cyrilzakka/clinical-trials huggingface dataset:
Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study

The goal of this study is to use a pilot RCT to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and comorbid insomnia in China. The main questions it aims to answer are:

1. Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD?
2. Does the addition of MBA to WET lead to greater reductions in comorbid insomnia symptoms compared to WET alone?

Researchers will compare WET alone and MCC to see if WET provides benefits in managing PTSD. Researchers will compare WET plus MBA and WET group to see if the integrated MBA treatment provides additional benefits in managing insomnia.

Participants will:

* Undergo random assignment to one of three groups: WET, WET plus MBA, or MCC.
* Receive clinical interviews for primary outcomes (PTSD symptoms) at baseline, posttreatment, and during follow-ups.
* Provide self-reported data on PTSD symptoms and insomnia severity at multiple time points.
* In the WET plus MBA group, additionally use a mindfulness-based app as part of their treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female aged between 18-65 years old;
2. A diagnosis of PTSD or subthreshold PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5);
3. If currently taking psychotropic medication, taking a stable one for at least 4 weeks;
4. A smartphone owner and no obstacle to the Now Meditation App;
5. Scoring 12 or more on Insomnia Severity Index (ISI; the symptoms appear after the diagnosis of full/subthreshold PTSD).

Exclusion Criteria:

1. A diagnosis of bipolar disorder or psychotic disorder;
2. Current substance dependence;
3. Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the baseline screening questionnaires);
4. Serious suicidal ideation (as determined by the Scale for Suicidal Ideation);
5. Other psychiatric disorders severe enough to warrant designation as the primary disorder;
6. Taking psychotherapy for PTSD currently.
Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized for a planned radical prostatectomy

Exclusion Criteria:

* Consent refusal from the patient
* Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
* Absence of a French Health Care Insurance coverage
A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants.
* Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolic blood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
* Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must have a corrected QT interval using QTcF value ≤ 450 msec.
* Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1.
* Must have adequate laboratory test results for renal and hepatic function as assessed by the PI (Principal Investigator). Laboratory testing may be repeated to find all possible well-qualified participants.

Exclusion Criteria:

* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases.
* Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition Patients

This study intends to strengthen the discussion on the risk factors of RFS in critically ill patients, and construct an RFS risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; In order to help medical staff to identify the high-risk groups of RFS in critically ill patients efficiently and accurately, and take targeted care and treatment for patients, so as to reduce the adverse consequences of RFS on critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥18 years old; (2) Patients with mechanical ventilation; (3) First admission to ICU； (4) The time of receiving enteral nutrition support in ICU was ≥ 3 days.

Exclusion Criteria:

* (1)Ppregnant women or lactating patients;(2) Patients with incomplete information;(3) There are other risk factors leading to hypophosphatemia, such as continuous hemodialysis , hyperphosphatemia treatment,Parathyroid gland resection was performed within 3 months.
Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;
3. Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
4. Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
5. Patients who have received education at the primary school level or above;
6. Patients who are able to visit the hospital for examinations;
7. Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

Exclusion Criteria:

1. Patients who have previously undergone surgery for pelvic organ prolapse (POP);
2. Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;
3. Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.
Genetics of Pediatric-Onset Motor Neuron and Neuromuscular Diseases

The goal of this study is to establish a genetic registry of patients with early-onset motor neuron and neuromuscular diseases. The investigators will collect samples from patients with a motor neuron or a neuromuscular disorder and their family members. The samples to be collected will be obtained using minimally invasive (whole blood) means. The research team will then extract high quality genomic DNA or RNA from these samples and use it to identify and confirm novel gene mutations and to identify genes which regulate the severity of motor neuron/neuromuscular diseases.

Diseases affecting the motor unit--which is composed of the motor neuron, its myelin sheath and its innervated muscle fibers--are a diverse, heterogeneous group having heterogeneous clinical presentations and genetic causes. Many of these disorders have a inherited component. In some cases, the genetics underlying a given neuromuscular/motor neuron disease, like spinal muscular atrophy (SMA) or Duchenne muscular dystrophy, are well characterized. There are, however, disorders whose genetic basis has yet to be determined or genetically characterized diseases which harbor novel mutations. The purpose of this genetic registry is to catalogue early-onset motor neuron and neuromuscular disorders and to determine their genetic bases. With samples obtained from this registry, the investigators will be able to provide a genetic diagnosis for a specific neuromuscular/motor neuron disease which will lead to better care for those patients affected by these diseases.

Many of these disorders have a wide spectrum of phenotypic variability. For example, the severity of SMA is quite variable even though it is caused by the loss of a single gene, i.e. survival motor neuron 1 (SMN1). The number of copies of the duplicated gene survival motor neuron 2 (SMN2) dictates phenotypic severity in SMA. In this study, the research team will also identify potential modifiers of phenotypic severity for specific disorders like SMA and Charcot-Marie-Tooth (CMT) disease. With the identification of novel modifier genes, the investigators will be able to more accurately predict disease outcomes and the investigators will also have novel targets for the development of therapeutic agents for these diseases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of motor neuron/neuromuscular disease confirmed by neurologist
* Be seen by one of the study investigators

Exclusion Criteria:

* not seen by one of the study investigators
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 20 years of age
2. Histologically or cytologically confirmed non-small cell lung cancer
3. Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
4. Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

1. Current or prior severe hypersensitivity to another antibody product
2. Multiple primary cancers
RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

This study is an before-after study in the same subject, which enrolled 26 individuals with high-risk psychiatric syndrome (CHR). The target of subjects intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period or not yet taking antipsychotic medication. The investigators assume that the intervention targets for each CHR subject are individualized.

