cyrilzakka/clinical-trials huggingface dataset:
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain

The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography) scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.

The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT scan-proven ureteral stone between 4 to 10 mm undergoing expectant management. Subjects will be distributed at a 1:1 ratio between the control and treatment groups. The treatment group will receive mirabegron and the control groups will receive a placebo. Both groups will receive analgesics and hydration will be recommended. All subjects will then be followed for 30 days to determine the proportion of subjects with spontaneous passage. Patients will record narcotic usage and pain scores during this time. If there is stone persistence in the ureter based on imaging (CT scan of the abdomen and pelvis versus renal ultrasound plus KUB), then the patient will undergo ureteroscopy with stent placement. In these patients, treatment will continue while the stent is in place and patients will fill out a validated questionnaire regarding stent pain.

Eligibility Criteria:
Inclusion Criteria:

* Single unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
* Serum creatinine within normal range
* Ability to tolerate oral fluids and oral pain medication
* Able to make informed medical decisions regarding consent
* Willingness to follow-up in the Urology Clinic in approximately 30 day
* Willing to undergo ureteroscopic extraction should the stone not pass in this time period

Exclusion Criteria:

* Adults unable to consent
* Age less than 18
* Multiple stones
* Solitary kidney
* Horseshoe kidney
* On immunosuppressant therapy
* On digoxin
* Uncontrolled hypertension (Systolic blood pressure \> 170, diastolic blood pressure \> 110)
* History of ureteral surgery or previous endoscopic procedure
* Allergy to mirabegron
* Current calcium antagonist or corticosteroid or tamsulosin usage
* Patients already taking a beta-adrenergic agonist medication
* Renal insufficiency \[Glomerular Filtration Rate (GFR) less than 60\]
* Patients with Childs B and C liver failure
* Signs of infection i. Temperature greater than 38 degrees Celsius ii. Urinalysis with any of the following positive:

  1. Positive nitrites
  2. White blood cell count greater than 15/hpf (high powered field)
  3. Positive urine culture \[defined as a single isolated bacterial species population of greater than 100,000 Colony Forming Units (CFU)\]
* Patients with chronic pain already undergoing treatment with narcotic medications
* Pregnant women and nursing mothers
* Prisoners
* No working phone number
Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid, to characterize focal liver lesion or to investigate diffuse liver disease
* OR, Liver living donor candidates
* AND subjects who sign the informed consent.

Exclusion Criteria:

* Minors under 18 years old
* All contraindication to MRI
* Hypersensitivity to Gd
* Biliary obstruction
Placental and Cord Blood Markers Associated With Premature Birth and Disorders of Premature Birth in Newborn Infants

The purpose of this study is to determine if changes in specific gene products in the placenta or cord/infant blood affect a baby's birth weight, increase the risk of premature birth, or increase the risk of developing diseases of prematurity. We would also like to characterize whether placental epigenetic changes or placental markers of environmental exposures are associated with premature birth.

Prematurity, diseases of prematurity and growth-disorders of newborn infants contribute significantly to morbidity and mortality seen in newborn infants \[1,2,3\]. One out of eight newborn infants in the USA is born premature (gestational age less than 37 completed weeks). In 2004, of the 27,860 infants dying within the first year of life, greater than 16,000 were born premature \[2\]. Moreover, premature infants who survive the neonatal period are at increased risk of cerebral palsy, developmental delays, growth impairment and long-term respiratory disability \[3-5\]. Additionally, fetal growth restriction and fetal growth excess results in infants being delivered as small for gestational age infants or large for gestational age infants, respectively. Infants born with such growth-disorders are at increased risk of perinatal morbidity and mortality and as adults are at significant risk of obesity, type II diabetes and heart disease \[6,7\].

While the etiology of preterm birth and growth-disorders can be ascribed to maternal conditions, chromosomal defects or specific maternal environmental exposures in some newborn infants, for a majority the etiology remains unknown \[8,9\]. There is increasing evidence pointing to the role of genetic susceptibility factors in the causation of prematurity and growth-disorders of the newborn infant \[8, 10-12\]. Further, epigenetic changes in growth regulating or inflammatory genes in the placenta can program the fetus for premature birth, growth-disorders and other diseases in the postnatal period.

The overall objective of this application is four-fold.

1. To determine whether altered placental or fetal expression of imprinted genes is associated with disorders of growth, prematurity or other postnatal diseases in newborn infants.
2. To determine whether altered placental expression of genes that regulate the innate immune response is associated with premature birth or other postnatal diseases in newborn infants.
3. To determine whether placental markers of environmental exposure (such as Polycyclic Aromatic Hydrocarbons or PAH) or epigenetic changes in placental inflammatory genes or growth genes are associated with prematurity or postnatal diseases in newborn infants.
4. To determine whether cord blood immune responses and markers of immune-cell function are different between preterm and term infants and are associated with postnatal diseases in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* all infants born alive

Exclusion Criteria:

* infants who are born with no signs of life
Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and almost no GVHD increases the importance of addressing later SCC even further. The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same.

Funding Source - FDA Office of Orphan Products Development (OOPD)

Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Currently, the only curative treatment option for the hematological complications of FA include hematopoietic cell transplantation (HCT). The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same.

This study is an open-label, single arm study. This study will enroll approximately 45 post-HCT patients with FA, and approximately 10 patients with FA without history of HCT. In both groups, patients with or without existing pre-malignant lesions or history of SCC will be allowed to participate, if they wish so and at the discretion of the PI. All patients will be treated with oral quercetin.

