cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia

The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.

Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:

1. Botox-Epic group received 20 units of Botox injection into lateral epicondyle;
2. Botox-Tend group had 20 units of Botox injected into tender point of muscles;
3. Steroid group had 40mg of triamcinolone injected into lateral epicondyle.

The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,
* local tenderness around the lateral epicondyle, and
* pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.

Exclusion Criteria:

* local steroid injection within the past six months,
* coexisting elbow arthritis or arthralgia,
* previous trauma or surgery history over the lateral epicondyle,
* pregnancy or lactation, and
* other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.
Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes

To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes.

Small fiber neuropathy (SFN) is a subtype of diabetic neuropathy, patients with SFN often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. Skin biopsy is an effective method to diagnose SFN with high diagnostic accuracy. The procedure is simple and minimally, and the wound usually heals within a few days. However, skin biopsy is not widely used in diagnose of SFN in Chinese patients with diabetes. This study is aimed to establish a normal reference range of intraepidermal nerve fiber density (IENFD) in the Chinese population, and to detect SFN in Chinese patients with diabetes by skin biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18 and ≦75 years old
* A history of diabetes
* Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes

Exclusion Criteria:

* Acute skin infection or injury
* Coagulation disorders
* History of malignant tumor
* Usage of neurotoxic drugs
* Alcohol abuse
* Vascular diseases, e.g. LEASO and stroke
* Infectious diseases, e.g. hepatitis B, HIV, and syphilis
* Metabolic disorders, e.g. hypothyroidism, hyperlipidemia, and amyloid lesions
* Connective tissue diseases
* Nutritional disorders, e.g.vitamin B6 deficiency, and vitamin B12 deficiency
* Other causes of peripheral neuropathy, e.g. lumbar disc herniation, Guillain-Barre Syndrome, and polyradiculopathy
Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth

This protocol is a study of HIV+ young people who were identified as having certain HIV-1 specific T-cell responses and genetic markers while previously enrolled in the 5-year longitudinal adolescent study, "REACH." Blood samples will be collected, a medical and medication history and physical examination will be performed every 6 months for a total of 2 years.

Numerous studies have demonstrated an association between HLA class I genotypes with differing progression to AIDS in individuals who are followed after being off antiretroviral therapy. These studies do not always associate the same HLA class I alleles with the risks of HIV-1 disease progression; however they consistently demonstrated that HLA-B\*35 and B\*53 portend a bad outcome compared to the better outcome observed in HLA-B\*27 and B\*57 carriers. Despite this information, very little data exists to explain the mechanism of this association.

This longitudinal study will look at the HIV-1 specific CD8+ T-cell responses and the dominant HIV-1 genotype among individuals identified as HLA-B\*27, B\*35, B\*53 and B\*57 positive through studies done in collaboration with the REACH project.

Eligibility Criteria:
Inclusion Criteria:

* HLA-Class I HLA-B\*27, B\*35, B\*53 and/or B\*57 positive identified through the REACH study
* Subject's ability and willingness to provide written informed consent
* Subject's ability and willingness to be followed at least one year on this ATN 026 study

Exclusion Criteria:

* On chronic immunosuppressive therapy, not including topical or inhaled steroid use.
* Any prohibited medication listed in protocol within 2 weeks prior to the Entry visit labs
A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland

The goal of this study is to investigate to what extent a 12-week training course for people with type 2 diabetes mellitus (T2DM) or MODY can be conducted in a clinical context with clinically relevant improvements in cardiometabolic risk factors and quality of life?

The main questions it aims to answer are:

1. To investigate the feasibility of supervised training for people with T2DM or MODY in a clinical context in Greenland.
2. To investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being.
3. To investigate the signs of efficacy and different interactions with the type of disease.

Globally, type 2 diabetes mellitus (T2DM) is a major public health issue. This is also the fact in Greenland, the biggest island in the world.

Twice as many Greenlanders as Danes have diabetes, and this is due to both lifestyle and genes. It is estimated that 7% of T2DM patients in Greenland have Maturity Onset Diabetes of the Young (MODY), which is hereditary and rare elsewhere.

