cyrilzakka/clinical-trials huggingface dataset:
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.

A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.

Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.

Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).

Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith \& Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.

Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.

A final consultation was made 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* All patients proposed for emergency laparotomy

Exclusion Criteria:

* Contra-indication for iNPWT
* Irreversible disease diagnosis with expected short term mortality
* Need for a staged procedure
Chronic Infection With Tropheryma Whipplei: Risk Factors Related to the Host

In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication.

The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).

Since the first isolation of a strain of Tropheryma whipplei (T. whipplei) and the development of molecular tools, the natural history of this bacterium continued to clarify. The currently proposed scheme is as follows: after contamination human oral-oral or fecal, patients will develop acute infections such as bacteremia, gastroenteritis and pneumonia. They can then produce specific antibodies. Likely depending on the host-related factors, three types of evolution appear to be possible: (i) some patients eliminate the bacteria and develop specific antibodies. (ii) some patients are chronic carriers of the bacterium with a strong immune response. (iii) Finally, patients develop subacute or chronic infections, with an insufficient immune response or non-existent answer to T. whipplei.

Subacute or chronic infections include Whipple's disease characterized by histological involvement of the small intestine, as well as localized without digestive impairment, such as endocarditis or encephalitis. Despite appropriate antibiotic therapy, patients with Whipple's disease will present relapse (30-40% of patients), but also of re-infection with different genotypes of T. whipplei.

Here the hypothesis is that HLA-DRB 13 and/or HLA-DQB1 06 alleles are associated with the presence of chronic infections with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis)

Eligibility Criteria:
Inclusion Criteria:

* Patient with a positive PCR to T. Whipplei diagnostics.
* Patient aged \> or = 18 years old.
* Patient who does not declined to have his medical records reviewed for research.
* Patient with health insurance.

Exclusion Criteria:

* Patient minors (age \<18 years)
* Pregnant woman, parturient or breastfeeding
* Adult Patient under guardianship .
* Patient deprived of liberty under court order
* Patient refusing to sign the informed consent form.
A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants

The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.


Eligibility Criteria:
Major Inclusion Criteria:

1. Healthy male and/or female participants aged 18 to 55 years, inclusive.
2. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
3. Females must be of nonchildbearing potential.

Major Exclusion Criteria:

1. Estimated glomerular filtration rate \<90 mL/min/1.73 m2
2. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
3. Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
4. History of alcohol abuse or excessive intake of alcohol
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Eligibility Criteria:
Key Inclusion Criteria:

* Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
* At least 3 months of contact lens wearing experience;
* Less than or equal to 0.75 diopter (D) astigmatism in each eye;
* Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
* Monovision and/or multifocal lens wearer;
* Routinely sleeps in habitual contact lenses.
* Other protocol-defined exclusion criteria may apply.
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers

This single-center, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on immune functions in healthy shift workers. Volunteers received either 200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a 1-month follow-up.


Eligibility Criteria:
Inclusion criteria: male and female aged 18-65 years; working in 2- or 3-shift work patterns (including night work); same job position for at least 4.5 months; a 19 to 30 kg/m2 body mass index; no symptoms of CIDs during the 2 weeks before product consumption; agreeing to a written informed consent.

Exclusion criteria: part time work (\<90%); allergy/hypersensitivity to components of the study product; severe respiratory allergy; a situation which, in the investigator's opinion, could interfere with optimal participation or constitute a special risk for the volunteer; a history of chronic metabolic/gastro-intestinal disease (except appendectomy); surgery/intervention requiring general anesthesia in the last 4 weeks; administration of systemic/topical treatments likely to interfere with the evaluation parameters in the last 4 weeks; chronic disease requiring antibiotics/antiseptics/anti-inflammatory medications; special medicated diet; chronic/iatrogenic immunodeficiency; cardiac/renal/respiratory insufficiency; severe evolutive/chronic pathology; pregnancy, breast feeding or lacking effective contraception in females; susceptibility not to comply with dietary recommendation during the study period.
Modifying Working Memory With Brain Stimulation

The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB.

Rationale: The survival rate of patients after cardiac arrest and resuscitation has increased considerably. A common consequence of cardiac arrest is ischemic-hypoxic brain damage leading to cognitive impairment. Currently, there is a lack of knowledge regarding effectiveness of treatments to improve outcomes of patients with cognitive impairment after a cardiac arrest.

Objective: The primary objective is to investigate the effects of rTMS (iTBS protocol) on working memory of people with memory impairments after a cardiac arrest in the past Study design: This will be a single blinded replicated randomized SCED withdrawal designs study.

Study population: Nine adults who had a cardiac arrest in the past will be participating in this study. They are recruited in the general population.

Intervention: If participants are suitable based on the screening. Participants are invited to the university of Maastricht. There they receive intermitted theta burst stimulation with a TMS coil for 3 minutes on the dorsolateral prefrontal cortex. Then they perform the N-back task for 8 to 12 minutes to estimate working-memory performance. Then they have a break (45 min). Then they receive 3 minutes of sham stimulation after which they have to perform the N-back task again for 8 - 12 minutes. This will be repeated (active stimulation - sham - active stimulation - sham).

