cyrilzakka/clinical-trials huggingface dataset:
N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE

The primary objective of the study is to assess the safety of N-Acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.

Preclinical studies demonstrated that N-Acetylcysteine (NAC) is able to break von Willebrand Factor (VWF) multimers by bisulfide bond reduction. Since thrombi in stroke patients are rich in VWF, NAC could be used as a thrombolytic agent during the acute phase. This study aims at assessing the safety of NAC in combination with alteplase (rt-PA) at the acute phase of ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with an acute ischemic stroke (non lacunar) as assessed by cerebral imaging (either CT or MRI), with or without visible vessel occlusion.
* Patient eligible to intravenous thrombolysis according to current criteria, including patients who will also benefit from endovascular treatment (if eligible).
* Personal or familial consent to participate in the study.

Exclusion Criteria:

* Known hypersensitivity to N-Acetylcysteine or to any excipient from the formulation.
* Coma and/or NIHSS \<4 or ≥20.
* Daily treatment with Nitrovasodilator before the inclusion.
* Known asthma or chronic obstructive pulmonary disease requiring bronchodilatators or steroids.
* Participation to another interventional study if it requires administration of an experimental treatment in the first 3 days after NAC treatment.
* Women of childbearing age (age \< or = to 50)
* Known history of prior treatment with vitamin-K antagonist or direct oral anticoagulant.
* Known history of severe hepatopathy including cirrhosis, portal hypertension (esophageal varices) and evolutive hepatopathy.
Optoelectronic Pletysmography and Diaphragmatic Thickness in Heart Failure Patients

The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP \<70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness


Eligibility Criteria:
Inclusion Criteria:

* Both sexes, 18-60 years;
* Functional Class II-III according to the New York Heart Association;
* Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
* Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)\> 54 mm, diameter of Systolic Left Ventricular (LVSD)\> 34mm) 30 measured by Teichholz method;
* Optimized by the medical point of view and
* Clinical stability

Exclusion Criteria:

* Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
* Orthopedic diseases, infectious or chronic metabolic diseases;
* The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) \<70% of predicted characterizing obstructive respiratory disorder and
* Active smokers.
Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma

This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit

Exclusion Criteria:

* Central nervous system involvement by melanoma
Artificial Intelligence + Care Coach Intervention

The purpose of this research study is to develop and test an artificial intelligence intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* age ≥65 years with a diagnosis of dementia within the electronic health record OR new cognitive impairment identified during an ED visit
* be fluent in English or Spanish
* discharge after an ED visit
* possession of a smart device (either a phone, tablet, or computer) that has internet access to utilize and interact with NeuViCare AI services

Exclusion Criteria:

- evidence of delirium, by the 4-AT screening tool
Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support

The purpose of this study is to implement a pragmatic intervention in four (4) family medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients with chronic diseases.

Chronic diseases represent a major health burden worldwide. Some people with chronic diseases require a higher level of care due to personal characteristics that increase their vulnerability. For these patients, nurse effective case management in primary care are associated with positive outcomes. Moreover, self-management programs, such as the standford program developed by the School of Medicine at the University of Standford in California (USA), are also recognized for their benefits on patients with chronic diseases.

The aim of our project is to implement, within four (4) FMGs of the region of Saguenay-Lac-Saint-Jean , a practical intervention involving case management by a nurse to promote interdisciplinary person-centered monitoring and self-management support for highly vulnerable individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain).

The objectives of our study : 1) To analyze the implementation of the intervention in the participating FMGs in order to determine how the various contexts have influenced the implementation and the observed effects; 2) To evaluate the proximal and intermediate effects of the intervention on patients; 3) To conduct an economic analysis of the effectiveness and cost-benefit of the intervention.

