cyrilzakka/clinical-trials huggingface dataset:
Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. Our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis B formulated according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis issued by the Chinese Society of Hepatology in 2019
2. The diagnosis of muscle mass loss conforms to SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
3. Patients aged between 18 and 60 years old
4. Patients with no history of drinking or abstinence for more than 1 year
5. Voluntary participants with informed consent

Exclusion Criteria:

1) the etiology of cirrhosis without hepatitis B virus (HBV), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without CT scan within 3 months; 8) patients who have exercise habits with the Physical Activity Rating Scale-3 (PARS-3) \> 19 points
Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District (PURPLE)

This is an observational prospective multicenter study of patients admitted for acute dyspnea in an emergency department of the participating centers in the Lorraine district.

The primary objective is to assess the outcome of this population according to the cause of acute dyspnea as well as identify the predictors of this outcome, both overall and according to each acute dyspnea cause.

This observational prospective multicenter study will be conducted using data from electronic medical records, acquired as part of usual care, in patients admitted for acute dyspnea in the emergency department. Clinical, treatment, laboratory and imaging data acquired during the hospitalization (in the emergency department and in the department that admitted the patients following the emergency department stay) will be collected.

Vital status will be recorded at 30 days and 1 year post-admission.

Eligibility Criteria:
Inclusion Criteria:

* Men or women \> or = 18 years.
* Patients with acute dyspnea admitted for acute dyspnea in the emergency department.
* Patient informed.

Exclusion Criteria:

* Cardiorespiratory arrest.
* Patient having expressed his or her opposition.
Protecting Allies in Risky Situations

The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.

The objective of the proposed study is to develop an innovative, friend-based motivational interview (FMI) that encourages and prepares friends to reduce sexual assault (SA) risk. Delivered to pairs of friends (dyads), the FMI will be designed to foster collaborative efforts to increase readiness for, and decrease barriers to helping behavior, and to teach and plan together for assault prevention skills. As the role of alcohol has been under-addressed in SA prevention efforts, the FMI also will explicitly attend to how intoxication may serve as a barrier to friend intervention, and strategies for overcoming this barrier. The completion of this project's aims will yield a novel intervention that capitalizes on the natural resource of women's friendships to decrease risk for sexual assault - a pervasive public health problem affecting a substantial portion of young adult women in the U.S.

Twenty-four friend dyads will participate in the friend-based motivational interview (FMI) along with 24 wait-list control dyads (total of 48 dyads). The study will compare groups on outcomes at post-intervention and at bi-weekly 3 month follow-ups, and also examine within participant change. The study will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. It is expected that participants receiving the FMI will demonstrate significant increases in readiness, and engagement in friend assault prevention behavioral skills (FAPBs), and demonstrate decreases in perceived barriers, at post-intervention and over the 3-month follow-up. Follow-up data will be utilized to provide a rich description of the role of alcohol in implementing FAPBs, and whether the FMI reduces the impact of alcohol use. In exploratory analyses, it will be examined whether the intervention may be associated with decreased assault risk, as well as decreased drinking.

Eligibility Criteria:
Inclusion Criteria:

* Female dyads who go out together at least once a week
* Undergraduates enrolled in a 4-year college or university
* Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly

Exclusion Criteria:

Not Applicable
Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )

The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy
* COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation

Exclusion Criteria:

* Pregnant woman
* Uncontrolled sepsis of bacterial or fungal origin
The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. After summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the year 2008, which is named GD-2008 ALL protocol. The diagnosis and classified criteria is according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.

The modification includes:

1. In the induction phase, the agent of dexamethasone 6 mg/m2 is used instead of prednisone after prednisone prophase.
2. The phase "CAM" is 2 weeks for SR patients and 4 weeks for IR and HR patients,respectively.
3. Both the SR and IR treatments involve the protocol mM /M (8 weeks) in the phase of consolidation. However, the folinic acid rescue starts at 36 hours instead of 42 hours. The type of HR enters the block treatment the same with the BFM protocol.
4. There is not randomized study in delayed intensification. The GD-2008 ALL protocol uses the same protocol II with the BFM study.
5. The randomized study focus on the phase of maintenance. The maintenance A is the same with the BFM protocol, while the maintenance B consists of 6mp/MTX and VCR/ dexamethasone. The cycle is 8 weeks: VCR at d1, Dexamethasone at d2 to d7, 6mp from d8 to d56, and MTX at d9,d16, d23, d30, d37,d44,d51.
6. The GD-2008 ALL protocol for HR patients use the re-blocks and protocol II phases.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically proven acute lymphoblastic leukemia (ALL)
* No relapse of a previously unrecognized ALL
* Patients must meet one of the following risk criteria:
* Standard-risk (SR) group meeting all of the following criteria:
* Blasts \< 1,000/μL in peripheral blood (PB) on day 8
* Aged 1 to \< 6 years
* Initial WBC \< 20,000/μL
* M1 (5%) or M2 (≥ 5% to \< 25%) blasts in bone marrow on day 15;
* M1 marrow on day 33.
* Intermediate-risk (IR) group meeting all of the following criteria:

