cyrilzakka/clinical-trials huggingface dataset:
Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section. Healthy pregnant women will serve as a control group.

The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study:

1. fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section.
2. Bloods will be analyzed for insulin, c-peptide, glucose and fat profile
3. Placenta and fat tissue will be analyzed for miRNA and total RNA
4. Clinical and anthropometric measurements will be taken from the mother
5. Placenta status will be taken

Eligibility Criteria:
Inclusion Criteria:

* age 18-45
* pregnant
* signed consent form
* going through an elective C-section
* Diabetic
* reference group: healthy women with no background illness

Exclusion Criteria:

* \<18 or \>45
* chronic illness that may effect the outcome
* polypharmacy
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* paroxysma, persistent, or permanent non-vlavular atrial fibrillation
* contraindicated to warfarin
* eligible for clopidogrel, ticlopdine, heparin, or aspirin
* CHADS score 1 or greater

Exclusion Criteria:

* NYHA Class IV
* LAA obliteration
* Heart transplant
* LVEF less than 30%
* greater than 50% carotid stenosis
Canadian Medical Assessment of JINARC™ Outcomes Registry

This study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. The study is also describing the time to renal replacement therapy (RRT), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in ADPKD patients treated with JINARC™ (tolvaptan)


Eligibility Criteria:
Inclusion Criteria:

* ADPKD patients ≥18 years old at the time of tolvaptan initiation
* The treating physician must have reached the decision to treat the patient with JINARC™ (tolvaptan) as per the Canadian Product Monograph prior to and independently of soliciting the patient to participate in the study
* The patient or legal guardian must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study

Exclusion Criteria:

* The patient does not comprehend or refuses to sign the informed consent
* The patient has any contraindications to the use of JINARC™ (tolvaptan) as specified in the Canadian Product Monograph
* The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.

In Acute Severe Ulcerative Colitis (ASUC), drug exposure may be affected by intestinal protein loss leading to hypoalbuminemia and rapid clearance of infliximab (IFX). Importantly, 2 studies have associated the loss of IFX in stool with poor outcomes. Multiple observational studies have identified that patients with faster IFX clearance have worse clinical outcomes and higher rates of antidrug antibody formation. To better understand optimal dosing of IFX in ASUC, the pharmacokinetics of IFX in association with outcomes must be better defined in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Present to hospital with ASUC based on Truelove and Witts criteria,33 defined as the presence of more than 6 bloody stools per day along with any 1 of the following: tachycardia \> 90 beats per minute, fever \> 37.8 °C, hemoglobin \< 10.5 g/dL, and erythrocyte sedimentation rate (ESR) \> 30 mm/h (or CRP \> 30 mg/L \[high-sensitivity CRP \> 300 mg/L\]) is a suitable surrogate if ESR is not available1).
* Have a partial MCS \> 7.
* Have a Mayo Clinic ES ≥ 2 with disease extending 15 cm or more beyond the anal verge.
* Require rescue inpatient IFX infusion as part of routine care. Note, the IFX treatment regimen is not defined by this protocol and any dosage regimen is acceptable for the purposes of this study, such as standard or accelerated induction regimens.
* Be able to speak English and participate fully in all aspects of this clinical trial.
* Provide written informed consent.

Exclusion Criteria:

* A known history of being positive for anti-IFX antibodies.
* Have a serious active infection, active malignancy, or any other known condition contraindicated with infliximab therapy, according to current prescribing information.
* Serious underlying disease other than ASUC, or other physical or psychosocial condition that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
* Prior enrollment in the current study.
A Study of LJPC-501 in Pediatric Patients With Hypotension

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients 2-17 years of age.
2. Patients requiring a total sum NE equivalent dose of \> 0.1 μg/kg/min for a minimum of 2 hours and a maximum of 48 hours prior to initiation of LJPC-501 dosing.
3. Patients must have clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
4. Patients are required to have central venous access, which is expected to remain present for the duration of LJPC-501 treatment.
5. Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 24 hours of LJPC-501 treatment.
6. Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and are adequately volume resuscitated in the opinion of the Investigator.
7. Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.