The analysis of the implementation will be conducted using realistic evaluation approaches and participatory practice within four categories of key players (FMG stakeholders, FMG/health center managers, patients and their families, health center partners or communities). The data will be obtained through individual or group interviews, literature reviews and documentation from the intervention undertaken. The evaluation of the effects in patients will be based on a pragmatic randomized experimental design before and after (six months) with delayed intervention in the control group. Economic analysis will include a cost-effectiveness analysis and a cost-benefit analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient of the participating FMGs
* Aged between 25 and 80 years
* Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain)
* Identified as a frequent user of health services (by a health care provider or/and a software)

Exclusion Criteria:

* Patient unable to provide consent
* With cognitive impairment
* With uncontrolled psychiatric illness
* Patient with a prognostic of less than one years
Expanded Indications in the Pediatric BONEBRIDGE Population

This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.

This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

Eligibility Criteria:
Inclusion Criteria:

* Under 12 years of age
* Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted
* Sufficient air-bone gap (ABG) at in the ear to be implanted
* HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
* Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
* Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
* Parental commitment to comply with all study procedures

Exclusion Criteria:

* Children under 3 years (36 months) of age
* Chronic or non-revisable vestibular or balance disorders
* Abnormally progressive hearing loss
* Prior use of a hearing implant in the ear to be implanted
* Current/ongoing use of a hearing implant in the contralateral/non-implant ear
* Evidence that hearing loss is retrocochlear in origin
* Medical condition that contraindicates implant surgery or anesthesia
* Skin or scalp condition precluding use of external audio processor
The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.

The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with Crohn's Disease

Exclusion Criteria:

* Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry
* Patients who are unable to participate in the program for 2 years or more.
Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

Explore the efficacy, safety and related influencing factors of intervention therapy based on PegIFN α- 2b in inactive hepatis B surface antigen (HBsAg) carriers (IHCs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (GM-CSF), high-dose hepatitis B vaccine and pegifn α- 2B feasibility, efficacy and safety of monotherapy for IHCs.The IHCs patients were randomly divided into two groups (group A: pegifn α- 2b single drug group, group B: pegifn α- 2b combined with GM-CSF and high-dose hepatitis B vaccine group). To start applying pegifn α- 2B was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. Patients in group B used GM-CSF and vaccine introduction for 16 weeks before baseline.The HBsAg clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years;
* HBsAg seropositive status for more than 6 months prior to enrollment;
* never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
* Serum HBsAg ≤1500 IU/mL;
* HBeAg negative with or without HBeAb positive;
* Serum HBV DNA ≤2000IU/ml IU/mL;
* normal ALT levels;
* normal white blood cell and platelet counts;
* abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.

Exclusion Criteria:

* Participants with other hepatotropic viruses or human immunodeficiency virus co-infection
* other chronic non-viral liver diseases or decompensated liver diseases
* tumours
* drug abuse
* severe psychiatric disease
* uncontrolled thyroid disease or diabetes
* pregnancy or lactation
A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:

Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment

Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients co-infected with TB
* Receiving any one of the standard anti-TB therapy regimens
* All patients must agree to use contraception since they will be on efavirenz.

Exclusion Criteria:

* Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
Glucose Monitoring During Chemotherapy

This is a research study to look at blood sugar changes during chemotherapy using a continuous blood sugar monitoring device. The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course. Each patch lasts for about 2-weeks. During chemotherapy visits, new patches will be placed and will be worn until the chemotherapy course is complete. Participants will be in this study for 6 months. Approximately 50 patients will be enrolled in this study.