  * Aged \< 1 or ≥ 6 years and/or WBC ≥ 20,000/μL
  * Blasts \< 1,000/μL in PB on day 8
  * M1 or M2 marrow on day 15
  * M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and \*M1 marrow on day 33.
* High-risk (HR) group meeting ≥ 1 of the following criteria:

  * Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)
  * Blasts ≥ 1,000/μL in PB on day 8
  * M2 or M3 marrow on day 33
  * Translocation t(9;22) \[BCR/ABL+\] (Philadelphia chromosome-positive) or t(4;11) \[MLL/AF4+\].

Exclusion Criteria:

* No Down syndrome
* No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
* Not requiring significant therapy modification owing to study therapy associated complications
* No complications due to other interventions
* No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm
Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible

This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.

Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).

This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and any race greater than 18 years of age
* patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically:

  1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
  2. a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
* patients must be physically able to tolerate conventional surgical and restorative procedures
* patients must agree to be evaluated for each study visit, especially the yearly follow-up visit

Exclusion Criteria:

* patients with active infection or severe inflammation in the areas intended for implant placement
* patients with a \>10 cigarette per day smoking habit
* patients with uncontrolled diabetes mellitus
* patients with metabolic bone disease
* patients who have had treatment with therapeutic radiation to the head within the past 12 months
* patients in need of allogenic bone grafting at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
* patients who are pregnant at the screening visit
* patients with evidence of severe para-functional habits such as bruxing or clenching
* patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site
Transfusion Requirements in Cardiac Surgery III

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Planned cardiac surgery using cardiopulmonary bypass
* Informed consent obtained
* Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

* Patients who are unable to receive or who refuse blood products
* Patients who are involved in a preoperative autologous pre-donation program
* Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
* Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
* Patients who are unable to receive or who refuse blood products
Validation of a Quality of Life Assessment Tool in Adult Generalized Dystonodyskinetic Syndromes Treated by Continuous Electrical Neuromodulation

In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. We have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " Unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under Deep Brain Stimulation (DBS).

The self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the Burke, Fahn \& Marsden Dystonia Rating Scale (BFMDRS) and the SF-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.

The construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. The self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. The scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (BFMDRS) and/or quality of life (SF-36) and finally with the patients' mood during their follow-up (BDI, STAI). Tolerance to surgery will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Adulte between 18 an 80 years
* Patient with a generalized dystono-dyskinetic syndrome treated by Electrical Neuromodulation Continue and follow-up in the unit
* Subject affiliated to the French social security system

Exclusion Criteria:

* non-French speaker
* patients who are physically unable to answer the questionnaire and who have no trusted person to help
* severe cognitive impairment (MoCA \<10, MDRS \<123, PM-38 \<70)
* lack of informed consent
Contribution of High-throughput Exome Sequencing in the Diagnosis of the Cause Fetal Polymalformation Syndromes

This research concerns the contribution of a new examination, high-throughput exome sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently available examinations, the causes of polyformative syndromes, which correspond to the association of several congenital malformations with varying degrees of severity in different organs, remain unknown in a large number of cases.

High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous analysis of all of the coding parts of DNA. This examination has already shown its superior diagnostic capability in every post-natal diagnostic context, in particulier in infants with malformations associated or not with intellectual deficiency. Its contribution has not yet been studied in a large number of fetuses with polymalformations. To investigate the usefulness of HTES, we propose to carry out the examination in 100 fetuses with polymalformations, as well as the usual examinations including chromosomal microarray analysis and possibly the study of specific genes that may explain these malformations. A blood sample will be taken from both parents to allow interpretation of the results.


Eligibility Criteria:
Inclusion Criteria:

* Fetus with at least 2 malformations, with no diagnosis (or several low-certainty diagnostic hypotheses, which require several molecular examinations) after fetopathological and radiological examinations
* Written consent from both parents
* Possibility to obtain samples from both parents

Exclusion Criteria:

* Refusal of parents to take part in the study
* Parents without National Health Insurance cover
* Parents under guardianship or in custody
* Impossibility to obtain samples from both parents
* Diagnostic hypothesis considered highly probable for which a molecular test cheaper that HTES is available
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

The research project is designed to determine which combination of tests will enable physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH) will improve with a shunt.

