cyrilzakka/clinical-trials huggingface dataset:
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.

Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically confirmed breast cancer and be deemed an appropriate surgical candidate with consent for a sentinel lymph node mapping by their oncologic surgeon.
* Age minimum: 18 years.
* Participant must be receiving a planned lymphoscintigraphy procedure.
* Participant must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants who choose not to proceed with sentinel lymph node biopsy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
* Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy

This study is a long-term study of ataluren in participants with nonsense mutation Duchenne muscular dystrophy.

This study is a randomized, double-blind, placebo-controlled, 72-week study, followed by a 72-week open-label period. The purpose is to characterize the long-term effects of ataluren-mediated dystrophin restoration on disease progression. Participants will be randomized in a 1:1 ratio to ataluren or placebo. Participants will receive blinded study drug three times daily (TID) at morning, midday, and evening for 72 weeks, after which all participants will receive open-label ataluren for an additional 72 weeks (144 weeks in total). Study assessments will be performed at clinic visits every 12 weeks during the double-blind period and every 24 weeks during the open-label period. The total sample size of \~250 subjects will include \~160 subjects who meet the criteria for inclusion in the primary analysis population (age 7 to 16 years old, baseline six minute walk distance (6MWD) greater than or equal to (\>=) 300 meters, supine to stand \>= 5 seconds). The study will be conducted in the United States and other countries around the world.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age ≥5 years
* Phenotypic evidence of Duchenne Muscular Dystrophy
* Nonsense point mutation in the dystrophin gene
* Use of systemic corticosteroids (prednisone/prednisolone or deflazacort)for a minimum of 12 months immediately prior to start of study treatment, with no significant change in dosage or dosing regimen for a minimum of 3 months immediately prior to start of study treatment
* 6MWD ≥150 meters
* Ability to perform timed function tests within 30 seconds
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

* Any change in prophylaxis treatment for cardiomyopathy within 1 month prior to start of study treatment.
* Ongoing intravenous (IV) aminoglycoside or IV vancomycin therapy.
* Prior or ongoing therapy with ataluren.
* Known hypersensitivity to any of the ingredients or excipients of the study drug
* Exposure to another investigational drug within 6 months prior to start of study treatment, or ongoing participation in any interventional clinical trial.
* History of major surgical procedure within 12 weeks prior to start of study treatment, or expectation of major surgical procedure during the 72-week placebo-controlled treatment period.
* Requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy.
* Uncontrolled clinical symptoms and signs of congestive heart failure
* Elevated serum creatinine or cystatin C at screening.
A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old

The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, female, age 30-55 years, from whom bi-lateral specimens can be obtained.

   The following additional considerations apply:
   * Women with prior mastectomy/lumpectomy may be considered for NAF-collection in the contralateral (non-operated) breast only if they were:

     * Stage I or Stage II at the time of surgery;
     * Have completed any and all hormonal therapy, chemotherapy, or targeted therapy at least one year prior to inclusion;
     * Are considered disease-free (NED- No Evidence of Disease) at the time of study entry;
   * Women under the age 30 may be enrolled if they are within 10 years of the age at diagnosis of breast cancer in a first-degree relative. No subject under the age of 21 may be enrolled.
2. Any woman for whom NAF-cytology testing is considered to be beneficial by her physician. This includes, but is not limited to women with first- and/or second degree relatives with breast- or ovarian cancer. Known presence of a BRCA-1 or BRCA-2 germline mutation is allowed but not required. If known, any such mutation will be noted on the Case Report Form. The protocol does not provide for testing of women without known germ-line mutations.
3. Non-lactating and non-pregnant.
4. Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
5. Willing to give informed consent and follow study procedures as directed.

Exclusion Criteria

1. Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
2. Pregnancy or suspicion of pregnancy.
3. Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
4. No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
5. Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
6. Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
7. Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult

Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of patients with sub-acute post-stroke

The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population for adult patients with subacute stroke.

The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.

The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in adulte patients suffering from subacute stroke..

Eligibility Criteria:
Inclusion Criteria:

* Phase aiguë ou subaiguë

Exclusion Criteria:

* Epilepsie instable
* Absence à déterminer sa volonté à participer
* Traitement toxine pendant le stage
Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector.