Exercise improves blood sugar control in T2DM, reduces cardiovascular risk factors such as hypertension and dyslipidemia, contributes to weight loss and improves fitness and well-being. Less is known of how people with MODY responds to exercise.

Today, the Greenlandic health care system only offers supervised physical training to people with osteoarthritis in two towns in Greenland, but in the future, they would like to offer supervised physical training to people with other conditions too.

Relevance: As mentioned above, this study aims to evaluate the feasibility of a 12-week supervised physical training intervention for people with T2DM or MODY and to investigate signs of efficacy and different interactions with the type of disease.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes or MODY
* Living in the capital in Greenland, Nuuk

Exclusion Criteria:

* Severe heart disease
Self-monitoring of the Intraocular Pressure Versus Hospital-based Diurnal Monitoring

Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.

Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.

Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.

The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Subjects aged 18 and older
* Glaucoma patients and healthy controls
* Best corrected visual acuity \>0.1
* Astigmatism ≤ 3dpt.
* Good compliance
* Central corneal thickness (400-650μm)
* Passed certification procedure (detailed description under: Measurements and procedures)
* Therapeutic regimen unchanged throughout the past 30 days

Exclusion Criteria:

* History of ocular trauma
* Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity \<0.1
* Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
* Dry eye disease
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Pregnancy
* Breastfeeding
AqueSys Microfistula Implant in Refractory Glaucoma

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Refractory Glaucoma
* Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
* Visual field mean deviation score of -3 dB or worse
* Shaffer Angle Grade ≥ 3
* Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

* Active Neovascular Glaucoma
* Previous glaucoma shunt/valve in the targeted quadrant
* History of corneal surgery, opacities or disease/pathology
* Anticipated need for ocular surgery
* Non-study eye with BCVA of 20/200 or worse
LifeVest Safety and Efficacy in Real Life Settings in France

This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF \<30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF \< 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a LifeVest prescription in clinical routine for the following indications:

  1. implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
  2. a bridge to heart transplantation,
  3. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \<30%),
  4. a recent coronary revascularization with LV dysfunction (LVEF \< 30%).
* Patients who have given their consent to participate.

Exclusion Criteria:

- There are no exclusion criteria for this study
TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

The purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (TDCS) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The recent use of TDCS over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. Previous studies of cognitive retraining have focused on implicit training techniques. This proposed study will attempt to enhance these implicit training techniques through the use of TDCS during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. The objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.


Eligibility Criteria:
Inclusion Criteria:

* Consume 10 or more cigarettes/day average for the past 60 days
* Able to provide informed consent
* Less than 3 months smoking abstinence in the past year
* Right Handed

Exclusion Criteria:

* Serious medical illness within 6 months (e.g. cancer, hepatic, or renal disease)
* Significant cardiovascular disease (e.g. recent stroke or heart attack, arrhythmias, worsening angina pectoris, uncontrolled hypertension) generalized skin disorders, or sensitivity to the nicotine patch
* Use of illicit drugs (excluding marijuana) in the previous 30 days
* Psychosis, psychotic disorder, or bipolar disorder
* Current active major depression (depressive episode within last month)
* Clinically significant suicidal ideation
* Prior seizure
* Current bupropion or tricyclic antidepressants
* Current pregnancy, trying to become pregnant, or breastfeeding
* Current active alcohol dependence (symptoms in last 30 days)
* Left-handedness
* Current medication known to interact with nicotine replacement therapy (NRT) or smoking cessation (e.g. adenosine, cimetidine, conivaptan, cyproterone, peginterferon alfa-2bg, tocilizumab, theophylline)
* Metal in the head
* Implanted brain medical devices
* Electromedical devices
* Latex Allergy
Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?

Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.


Eligibility Criteria:
Inclusion criteria are :

* Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication.
* Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of:

  * Fever (\>38.5° rectal, \>38° oral) AND
  * Vesicular or ulcerative lesions located in the anterior of the mouth
  * Associated or not with perioral vesicular lesions Visiting the emergency department within the first 96 hours of the disease begin.

