cyrilzakka/clinical-trials huggingface dataset:
E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis

Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.

The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.

The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.

The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.


Eligibility Criteria:
Inclusion Criteria:

Patient (\> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide, dimethyl-fumarate.

Exclusion Criteria:

Patient with progressively progressive secondary or multiple sclerosis. Patient suffering from multiple sclerosis not treated with a first line treatment.
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2

Single usage, open label study in up to 40 adult healthy males. Eligible subjects will receive a single usage of the investigational or commercial device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.


Eligibility Criteria:
Inclusion Criteria:

* Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test
* Are able to tolerate the procedure and
* Be generally healthy

Exclusion Criteria:

* Have history of allergy or hypersensitivity to the study ingredients
* Major diseases
* Taking medication regularly
* Radiation exposure recently
Impact of Y90 Radiation Segmentectomy on HCC

The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years, regardless of race or gender
* Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
* Child-Pugh class A or B7 without ascites
* Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
* No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
* No confirmed extrahepatic metastases
* No evidence of macrovascular invasion
* ECOG 0
* Albumin \> 3.0 g/dL
* PLT ≥ 40 x103/μL
* WBC ≥ 1.5 x103/μL
* AST/ALT ≤ 5 times the upper limit of normal (U/L)
* Creatinine ≤ 2.0 mg /dL
* No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
* No contraindication to angiography or selective visceral catheterization
* No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
* Negative serum pregnancy test
* Signed informed consent form

Exclusion Criteria:

* Not meeting the inclusion criteria
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening
* Males and females must be willing to use birth control as indicated

Exclusion Criteria:

* Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening
* Breastfeeding or pregnant
* Known immunodeficiency or subject is immunocompromised
* Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
* Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
Hand & Foot Nocturnal Enuresis TENS Study

The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.

Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history, nocturnal enuresis is a DSM V diagnosable medical condition
2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
3. Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
4. Having been assessed for and treated if applicable for constipation

Exclusion Criteria:

1. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
2. Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
3. Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
4. Children who are not adequately potty trained
5. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
6. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
7. Children with any implantable medical devices such as a pacemaker will be excluded from the study

Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction

The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).

In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
* STEMI patients
* Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months

Exclusion Criteria:

* Patients taking anticoagulants
* Patients under 18 years old
* Patients with less than 1 year prognosis
* Patients participating in other intervention studies
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension

The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* Aged from 18 to 70 years
* Had a history of essential hypertension
* Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg

Exclusion Criteria:

* Malignant hypertension
* Average sitting systolic blood pressure≧180mmHg
* Type 2 diabetes with hemoglobin A1c≥9%
* Type 1 diabetes
* New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
* Unstable angina
* Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
* Atrial fibrillation
* Bradycardia (\<60 bpm, seated)
* Asthma or other obstructive pulmonary disease
* History of myocardial infarction
* Stroke in the 6 months before screening
* Known contraindications to β-adrenergic blocker therapy
* Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase\>3 times upper limit of normal
* Crea\>2 times upper limit of normal
* Pregnancy or lactation
Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery

The purpose of this study is to investigate the difference of the accuracy and safety between traditional spine surgery and computer assisted navigation system spine surgery.

The object of study is the patients who are going to undergo pedicle screw fixation operation. there are two clinical trial centers.one is beijing jishuitan hospital,the other is beijing shuili hospital.the study protocol will be reviewed by the Ethics Committee of Beijing Jishuitan Hospital. after the patients sign the informed consent,they will be divided into two groups randomly.the patients' basic information and medical informations including the accuracy and safety will be collected.the data above all will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need to undergo pedicle screw fixation surgery
* Sign informed consent
* Capacity person

Exclusion Criteria:

* refused to sign the informed consent
* the age is not between 18 and 75 years old
Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients being treated for hypertension.

Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were recorded preoperatively at ward, immediately after study drug administration, and at 1, 3, and 5 minutes after endotracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II
* Scheduled for elective noncardiac surgery
* Being treated with anti-hypertensive medication

Exclusion Criteria:

* Endotracheal intubation attempted more than twice
* Morbidly obese (BMI \> 35 kg/m2)
Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage

Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.

The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.

The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.

This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance.

* Data Collection: This study utilized two public databases. The model leveraged clinical data obtained from the Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) and selected corresponding patients for external validation from the eICU Collaborative Research Database (eICU-CRD). Data on ICH patients were extracted from the MIMIC IV public database, including baseline characteristics, clinical parameters, therapeutic interventions, and outcomes. The data were randomly divided into two groups, with 70% serving as the training set and 30% as the validation set.
* Model Development: Feature selection was performed using Lasso regression to construct various machine learning models (such as Random Forest, Logistic Regression, and Neural Networks).
* Model Validation: In addition to the internal validation set, external validation was also conducted on the eICU database to test the model's generalizability.
* Statistical Analysis: The predictive performance of the model was evaluated using metrics including the area under the ROC curve (AUC), sensitivity, and specificity.
* Clinical Applicability Assessment: The clinical utility of the model was assessed using Decision Curve Analysis (DCA).

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed with primary intracerebral hemorrhage by ICD-9/10 coding.
* 2. Aged 19-89 years old.

Exclusion Criteria:

* 1. Patients admitted to the hospital but not to the ICU.
* 2. Patients with missing follow-up data or incomplete variables.
* 3. Patients with a hospital stay exceeding one month.
Professional Quality of Life in German Psychiatrists

The purpose of this study is to assess professional quality of life in German psychiatrists working with patients with mental disorders.

The purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in psychiatrists, working with patients with mental disorders, in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Psychiatrits (Physician with specialization in psychiatry or currently in specialization for psychiatry)
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None
Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults

Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties.

The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.


Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years of age,
* lumbar pain and/or referred pain above or below the gluteal fold , with intensity \> 3/10, persisting for \> 6 months and presenting during the day \> 50% of the time.

Exclusion Criteria:

* history of serious spinal or lower extremity injury or surgery in the last year
* identifiable back pain or known pathology
* known rheumatological condition
* oral or injectable corticosteroids in the lumbar spine within the last 3 months
* psychiatric disorder
* pregnancy
* manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study
Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors

This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.

This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.

The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .

Eligibility Criteria:
Inclusion Criteria:

1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;

2.18-75 years old (including boundary value), no gender limit;

3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;

4.The expected survival time is at least 12 weeks;

Exclusion Criteria:

1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
3. Women who are pregnant or breastfeeding;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.

This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
* 2-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
* Max. 2 restorations per participant in different quadrants.
* Vital tooth
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills

Exclusion Criteria:

* Sufficient isolation not possible, dry working field cannot be guaranteed
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Nonvital tooth or tooth with irreversible pulpitis
* Indication for direct pulp capping
* Symptoms of SARS-CoV2 infection