The investigators will determine the efficacy of Quercetin in reducing buccal micronuclei (a surrogate marker of DNA damage and susceptibility to squamous cell carcinoma due to genomic instability) in post-HCT patients with fanconi anemia (FA).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FA
* Able to take enteral medication
* Patients ≥2 years

Exclusion Criteria:

* Renal failure requiring dialysis
* Total bilirubin \>3 mg/dl and/or SGPT \>200 at time of enrollment
* Patients receiving digoxin therapy, who are unable to discontinue either treatment due to medical reasons
* Patients who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable methods of birth control during the length of the study
* Patients who have received quercetin supplementation or other antioxidants within the last 30 days
* Patients receiving radiation therapy, chemotherapy or immunotherapy for treatment of SCC.
Aerobic Exercise, Balance Training, and Ataxia

The first aim is to show aerobic training improves degenerative cerebellar patients functionally

The second aim is to compare the effects of balance and aerobic training on degenerative cerebellar disease.

Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. The investigators hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spinocerebellar ataxia
* Cerebellar atrophy on MRI
* Prevalence of ataxia on clinical exam
* Ability to safely ride a stationary exercise bike

Exclusion Criteria:

* Other neurologic conditions
* Heart disease
* Cognitive impairment
* Medical instability
COVID-19 Antibody Responses in Cystic Fibrosis

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed


Eligibility Criteria:
Inclusion Criteria:

* Person with cystic fibrosis of any age, genotype, transplant status and disease severity.
* Express consent obtained after informing the patient and/or his legal representatives or parents In France, written and informed consent will be requested.
* For France, affiliation to a social security scheme or similar

Exclusion Criteria:

* Refusal to give informed consent
* Contraindication to venepuncture
* For France

  * Person under guardianship / curatorship
  * Person under legal protection
CLA Metabolism and Effects on Human Health

The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.

After collecting baseline blood samples, CLA-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a CLA-enriched butter for another 8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of CLA on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers;
* 20 to 40 years;
* BMI between 18.0 and 29.9 kg/m2.

Exclusion Criteria:

* Use of dietary supplements;
* Smoker;
* Alcoholic;
* Under medication;
* History of chronic disease
Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching

One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching.

The null hypotheses will be:

1. Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching.
2. Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
3. Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.

Selecting the proper shade for a restoration is of vital importance for achieving optimal aesthetic results. However, shade selection can be time-consuming, somewhat subjective, and heavily reliant on the clinician's visual judgement.

This study will explore the ability of Omnichroma restorations to shade match tooth structure after bleaching. Patients visiting the JUST dental clinics who have at least two anterior restorations (one Omnichroma restoration and one multi-shade nanohybrid composite restoration) will be recruited for this study. The calculated sample size for the study is 240 teeth.

The shade and the L\*a\*b\* scores will be recorded using spectrophotometer prior to bleaching and after bleaching. Two blinded, calibrated dentists will independently evaluate the resulting shade outcomes and assess the degree of color match between the restorations and the adjacent teeth after bleaching. This assessment will be categorized as either match or no match. The patient's satisfaction will also be recorded two weeks after bleaching.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are willing to come back for follow-up appointments.
2. Patients who are willing to sign an informed consent form.
3. Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
4. Patients aged 18 years or older.
5. Patients with good oral hygiene
6. Patients with vital teeth.
7. Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment.

Exclusion Criteria:

1. Individuals with severe bruxism or periodontal disease.
2. Patients with non-vital teeth restored with composite fillings.
3. Patients with severe tooth discoloration.
4. Patients with fluorosis or tetracycline staining.
5. Heavy smokers.
6. Pregnant or nursing women.
7. Patients undergoing orthodontic treatment.
8. Patients with enamel or dentin deformations.
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* primary liver transplantation
* retransplantation within two weeks
* written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* chronic kidney disease:
* Creatinine Clearance \< 35 ml/min or Serum Creatinine \> 2,5 mg/dl
* known hypersensitivity to Zoledronate, or any of the recipients of the drug
* bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation
Better Diabetes Control, Quality - Educate to Achieve Compliance.

Prospective study to evaluate the impact of an educational programme about diabetes, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal

Prospective study to evaluate the impact of an educational programme about diabetes focusing on treatment compliance, exercise and nutrition, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 2 diabetes
* HbA1c \<= 8,5%
* Treated with oral antidiabetics for at least 6 months

Exclusion Criteria:

- Treatment with insulin
Investigation of Coagulation Parameters in Hereditary Haemorrhagic Telangiectasia

We will address coagulation parameters in hereditary haemorrhagic telangiectasia (HHT) compared to controls.

The inherited disease hereditary haemorrhagic telangiectasia (HHT) causes bleeding from dilated fragile vessels, particularly in the nose and gut. However, many HHT patients develop deep venous thromboses and/or pulmonary embolism, necessitating treatments with anticoagulants that further impair control of their haemorrhagic state. Our initial observations using general coagulation tests suggest that the blood of HHT patients is intrinsically hypercoagulable.

We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of one or several of the proteins which affect blood clotting leading to a hypercoagulable state.

We propose to study levels and activity of blood coagulation factors in people with hereditary haemorrhagic telangiectasia and in normal volunteers. This should define the significance and basis for our initial observations, and will have significant implications for the clinical management of HHT patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HHT and normal controls

Exclusion Criteria:

* Previous thrombosis, recent ill health
The Concept of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds and to Develop an Algorithm for Analgesia at the Stages of Treatment

in 82.1% of cases it is not possible to achieve a positive result of pain treatment

The concept of pain treatment in patients with gunshot and mine-explosive injuries and the developed pain relief algorithm at the stages of treatment will have an impact on the results of pain treatment in this category of patients.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries