for both patients and controls
* male or female willing to participate and who have signed up the legal document
* under the protection of health insurance for patients only
* schizophrenia or schizo-affective disorder according to the DSM-IV-TR criteria
* clinically stable for at least 2 months for controls only
* no psychiatric history

Exclusion criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (epilepsia, brain injury, brain surgery...)
* current substance use disorder (DSM-IV-TR)
* current major depressive disorder (DSM-IV-TR)
* mental retardation (IQ \< 70)
* pregnancy, breast feeding
* current legal control for patients only
* treatment comprising benzodiazepines
* benzodiazepines intake during the last 3 weeks for controls only
* psychotropic intake during the last 3 weeks
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female children aged 5 -11y
2. Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
3. Children with stable asthma
4. Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
5. Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
6. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.

Exclusion Criteria:

1. Past or present diagnoses of cardiovascular, renal or liver disease
2. Known hypersensitivity to the active treatments
3. Exacerbation of asthma symptoms within the previous 4 weeks
4. Inability to perform the required breathing technique and blood sampling
5. Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
6. Lower respiratory tract infection within 1 month prior to screening (visit 1)
7. Disease (other than asthma) which might influence the outcome of the study
8. Obesity, i.e. \> 97% weight percentile by local standards
Plant-Based Dietary Intervention in Type 2 Diabetes-2

The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.

Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

- hemoglobin A1c values \<6.5% or \>10.5% use of insulin for \> 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.
Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.


Eligibility Criteria:
Inclusion Criteria:

* Referral for screening mammography from a Whiteriver Indian Health Service provider
* Self-identify as American Indian or Alaska Native (AIAN)
* Female
* Live on within 60 miles of the Fort Apache Indian Reservation

Exclusion Criteria:

* Women who have received a mammogram within the prior 12 months
* Women with a personal history of breast cancer
* Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)
* Unwilling to be randomized
Medium and Long-term Complications of the Patients Having Had a Vaginal Caesarian in Hospital René Dubos

This database has for objective to include the medical data of patients which underwent a vaginal Cesarean Section in our establishment. This collection will allow to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

It is about an operating technique little known which is used as an alternative of the abdominal Cesarean Section for very premature pregnancies and the main indication is the maternal rescue.

It has several advantages: simplicity of the technique, the dissection of tissues is limited, low risk of bleeding and no abdominal scar.

The purpose is to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

Eligibility Criteria:
Inclusion Criteria:

* patients operated to vaginal Cesarean in Hospital Rene DUBOS

Exclusion Criteria:

* patients followed in a maternity which do not participate to the study
Memory Training and Neural Plasticity

This study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (MCI).

Working memory (WM) is the ability to hold information actively in mind and is fundamental for higher-order cognition. This pilot study aims to (1) evaluate the efficacy of WM training in older adults with MCI and (2) understand if and how it works. The study will use behavioral and brain imaging assessments to see whether WM training changes how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and functional near infrared spectroscopy (fNIRS) methods will be used. The study will also use cognitive tests and questionnaires to determine whether participants' cognitive abilities change with training. The study will enroll participants with a diagnosis of MCI as well as cognitively intact older adults (healthy controls, HC).

Eligibility Criteria:
Inclusion Criteria:

* MCI Diagnosis
* Right-handedness
* MRI-eligibility for MRI participants

Exclusion Criteria:

* History of other contributing neurological or medical conditions known to affect cognitive functioning
* Significant mental illness
* Sensory impairments that limit ability to participate
* History of alcohol or drug abuse/dependence
Feasibility Study of a Novel Single Use Robotic Colonoscopy System

This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Males aged between 40 and 70 years, inclusive, at the time of informed consent
* Females aged between 55 and 70 years, inclusive, at the time of informed consent (Rationale: to include only women with non-childbearing potential to avoid completely pregnant trial subjects)
* Symptomatic adults indicated for elective colonoscopy, or asymptomatic adults willing to undergo a colonoscopic screening for polyps or colorectal cancer
* Adults without prior colonoscopy
* Able to provide a written informed consent form approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study-specific procedures
* Willing and able to comply with the study procedures

Exclusion Criteria:

* History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, familial polyposis coli, hereditary nonpolyposis colorectal cancer syndrome, active diverticulitis or toxic megacolon
* Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
* Known bleeding tendency
* Received antiplatelet or anticoagulation therapy within 3 days prior to the colonoscopy day
* Known colonic stricture
* Known multiple sigmoid colon diverticula
* History of any abdominal or pelvis surgical procedures including colonic and rectal surgical resection
* Known abdominal wall hernias
* History of radiotherapy to the abdomen or pelvis
* Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy day
* Contraindication to the proposed anaesthesia
* Received any investigational medicine or treatment within 28 days prior to Screening
* Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study
Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments

The aim of this study is through a randomized clinical trial, double blind, splitmouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

The need for endodontic treatment is still very common in the clinical routine, whether due to dento-alveolar trauma or caries. In some cases, the temporary filling procedure is required until the endodontic treatment is completed. The temporary filling material should be biocompatible and bacteriostatic. The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with the need of endodontic treatment will be selected. The teeth will be randomly divided into 2 different groups according to the temporary filling material composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Both genres
* Presence of at least two teeth with indication of endodontic treatment
* Good oral hygiene

Exclusion Criteria:

* Dentures or orthodontics
* Presence of periodontal disease
* Presence of parafunctional habits
* Presence of systemic disease
* Presence of severe psychological disturbe;
* Constant use of analgesic and, or anti-inflammatory
* Allergic response to dental products
Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.

A pre-planned interim analysis is expected to take place in Q1 of 2013.

Eligibility Criteria:
Inclusion Criteria:

* Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria.
* Patients must have relapsed (progressed \> 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies.
* Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
* Patients must have adequate organ and marrow function.

Exclusion Criteria:

* Patients must not be refractory to any bortezomib-containing regimen.
* History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components.
* Prior treatment with perifosine or an investigational proteasome inhibitor.
* Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
* Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.

Exclusion Criteria:

* Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
* Subjects who take acetylsalicylic acid at doses \> 100 mg daily and cannot discontinue usage during the study.
* Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
* Subjects with immunodepression.
* Subjects with a history of intolerance to the study drug or to any NSAI drug.
* Subjects who are monocular for any reason other than cataract.
* Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.