cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time

Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.

Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".

THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom CMR-LGE is performed for a clinical reason
* Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
* Both sexes
* Any age
* Availability of serum creatinine, measured within one month prior to CMR
* Provision of the written informed consent

Exclusion Criteria:

* Non-contrast CMR
* First-pass perfusion stress-CMR
* Absolute contraindication to CMR
* Inadequate overall image quality
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

The aim of this study is to assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.

Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
* Be at least 18 years old, male or female
* Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses
* Correctable to at least 6/12 (20/40) or better in each eye with contact lenses
* Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent)

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants
* Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery
* Contraindications to contact lens wear
* Known allergy or intolerance to ingredients in any of the clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests
Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer: a Randomized Controlled Trial

The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.

Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.

Exclusion Criteria:

* Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from the study.
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment)
* Ability to comply with study requirements
* Age at least 18 years old

Exclusion Criteria:

* Underlying IBD
* History of stomach surgery or bowel resection
* Anticipated antibiotic exposure during the study period
* Advanced liver disease
* Ongoing alcohol or drug abuse
* Pregnancy
* Any reason felt by the investigator to complicate the feasibility of participation
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique

In this COMPLETE randomized trial, using the contemporary second-generation drug-eluting stent, we aimed to test whether the crush technique is superior to the culotte technique for the treatment of bifurcation lesions in terms of 1-year target-lesion failure.


Eligibility Criteria:
Inclusion criteria:

1. Age ≥19 years
2. De novo coronary lesions eligible for drug-eluting stent implantation
3. Medina 1,1,1 or 1,0,1 or 0,1,1 de novo bifurcation lesions (LM or non-LM) and those of main vessel or side branch can be covered by 2 stents
4. Reference vessel diameter of side branch ≥2.5 mm by visual estimation

Exclusion criteria

1. Current or potential pregnancy
2. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
3. Subjects with ST elevation myocardial infarction \<24 h from the onset of chest pain
4. Cardiogenic Shock
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit

The purpose of this observational research study is to examine how point-of care ultrasound affects the workup and management of perioperative complications for specific clinical scenarios of low blood pressure (hypotension), low blood oxygen (hypoxemia), in the post- anesthesia care unit (PACU).


Eligibility Criteria:
Inclusion Criteria:

* Patients in the post-anesthesia care unit with the following events
* Mean arterial blood pressure \<60 mmHg or \<20% of pre-operative baseline mean arterial blood pressure,) hypoxemia (pulse oximetry saturation \<95% or Pao2 \<80), altered mental status, decreased urine output, chest pain/EKG changes, or to confirm endotracheal Lube placement.

Exclusion Criteria:

* Patients who are not able to have a point of care ultrasound examination in the post anesthesia recovery area.
Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

The purpose of this study is to compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable/uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to any products to be administered - Concerns for subject's compliance
ESP vs TAP in Total Laparoscopic Hysterectomy

The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.

From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.

For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.

Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.

In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.

The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.

Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) I-III risk
* no contraindication to the execution of the peripheral nerve block
* signature of the informed consent
* total videolaparoscopic surgery (no conversion to open-abdomen)

Exclusion Criteria:

* allergies and / or contraindications to the administration of the drugs used in the study
* infections and injuries at the puncture site
* BMI ≥40
* history of opioid abuse or use of opioids in chronic therapy
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)

This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an alternative to liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female and at least 18 years of age
* Generally good health
* Willing to fast for 8 hours prior to each study visit

Hepatitis C Virus (HCV) Inclusion Criteria:

* Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;

For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)

* Never been treated for HCV

Healthy Participant Inclusion Criteria:

* Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening

Exclusion Criteria:

* History of stroke, seizures, or neurological disorders
* Consumption of excessive amounts of alcohol
* Use of products containing nicotine
* Unable to hold a breath for 20 seconds
* Claustrophobia
* Use of illicit drugs or history of drug or alcohol abuse

HCV-Positive Exclusion Criteria:

* Evidence or history of chronic hepatitis not caused by HCV
* HIV
Urine pH and Urinary Tract Infection

Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI.

This study aims at following urine pH progression at the time of diagnosis of UTI and during the treatment phase.

Description of the change in urine pH over time will help understanding the risk of struvite formation and potential timing of intervention.

Adults presenting with UTI symptoms will be screened for infection and instructed to monitor urine pH during the course of treatment and 1 week after. Urine pH will be measured by the patients using calibrated pH-stix. Type of bacteria, antibiotics, and the type of diet will be monitored during the study.

Eligibility Criteria:
Group 1. Cystitis

Inclusion Criteria:

* Symptoms of dysuria, pollakiuria, no fever AND
* urine-stix positive for leucocytes OR positive culture (\>10E5 cfu/ml)

Group 2. Pyelonephritis

Inclusion Criteria:

* Unilateral flank pain, pollakiuria, dysuria, fever (\>38.5°C) AND
* urine-stix positive for leucocytes OR positive culture (\>10E5 cfu/ml)

Exclusion Criteria (both groups):

* known urinary tract anatomic abnormalities
* Presence of a urine catheter
* Sepsis - septic shock
* Patient taking drug interfering with urine pH (diuretics, citrate, acetazolamide, topiramate,...)
* Patients with UTI diagnosed in the preceding month
* Patients having received antibiotics during the preceding month
* Male patient with a diagnosis of prostatitis
* Presence of infected kidney cyst
* Patient with diabetes
* Pregnant female
* Patient with obstructive pyelonephritis
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-75 years of age;
* type 2 diabetes diagnosed \>=1 month before screening;
* no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

* type 1 diabetes;
* type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
* patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells.

The scarcity and the inadequacy of data make impossible the writing of evidence-based recommendations for prevention and management of infections in myelodysplastic syndrome.

The aim of this study is to evaluate the incidence and the spectrum of the infections of MDS patients. Will be also evaluated potential risk factors.

This study could help the definition of the optimal management of MDS patients in terms of prophylaxis of the infective complications and in terms of the correct administration of growth factors.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
* Signed written informed consent;

Exclusion Criteria:

* Psychiatric patients;
* Patients with life expectancy less than three months.
Glucose Monitoring Comparison in Primary Care

This research trial will randomize 50 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.

The trial will evaluate the comparative effectiveness of SMBG (self-monitoring of blood glucose, also known as blood glucose monitoring \[BGM\] or fingerstick blood glucose monitoring) vs. continuous glucose monitoring (CGM), in managing glucose levels in individuals with type 2 diabetes (T2D) using insulin, with or without other glycemic therapies, in a primary care setting.

The study will use a 2-arm, parallel group, cluster-randomized trial over a 12-month period. 50 primary care clinics will be randomly assigned to either use SMBG for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care, or CGM for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care using CGM and Ambulatory Glucose Profile (AGP) reports in a typical clinic setting. The study will use glycemic monitoring devices available to participants using real-world resources to cover the cost of the devices, and will be fundamentally pragmatic in nature.

354 patients (approximately 7/clinic) will be enrolled over 13 months (12 months of active intervention) with an intention-to-treat primary analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 (inclusive)
2. Diagnosis of type 2 diabetes
3. A1C 7.5% to 12% (inclusive) in the last 2 months. (If A1C is older than 2 months at the baseline visit, a point-of-care or lab A1C may be done for eligibility)
4. Insulin use with or without other classes of glycemia medication use
5. No significant comorbidities that could impair the ability of a primary care team to manage diabetes, including but not limited to end stage renal disease, cognitive impairment, active cancer, and pregnancy
6. Established care within the HealthPartners Care Group, no plans to move within the next year, and willing to participate for the duration of the study
7. Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
8. Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
9. Willing to use SMBG or CGM, depending on randomization, in the way that their care team recommends and/or how they feel is most useful in managing their diabetes
10. Not currently using personal CGM
11. Not planning to become pregnant

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent
2. Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)