cyrilzakka/clinical-trials huggingface dataset:
KVUS at Neoadjuvant CTx of Breast Cancer

Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy

The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.

To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.

Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.

The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age \> 18 yrs
* histologically confirmed primary breast cancer including all intrinsic subtypes
* treatment with neoadjuvant chemotherapy
* persons who are legally competent and mentally able to follow the instructions of the study team

Exclusion Criteria:

* hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
* right-left shunt,
* severe pulmonary hypertension (pulmonary arterial pressure \> 90 mmHg)
* uncontrolled systemic hypertension
* acute respiratory distress syndrome
* pregnancy
* commitment of the patient to any resident institution by order of any court or authority
* expectation of missing compliance
* alcohol or drug abuse
* patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

There is still unresolved question whether isolation of superior vena cava (SVC) in conjunction to conventional pulmonary vein isolation (PVI) improves outcomes in the treatment of paroxysmal atrial fibrillation. The investigators are conducting a randomized study to determine if SVC isolation (in addition to pulmonary vein isolation) with the cryoballoon technology can improve freedom from atrial arrhythmias in one year follow up after the ablation.

Paroxysmal atrial fibrillation can be triggered by non-pulmonary vein foci, like the superior vena cava. There are some older publications showing improved result in terms of freedom from atrial tachycardias when electrical isolation of this vessel utilizing radiofrequency energy is achieved. Recent retrospective studies showed that isolation of superior vena cava by the means of cryoballoon technology is safe and feasible procedure. Furthermore, one retrospective cohort study showed improved outcomes of SVC insolation + PVI versus PVI only strategy. To our knowledge there is still no randomized data that compared SVC isolation + PVI vs PVI only strategy when using cryoballoon technology.

The investigators want to determine if SVC isolation by the means of cryoballoon technology in conjunction with PVI can improve the patients outcomes. Also, there will be focus on the safety of the procedure, especially regarding the right sided phrenic nerve palsy. The primary objective of the study is freedom from atrial arrhythmias defined by standard postprocedural monitoring by ECG and Holter monitors. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up. One group will receive conventional cryoballoon pulmonary vein isolation, and other group will receive SVC isolation after the PVI procedure.

Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation scheduled for cryoballoon the ablation of atrial fibrillation (indication not related to the study)

Exclusion Criteria:

persistent atrial fibrillation

* renal failure
* contrast allergy
Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures

The investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.

The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.Bone impaction grafts are an important treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic patients. Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture. Bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 50-75 years with closed Neer type 4 proximal humerus fractures

Exclusion Criteria:

* Patients under 50 and over 75 years of age,
* Patients with pathological fractures,
* Patients with neurological deficits such as brachial plexus injury
* Patients with previous shoulder surgery
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.

This randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.

Approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment.
3. General good health
4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly)
5. Positive skin-prick test to at least one common aeroallergen

Exclusion Criteria:

1. Current lung disease other than mild allergic asthma
2. Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic
3. Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period
4. History of anaphylaxis to any biologic therapy or vaccine
Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin

In this study we compare the vitamin B12 status by measuring serum vitamin B12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. Afterwars we investigate which biomarker could be adequate to reflect B12 status in metformin-treated patients.

With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM \> 6 months
* Metformin treatment for at least 6 months
* Age \> 18 years
* Ability to give written informed consent
* No metformin treatment in the last 6 months (control group)

Exclusion Criteria:

* Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation)
* Lack of written and/or oral understanding in German, French, Italian or English languages
* Diagnosis of Transcobolamin transporter defect
* Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis
* Diagnosis of Renal disease (Creatinine-Clearance \<60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of epilepsy with partial seizures for more than 24 weeks.
* Must experience at least 8 partial seizures during an 8-week Baseline Phase.
* Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
* Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria:

* Previous treatment with lamotrigine.
* Exhibits any primary generalized seizures.
* Receiving treatment with felbamate or currently following the ketogenic diet.
* Pregnant, breastfeeding, or planning to become pregnant.
The Oral Microbiome in OSCC