The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic drug exposure (adenosine). The 2 main objectives of the study are:

1. Perform a methods comparison between cFFR and the reference standard aFFR, where cFFR is performed using an automated injector with a standardized volume and rate of delivery of contrast with known osmolality.
2. Evaluate the association between final post-PCI FFR and long-term clinical outcomes. The long-term clinical outcomes will include TVR and composite MACE (death, MI, and TVR) at 30 days and 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Have the capacity to understand and sign an informed consent or have a legally authorized representative (LAR) that can understand and sign an informed consent prior to initial arteriotomy access
2. Age \> 18 years of age at the time of signing the informed consent
3. Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications
4. Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events.
5. Target vessel with an intermediate lesion of 40-70% stenosis by angiographic assessment (a visual estimation by the operator). Serial lesions, diffuse disease, or ostial lesions ("all-comer" lesions) are acceptable if the operator would normally perform FFR and proceed with PCI (or other revascularization) if positive.

Exclusion Criteria:

1. Any condition associated with a life expectancy of less than 1 year
2. Participation in another clinical study using an investigational agent or device within the past 3 months
3. Ejection fraction ≤ 35%
4. Creatinine ≥ 2
5. Severe valvular heart disease
6. Decompensated acute diastolic or systolic heart failure
7. Bronchospastic chronic obstructive pulmonary disease or other intolerance to adenosine
8. ST-segment elevation myocardial infarction culprit lesion or lesions with any thrombus burden after diagnostic angiography
9. Lesions with severe calcification after diagnostic angiography
10. Lesions in a target vessel supplied by a patent graft
Study of Metformin Overdose

The objective of the METINFO study is an observational single-center retrospective and descriptive study. The main objective is to estimate the real mortality rate associated to a Metformin overdose. Second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of July 2019 and the 1st of July 2021.

Exclusion Criteria: None.
French Register of Patients With Spinal Muscular Atrophy

The primary objectives of the study are to obtain clinically meaningful data on survival and outcomes of all the patients with spinal muscular atrophy (SMA) 5q types 1 through 4 (according to international classification), being followed in the reference centers of the disease in France between September 1, 2016 and August 31, 2024. The registry will collect retrospectively and prospectively the longitudinal data of the long-term follow-up for child and adult patients, under real life conditions of current medical practice, in order to document the clinical evolution of patients (survival, motor, respiratory, orthopedic and nutritional), the conditions of use of the treatments, the mortality rates of treated and untreated patients, the tolerance of the treatments, adverse events in order to better define their places in the therapeutic strategy.

As secondary objectives, the study aims:

* to estimate the frequencies of patients with SMA 5q types 1 through 4 who have being treated in the reference centers between September 1 2016 and August 31 2024;
* to describe overall demographic, familial, clinical, biological, and genetic characteristics of SMA 5q patients treated in all regions of France, by the type of SMA (type 1,2,3, and 4);
* to study the impact of proactive and symptomatic medical interventions (bracing, IPPB devices) and medications (vaccinations, anti-infectious, digestive, nutritional supplements) in the evolution of patients;
* to study the long-term evolution (survival, motor and respiratory functions, spinal shape, growth and nutritional function) of SMA 5q in treated and untreated populations, by new available therapies, throughout the register;
* to study mortality rate of SMA 5q in treated and untreated populations, by new available therapies, throughout the register;
* to identify and document the different therapeutic strategies by sub-populations and by discontinuation or follow-up of treatments;
* to evaluate prognostic factors of responses to therapies;
* to study the tolerance of treatments by type of treatments, by type of SMA and overall tolerance (including adverse events);
* to estimate the costs of care for SMA 5q patients in different groups (types, ages);
* to provide needful elements to evaluate the health care costs for the disease;
* to study the autonomy and the quality of life of patients depending on different therapeutic strategies;
* to study the impact of the disease on caregivers;
* to facilitate development of scientific research on SMA in the conduct of trials on new therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed SMA 5q patients through 1 to 4 types treated in reference centers in France between September 1, 2016 and August 31, 2024.
* for prospective study: inform consent form signed by patient.
* for retrospective data: information form with non-opposition have been given to participant.
* Covered by a health insurance.

Exclusion Criteria:

* Other type of SMA (not 5q).
* Under guardianship or curatorship.
* Unable to understand french language.
Heart Outcomes Prevention and Evaluation 4

The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (NPHW) and supported by e-health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication and lifestyle adherence.

Study design: open-label, parallel cluster randomized controlled trial design.

HT Phase: Up to 30 urban and rural communities in Canada, Colombia and Malaysia will be randomized to participate in an intensive CV risk detection and control programme by NPHW or to care as usual for 12 months. NOTE: Canada will serve as a pilot study, which will be used to evaluate feasibility, time, cost and program improvements.

