cyrilzakka/clinical-trials huggingface dataset:
Needle Guidance in Ultrasound Guided Nerve Blocks

An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety.

This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle.

Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18-85 years old
* Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter
* Written informed consent

Exclusion Criteria:

* Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics
* Pregnancy
* Preexisting neuropathy involving the surgical limb
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase 1a and Phase 1b. Phase 1a has 3 stages, Single administration stage, Multiple administration stage and Visceral stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

All of the following conditions should be met at screening:

* Male or female patients 18-75
* Patients with malignant solid tumors that have been diagnosed by pathology and/or cytology
* Patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist
* Patients with at least one non-injected measurable tumor lesion per RECIST v1.1
* Patients with lesions suitable for intratumoral injection (the lesion length is at least 10 mm and not exceeding 80 mm)
* Patients enrolled in the single and multiple administration stages of Phase 1a must agree to provide pre- and post-treatment tumor biopsy tissues
* Patients must have adequate organ and marrow functions
* Patients with treated brain metastases are eligible if meeting protocol's requirement
* Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

* Patients who have received prior IL-12 either alone or as part of a treatment regimen
* Patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
* Patients requiring therapeutic doses of anticoagulation
* Patients with tumors that impinge on major airways, blood vessels, or nerve bundles
* Patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications
* Patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment
* Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment
* Patient with history of solid organ or allogenic bone marrow transplantation
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.

The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Confinement to bed for more than 3 days, due to:
* Heart failure
* Exacerbated chronic obstructive pulmonary disease
* Acute rheumatic involvement
* Written informed consent

Exclusion Criteria:

1. Cancer
2. Anticoagulant treatment in the previous 3 months
3. Stroke or major surgery in the previous 3 months
4. Systolic pressure \>200 mmHg or diastolic pressure \>120 mmHg
5. Known chronic hepatopathy
6. Active hemorrhage in any site in the previous 3 months
7. Active peptic ulcer
8. Bacterial endocarditis
9. Conditions that can increase the risk of hemorrhage
10. Known coagulation disorders
11. Hypersensitivity to heparin or HIT
12. Life expectancy of less than 3 months
13. Previous confinement to bed during more than 3 days
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
* continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B12 deficiency.
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have sought doctor's care for this condition.
* Patients must be having menstrual cycles.

Exclusion Criteria:

* Patients must not have any vaginal infections.
* Patients must not be pregnant or nursing.
* Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.
Comparison Study of a New Fiberoptic Intubation Device to Standard Intubation Techniques

This is a two part study comparing the Trachview videoscope to standard laryngoscopy in their ability to visualize the glottic opening. It is hypothesized that the glottic view is improved with the Trachview videoscope. Not only can the Trachview provide an alternative and often improved view of the airway, but can be used for teaching novice intubators. Furthermore, the Trachview requires minimal deviation from standard intubating techniques and thus, it is much easier to learn and use than many fiberoptic scopes currently available.

This is a two part study. Part one: Adult airway mannequins were used. Subjects were medical students with no previous experience in intubation.

Part two: This was a convenience sample of patients undergoing elective surgery. All patients were consented. The subjects were physicians and nurse anesthetists who were going to be intubated in the operating room setting.

For both parts of the study, the subjects viewed the glottic opening using direct laryngoscopy followed or preceded by visualization of the glottic opening using the Trachview. The subjects were asked to score the amount of the glottic opening that could be visualized using the POGO (percent of glottic opening)score. Subjects were only given a very brief inservice on how to use the Trachview. Additional measurements such as presurgical airway assessments of the patients were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18 years old and older

Exclusion Criteria:

* Individuals less than 18
* Pregnant patients
* Inability to give consent
Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.

Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.

There are currently two methods of analgesia in postoperative abdominal surgery : patient-controlled analgesia (PCA) with opioids and epidural analgesia.

No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Surgery scheduled under laparotomy
* Extended ileal resection
* Total proctocolectomy
* Colectomy left/right/total
* Rectosigmoidal resection
* Anterior resection of rectum
* Abdomino-perineal amputation
* Adult patient
* Written consent obtained
* Planned hospitalization in the intensive care unit
* Patient affiliated to social security

Exclusion Criteria:

* Patients inapt to give consent
* Emergency surgery
* Contraindication to epidural analgesia
* Contraindication to levobupivacaïne, morphine or sufentanil
* Dementia
* Participation in another research protocol
* Pregnancy or breastfeeding
FRAME, External Support for Lower Limb Autologous Grafts

30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.

Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
2. Rutherford classification 3-6
3. Adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
4. Patient is able and willing to give their informed written consent.
5. Patient is able and willing to comply with study follow up requirements.
6. Patient is ≥ 18 years of age

Exclusion Criteria:

1. Patients indicated for endovascular treatment
2. Prior surgical bypass procedure in ipsilateral lower limb.
3. Active ulcer/infection/gangrene at the intended distal anastomosis site.
4. Severe vein varicosity
5. Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
6. Spliced vein technique
7. In-situ vein technique
8. Pedal/plantar distal anastomosis
9. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
10. Patients with history of hypercoagulable conditions.
11. Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
12. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
13. Contraindication to recommended study medications
14. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Does the Aid of MelaFind Affect Clinical Management Decisions

The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists.

Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind.

A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).

Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. The diagnostic performance of dermatologists for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to excise the lesion. To aid dermatologists in the detection of early melanoma, MelaFind was developed, a non-invasive and objective multi-spectral computer vision system technology. It was designed to generate output - MelaFind Positive or MelaFind Negative- for consideration in the lesion management decisions.

This survey study will determine and compare the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) without MelaFind output to the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) with MelaFind output. Another purpose is to determine and compare the sensitivity to melanoma and specificity of MelaFind to the average excision sensitivity to melanoma and specificity of dermatologists without MelaFind output.

Eligibility Criteria:
Inclusion Criteria:

-Only board certified dermatologists

Exclusion Criteria:

-May not have previously participated in MELA Protocols 20061, 20081 or 20063
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup

The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index.

Insulinemic index is measure with the same methodology.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years
* male
* healthy volunteers
* BMI above 25 kg/m²

Exclusion Criteria:

* no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance
* food allergy
* kidney deficiency
* liver troubles
* gastro-intestinal troubles
* drugs which impair sugar and lipid metabolism
Arterial Access for Coronary Intervention in Myocardial Infarction

The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.

Some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. The advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. The radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.The patients with ST elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.On the other hand, the time and success of the procedure are significant prognostic issues.In this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. For this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms.

Exclusion Criteria:

* Patients in cardiogenic shock were excluded following operator criteria.
* Previous coronary surgery with mammary artery graft
* Coronary artery intervention in the previous month
* Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine \>3 mg/dl).
* Patients with absolute or relative contraindication for the use of the femoral route.
* Absence of informed consent from the patient
Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients

The purpose of this study is:

1. To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects.
2. To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD.
3. To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS.
4. To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.

Depressive symptoms of PD patients are major predictors of their prognosis and quality of life. Therefore, successful treatment of depression is crucial in PD patients. Using deep brain stimulation as an antidepressant (or to augment a standard antidepressant) could be a promising new direction. The hypothesis to be tested in the current project is that treatment with deep brain stimulation will improve both the neurological and the psychiatric (depressive) symptoms of PD. It is further hypothesized that the improvement in depressive symptoms will not be a simple consequence of improvement in neurological status. Data from this open label study will form the basis for planning a larger scale controlled trial in depressed PD patients and exploratory studies in patients with major depression who do not have PD.

Today, programming of DBS is based on the neurological evaluation of the motor features of PD. If our hypothesis is proven, i.e. parameter manipulation of DBS affects the mental features of PD, it is crucial to establish a valid database that will enable to study these effects. Moreover, such a detailed database will be the basis for the development of a computer-assisted decision making protocol for programming of DBS. A novel decision making protocol will maximize the benefits of DBS in both depressed and non-depressed PD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically definite PD treated / candidates for treatment with DBS (patients with advanced idiopathic PD who are deemed appropriate for DBS surgery).
2. Patients will be included in the study irrespective of whether a diagnosis of major depression (mild to moderate but not severe MDD) is fulfilled at baseline. Patients without depression will be monitored in the study for evidence of treatment emergent depression. Patients with depression will be monitored for antidepressant effects of stimulation change.
3. Age 40-75 years
4. Male or female.
5. Competent and willing to give written informed consent.

Exclusion Criteria:

1. Significant suicidal risk \[Hamilton Depression scale item 3 (suicide) \>2\].
2. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
3. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
4. Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) and the Frontal Assessment Battery (FAB).