This study is divided into two parts:

1. Target determination. Firstly, MEG data of the subject's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the subject's abnormal signals in the brain, which is then used as the intervention target. Based on the subject's tolerance for single day intervention, the appropriate number of targets is generally 2-4. The upper limit of targets is 4.
2. RTMS individualized intervention. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour. The pseudo stimulation intervention lasted for 10 days in the first and second weeks, and the scale was evaluated after the end of the pseudo stimulation. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. 2-4 targets per day, 23 minutes per target, with 30-60 minutes between interventions for each target. After the fourth week, evaluate the scale. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th day after intervention. By analyzing and evaluating data, explore individualized treatment plans for CHR in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Clinical High-Risk Syndrome for Psychosis
* Must be able to right-handed
* Primary school education or above
* Understand and sign a written informed consent form (jointly signed by the guardian and the participant if under 18 years old)

Exclusion Criteria:

* Major physical illnesses (organic lesions such as sensory and motor disorders, neurological disorders, and traumatic brain injury)
* Taboo symptoms for rTMS treatment (such as intracranial metal implants)
* Metal (including orthodontic treatment, dental implants) and tattoos inside the body
* Claustrophobia
GFAP Auto-immunity : a French Cohort Study

Glial fibrillary acidic protein (GFAP)-Immunoglobulin G (IgG) have recently been described as a biomarker of a novel inflammatory central nervous system (CNS) disorder, termed autoimmune GFAP astrocytopathy. Thus far, four major clinical series have been published (two from Mayo Clinic USA, one from Italy and one from China). GFAP-IgG detected in serum or in cerebrospinal fluid, by tissue-based assay and confirmed by cell-based assay, are associated with encephalitis or meningoencephalitis of acute or subacute onset, less frequently with myelitis or optic disk edema. The characteristic MRI feature is brain linear perivascular radial gadolinium enhancement in the white matter perpendicular to the ventricle, consistent with the immunohistochemical staining pattern of GFAP in rodent brain sections. Approximately 20% of reported cases are associated with a neoplasm (ovarian teratoma mostly). Coexisting neural autoantibodies are described in some patients, N-methyl-D-aspartate (NMDA)-receptor (R)-IgG mostly, followed by aquaporin 4 (AQP4)-IgG. The disease is usually corticosteroid responsive although relapse can occur. In contrast, Chinese patients display poorer outcomes. Pathophysiology is not well understood but the intracellular antigen location makes GFAP-IgG unlikely pathogenic whereas animal models and neuropathologic data suggest a T-cell immune-mediated disorder.

The aim of the investigators is to report the first French cohort of patients GFAP-IgG positive. Investigators retrospectively assessed clinical, immunological and radiological features, treatment response and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Positive GFAP-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing GFAP.
* Diagnosis and follow-up in France
* No age limit : from 0 to unlimited age

Exclusion Criteria:

* Patients GFAP-IgG negative in serum and CSF
* Absence of complete clinicopathological data
* Foreign follow-up
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.

The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

Exclusion Criteria:

* Revision surgery
* Surgery occurring more than 2 weeks post-injury
* History of blood dyscrasia or renal insufficiency
* History of any thromboembolic disease
* Pregnancy or nursing, color vision defects
* History of retinal detachment/degeneration
* Intracranial hemorrhage
* Hypersensitivity to tranexamic acid
* Contraceptive Use (estrogens/progestins)
* FEIBA (anti-inhibitor coagulant complex) use
Creation of the Biobank Related to Eye Disease

The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases.

The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases.

Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach.

Eligibility Criteria:
Inclusion Criteria: All pediatric and adult patients age 0-99 years -

Exclusion Criteria: All patients who do not agree to consent for collection of blood, fluids, tissue.

Patients who are cognitively impaired and are not able to verbalize understanding of the risks/benefits.

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Paclitaxel-Coated Balloon for the Treatment of AVF

To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.


Eligibility Criteria:
Inclusion Criteria:

* Age during 18-85 years old
* Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
* Venous stenosis of the AV fistula
* target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
* the length of target lesion ≤100mm
* Patient able to give informed consent
* residual stenosis ≤30% after predilation

Exclusion Criteria:

* Women who are breastfeeding, pregnant or are intending to become pregnant
* AVF located at lower limbs
* Two or more than two stenosis at the target vessel.
* Obstruction of central venous return
* ISR
* AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
* Vascular access has surgery in 30 days or intending to undergo a surgery
* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* Patients undergoing immunotherapy or suspected / confirmed vasculitis
* Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
* Vascular access infection or systemic active infection
* Patients's life expectancy is less than 12 months
* Renal transplantation has been planned or converted to peritoneal dialysis
* Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
* Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test