cyrilzakka/clinical-trials huggingface dataset:
Natural History, Genetic Bases and Phenotype-genotype Correlations in Autosomal Dominant Spinocerebellar Degenerations

The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically and genetically, group of rare diseases and of severe evolution. So far, the responsible genes for less than 50% of the cases are known and because of their rarity, there are no phenotype-genotype correlations and well-defined disease history.

The aims of the project are to develop and validate quantitative tools of the cerebellar syndrome and of the spasticity, to establish links between the phenotype and the result of the molecular analysis, to identify new loci/genes responsible for these disorders, and to establish the natural history of the disease according to the genotype.

To this end, a prospective and multicentric study is proposed for recruiting and evaluating, clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers involved. A DNA collection will be set up in order to search for the implication of new loci and genes. A clinico-genetic database will be set up combining data from successive clinical evaluations and those of genotyping.

This strategy will allow access to genetic counselling and molecular diagnosis (positive, presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype correlations and the information concerning the relative frequency of the genes. The detailed description, with the help of new evaluation tools and of the follow-up of the natural history of the disease according to the genotype, constitutes a crucial step in the design of therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by specialized centers will allow better care of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Progressive ataxia or paraplegia,
* Familial history of the disease (patients),
* Over 18 years of age
* No presentation of neurological or osteoarticular disorders

Exclusion Criteria:

* Refusal to participate in the protocol,
* An unknown familial history,
* Presenting with an interrecurrent disorder making the evaluation of the disease (stroke, dementia) impossible
SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).


Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
5. Currently receiving intravitreal steroid injections
6. Concurrent participation in another clinical trial
7. Females who are pregnant, planning to become pregnant or lactating
A Comparison of the Effectiveness of Two Types of Memory Training Programs in People With a Diagnosis of Mental Illness.

This study will compare the effectiveness of a psychoeducational memory program versus a computerized memory program in individuals with mental illness. Although improvements are expected with both form of interventions, we do not know which will provide maximal benefit in this population.

The aim of the current study is to compare two memory strategies, a top-down (i.e., educational and interventional)protocol vs. a bottom-up (computerized)protocol, in a population of individuals diagnosed with mental illness. Performance on ecologically validated memory tasks will be measured before and after each intervention protocol. Improvements are expected following each protocol. However, there is no evidence available to support added benefits from one protocol over another. As such, the current study will endeavour to contrast the two intervention types (top-down vs. bottom-up) to determine which, if any, provides maximal benefit.

Eligibility Criteria:
Inclusion Criteria:

* Memory impairment equivalent to 1.5 std. dev. below average for age
* Speak and read English fluently

Exclusion Criteria:

* Older than 65 years of age
* Significant visual impairment (e.g., cataracts, macular degeneration)
* Motor impairment (e.g., hemiplegia on dominant side)
* Diagnosis of Dementia
* Alcohol and/or substance abuse (in past 3 months)
The Value of FeNO in Predicting Airway Eosinophilic Inflammation

To investigate and compare the value of FeNO, blood Eos, serum TIgE in predicting the airway eosinophilic inflammationin chronic cough, asthma and COPD.

Cough is the most common complaint in the respiratory department, while asthma and chronic obstructive pulmonary disease(COPD) are two major respiratory disease that seriously endanger human health. The common test to identify the cause and evaluate the therapeutic effect such as induced sputum, pulmonary ventilation function test, bronchial provocation test, etc. are time-consuming and laborious. There is an urgent need for an easily detectable index in the clinic to quickly identify airway eosinophilic inflammation in chronic cough, asthma and COPD, which will provide important guidance for clinical treatment.

As a new marker of airway inflammation, exhaled nitric oxide(FeNO) can reflect eosinophilic airway inflammation. Mean while, FeNO has the advantages of non-invasive, simple operation, time-saving, labor-saving, and good reproducibility, which is suitable for clinical application.

This prospective, multi-center study aims to explore the value of FeNO in predicting airway eosinophilic inflammation and compare it with blood Eos and TLgE in patients with chronic cough, asthma and COPD.

Eligibility Criteria:
Inclusion Criteria:

* Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.
* Patients with chronic cough

  1. Coughing lasting ≥ 8 weeks,
  2. There is no obvious abnormality in the chest X-ray
  3. No clear history of upper respiratory tract infection in the past 4 weeks,
  4. Newly diagnosed or untreated in the last 4 weeks
  5. Non-smokers.
* Patients with Asthma

  1. For newly diagnosed and previously diagnosed asthma patients, the diagnosis criteria for asthma:
  2. Including various disease severity (mild, moderate, severe), various disease states (chronic duration, acute exacerbation period).
  3. Non-smokers.
* Patients with COPD 1) Including patients in stable phase and acute exacerbation phase.

