cyrilzakka/clinical-trials huggingface dataset:
"Family Connections": a Program for Relatives of People With Borderline Personality Disorder

The aim of this study is to validate an intervention for relatives of people with borderline personality disorder in Spanish population in a randomized control trial.

Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. It consists of 12 sessions with an approximate duration of two hours each. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. The investigators have translated and adapted the program so that it could be applied to the Spanish population. The aim of the present study is to evaluate the effectiveness of the adaptation of "Family connections" in Spanish population through a controlled clinical trial. The first hypothesis of the study is that "Family Connections" will be more effective (significant reduction in the primary outcome variables), compared with a Treatment As Usual (TAU), in the posttest time and in the follow-ups of 3 and 6 months. In addition, a second hypothesis is that "Family Connections" will be more efficient (fewer abandonments, better opinion on the part of the patients) than TAU.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Having a relative with DSM-5 diagnosis of Personality Disorder
* Understand spoken and written Spanish.
* Grant informed consent.

Exclusion Criteria:

* Diagnosis of severe mental disorder.
* Presence of medical illness that may interfere with psychological treatment.
* Suicide risk.
Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Adult males/Females aged over 18 years
* Patients with symptom of Acute skeletomuscle myospasm and Back pain
* Patients with Pain VAS Value over 40 mm in Visit 2
* Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

* Patients with Back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection
* Muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis
* Patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point
* Patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point
* Patients with severe GI tract disorder, heart disease, hypertension
* Patients who had taken NSAIDS within 24hours from the screening point
Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

The aim of this prospective longitudinal study is to compare the quality of life of short bowel patients prior to and on teduglutide treatment with a non-treated patient group in a matched-pair design.

Short bowel syndrome (SBS) is a malabsorptive disorder mostly caused by surgical interventions, which may result in chronic intestinal failure (cIF). The incidence is progressively increasing due to more aggressive surgical and medical approaches. Parenteral nutrition is still the mainstay of treatment for patients with irreversible cIF. New hormonal therapies hold promise by romoting mucosal growth and intestinal absorption and thereby leading to a consequent reduction in parenteral support and symptoms related to large stomal or faecal losses. Outside the typical primary endpoints of cost data, quality of life (QoL) is an important and yet underappreciated consideration of the effectiveness of targeted therapies. In the clinical STEPS trial, Jeppesen et al. have previously shown a significant improvement of the SBS-QoL total score after 24 week treatment with teduglutide longitudinally but could not identify a statistical significance to the placebo group. Accordingly, Chen and colleagues carried out a post hoc analysis of the afore mentioned clinical trial data based on 86 patients and could confirm the results auf Jeppesen et al. Taken together, these clinical trial data did not show a direct benefit of teduglutide treatment on QoL in these patients, while real life data on QoL changes are not available yet. During the release of teduglutide in Germany, the PNLiver trial (DRKS00010993) recruited chronic intestinal failure patients with parenteral nutrition from 2014 till 2019 to evaluate the capability of non-invasive liver function tests in cIF patients in a cross-sectional (n=90) and longitudinal study (n=20. All participants underwent study visits including clinical examination, dynamic liver function assessment, comprehensive blood tests, nutritional status assessment and quality of life assessment (Short Form 36 \[SF-36\] and SBS-QoL). Therefore, we have a comprehensive data set of a large monocentric cIF cohort prior to teduglutide treatment. Consequently, our unique QoL data from the PNLiver trail enables a followup assessment for an observation period above 24 weeks of patients who were in the meantime exposed to teduglutide in a real life setting. Nevertheless, QoL also tends to improve with longer duration on HPN. Therefore, we are aiming to extend the results with a pairwise matched control group from non teduglutide-treated PNLiver trail patients and collect follow-up data from this group accordingly.

Eligibility Criteria:
Inclusion Criteria:

* SBS-associated adult chronic IF with parenteral nutritional support
* previous inclusion in the PNLiver trial with existing SF-36 and SBSQoL data
* signed informed consent

Exclusion Criteria:

* teduglutide stop before study initiation
* refusal or withdrawal of consent
A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer

The purpose of this research is to collect surgical drain fluid and blood from patients who have undergone surgery for gastric or esophageal cancer, and to analyze the fluid and blood using a variety of laboratory techniques for molecular markers capable of predicting response to immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophagectomy or gastrectomy for gastroesophageal cancer.
* Adult males and females at least 18 years of age
* Ability to complete testing in the protocol and attend study visits
* Able and willing to consent to protocol
* Adequate organ function Absolute Neutrophil Count (ANC) ≥1.5 x 103/μL Platelets ≥100 x 103/μL Hemoglobin \>9.0 g/dL Total Bilirubin (\</= 2.0 mg/dl at time of Y90 radioembolization) AST/ALT ≤5 x upper limit of normal Albumin \>3 g/dL Creatinine ≤1.5 mg/dL

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
* Life-threatening intercurrent illness
* Anticipated poor compliance
* Prisoners or subjects who are involuntarily incarcerated
* Persons with decisional incapacity/cognitive impairment
* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study
* Subject is enrolled in a separate interventional clinical trial
Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers

Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.

