cyrilzakka/clinical-trials huggingface dataset:
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 85 years old
* Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
* Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
* Life expectancy of at least 24 months
* If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.

Exclusion Criteria:

* Malignancy or treatment for malignancy within the previous 6 months
* Immunodeficiency including AIDS / HIV or Active autoimmune disease
* Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
* Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
* History of failed organ transplant on immunosuppression.
* Subjects with known active infection (infection which is being treated)
The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction

Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glands may become obstructed due to change in meibum quality. When meibum thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment for MGD is a procedure called "warm compresses". It is a combination of applying heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland openings, and allow oils to flow normally onto the tear film once again. One way to apply heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes are gently massaged afterwards.

The purpose of this study is to determine how effective the EyeBag is at improving MGD and dry eye symptoms.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. OSDI score ≥ 23;
5. Meibomian gland score of ≤ 9 (out of 15).
6. Is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen
7. Agree to using MetricWire for online data entry
8. Is not a contact lens wearer (Infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)).

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study;
2. Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag
3. Has any known active\* ocular disease and/or infection;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment, as determined verbally;
8. Is aphakic;
9. Has undergone refractive error surgery; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. An exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients

In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.

The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.

Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Single ventricle physiology congenital heart disease status post Fontan palliation
* Undergoing clinically-indicated liver biopsy
* Ability to tolerate 60 minutes in an MRI scanner without sedation

Exclusion Criteria:

* Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
* Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing prior to imaging
Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma
* Disease progression after prior therapy in locally advanced or metastatic setting
* Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
* Age 12 months to \<21 years
* Adequate bone marrow reserves, hepatic function, and renal function
* Recovered from effects of any prior surgery or cancer therapy
* Patients 18 years or older will provide written consent. A parent or legal guardian of a patient \<18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy.

Exclusion Criteria:

* Clinically significant gastrointestinal disorders
* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
* Active infection or unexplained fever
* Known hypersensitivity to any of the components of MM-398 or other liposomal products
* Recent Investigational therapy
* Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention

Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.

The link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.

Experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.

To address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.


Eligibility Criteria:
Inclusion Criteria:

1. CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations
2. Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.
3. At risk of or already documented respiratory infections requiring antibiotics.
4. Age between 0-72 months at inclusion.

Exclusion Criteria:

1. Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.
2. Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.
3. Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.
4. Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.
5. Neurological or psychiatric disorders
6. Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.
7. Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.
8. Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses;

Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management.

Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of claudication
2. Be undergoing one of three treatments for claudication:

   * Surgical bypass (use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral or popliteal artery)
   * Endovascular therapy (angioplasty and/or stent to treat lesions in the superficial femoral, common femoral or popliteal artery)
   * Medical management (i.e. smoking cessation, walking therapy, long-term monitoring by physician)

Exclusion Criteria:

1. those with documented acute ischemia, rest pain or ulceration
2. those with claudication determined to be of aortic or iliac origin
3. those with claudication that is not caused by atherosclerotic disease
4. those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
5. those who otherwise refuse to participate (assessed in patient screen)
6. those who have a diagnosis of dementia confirmed in their medical record
7. those who are not English speaking
8. children and young adults up to and including age 20-years
A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).


Eligibility Criteria:
Inclusion Criteria:

* 2 visible moderate to severe nasolabial folds
* Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study

Exclusion Criteria:

* Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months
* Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months
* Received semi-permanent fillers or permanent facial implants anywhere in the lower face
Treatment Use Study for Advanced Melanoma.

The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.

This is an expanded access trial that canceled prior to enrolling patients.

Eligibility Criteria:
Inclusion Criteria:

* Advanced melanoma with life expectancy of at least 6 months.
* Melanoma must be considered unresectable.
* Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.

Exclusion Criteria:

* Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment.
* History of chronic inflammatory or autoimmune disease.
* History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.
Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.

We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1, 2002 through July 31, 2004. We excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment. Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers. The statistical analysis was performed in accordance of the intention-to-treat principle. Student t test, Chi square and Fisher exact test were used for analysis. A P value of \< .05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Women in preterm labor with intact membranes
* Women with preterm premature rupture of membranes
* Women been delivered for fetal and maternal indications
* Gestational age between 24 and 33 6/7 weeks'.