This is a prospective observational cohort study monitoring trends in glucose in patients with early stage breast cancer treated with neoadjuvant or adjuvant chemotherapy. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for the duration of chemotherapy. The primary goal of this trial is to evaluate the prevalence of hyperglycemia in patients with early-stage breast cancer during neoadjuvant/adjuvant chemotherapy. Fifty patients will be enrolled. During each chemotherapy encounter, subjects will have their glucose sensor scanned in order to download subjects' glucose data. If the sensor has become no longer adherent to the participant's skin, participants will bring the sensor with them to the chemotherapy infusion center to be scanned. During each chemotherapy encounter, the Free Style Libre sensor will be replaced by the study team. Participants who receive chemotherapy every three weeks will be asked to come in 10-14 days after their chemotherapy infusion to replace the sensor. The sensors will be worn through completion of chemotherapy (the duration will vary based on the individual's chemotherapy regimen). Patients will have fructosamine, a glucose biomarker, and serum creatinine testing at baseline and every 3 weeks (weeks 3, 6, 9, 12, 15, 18, 21, 24) until week 24 (note: week 15, 18, and 21 are optional). Patients will have additional glucose biomarker testing (hemoglobin a1c, glucose, and insulin \[fasting preferred\]) at baseline, week 12 and week 24. Patients will also complete questionnaires assessing for symptoms of chemotherapy induced peripheral neuropathy, quality of life, and fatigue at baseline, week 12 and week 24. Visits will be conducted within the below specified windows forbidding unexpected circumstances such as missed appointments or loss to follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* History of stage I-III breast cancer
* Patient scheduled to receive adjuvant or neoadjuvant chemotherapy
* Signed informed consent

Exclusion Criteria:

* Current treatment with insulin
* Current treatment with non-topical steroids, with the exception of steroid treatment as a supportive chemotherapy medication
* Inability to provide informed consent
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis

The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)

The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to severe erosion and denudation/skin loss with or without secondary infection. The durable, long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin surfaces (i.e., superficial, partial thickness skin loss) to provide better protection against moisture and irritants under challenging conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Is the patient 18 years or older?
2. Has the patient or their legally authorized representative signed the Informed Consent Form?
3. Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
4. Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
5. Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
6. Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?

Exclusion Criteria:

1. Is the patient pregnant or breast feeding?
2. Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
3. Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
4. Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
5. Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
6. Does the patient have any other local dermatological disease or skin condition interfering with this study?
7. Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study?
8. Does the patient participate in another study with a known or implied effect on skin barrier function?
Measuring Levels of SMN in Blood Samples of SMA Patients

Spinal muscular atrophy (SMA) is a disorder that affects the motor neurons. SMA is caused by a mutation in a part of the DNA called the survival motor neuron (SMN1) gene, which normally produces a protein called SMN. Because of their gene mutation, people with SMA make less SMN protein, which results in the loss of motor neurons. SMA symptoms may be improved by increasing the levels of SMN protein. The purpose of this study is to determine whether a drug called a histone deacetylase inhibitor can increase SMN levels.

After undergoing a general medical and neurological evaluation, study participants will donate a blood sample. Researchers will use this sample to measure SMN levels. They will also isolate cells from the blood and treat the cells with various drugs that may increase SMN levels.

Spinal muscular atrophy (SMA) is a currently untreatable, autosomal recessive motor neuron disease that is caused by deficiency of full-length survival motor neuron (SMN) protein. One promising therapeutic approach to SMA is to pharmacologically increase full-length SMN protein levels. Several compounds have been shown to increase SMN levels in immortalized cell lines derived from SMA patients. The objective of this study is to determine baseline SMN levels in primary peripheral blood cells of SMA patients and heterozygous carriers compared to unaffected controls and to investigate the effects in vitro of pharmacological compounds that are expected to increase SMN levels. It is anticipated that these studies will provide further evidence to support the use of one or more of these compounds in a clinical trial for SMA patients. The study population will include patients with genetically proven type I, II, or III SMA and their family members. Blood samples from anonymous, unaffected control patients will be obtained through the department of transfusion medicine (99-CC-0168). This is an investigative study that involves blood drawing only. No new therapy will be provided except the standard of care.

Eligibility Criteria:
* INCLUSION CRITERIA:

Diagnosis of SMA with genetically proven mutations in the SMN1 gene or unaffected family members (age greater than or equal to 2 years).

No exposure to valproic acid or any other HDAC inhibitors for a period of at least 2 weeks.

Written, informed consent (and assent, if applicable).

EXCLUSION CRITERIA:

History of valproic acid or other HDAC inhibitor use within the past14 days.

History of bleeding disorder, which would make a blood draw unsafe.