Exclusion Criteria:

* Diagnose patients with ACO;
* Those who cannot cooperate with the completion of research-related test, follow-ups and other reasons cannot cooperate with the progress of the research;
* Combined with serious diseases of other systems (such as cardiovascular, metabolic, immune, neurological, etc.). With other diseases of the lung, including bronchiectasis.
Topical Voltaren in Otitis Externa

Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

Eligibility Criteria:
Inclusion Criteria:

* Adults having otitis externa as single diagnosis mild to moderate

Exclusion Criteria:

* Diabetes
* Children
* Pregnant women
* Immune compromise
* Starting other treatment
* Moderate to severe otitis externa
Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. It accounts for substantial morbidity and represents a substantial cost to health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and neutrophil/endothelial cell attachment, which is believed to play a key role in the pathogenesis of acute pancreatitis.

Other possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2 existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying compared with saline spraying or no intervention indicates a potential relative risk reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce post-ERCP pancreatitis is needed.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old patients planned for ERCP.

Exclusion Criteria:

* contraindications to ERCP
* allergy to epinephrine or NSAIDs
* Not suitable for pre-ERCP indomethacin (received NSAIDs within 7 days before the procedure; gastrointestinal hemorrhage within 4 weeks; renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure)
* previous biliary sphincterotomy without planned pancreatic duct manipulation
* ERCP for biliary stent removal or exchange without planned pancreatic duct manipulation
* acute pancreatitis within 3 days before the procedure
* unwilling or inability to provide consent
* pregnant or breastfeeding women
Metabolic Response to Chardonnay Grape Marc Powder

To determine if the addition of chardonnay grape marc (also called pomace) powder enriched with grape seed extract to the diet will result in reducing blood levels of cholesterol or triglycerides.

Previous research on grape seed nutritional properties has predominantly been confined to grape seed extracts (GSE) containing only soluble components. In animal models, GSE has been shown to prevent increases in blood pressure, blood cholesterol, and insulin resistance. In humans, there have been improvements in blood pressure, however no significant effect on blood cholesterol levels. Whole milled grape marc flours deliver more dietary complexity than seed extracts alone. In addition to the extractable and non-extractable polyphenols, flour offers dietary fiber, minerals, sterols and polyunsaturated fats. Grape marc flour is currently used as a food ingredient that is incorporated into various baked goods. However, to obtain good control of the dose level, the product will be provided in capsule form for this study. For reference, a ½ cup of of a high polyphenol food such as blueberries, contains about 325 milligrams of polyphenols, thus even with the higher dose, participants will be receiving an amount of polyphenols that is less than ¼ cup of blueberries. The grape marc powder is prepared in a facility that is certified for producing food-grade products, and the nutritional composition and safety of the product will be thoroughly evaluated before we begin the study. The objective of the current study is to determine if this chardonnay grape marc powder enriched with grape seed extract supplementation has beneficial impacts on the human blood lipid profile and to correlate gut biome changes to human metabolism.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25 and \< 40 kg/m2
* Dyslipidemia as defined as (any one or all of the following values):
* Total cholesterol \> 190 mg/dL but \< 240 mg/dL
* LDL-cholesterol \> 130 mg/dL but \< 160 mg/dL
* HDL-cholesterol \< 40 mg/dL (men)/\<50 mg/dL (women)
* Fasting triglycerides \> 150 mg/dL but \< 300 mg/dL

Exclusion Criteria:

* Renal, cardiovascular, gastrointestinal or hepatic disease, by medical history
* History of a previous cardiovascular event
* Diagnosis of type 2 diabetes
* Pregnancy or lactation
* Use of tobacco
* Food sensitivities or allergies to the foods or components of foods provided in the standard meals including gluten, dairy, egg, soy, nuts, or seafood
* Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study.
* Use of lipid-lowering, glucose-lowering, anti-hypertensive, or weight loss medications
* Use of antibiotics in the last three months.
Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women

Develop and evaluate a peer navigator intervention to assist Korean women with a potential breast abnormality, who have missed their first follow-up appointment, to complete all diagnostic follow-up tests.