CVD Phase: If funded, this phase will be a continuation and expansion of HT Phase to include up to 190 urban and rural communities in countries within Asia, South America, Sub-Saharan Africa, and Canada that will be allocated to participate in an intensive CV risk detection and control programme supported by NPHWs or to care as usual for up to 6 years. NOTE: CVD Phase - currently not initiated.

Communities will be randomized 1:1 with a central randomization system to either a) intervention or b) control, after screening in the community is complete.

Eligibility Criteria:
Inclusion Criteria:

Individuals (≥ 50 years) with at least ONE of the following criteria:

1. SBP ≥160 mmHg in one visit
2. SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension
3. SBP 140-159 mmHg in one visit AND participant taking anti-HT medication
4. SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes
5. SBP ≥130 mmHg in one visit AND participant taking medication for diabetes
6. Participants that do not meet criteria 1-5 AND SBP 140-159 mmHg in one visit AND SBP ≥140 mmHg in a second visit ≥24 hours apart

Exclusion Criteria:

1. Refusal to Consent
2. Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
3. Severe co-morbid condition with life expectancy \< 1 year
4. Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
Cesarean Postoperative Pain Satisfaction

Hypothesis:

There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.

There is a significant difference between Cesarean patients' perceptions of advantages and disadvantages of three postoperative pain management methods identified by obstetrical patients.

Participants will be introduced to study by anesthesia personnel in labor and delivery. The subject will be informed of the desire for their input on their perceived satisfaction with their chosen method for post-operative pain management and will be asked to participate in an anonymous survey by their second day after surgery. They will be informed that this is voluntary. Method of post-operative medication administration will be determined by attending physician to be either: epidural, IVPCA, or oral medication. Methods will be initiated in recovery room or the operative suite.

Subjects will be identified on a postpartum admission log and a screening log will be created for study purposes.

Informed Consents will be obtained. The screening log entries will be numbered corresponding to a numbered survey. The screening log will contain demographic and other patient identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission status of baby, cost associated with method and presence of rescue drugs and costs of rescue drugs and method services. Refusal information, exclusion criteria, and time/date of survey completion will also be recorded. This log will be maintained under lock and key.

Eligibility Criteria:
Inclusion Criteria:

* English speaking post-operative cesarean patients

Exclusion Criteria:

* Cesarean patients with know fetal demise
* General/Local Anesthetic Method for Cesarean
Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax

The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.

Hepatic hydrothorax (HH) is defined as a transudative pleural effusion in patients with liver cirrhosis in the absence of cardiopulmonary disease. The estimated prevalence among patients with liver cirrhosis is approximately 5-6% (Baikati et al., 2014).

HH is an infrequent but a well-known complication of portal hypertension. Trans-diaphragmatic passage of ascitic fluid from peritoneal to the pleural cavity through numerous diaphragmatic defects has been shown to be the predominant mechanism in the formation of HH (Kumar\&Kumar, 2014).

Patients with hepatic hydrothoraces often have few options (Goto et al., 2011). Diuretic-resistant HH could be managed with liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS) or indwelling pleural catheters. However, tube thoracotomy and pleurodesis failed in most patients (Singh et al., 2013).

Case reports and small case series have reported a high rate of complications associated with chest tube placement for hepatic hydrothorax. The most common reported complications were acute kidney injury, pneumothorax, and empyema. Death has been recorded in some cases. Chest tube insertion for hepatic hydrothorax carries significant morbidity and mortality, with questionable benefit (Orman\&Lok, 2009).

Pigtail catheter insertion is an effective and safe method of draining pleural fluid. Its use is safe and recommended for all cases of pleural effusion requiring chest drain except for empyema and other loculated effusions that yielded low success rate (Bediwy and Amer, 2012).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhotic liver and recurrent pleural effusion.
* Pleural fluid should be transudate according to Light's criteria:

  * Pleural fluid-to-serum protein ratio less than 0.5
  * Pleural fluid lactic dehydrogenase (LDH) less than 200 IU
  * Pleural fluid-to-serum LDH ratio and pleural fluid-to-high normal serum LDH ratio less than 0.6

Exclusion Criteria:

* Diagnosis of hepatocellular carcinoma or other neoplasm able to shorten life expectancy.
* Congestive heart failure.
* Recent (i.e. within the previous 2 weeks) episode of digestive hemorrhage.
* Exudative pleural effusion.
* Ascitic fluid or pleural fluid infection
* Platelet count below 50,000
* Prothrombin activity below 50%