Exclusion criteria are :

* Duration of fever \> 4 days
* Hospitalised patients
* Immunocompromised patients
* Patients with known hypersensitivity to Valacyclovir
* Patients with renal failure
* Children with complete incapacity of oral treatment intake
* Unable to be contacted for phone follow-up
Young With Diabetes Type 1 - Test of an mHealth App

A multicenter randomized controlled trial testing the app "Young with Diabetes"

Young people with diabetes type 1, their parents and health care providers have participated in developing the mHealth app "Young with Diabetes".

The aim of the app is to support young people to self-manage their diabetes type 1.

A test group of 70 young people with diabetes type 1 test the app for 12 months as a supplement to standard care and the control group receives standard care only.

At baseline and after 2, 7 and 12 months HbA1c, problem areas in diabetes, perceived competences in diabetes and health care climate are measured.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* 14 to 22 years old
* followed at one of the six diabetes departments/centers

  1. Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
  2. Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
  3. Pediatric and Adolescent Department, Herlev Hospital
  4. Steno Diabetes Center, Gentofte
  5. Pediatric Department, Roskilde Hospital
  6. Department of Endocrinology, Køge Hospital
* have an iOS or android smartphone
* last measured HbA1c before sending out recruiting letters: 64 mmol/mol or more (if the last measured HbA1c is older than 6 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)
* mean of the three last measured HbA1c before sending out recruiting letters: 58 mmol/mol or more (if the third last HbA1c is older than 18 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)

Exclusion Criteria:

* A psychical or psychiatric disorder that enables them to use the app
* Participates in other diabetes interventions
* Sees a psychologist or psychiatrist
* Have participated in developing the app Young with Diabetes
Functional and Structural Characterization of Arteriopathy in Pseudoxanthoma Elasticum (PXE)

To determine the specific structural and functional features of the peripheral arteriopathy in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.

The primary objective of this study is to characterize the structural and functional characteristics of the peripheral arteries (lower and upper limbs) . a secondary objective will be to determine the arterial calcification using CT-scan as a useful tools for the diagnosis and the follow-up of this disease. Data will be collected from a cohort of patients PXE monitored in our Health and Research PXE center at the University Hospital of Angers. The structural and functional variables of the distal arteries (radial and tibialis arteries) will be studied using high-resolution echography. Scoring of the arterial calcium load will be determined by helicoidal CT-scan in the lower limb arteries. These variables will be compared to matched (gender and age) controls without PXE.

Eligibility Criteria:
Inclusion Criteria:

* Patients with phenotypically and genetically (ABCC6) proved PXE or control patients paired for age and gender
* Written formed consent obtained
* Patient affiliated to a Health care system

Exclusion Criteria:

* Patient with unproved PXE
* Pregnant woman
* Patient unwilling to participate to the study
* Not affiliated to a Health care System
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

* Patients \< 18 years of age
* Emergency surgery
* Pre-existing valve prosthesis
* Aortic root replacement
* Active endocarditis
Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.

This clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.

Natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries.

Previously, herbs are used in dentistry for prevention and curative purpose of dental caries. The main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance.

Grape seed extract (GSE) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth.

Grape seed extract (GSE), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. There are multiple bioactive properties in GSE, but in particular, its rich content of proanthocyanidins (PACs) plays a role in its theoretical benefit in caries prevention.

PACs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates.

The remineralization effect of GSE appears to be featured. First, it participates in mineral deposition on the superficial layer of the lesion through forming insoluble complexes and combines with calcium to enhance remineralization. Second, GSE may interact with the organic portion of enamel through PA-collagen interaction, thereby stabilizing the exposed collagen matrix.

Proanthocyanidin (PA) has been proved to strengthen collagen-based tissues by increasing collagen cross-links. It is claimed that it can increase collagen synthesis and accelerates the conversion of soluble collagen into insoluble collagen. Proanthocyanidin has proved safe in different clinical applications and has been used as dietary supplements as well.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy
* Age range between 13 and 30years.

Exclusion Criteria:

* Severe or active periodontal disease.
* Patients had received therapeutic irradiation to the head and neck region.
* Patients had participated in a clinical trial within 6 months before commencement of this trial.
* Patients unable to return for recall appointments
* Presence of abnormal oral, medical, or mental condition.
* Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.