cyrilzakka/clinical-trials huggingface dataset:
Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies

Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.

The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.

Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18 and 50 years old;
* Native French speaker;
* Level of education higher than the 3rd school level;
* Certain diagnosis of the pathology of the experimental group with which he will be associated, more precisely:
* Group of patients with epilepsy \[Group E\]: definite diagnosis of drug-resistant epilepsy (epileptic seizures persist despite the administration of daily treatment) established by a specialist physician.
* Group of patients with a heart rhythm disorder \[Group C\]: definite diagnosis of one of the following disorders: Atrial Fibrillation (AF); Syncope and Bouveret's disease established by a specialist.
* Group of patients with T1 diabetes mellitus \[Group D\]: definite diagnosis of type 1 diabetes established by a specialist doctor.
* Group of patients with PTSD \[Group T\]: definite diagnosis of PTSD established by a specialist doctor.
* Person having given his non-objection

Exclusion Criteria:

* Pregnancy;
* Breastfeeding women;
* Severe cognitive impairment
* Addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has);
* Other neurological and / or psychiatric disorders than CNEP or epilepsy except anxiety and depressive disorders;
* Adults under guardianship or under judicial protection
* People deprived of their liberty
* Inability to read French.
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC

To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

A multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer. The main purpose was to compare pharmacokinetics Index between two groups, secondly to observe safety, efficacy, and immunogenicity

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤70 years old, female.
* BMI index in the range of 19.0\~28.0
* ECOG≤1, and the expected os ≥3 months
* Unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens.
* HER2 overexpression is +++ by immunohistochemistry (IHC) or + by fluorescence hybridization FISH.
* At least one measurable lesion.
* Sufficient organ function
* Voluntarily signed an informed consent form.
* Subjects with good compliance

Exclusion Criteria:

* Rapid disease progression or threaten important organs and require urgent replacement therapy.
* Undergone surgery within 28 days before treatment (except for biopsy)
* Received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1
* Suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.)
* Suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time.
* Severely infected
* Clear history of mental illness, or have a history of alcoholism or drug abuse.
* Central nervous system metastasis or meningeal metastasis with clinical symptoms
* Cardiac function left ventricular ejection fraction \< 50%
* Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve Membrane disease patients
* Poorly controlled hypertension
* Patients with coagulopathy: INR or APTT ≥1.5×ULN
* Allergic to the test drug or its excipients in the study treatment, or have a severe allergic reaction to other monoclonal antibody drugs in the past
* Pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication Giver
* Have received a certain test drug in other interventional clinical trials, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
* Have used a monoclonal antibody within 6 months before receiving the first study drug treatment
* Have received other drugs that may affect the pharmacokinetic results of the study drug, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
* Have received organ transplants (including autologous/allologous stem cell transplants) in the past
* Other conditions judged by the investigator to be inappropriate for participating in this trial
Prognostic Study of Prostate Cancer Via Dynamic Change of PSA in Peritoneal Drainage Fluid After Radical Prostatectomy

This study investigates the prognostic value of dynamic changes in Prostate-Specific Antigen (PSA) levels found in the peritoneal drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of PSA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

This study examines the prognostic significance of Prostate-Specific Antigen (PSA) levels in the peritoneal drainage fluid following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of PSA in the drainage fluid.

The study involves continuous monitoring of PSA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid PSA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.

By investigating this novel source of PSA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients treated with radical prostatectomy

Exclusion Criteria:

* 1. Received neoadjuvant endocrine/chemotherapy before surgery;
* 2. Urine leakage after surgery (positive creatinine test of drainage fluid).
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines

To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening

Exclusion Criteria:

-
Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry

An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.

Pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. Chinese Alliance of Pediatric Rheumatic \& Immunologic Diseases (CAPRID) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in China. The CAPRID Registry is an observational, multi-center, longitudinal registry for Chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of Chinese pediatric patients with rheumatic and immunologic diseases.

Hospital-based databases are established and standardized with Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) for routine data collection. A web-based registry website is established with standardized electronic case report forms to register patients from CAPRID centers. A mobile application is created to allow long-term follow up and patient-reported outcome collection. The data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. Treatment plans are determined by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Age \<= 18 years old
* Diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity)
* Diagnosed and Treated in China

Exclusion Criteria:

* Disagreement of involving in this study by the patient or his/her family.
Transcranial Magnetic Stimulation for Borderline Personality Disorder

Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.

Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 45 years old
* Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder \> 8)
* psychiatric follow-up
* righthander
* informed consent
* affiliated to medical insurance

Exclusion Criteria:

* bipolar disorder
* substance use disorder
* Major Depressive Disorder or Stress Post Traumatic Disorder
* history of epilepsy
* neurosurgery
* cardiac pacemaker
* lefthander
* involuntary admission
* participation in an other research
* legal guardianship
* poor mastery of french.
Transform CV Risk in Diabetes

This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).


Eligibility Criteria:
Inclusion Criteria:

* T2D diagnosis in the medical record
* ASCVD, defined as follows:

  1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
  2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
  3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization

Exclusion Criteria:

* Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
* Currently receiving any SGLT2i or GLP-1RA
* Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
* Currently receiving comfort care or enrolled in hospice
* Life expectancy \<1 year
* History of or plan for heart transplantation or ventricular assist device
* Current or planned hemodialysis
* Decompensated end stage liver disease
* History of Fournier's Gangrene
* Type 1 diabetes
* Prior history of diabetic ketoacidosis
* Pregnancy or active breastfeeding
* History of Pancreatitis or pancreatic cancer
* History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)
A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Random blood glucose ≥11.1mmol/L
6. Subjects with abnormal liver function
7. allergies to opioids and other medications that may be used during the trial
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy

Continuous thoracic epidural analgesia plays a very vital role in patients undergoing exploratory laparotomy. It not only supports a stable perioperative hemodynamics but also helps in early return of bowel activity.