The purpose of this study is to design an intervention to assist Korean American women who have been identified with a potential breast abnormality through the Breast Cancer Early Detection Program and who have missed their first follow-up appointment (at risk women). Intervention activities will include reminder phone calls or home visits by a trained peer navigator to explain the importance of follow-up procedures, emotional support, help with transportation to follow-up appointments, translations, organizing care for children or grandchildren during medical appointments, and other assistance to overcome barriers to follow-up identified during the initial phase of the study. The investigators will collect extensive process measures including number and type of intervention activities requested and delivered in order to estimate the feasibility for institutionalizing intervention activities. The investigators will conduct chart reviews and a follow-up survey to evaluate the effectiveness of the intervention in increasing adherence to follow-up procedures.

Eligibility Criteria:
Inclusion Criteria:

* Being: a Korean American woman
* Screened through the Breast Cancer Early Detection Program
* With a potential breast abnormality
* Having missed a first diagnostic follow-up appointment

Exclusion Criteria:

* Not a Korean American woman
* Not screened through the Breast Cancer Early Detection Program
* No potential breast abnormality
* Not having missed a first diagnostic follow-up appointment
Dapagliflozin DPPIV Inhibitor add-on Study

This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
* Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Exclusion Criteria:

* Patients with type 1 diabetes
* Patients with very poorly controlled diabetes
* Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
fMRI Study of Effects of Nasal Insulin on Memory

Recent research has suggested insulin may be involved in how human's form and recall memories. This study is designed to look at how nasal insulin is used in the brain. Specifically, how insulin alters the various connections within brain regions that occur while adults perform simple attention and memory tasks. This study is divided into two parts: blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood draw procedure is designed to look at the effects of intranasal insulin using a Precision Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to participate will receiving a low-dose saline solution and low-dose of insulin through a nasal spray followed by a blood draw session to measure your blood glucose and insulin levels over a 90 minute period.

Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During the scan, participants will complete a series of memory tasks reflected on a computer screen. The trial will be randomized and double-blinded.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults over the age of 18

Exclusion Criteria:

* any existing health conditions: including diabetes, history of alcoholism or drug dependence
* contraindications to Magnetic Resonance Imaging (MRI): any non-titanium metal in the head or body
Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

Peri - operative ultrasonography was used to evaluate the effects of protective lung ventilation on the postoperative lungs of obese patients.The purpose of this study was to apply ultrasound lung ventilation area score to the monitoring of pulmonary complications in patients with postoperative obesity.To verify the reliability and practicability of perioperative lung ultrasound quantitative scoring.

Ultrasound lung ventilation area score was applied to monitor the pulmonary complications of patients after obesity operation to verify the perioperative period.

The reliability and practicability of quantitative lung ultrasound score to clarify the effect of protective lung ventilation under perioperative pulmonary ultrasound monitoring on obesity patients.To guide the management of mechanical ventilation under general anesthesia and the prevention and treatment of postoperative pulmonary complications

Eligibility Criteria:
Inclusion Criteria:

* enrollment of patients aged 18 years or above；
* Eligible adult patients had an American Society of Anesthesiologists (ASA) physical status classification of I to IV
* undergoing elective or expedited nonurgent, noncardiac surgery with general anesthesia

Exclusion Criteria:

* patient refusal;
* morbid obesity (BMI \>40 kg/ m²);
* American Society of Anesthesiologists (ASA) physical status categories IV-V;
* previous intrathoracic procedure;
* severechronic obstructive pulmonary disease (forced expiratory volume in 1 s \<30% of the predicted value;
* a contraindication to radial artery cannulation.
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.


Eligibility Criteria:
Inclusion Criteria

* Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
* Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

Exclusion Criteria

- None
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Baseline measurements will include successful use of an external telescope.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Eligibility Criteria:
Inclusion Criteria:

* Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical

Exclusion Criteria:

* Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.
CLE for Differential Diagnosis of IBD

Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.


Eligibility Criteria:
Inclusion Criteria:

* equal or above 18 years of age
* ability to provide written informed consent
* well-established diagnosis of CD or UC

Exclusion Criteria:

* history of IBD reclassification in the last 3 years
* Boston Bowel Preparation Scale score's \< 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
* inability to provide written informed consent
* severe uncontrolled coagulopathy
* impaired renal function
* pregnancy or breast feeding
* active gastrointestinal bleeding
* known allergy to fluorescein
* residence in institutions