cyrilzakka/clinical-trials huggingface dataset:
Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous rectal diseases. However, this has not always been the case and this development has been facilitated by the invention of circular stapling instruments, which allow the bowel to be reconnected to the anal sphincters, where it would almost be impossible to do so manually. Nevertheless, some patients still require a permanent ostomy, as even with stapling devices ultra low joins of the bowel and sphincter muscles cannot always be performed by a conventional surgery. Therefore, a variety of alternative techniques have been proposed to avoid a permanent ostomy, but these have not become widespread due to the technical difficulty in performing them, their failure to completely eradicate rectal disease, and the damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.

The ideal ultra low sphincter preserving operation should remove the rectal disease entirely, allow the small or large bowel to be safely joined to the anal sphincters under direct vision, and retain the sphincter mechanism in its entirety. We propose such a technique that we term the APPEAR procedure, which approaches the lower third of the rectum via an incision between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter integrity, and allows either a stapled or manual join of the bowel to the sphincter mechanism, under direct vision. This trial is being conducted as a pilot study, with the procedure only offered to patients for whom a conventional sphincter saving procedure was technically impossible, or contraindicated.

This study is recruiting patients with distal third rectal pathology, for whom a conventional sphincter saving procedure is contraindicated, or likely to be technically impossible.

Recruited patients will initially undergo trial dissection by conventional sphincter preserving surgical techniques, which if successful will result in patients entering study arm 1.

However, should this not be possible, a trial anterior perineal dissection will be attempted, with patients entered into study arm 2 if perineal dissection is adequate to allow full rectal excision, and preserve sphincter integrity.

If during a trial of anterior perineal dissection it is decided that sphincter preservation is not safe, or will not allow eradication of rectal disease, conventional proctectomy will be performed, with patients entering study arm 3.

Eligibility Criteria:
Inclusion Criteria:

* All patients regardless of sex
* Undergoing surgery (with curative intent) to excise the lower third of the rectum who may require a permanent stoma
* Deemed suitable by multidisciplinary team.

Exclusion Criteria:

* Patients under the age of 16
* Patients in whom sphincter preservation has already been deemed inappropriate for medical or surgical reasons (e.g. by an MDT for oncological cure), or in whom surgery has been deemed generally inappropriate.
Digital Pathology and AI for Liver Outcomes in MASLD

The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).

MASH, or metabolic dysfunction-associated steatohepatitis, presents histological liver changes resembling those caused by alcohol abuse, but in the absence of alcohol intake. Common among adults with conditions like obesity and type-2 diabetes, MASH, especially its severe form, is anticipated to become a leading cause of end-stage liver disease.

Currently lacking approved treatments, MASH poses a significant burden on liver health and transplantation. Diagnosis and assessment rely on subjective histological review, prone to variability and limitations in detecting subtle changes. Consequently, there's an urgent need for accurate, continuous histological biomarkers.

The FibroNest Ph-FCS offers a promising solution, utilizing high resolution digital pathology and sophisticated algorithmic methods for sensitive and reproducible fibrosis severity assessment and prediction of clinical events. In a 2003 proof of concept retrospective study on 400 patients, its prognostic performance was excellent.

In this proposed multi-center retrospective study, we aim to confirm the Ph-FCS's prognostic value on a large cohort of 1,700 MASLD patients. We will also compare the prognostic performance of the Ph-FCS with the prognostic performance of the NASH-CR Fibrosis stages, and with non-invasive biomarkers like Fib-4 and elastography/Fibroscan, also collected retrospectively from the point of initial diagnosis.

This study seeks to:

(i) Confirm Ph-FCS's prognostic utility on a large scale.

(ii) Compare biopsy-based Ph-FCS with NASH-CRN F Stages

(iii) Compare biopsy-based Ph-FCS with non-invasive biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Adult pts ( \>=18 years old) with MASLD defined histologically.
* Liver biopsy with fibrosis stains available for digitization or already digitized.
* Clinical follow-up \>1 year available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation

Exclusion Criteria:

* Liver diseases other than MASLD Note: no exclusion based on bariatric surgery, significant weight loss or enrollment in NASH clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)
Developing and Testing a Comprehensive MS Spasticity Management Program

This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of definite MS

* At least 18 years old
* Able to walk 25 feet independently with common assistive devices if needed
* Presence of spasticity by self-report interfering with usual daily activities
* Have an email account and be familiar with using it
* Willing to track daily exercise for 4 weeks
* Fluent in English

Exclusion Criteria:

Other medical or behavioral conditions that would limit participation or completion of the study.
Taking Care of Us: A Dyadic Intervention for Heart Failure Couples

This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.