Previous work by a number of scientific teams has revealed that the types of bacteria that colonize the mouth differ between health and pre-cancerous or cancerous oral lesions. The purpose of this study is to investigate the extent of these changes and to correlate the changes with alterations in the activities of the host's own oral tissues. In doing so, we believe we can gain a better understanding of how particular bacterial species, or consortia of species, can result in an individual having an increased risk of the most common type of oral cancer -- oral squamous cell carcinoma. This knowledge may also lead to the identification of salivary biomarkers that can be used for clinical evaluation or screening. In addition, we seek to determine the extent to which a probiotic regimen can help prevent or rectify the disease-related changes in the types of bacterial colonizing the mouth. The microbiome in health, pre-cancerous lesions, and cancerous lesions will be determined from remnant microbial DNA in banked tissue samples. The effects of probiotics on the oral microbiome will be determined from DNA collected from swabs of oral tissue at baseline and then after 3 to 6 months of probiotic usage.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or
2. Adults (21-70 years old) or who have been diagnosed with oral squamous cell carcinoma, or matched healthy controls free of any oral lesions

Exclusion Criteria:

1. Adults who have had a course of antibiotics that was completed less than 3 months prior to the study;
2. Adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics;
3. Adults who regularly use probiotic dietary supplements
4. Adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.
Treatment of Obsessive-Compulsive Disorder (OCD) in Children

The purpose of this study is to compare 3 treatments for children with OCD: medication (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of medication and/or Educational Support (ES, non-psychological treatment) instead of therapy.

One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and medication seem to be effective, but their effectiveness, alone and in combination, has not been evaluated.

There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6 treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5) SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12 (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how effective and durable the treatment is in treating your child's OCD.

A child may be eligible for this study if he/she:

Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.

To contrast the degree and durability of improvement in pediatric obsessive-compulsive disorder (OCD), patients will be treated with 1 of 6 conditions (3 active treatments and 3 control treatments): sertraline alone (SER), OCD-specific Cognitive Behavior Therapy (CBT), both SER and CBT (SER plus CBT), pill placebo (PBO), pill PBO plus Educational Support (ES), and SER plus ES.

One in 200 youth suffers from OCD, yet relatively few receive appropriate treatment. Both CBT and medication appear beneficial in controlled studies; however, the relative efficacy of CBT and medication, alone and in combination (COMB) is unknown. Thus, well-designed treatment outcome studies are necessary to improve care for youth with OCD.

The experimental design covers 2 phases. Phase I is a 2 (site) x 2 (SER or pill PBO) x 3 (CBT, ES or non- psychosocial treatment) x 5 (repeated measures) factorial 12-week comparison of SER, CBT, COMB and the control conditions. In Phase II, responders advance to a 16-week discontinuation study to assess treatment durability. The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale. Assessments blind to treatment status take place at Week 0 (pretreatment); Weeks 1, 4, 8, 12 (Phase I treatment); and Weeks 16, 20, 24 and 28 (Phase II discontinuation). Besides addressing comparative efficacy and durability of the specified treatments, the investigators also examine time-action effects, differential effects on specific aspects of OCD, including functional impairment, and predictors of response to treatment.

Eligibility Criteria:
Inclusion Criteria:

-

Patients must have:

DSM-IV diagnosed OCD.
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain that is not controlled by standard pain medications. JNJ-42160443 (10 mg/ml) or matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks); one of four JNJ-42160443 doses (1 mg every 4 wks; 3 mg every 4 wks; 6 mg loading dose on Day 1 followed by 3 mg every 4 wks; or 10 mg every 4 wks, or matching placebo for up to 104 wks (12-wk double-blind efficacy period + 92-wk double-blind extension period).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic low back pain

Exclusion Criteria:

* Pain with radiation to the extremity and with neurologic signs
* history within the past year of any of the following: seizure disorder
* intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or transient ischemic attack, meningitis
* History of brain injury within the past 15 years consisting of \>= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours
* History of epilepsy or multiple sclerosis
* Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm
* Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus.
* Cardiovascular disease
* Hypertension

Exclusion Criteria:

* Patients with type 1 diabetes or diabetes insipidus
* Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
* Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Strain Analysis as a Right Ventricle Contractility Marker

The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years
* Patients with renal failure treated with intermittent hemodialysis
* Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.

Exclusion Criteria:

* Patients with heart disease (valvular, ischemic, rhythmic)
* Patients with ejection fraction of left ventricular altered \<45%
* Chronic dialysis patients
* Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:

  * Pregnant women, parturients or nursing mothers
  * Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
  * Minor Patients
  * Major persons who are subject to a legal protection measure or are unable to express their consent
* Patients not willing to participate in the study
* Patients not affiliated to a social security
Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes

The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.

The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'. 'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Type 2 diabetes
* Have access to internet
* Being computer literate

Exclusion Criteria:

* not Dutch Speaking