Main study parameter: The main study outcomes are performance on the N-back task with regard to accuracy.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participant has to come to the university twice. The screening session takes approximately 1-1,5 hour, the experimental session 3,5 hours. The participant could experience side effects of the rTMS, these include: headache, scalp discomfort, tingling or twitching of the facial muscles, and light-headedness. Serious side effects are very rare, but they may include: seizures. The N-back task can be experienced as tiring.

Eligibility Criteria:
Inclusion Criteria:

* Had a cardiac arrest between 3 months and 5 years prior to the experiment session.
* Scores lower than the general population (corrected for age, education, and sex) on at least one of the cognitive tests ( SD \< -1 on the Stroop, digit span, or TMT).
* Age 18 up to and including 75.
* Proficient in Dutch or English to understand the instructions for the N-back task.
* Has sufficient understanding to perform the N-back task.
* Written informed consent

Exclusion Criteria:

* Has a pacemaker or ICD (implantable cardioverter-defibrillator)
* A history or a family member with a history of seizures / epilepsy (asked on the phone and checked on the first appointment).
* Metal implants in or near the head.
* Pregnancy
* Any other neurological disorder impending working memory performance besides the OHCA.
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Carotid Artery Stenting

Eligibility Criteria:
Inclusion Criteria:

* High-surgical risk patients to be treated consistent with IFU labeling
* The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee.

Exclusion Criteria:

* Patients not treated per the IFU
* Patients who are contraindicated per the IFU
* Patients previously enrolled in the study
* Patients requiring stenting of in-stent restenosis after CAS
* Inability or refusal to provide informed consent.
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain.
* Requires daily opioid medication

Exclusion Criteria:

* Patients who do not have bone pain caused by cancer are not eligible for the study.
* Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
* Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
* Known history of rheumatoid arthritis.
Study of EBI-005 in Dry Eye Disease (DED)

This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.


Eligibility Criteria:
Key Inclusion Criteria:

1. Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1
2. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study

Key Exclusion Criteria:

1. Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
2. Have had penetrating intraocular surgery within 12 months prior to Visit 1
3. Be unwilling to comply with the study requirements
Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms

The principal objective of this research is the evaluation of the effect of mineralized water consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low mineralized water consumption.


Eligibility Criteria:
Inclusion Criteria:

* BMI included between 18.5 and 25 kg/m²
* non smoking
* moderated hypercholesterolemia

Exclusion Criteria:

* food allergy
* diabetes
* high blood pressure
* kidney deficiency
* thyroid deficiency
* metabolism deficiency
Role of Axumin PET Scan in Germ Cell Tumor

Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.

Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND
* Patients must be over 18 years old and capable and willing to provide informed consent.
* Medically stable as judged by patient's physician.
* Life expectancy must be estimated at \> 6 months.
* Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age \>70 years).
* Patient must be able to lie still for a 20 to 30 minute PET/CT scan. Patients will be asked if they have problems or issues with lying flat

Exclusion Criteria:

* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible.
* Patients with liver failure are NOT eligible.
* Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible
Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer

The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.

Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
* Patients with central tumors located at the origin of a lobar bronchus.
* ECOG performance status 0-1
* Hematopoietic: WBC at least 4,000/mm\^3; Platelet count at least 100,000/mm\^3
* Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
* Renal: Creatinine clearance greater than 60 ml/min
* Cardiovascular: Cardiac function normal

Exclusion Criteria:

* Severe complications or infections
* Pregnant or breast-feeding women
* Clinically significant heart disease
* Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
* Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects between the ages of 19 and 64 years, both inclusive
* Diagnosed with influenza A at screening using rapid influenza diagnostic test
* Onset of influenza symptoms and fever is within 48 hours at screening
* At least 2 of symptoms (moderate to severe in intensity)
* ≥38.0'C body temperature at screening

Exclusion Criteria:

* Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
* Positive influenza B or A+B infection
NovaTears® Eye Drops Observational Study NT-002

This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* According to NovaTears® instruction for use
* ≥ 18 years
* Patients with dry eye disease due to meibomian gland dysfunction applying eye lid hygiene for at least 14 days
* Ability and willingness to provide written Informed Consent
* Ability and willingness to participate in all examinations
* Willingness and ability to return for follow up visit

Exclusion Criteria:

* Patients with hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with dry eye disease not caused by meibomian gland dysfunction
* Patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease
Single Versus Multiple Injections for Axillary Plexus Block

Patients will be randomized to one of two groups:

1. Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound;
2. Single injection group: Axillary brachial plexus block with a single injection, with the arm placed behind the head and the elbow flexed, performed with the aid of ultrasound

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups The first group - multiple injection group - will receive an ultrasound-guided axillary brachial plexus block with the traditional technique, i.e. multiple injections of local anesthetic in proximity to the 4 nerfs that innervate the arm. The arm will be abducted during the block procedure.

The second group - single injection group - will receive an ultrasound-guided axillary brachial plexus block with the arm placed behind the head and the elbow flexed. In this position the different nerfs group around the axillary artery where they will be blocked with a single injection of local anesthetic.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome measure is the time needed for the performance of the block. Secondary outcomes are: success rate of the block at 30 minutes after the injection, needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction. These outcomes are further defined in the section below.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergo forearm or hand surgery under axillary brachial plexus block

Exclusion Criteria:

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders