cyrilzakka/clinical-trials huggingface dataset:
Virulence of Staphylococcus Lugdunensis in Severe Infections

The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Signed informed consent form
* Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.

Exclusion Criteria:

* Age under 18
* Pregnancy or breastfeeding
* Contamination by Staphylococcus lugdunensis
Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

This study evaluated whether laser acupuncture at the time of embryo transfer (following in vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser acupuncture, 4) no treatment.


Eligibility Criteria:
Inclusion Criteria:

* All patients seeking pregnancy via in vitro fertilization during the study period

Exclusion Criteria:

* Bleeding disorders (due to the possible use of needles)
* Prior exposure to acupuncture
* Preimplantation genetic screening or diagnosis
Minima Stent System Post- Approval Study (PAS)

This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

Eligibility Criteria:
Inclusion Criteria:

* The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
* Indicated for treatment with the Minima Stent System per the IFU.

Exclusion Criteria:

* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
* Aortic or pulmonary artery aneurysm in the location targeted for treatment
* Body weight \< 1.5 kg
* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
* Target vessels larger or smaller than the Minima System balloon size ranges
* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
* Currently participating in an investigational drug study or another device study
* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated
Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study

Miltefosine is the only oral treatment currently available for Cutaneous Leishmaniasis.

Despite several reports of good efficiency in other countries of South America, miltefosine remains limited to a compassionate use in France. The objective of this study is to collect data regarding the efficacy, safety and acceptability of miltefosine in patients treated in French Guiana since 2017.

In French Guiana, Cutaneous Leishmaniasis is mostly caused by Leishmania guyanensis (80% of cases), followed by L. braziliensis (10%) and rarer species. L. guyanensis is usually treated with a single injection of pentamidine. However, pentamidine-resistant infections (10%) and all L. braziliensis are treated with either amphotericine B or meglumine antimoniate. These treatments can only be used during an hospitalization, which is the source of important indirect costs and discomforts for patients from the remote areas of French Guiana. Miltefosine is the only oral treatment available for Cutaneous Leishmaniasis. While it is widely used in South America (with good reported efficacy), the data available in France are scarce. This treatment, if available on a larger scale in France, would allow a treatment without hospitalization, which would be very suitable for French Guianese patients.

Our objective is to collect data on patients already treated with miltefosine in French Guiana (current indications being failure, side effect or impossible delivery of amphotericine B and meglumine antimoniate) in order to assess its efficacy, safety and acceptability. Patients treated with miltefosine at the Cayenne Hospital Center between 2017 and 2022 will be contacted by phone so as to answer questions regarding their quality of life during the infection and their satisfaction concerning miltefosine as a treatment. Data on their symptoms and general informations will be extracted from the medical files.

Primary objective: To assess the efficacy, tolerance and acceptability of Miltefosine among patients already treated with this drug as part of its AAC in French Guiana.

Observational, retrospective and prospective, monocentric study Research Involving Human Person Category 3 (RIPH3) - Non-Interventional (RNI) - Questionnaire (Jardé Law)

Eligibility Criteria:
Inclusion Criteria:

* Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR)
* Seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC
* Having received treatment with Miltefosine
* Patient who consented to participate in the study
* Age equal or superior to 18 years

Exclusion Criteria:

* Clinically suspected but not parasitologically proven leishmaniasis
* Refusal to participate
* Age \< 18
* Patient under legal guardianship
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.

The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
* The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope.
* Ability to sign informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
* Inability to give informed consent.
* Known hypersensitivity to adhesive rings.
* Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
* Individuals with or without HIV-1 coinfection

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
* Co-infection with active hepatitis B virus
* Laboratory results outside the acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 \[NCT06076642\], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.

All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.

Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.


Eligibility Criteria:
Inclusion Criteria:

1. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
2. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
3. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of the expanded access program and can provide written informed consent/assent (if applicable), including providing consent/assent for use of the investigational medical device, before initiation of any program procedures.
4. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
5. Participant does not have a known hypersensitivity to TAK-881 or its components.

Exclusion Criteria:

1. Participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program.
2. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.
A Predictive Model Based on Quantitative Fecal Immunochemical Test Can Stratify the Risk of CRC in an Organized Screening Program

The COVID-19 pandemic has disrupted every aspect of medical care, including screening programs and preventive medical care . Organized FIT-based colorectal cancer screening programs make no exception, since their efficacy depends on a multi-tiered series of interventions that were hampered by the pandemic at multiple levels. In detail, the first level of intervention, namely population based FIT tests distributed to the population, has seen a dramatic decrease of number of tests performed for both organizational reasons (i.e. less personnel deployed to testing sites) and for failure to present fecal samples from patients for fear of contagion or impossibility to reach the drop-off sites for state-imposed limitations. Secondly, the referral of FIT positive patients to subsequent colonoscopy was stopped or delayed since endoscopy services have been undergoing only emergent and urgent procedures. Thirdly, patients diagnosed with advanced neoplasia or cancer have seen their endoscopic or surgical removal procedures delayed or canceled . Regarding post-FIT colonoscopy workup, European Screening Guidelines recommend a 30-day maximum span between a positive FIT test and subsequent colonoscopy. It is well known that any delay in post-FIT+ colonoscopy results in an increase in advanced neoplasia and colorectal cancer, that reaches dramatic levels after 6 months .

Our purpose is to develop and validate, using the quantitative level of faecal hemoglobin found in FIT, a simple scoring system to effectively sub-stratify CRC risk of FIT positive patients.


Eligibility Criteria:
Inclusion Criteria:

* All FIT+ patients awaiting to be scheduled for colonoscopy workup. Patients will be invited to undergo a colonoscopy, and depending on its outcome, patients are referred for surgery, postcolonoscopy surveillance, or further rounds of FIT.

Exclusion Criteria:

* Individuals with a prevalent diagnosis of CRC are excluded from the program, as well as patients that have already undergone a high quality colonoscopy.
The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession

There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%.

The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage)
* Patients with fixed orthodontic appliances at least between their lower first premolars
* No lower anterior teeth crowding (total irregularity index score = 0)
* Patients with no need of removable retention appliances on their lower teeth

Exclusion Criteria:

* Active caries on adjacent or lingual surfaces of lower anterior teeth
* Active periodontitis
* Supragingival calculus
* Gum bleeding during bonding of fixed retainer
* Gingival pocket depth greater than 3mm
* Syndromes or other anomalies of the craniofacial complex or other mental illness
* Missing or impacted teeth or other dental anomalies
* Congenital anomalies/syndromes
* Allergies regarding the alloys of fixed retainers
* Need for chemoprevention before data collection of periodontal indexes
* Diabetes
* Smoking
* Usage of antibiotics
* Pregnancy
* Participation in other clinical trials
Ocular Comfort and the "Aging" Lens (ERBIUM)

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Eligibility Criteria:
Inclusion Criteria:

* At least 17 years of age.
* Ocular exam in the last two years.
* Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
* Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
* Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease.
* Systemic condition that may affect a study outcome.
* Using any systemic or topical medications that may affect ocular health.
* Wears lenses on an extended or continuous wear schedule.
* Habitually wears multifocal lenses.
* Other protocol-defined exclusion criteria may apply.
Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia

The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.


Eligibility Criteria:
Inclusion Criteria:

* Discontinuation of all cholesterol lowing drugs, including dietary supplements.
* Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
* Abnormal laboratory parameters as defined in the protocol.
First-In-Human PainCart Study for STR-324

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects, 18 to 45 years of age, inclusive at screening.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
* All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
* Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria:

* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
* Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
* Abnormal renal function (eGFR (MDRD) \< 60 mL/min/1.73m2).
* Previous history of seizures or epilepsy.
* Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Use of any medications (prescription or over-the-counter \[OTC\]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Participation in an investigational drug or device study within 3 months prior to first dosing.
* History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
* Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
* Loss or donation of blood over 500 mL within three months prior to screening
* Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.
* A histologically-confirmed colorectal tumor
* Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.
* Patients must not have received cytotoxic chemotherapy previous to enrollment.

Exclusion Criteria:

* Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
* Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
* Pregnant or breastfeeding
* Any known brain metastases
* Non-English speaking patients
* Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.
* Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.