There is a critical need for theoretically- and empirically-driven dyadic interventions to improve the outcomes of both adults with heart failure and their partners. The proposed study will evaluate a novel, dyadic program, Taking Care of Us, versus an educational counseling condition using a randomized controlled trial on 72 couples living with heart failure. Both programs are offered via Zoom by trained interventionists and last approximately two months.

Specifically, we will 1) determine the efficacy of the Taking Care of Us intervention on dyadic health; 2) determine the efficacy of the Taking Care of Us intervention on dyadic appraisal and dyadic management; and 3) determine the feasibility and acceptability of the Taking Care of Us intervention.

Eligibility Criteria:
Inclusion Criteria: Adults with Heart Failure:

* Diagnosis of heart failure for at least three months
* Current heart failure symptoms (i.e., NYHA Class II-III; AHA/ACC Stage C)
* Age greater than or equal to 18 years
* Willing and able to provide informed consent
* Reachable by telephone/email
* Access to device with camera (e.g., computer, tablet) to participate in Zoom sessions
* Have a co-residing spouse/unmarried partner willing to participate

Inclusion Criteria: Spouses/Partners:

* Age greater than or equal to 18 years
* Co-residing with the adult with heart failure at time of recruitment
* Have lived with the adult with heart failure for at least one year
* Willing and able to provide informed consent

Exclusion Criteria:

* Major and uncorrected hearing impairment
* Significant cognitive impairment
* Heart transplantation/mechanical circulatory support prior to enrollment
* Concomitant terminal illness that would impede participation
* Active psychosis or severe substance abuse that would impair the ability to complete the study
* Inability to complete the requirements of the study, including enrolment in an additional trial
Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage IIb, IIc, III melanoma
* Surgical resection within 90 days of first dosing
* Persons with positive sentinel nodes must have a complete lymphadenectomy
* ECOG performance status 0 or 1

Exclusion Criteria:

* Any prior melanoma treatment other than surgery or regional irradiation
* Use of biologic response modifiers within 60 days of first dosing
* Subjects with history of other malignancy within past 5 years (with exceptions)
Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing


Eligibility Criteria:
Inclusion Criteria:

* history of grass pollen induced allergic rhinoconjunctivitis
* positive skin prick test

Exclusion Criteria:

* uncontrolled severe bronchial asthma
* previous treatment with immunotherapy within the previous 5 years
* contraindication for specific immunotherapy
Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

Noninvasive evaluation of the electrical status of the heart is based on the standard ECG but remains suboptimal due to difficulties with arrhythmia characterization and location. Electrocardiographic Imaging (ECGI) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. The applicant will develop a systematic evaluation of the ECGI as a tool to detect cardiac regions of interest in cardiac arrhythmias.

The specific aim of this multicenter observational study is to evaluate the precision of non-invasive cardiac mapping system ECGI using multipolar intracardiac recordings as the gold standard. We will develop a non-invasive ECGi and intracardiac recordings in patients undergoing electrophysiology studies and/or intracardiac devices implantation to correlate the position of the regions of interest at predefined anatomy sites in patients with different organized arrhythmias. The long-term outcome of the electrophysiological characterization using ECGI will be also evaluated. Finally, the cost-efficiency of ECGI system as a support tool in cardiac arrhythmias diagnosis will be assessed.

Objectives: to perform a systematic evaluation of the ECGI with recordings using multipolar intracardiac recordings as the gold standard. Secondly, the study will also validate the ability of the ECGI recordings to increase the precision of the standard ECG interpretation by an expert.

Eligibility Criteria:
Inclusion Criteria:

* Indication for an invasive electroanatomic study and/or intracardiac device implantation.
* Having obtained and signed the informed consent for study participation.
* Ability to stand, to be able to obtain the 3D torso reconstruction necessary for the ECGI system.

Exclusion Criteria:

* \<18 years old
* Inability to perform an endocardial catheterization and/or device implantation.
* Physical or mental disability to understand and accept the informed consent.
* Inability to stand to obtain the 3D torso reconstruction.
* active coronary ischemia or decompensated heart failure
* Intracardiac clot on trans-esophageal echocardiography
* Pregnancy.
* Disorganized arrhythmias (i.e. atrial fibrillation, polymorphic ventricular tachycardia).
Safety and Efficacy Study in Infant With SBS

The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection


Eligibility Criteria:
Inclusion Criteria

1. Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
2. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
3. After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption.

Exclusion Criteria

1. Subject has undergone any bowel lengthening procedure.
2. Subject has a malabsorption disorder due to:

   * congenital etiology (such as microvilli inclusion disease, tufting enteropathy)
   * Untreated Hirchsprung's disease
3. Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.
4. Subjects with hyperinsulinemia.
5. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life.

Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic ultrasound (EUS).

Patients with PEI (FE1 \<200) receive Pertzye or placebo in a cross-over fashion, each for 4 weeks.

Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).

Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-80 years
* Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)
* On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study
* Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool

Exclusion Criteria:

* Common bile duct obstruction resulting in obstructive jaundice
* Celiac disease
* Crohn's disease
* Benign pancreatic conditions
* Bowel obstruction
* Surgically altered bowel anatomy
HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10\^6U/m\^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10\^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m\^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m\^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Pathologically confirmed diagnosis of mucosal melanoma;
4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
5. No prior systemic adjuvant therapy or regional radiotherapy;
6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
7. Normal bone marrow function; and adequate liver and renal function \[including white blood cell (WBC) count \> 3,000/mm\^3;absolute neutrophil count \> 1,500/mm\^3; platelets \>100,000/mm\^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN\].

Exclusion Criteria:

1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
2. Incomplete resection or primary tumor unable to be resected;
3. A second cancer diagnosis;
4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
5. Severe depression; and pregnant or lactating female.
Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma.They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.

Eligibility Criteria:
Inclusion Criteria:

Presence of all the following three criteria:

* Immediate cutaneous hyperreactivity on aspergillus skin test
* Elevated total IgE levels \> 1000 IU/mL
* A fumigatus specific IgE levels \> 0.35 kUA/L

And, two of the following criteria:

* Presence of serum precipitating antibodies against A fumigatus
* Fixed or transient radiographic pulmonary opacities
* Total eosinophil count \> 1000/µL
* Central bronchiectasis on HRCT

Exclusion Criteria:

* Failure to give informed consent
* Intake of glucocorticoids for more than three weeks in the preceding six months
* Enrollment in another trial of ABPA
* Any exposure to azoles in the last six months
Investigation of Multiple Ultrasound Techniques for the Assessment of Carotid Plaque Vulnerability

Stroke is a common clinical disease with high disability and mortality, which seriously threatens human life and health.Carotid atherosclerotic plaque rupture is an important pathogenic basis of ischemic stroke, so judging the stability of plaque has important clinical significance in preventing ischemic stroke.Ultrasound, as a convenient, rapid, noninvasive, radiation-free auxiliary examination technology, is widely used in carotid plaque stability examination.At present, there are many methods to judge the stability of carotid plaque based on ultrasound, including two-dimensional ultrasound, contrast-enhanced ultrasound, ultrasound elastography and so on. However, the results of plaque stability judgment by various technologies deviate greatly, which is not conducive to the development of standardized diagnosis and treatment strategies by clinicians.Studies have shown that because the neovascular epidermal cells in atherosclerotic plaques are imperfect, they are easy to rupture after stress, and the ruptured neovasculature will lead to intraplaque hemorrhage, thus causing plaque shedding, and eventually obstructing the cerebrovascular cause stroke.Contrast-enhanced ultrasound can sensitively detect the distribution and course of blood vessels.The plaque's softness and hardness determine its stability, while the difference of lipids, fibers and calcium in the plaque determines its softness and hardness.Real-time ultrasound elastography can provide tissue mechanical parameters, express the soft and hard of tissue with strain value, and provide important reference information for judging plaque stability.At present, elastography technology is used to reflect the hardness of plaque, so as to further judge its stability.However, the elastography parameters are prone to deviations due to the influence of the selected section and the selected region of interest.It can be seen from the above that there is currently a multi-modality method to evaluate the stability of carotid plaque using ultrasound, but there is a lack of a unified and objective reference standard for plaque stability assessment.The purpose of this study is to explore the comprehensive utilization of these modalities under the premise of optimizing each ultrasound modality to provide a unified and objective criterion for judging the stability of carotid plaque.


Eligibility Criteria:
Inclusion Criteria:

* At least one examination suggested the presence of carotid plaque
* Suitable for CEUS examination
* Voluntary enrollment in this study and signing of informed consent

Exclusion Criteria:

* Among ischemic brain rates caused by non-carotid plaque shedding
* Follow-up Lost
* Pregnant women