Exclusion Criteria:

* Clinical chorioamnionitis
* known major fetal structural anomalies,
* known fetal chromosomal abnormalities,
* prior antenatal steroid exposure,
* quadruplets and higher order multiple gestation
* Women who declined enrollment.
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.


Eligibility Criteria:
Inclusion criteria:

* HRPC patients
* Evidence of disease progression
* Self care, able to perform light work activities
* Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion criteria:

* History of other cancers not curatively treated with no evidence of disease for more than 5 years.
* Prior radiotherapy within 3 weeks of starting study treatment
* Prior radiopharmaceuticals (strontium, samarium).
* Impaired cardiac function
* Heart disease
* Liver or renal disease with impaired functions.

Other protocol-defined inclusion/exclusion criteria may apply
OSPM-Enhanced AI Model to Identify Premalignant and Malignant Ocular Surface Tumors

An OSPM-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. To further substantiate the model's effectiveness, we intend to evaluate it prospectively at Ningbo Eye Hospital.


Eligibility Criteria:
Inclusion Criteria:

● Ocular surface tumor images with histopathological findings

Exclusion Criteria:

● Low-quality images
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants

Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24-33.6
* Physician decision on the need for non invasive ventilation
* parental consent

Exclusion Criteria:

* Pneumothorax before recruitment
* Significant congenital heart disease or chromosomal disorder
Sleepiness and Sleep-disordered Breathing in Fabry Disease. A Prospective Cohort Study.

Prospective, observational cohort study to investigate the prevalence of sleepiness and sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in all subjects.

There are 76 patients with Fabry disease in the region of eastern Switzerland who are observed and treated in the University Hospital Zurich. All patients are encountered in retrospective cohort study, and all patients are asked to participate in the study by obtaining written informed consent.

Eligible Fabry patients are investigated by completion of ESS and one ambulatory overnight respiratory polygraphy (oRP). An ESS over 11 is defined as excessive daytime sleepiness(EDS). An apnoea/hypopnoea index (AHI) over 5 per minute is defined as sleep apnoea. Distinction of obstructive sleep apnoea (OSA) and central sleep apnoea (CSA) is performed by analysis of oRP. Medical history, clinical and laboratory data, and current treatment will be extracted from patient files and the retrospective cohort study, respectively.

The patients are asked to participate in the study at clinically regular follow-up visits. After obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. For this, additional laboratory analyses and completion of ESS and patient's health questionnaire (PHQ-9) is required.

The screening visit is encountered in the routine clinical follow-up examination. After obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. For this, the laboratory results (s. exclusion criteria), which are part of the routine follow-up examination, are checked, and PHQ-9 and ESS are completed together with the patient.

In case of fulfilling all inclusion criteria without presence of exclusion criteria, the patients are scheduled by telephone call for visit 1 (oRP).

Eligible Fabry patients are investigated one ambulatory overnight respiratory polygraphy (oRP). For this reason, the subjects are asked to pick-up and learn the self-administration of the oRP device (ApneaLink™ Plus (ResMed)). The oRP itself is easily performed at subject's home. The following day, the patients need to return the device, or, alternatively, they can send it by post. After oRP, there is no need for further visits for purpose of the study. The subjects are informed about the results of oRP during the next regular clinical follow-up visit.

ORP is a non-invasive medical examination technique, which is routinely applied to detect sleep-related breathing disorders. For purpose of the oRP, the ApneaLink™ Plus (ResMed), a home sleep testing diagnostic device that provides simple, cost-effective and reliable results, is applied. The subjects will be instructed in the usage of the device, so that they can install themselves in the study night.

Eligibility Criteria:
Inclusion criteria: Established diagnosis of Fabry disease, who

* are 18 years or above
* have signed informed consent.
Cicatrix Cream in Cutaneous Groves

The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will be 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent

Exclusion Criteria:

* Patient that refer manifestations of high sensibility to the medication or to some of the components of the product.
* Patient that don't want to participate in the study.
* Patient not very cooperative.
* Responsible family not very cooperative.