Exclusion Criteria:

1. Patients who are \< 2 years of age or ≥ 18 years of age.
2. Patients with a standing Do Not Resuscitate order.
3. Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
4. Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
5. Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
6. Patients with a clinical suspicion of cardiogenic shock.
7. Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
8. Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
9. Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
10. Patients with active bleeding AND hemoglobin \< 7 g/dL or any other condition that would contraindicate serial blood sampling.
11. Patients with an absolute neutrophil count (ANC) of \< 500 cells/mm3.
12. Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
13. Patients with an expected lifespan of \< 12 hours or withdrawal of life support within 24 hours of Screening.
14. Patients with a known allergy to mannitol.
15. Patients who are currently participating in another investigational clinical trial.
16. Patients of childbearing potential who are known to be pregnant at the time of Screening.
Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19

The goal of this clinical trial is to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in the treatment of the Omicron variant of COVID-19. The main question it aims to answer is: Whether the use of the drug can help patients recover from COVID-19.

Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature \>38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of COVID-19 infection within 24h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA；
* Age ≥12 years and weight ≥ 40Kg；
* Subjects of fertility must agree to use highly effective contraceptive methods.

Exclusion Criteria:

* Previous history of COVID-19 treatment；
* The known history of active liver disease；
* Patients on renal dialysis or have moderate to severe impaired renal function；
* The known human immunodeficiency virus (HIV) infection;
* Suspected or confirmed concurrent active systemic infections other than COVID-19 infection；
* Allergy or other contraindication to any component of the study intervention;
* Any drug or substance that is currently or expected to be used that is a high reliance on CYP3A4 enzyme clearance or strong CYP3A4 enzyme inducers；
* pregnant or breastfeeding women.
Safety and Tolerability of Artificial Tears in Dry Eye Subjects

The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.


Eligibility Criteria:
Inclusion Criteria:

* Mild, moderate or severe symptoms of dry eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Contact lens wear
* Participation in another clinical study
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.

In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.

During 12 weeks,

15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).

and

14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).

After 12 weeks of treatment patients were evaluated.

Baseline and Post-THT measures were determined: Insulin, body mass index, waist circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.

Eligibility Criteria:
Inclusion Criteria:

* A body mass index between 18 and 27 kg/m2;
* Sex live complaints;
* No evidence of cardiovascular disease;
* General good health based on history and physical examination.

Exclusion Criteria:

* A past history of neurological disorder;
* Had received pharmacotherapy for cardiovascular disease before screening
* Taking medication known to interfere with steroids;
* Recent psychiatric or systemic illness;
* Uncontrolled hypertension (blood pressure\>160/95mmHg),
* Unstable cardiovascular disease;
* Genital bleeding;
* Use of psychoactive medications,
* Alcohol excess consumption or any other drug abuse;
Intraoperative Imaging of Lymph Nodes

One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers.

The objective of this study is to evaluate the sensitivity of our two new imaging technologies (bioinspired imaging sensor and low noise imaging sensor) to detect positive sentinel lymph nodes in patients with breast cancer. We will achieve this by recording fluorescence emitted by an FDA-approved fluorescent probe known as Indocyanine Green (ICG) in ex vivo resected samples. ICG is routinely used during cancer surgeries around the world because it passively accumulates in sentinel lymph nodes. Due to the bright green coloration of ICG, surgeons can visually identify the location of the sentinel lymph node, resect them and stage the patient's cancer based on pathology results. Since ICG is also fluorescent in the near infrared spectrum, our imaging sensor can locate the sentinel lymph node quicker and more accurately than when using unaided visual inspection. Once the lymph node is located using near-infrared (NIR) imaging with indocyanine green (ICG), the extracted samples will be placed on a separate table. These samples will be subjected to ultraviolet (UV) light to check for any natural autofluorescence. A strong autofluorescence indicates the sample is likely positive or metastatic, suggesting the presence of cancer cells. Subsequent histopathological analysis will further examine these samples. The findings will be used to construct a receiver operating curve, which will help in determining the accuracy of detecting cancer-positive lymph nodes using both exogenous (ICG-induced) and endogenous (natural) fluorescence with the two imaging systems.