The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.

Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.

Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.

Restaging impact on prognosis and clinical management remains poorly understood.

Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven HSNCC
* written consent

Exclusion Criteria:

* previous head and neck malignancy
Resveratrol's Effects in Diabetic Nephropathy

The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy.

Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine.

Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals.

We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (DM)
* Controlled blood sugar \[fasting blood sugar (FBS) \<130mg/dl and glycosylated hemoglobin (A1C)\<7%
* Urine albumin \>20mg/lit in two separate occasions during the last 3 months period
* Serum creatinin \< or = 2mg/dl

Exclusion Criteria:

* Pregnancy
* Lactation
* Alcoholism
* Liver failure (acute or chronic)
* Renal failure: serum creatinin \>2mg/dl
* Glomerulonephritis
* Uncontrolled hypertension
* Congestive heart failure
* Prostate disease
* Malignancy
* Bilateral renal artery stenosis
* Any systemic disease other than DM
* Any infection or rheumatologic disorder
* Use of warfarin
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening
* Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration
* Participant must be willing to provide verifiable identification
* All female participants of childbearing potential must have:

  1. a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening
  2. a negative urine (beta-hCG) pregnancy test immediately prior to each study vaccine administration

Exclusion Criteria:

* Participant has a known history of flavivirus infection or previous receipt of flavivirus vaccine such as dengue virus (DENV) types 1-4, yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV)
* Participant has traveled to an area with active flavivirus transmission (as per Centers for Disease Control and Prevention \[CDC\]'s 'Zika travel notices') or Zika cautionary areas ('Yellow and Red areas') within 4 weeks before screening
* Participant has chronic active hepatitis B or hepatitis C virus infection, verified at screening by hepatitis B surface antigen (HBsAg) or hepatitis C antibody, respectively
* Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
* Participant received or plans to receive licensed live-attenuated vaccines within 28 days before or after each planned study vaccine administration; licensed inactivated, subunit, or conjugate vaccines within 14 days before or after each planned study vaccine administration
ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study

To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 year-old
* Diagosed as invasive aspergillus infection

Exclusion Criteria:

* Pregnant
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization

To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients who require a central venous catheter for their thoracic surgery

Exclusion Criteria:

* Refuse to enroll
* Infection at insertion site
* Carotid artery disease
* Anomaly of central vasculature
* Hypertrophied thyroid
* History of recent neck surgery
Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage

This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old.
* nontraumatic spontaneous intracerebral hemorrhage.
* postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk\>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score\>2 is defined as a high risk of venous thrombosis.
* patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration.
* patients who signed informed consent.
* no history of allergy to salicylic acid preparation.
* patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head CT showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction.

Exclusion Criteria:

* there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions.
* ischemic stroke with hemorrhagic conversion.
* secondary bleeding due to venous embolism.
* the malignant tumor is expected to have a survival of no more than 3 months.
* take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.
* previous history of thrombocytopenia or coagulation disorders.
* previous history of atrial fibrillation.
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail

Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. The administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and P-gp in a single test.

When a cocktail approach is used it is important to make sure that no drug-drug interactions occur between the probes within the cocktail. The validation of the lack of interactions, which is the aim of the study, consists of demonstrating that there is no difference in the pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

Probe and metabolite concentrations will be measured in capillary blood using a dried blood spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to ensure the precision of capillary blood collection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged from 18 to 60 years
* BMI between 18 and 27
* Understanding of French language and able to give a written inform consent.

Exclusion Criteria:

* smoker
* pregnant women
* taking drugs which alter cytochrome P450 (CYP) activity
* renal or hepatic impairment
* medical history of chronic alcoholism or abuse of psychoactive drugs
* liver transplantation
* sensitivity to any of the drugs used
* Alteration of hepatic tests, more than 2x normal (aspartate transaminase \>100U/L ; alanine transaminase \>100 units/L ; gamma-glutamyl transferase \>80 units/L ; bilirubin \>50µmol/L)
* Presenting genetic polymorphism of poor CYP2C9, CYP2C19, CYP2D6 metabolizer