Normal pressure hydrocephalus (NPH) is a potentially reversible progressive neurological condition disproportionately affecting the elderly population. Given current controversies regarding its exact definition, accurate incidence and prevalence figures are elusive. NPH was first described forty years ago as a triad of symptoms consisting of gait difficulties, urinary incontinence, and memory problems in patients with enlarged ventricles in the absence of increased intracranial pressure (ICP). The cause of primary, or idiopathic NPH (INPH) remains elusive, while secondary NPH results from intracranial insults such as head trauma, meningitis, or intracranial hemorrhage. NPH can be successfully treated with cerebrospinal fluid (CSF) shunting. However, the accurate diagnosis and treatment of patients with NPH remains problematic, despite significant advances in brain imaging and ICP physiology.

Objectives - The primary aims of this study are:

1. to confirm the ability of external lumbar drainage to increase the success rate of selectively shunting patients with NPH compared to historical controls
2. to refine the diagnosis of NPH by determining whether the factors that change before and after lumbar drainage will predict failure to improve after shunting. A related aim is to assess the complications attributable to lumbar drainage.
3. to perform a preliminary evaluation of programmable shunt valves for NPH compared to historical controls using fixed-pressure valves. A related aim is to determine whether post-op objective analysis of gait, cognitive function and urinary symptoms will help refine the programmable shunt setting on an individual basis.

Secondary study aims include:

Investigating the pathophysiology of NPH by: 1) correlating cortical vein compliance measured by MRI flow quantification studies with CSF pressure waveform analysis; 2)assessing funduscopic changes before and during ELD; 3) performing and cross correlating CSF chemical analysis on screening positive and negative patients as well as screening-positive patients who are shunt responsive versus unresponsive.

Eligibility Criteria:
Inclusion Criteria:

* Walking difficulties in both legs which has developed gradually, not explained by other conditions, either in combination with mental impairment and urinary incontinence
* Brain CT or MRI findings of enlarged ventricles compared to established standards (minimum Evans ratio of 0.30 as measured by reviewing films)
* Mental impairment must be mild to moderate, emerging with or after the walking difficulties
* Age \> or = 18 years old
* MMSE (Mini-mental status exam): \< or = 10
* Urinary incontinence

Exclusion Criteria:

* No or only minimal walking difficulties combined with severe dementia
* Severe medical problems with limited life expectancy (less than six months)
* Contraindications to surgery
* Lack of informed consent
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry

The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.

This is a multiple site, prospective, non-randomized single arm observational study. It has been designed to document the treatment of serial rib fractures with MatrixRIB implants in a registry. A flail chest is an injury in which three or more consecutive ribs are broken. This injury causes a segment of the chest wall to become unstable und prevents effective respiration. Non-operative management requires long-term mechanical ventilation and is associated with a mortality rate of 17-47%. Surgical stabilization of the rib fractures has shown to decrease this mortality by 38% - 72%. Surgical stabilization is typically performed with generic plates that require extensive bending during surgery to conform the plate to the rib in a difficult and time-consuming procedure.

The MatrixRIB system is the first implant system that has been specifically designed for fixation of flail chest injuries. It has been developed at Legacy Health System, has been extensively tested in biomechanical studies, and has been approved by the FDA. It provides anatomically contoured rib plates that can reduce the time and complexity of intra-operative plate contouring. These plates will be used in the present study in place of generic plates. It furthermore provides intramedullary rib splints that enable less invasive fixation of posterior rib fractures that are difficult to access for plate fixation.

The primary objective of this study is to document stabilization of flail chest injuries with MatrixRIB implants in a registry. Twenty consecutive patients with flail chest injury that receive surgical stabilization of rib fractures with MatrixRIB implants will be documented in the registry. Data collected will include baseline patient demographics, and information related to injury severity, surgical procedures, and post-operative recovery. The patients' functional outcome will be assessed up to the standard follow-up visit 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mono-lateral or bi-lateral flail chest injury and paradoxical motion of the chest wall, whereby a flail chest is defined by three or more consecutive ribs broken in at least two locations.
* Male and female patients, ages 21 to 80 years.
* Able and willing to obtain informed consent from patient or next of kin.
* Able and willing to adhere to 3-months follow-up visit

Exclusion Criteria:

* Pregnant women
* Patients who are enrolled in another investigational treatment trial.
* Severe closed head injury (AIS head \> 3)
* Severe spinal injury with neurological deficit above thoraco-lumbar junction.
* Chronic preexisting heart, pulmonary, hepatic, and/or renal disease.
* Patients who are not expected to survive the follow-up period.
* Patient with an acutely paralyzed hemidiaphragm.
* Considered an inappropriate participant by the study physician.