Intestinal perforation is one of the commonest surgical emergency that the investigators encounter in emergency. Perioperative management of most of such patients is a challenging task for the anesthesiologist, as patients are often hemodynamically unstable at the time of their presentation to emergency. Usual plan of anesthesia for these patients is general anesthesia with or without an epidural block. In routine practice the investigators often place an epidural catheter, primarily for postoperative analgesia, unless there is some contraindication to epidural analgesia. Most often lower thoracic epidural is preferred because of longer length of the laparotomy incision. Thoracic epidural analgesia with local anesthetic (LA) is not only effective in managing the post-operative pain; it is also helpful in supplementing intra-operative analgesia with reduced requirement of anesthetic, muscle relaxant and the analgesic (opioid) drugs. In addition, it has also been reported to be associated with early return of gut motility.

It appears that absent / significantly reduced pain leads to lesser stress response, leading to less sympathetic activation and lesser catecholamine release. As catecholamines are inhibitory to gastrointestinal motility, earlier return of gastro intestinal (GI) motility can be achieved by reducing perioperative pain by continuous epidural analgesia. Moreover, an effective epidural analgesia with LA results in avoidance of opioid analgesics for optimal perioperative pain relief, which too may be helpful in achieving earlier return of gut motility.

Thus the investigators aimed at determining the effect of continuous thoracic epidural analgesia on return of gut motility in patients undergoing emergency exploratory laparotomy following intestinal perforation and compare it with those in whom epidural analgesia was not used.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Age 20-60 years
* Intestinal perforation posted for emergency exploratory laparotomy

Exclusion Criteria:

* Patient's refusal and uncooperativeness for epidural analgesia
* Hemodynamically unstable patients
* Patients with coagulation disorder
* Infection at the site of epidural insertion
* Spine deformity or spinal cord disease
* Raised intracranial pressure
* History of drug abuse
* Other comorbid conditions like diabetes mellitus, hypertension, thyroid disease
Pressure Support Ventilation During CF Exacerbations

Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is particularly important during treatment of pulmonary exacerbations. For some patients, especially those with moderate to severe compromise of lung function, this therapy may impose a high demand in the work of breathing and energy expenditure. The goal of this study is to evaluate the effectiveness of adding pressure support ventilation (PSV) during chest physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function compromise being treated for a pulmonary exacerbation.

The proposed study will be conducted over three years. Cystic fibrosis patients with moderate to severe pulmonary disease who are experiencing an acute exacerbation that requires hospitalization will be admitted to the GCRC. Subject participation in the study will be for the first 10 days of hospitalization. Subjects will be randomized into one of two treatment groups: usual care or usual care plus non-invasive pressure support ventilation (PSV).

Eligibility Criteria:
cystic fibrosis subjects with pulmonary exacerbation
Intervention Toward Truth-Telling and Advanced Directives in the Patient With Advanced or Metastatic Disease

Family usually had a lot of burden to tell the truth to patients. The purpose of this study is to assess the effect of education materials and family conference for advanced cancer patients and family.


Eligibility Criteria:
Inclusion Criteria:

* advanced or metastatic cancer patients
* more than 20 years old
* clear consciousness and be able to communicate

Exclusion Criteria:

* refuse to know the statement of himself/herself disease
Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).

Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?

Compare the efficacy of 1 year of participation, of three programs of care for patients with chronic law back, referred to specialists rehabilitation centers or directly to the multidisciplinary consultation of university hospital of Angers.

The primary objectif is to assess the efficacy of 1 year of the three therapeutics strategies with the number of days off work in the year following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Obtaining the signature of consent to participate in the study.
* Male or female, aged 18-55 years.
* Diagnosis of common chronic low back pain.
* Chronic low back pain that led to at least a month off work in the previous year or at least 3 months of stops in the previous 2 years.
* Employee and holds a permanent contract or a fixed-term contract in the public or private sector.

Exclusion Criteria:

* Lack of consent to participate in the study.
* No possibily to follow one of three programs of study
* Pregnant women, new mothers or mothers who are breastfeeding.
* No affiliation to the french social system.
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

The use of forced coughing during cervical punch biopsy may reduce pain \& discomfort associated with the procedure.

Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection.

Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception.

Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.

Eligibility Criteria:
Inclusion Criteria:

- Women undergoing cervical punch biopsy

Exclusion Criteria:

* Women under 18 years old
* Women currently taking prescription pain medications
* Women who consumed pain medication up to 2 hours prior to the scheduled biopsy.
* Women who refuse to take part in the study
Prehabilitation in Patients With Esophageal or Gastric Cancers

Objectives: The primary objective of this study is to assess the feasibility of a internet-based preoperative exercise program in patients with esophageal or gastric cancers. Secondary objectives are to evaluate the effects of this preoperative program on functional capacity, anxiety and depression, quality of life and fatigue Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels. Twenty patients with esophageal or gastric cancers will participate in internet-based program 3 sessions per week. Each session will combine aerobic and resistance training. Moreover, inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct weekly telephone calls to educate and motivate subjects. Assessments will be performed at baseline, one day before surgery, 1 month and 3 months after surgery. The following parameters will be measured: functional capacity, quality of life, fatigue, anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of esophageal cancer or gastric cancer requiring surgery
* More than 18 years
* Able to read, write and understand French or English
* Time before surgery \> 2 weeks

Exclusion Criteria:

* Surgical emergency
* Cognitive or neuropsychiatric diseases
* Neuromuscular or orthopedic disorders limiting exercises
* Cardiopulmonary disease contraindicating exercises