Eligibility Criteria:
Inclusion Criteria:

* early or progressive stage of breast cancer who needs to be treated with breast surgery

Exclusion Criteria:

* pregnant women
* previous breast cancer surgery
* history of allergic reactions to iodide or seafood allergy.
* man
Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.

This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.

This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.

It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).

Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).

For all 40 patients:

1. Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated;

   Only for Group 1 children it will be also evaluate:
2. The presence of the same strains during 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 and after 60 days from the suspension of the administration.

Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics, Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility. The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45 amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a final cooling step at 40°C for 30 sec. Absolute quantification was performed using the "second derivative maximum method"

Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.

Eligibility Criteria:
Inclusion Criteria:

- Age between 10 and 14 months

Exclusion Criteria:

* gastrointestinal disease in progress or appearance in the last 30 days
* metabolic diseases
* antibiotic treatment in the 2 weeks prior to the start of the study;
* intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.
Monitoring Community Trends in Heart Failure

To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its therapeutic management, and changes over time in the hospital and long-term survival of patients with heart failure.

BACKGROUND:

Heart failure is estimated to contribute to nearly 1 million hospitalizations and approximately 250,000 deaths annually in the U.S. The number of new cases of heart failure in the U.S. is estimated to exceed 400,000 annually. Though reliable estimates of the magnitude, incidence, and mortality of heart failure remain sorely lacking, heart failure is associated with a grim prognosis. However, little recent data exist, particularly from a community-wide perspective, to determine whether the incidence or survival associated with heart failure, and the management of this clinical syndrome, has changed over time.

DESIGN NARRATIVE:

The study uses residents of the Worcester (MA) metropolitan area (1990 census 437,000) and examines changes over time in these and additional outcomes for patients with validated heart failure during 1995 and 2000. Complimenting the hospital surveillance of heart failure, newly diagnosed cases of heart failure occurring in members of the largest HMO in Central Massachusetts during 1995 and 2000 will be identified and monitored over time. To accomplish the study objectives, the medical records of residents of the Worcester metropolitan area hospitalized with a discharge diagnosis of heart failure and related diagnostic rubrics will be individually reviewed and validated according to pre-established diagnostic criteria. The use of traditional criteria for heart failure as well as development of new criteria for the epidemiological study of heart failure will be an important focus of this observational study. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term survival of discharged hospital patients through the year 2005.

Eligibility Criteria:
No eligibility criteria
Ankle Strengthening in Athletes With Chronic Ankle Instability

Chronic ankle instability (CAI) is a common complication following an ankle sprain, affecting joint stability and leading to decreased muscle strength and poor neuromuscular control. These symptoms can significantly impact athletes' sports performance. Rehabilitation training for CAI majorly involves strengthening or balance training. Few studies have discussed treatment plans that combine the above two training, and the effectiveness of combined training is similar to that of single training content. Due to the lack of machines to train ankle strength, thera-bands were often used for ankle strengthening. However, the resistance thera-bands provide is limited and may need more for athletes requiring high-intensity training. In recent years, a local company has developed a multiaxial ankle training system for machine-based ankle strengthening. This machine allows for training the ankle joint in various directions while sitting and can provide greater training resistance. As this machine has recently been developed and there is seldom evidence for its use in training, this project aims to discuss the effectiveness of using the ankle training machine in athletes with chronic ankle instability. This study will compare the differences in muscle strength, morphology, muscle material properties, balance ability, and functional performance of athletes after a six-week combined training program with thera-band or the multiaxial ankle training system for providing resistance. Thereby establishing a training plan for athletes suffering from chronic ankle instability.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral CAI: Cumberland Ankle Instability Tool (CAIT) score ≤ 24
* Age between 18 and 28 years
* Engages in sports training at least 3 days a week, for more than 1 hour each session
* Able to perform training and assessment movements

Exclusion Criteria:

* Bilateral CAI
* Less than 6 months since the first ankle sprain
* Acute ankle sprain within the last 6 weeks
* Foot or ankle surgery within the last 3 months
* Neuromuscular diseases.