cyrilzakka/clinical-trials huggingface dataset:
Thick vs. Thin Acellular Dermal Matrix (ADM)

To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.


Eligibility Criteria:
Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form.
Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

Maternal undernutrition concerns 10-19% of women of reproductive age globally, the vast majority of which live in sub Saharan Africa and south Asia. Recommendations for nutritional interventions to tackle the problem range from per-pregnancy supplementation to upstream interventions targeting women of reproductive age before conception. To render the latter interventions cost-effective and sustainable, experts recommend to focus on food processing that leads to an enhanced nutrient content. One such method, which has been known and practiced for centuries in diverse societies, is fermentation. Traditionally fermented foods are diverse, widespread and highly appreciated in Burkina Faso. The present study aims to investigate the effect of fermented millet porridge on gut microbiota diversity, stool short chain fatty acid concentration and inflammation markers level in women of reproductive age living in rural Burkina Faso.


Eligibility Criteria:
Inclusion Criteria:

Participant are

* 18 to 49 years old
* Resident in the study area and do not plan to move within 5 months following the start of the study
* Are not on antibiotic treatment on inclusion and have not been in the previous 3 weeks.
* Do not suffer from any pathology that could interfere with their diet.
* Have no known allergy to pearl millet or its derivatives
* Agree to sign a consent to participate in the study-

Exclusion Criteria:

* Women under 18 or over 49
* Women not consuming pearl millet porridge due to allergy or food preference
* Women planning to move from the study area within 5 months of the start of the study
* Women with serious illnesses that may interfere with their diet
* Women on antibiotic treatment or at the time of inclusion or having been in the previous 3 weeks.
* In addition, women who will benefit from antibiotic therapy during the study will be excluded from the analysis
Chronic Kidney Disease Prevention of An-Lo District, Keelung

The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004 (2). The disease had not only caused a significant impact in personal life, but also a great burden on social security and government-run health insurance. However, despite this high prevalence, the awareness of chronic kidney disease (CKD) in general population remains low (3, 4). The patients always come out too late for the intervention to slow down the progression of renal failure. Furthermore, most of them are not well prepared for the renal replacement therapy. The facts result in high mortality and morbidity in this specific population (5). It is mandatory to screen out and treat these patients early enough. However, these patients are deep into the community as the asymptomatic nature of CKD.

The major purpose of the study is to screen the community for the early CKD and provide the appropriate intervention at time. The study will collect the characteristic demographic epidemiological data and find out risk factors for CKD of this geographic area, provide multidisciplinary education of CKD and establish timely referral for appropriate nephrologist care for treatment and monitoring of complications.

The project will be last for 3 years. We will start to screen the patients within the community to identify the CKD population. This population will randomized into two group (one group with standard nephrologist care and another group with standard nephrologist care plus multidisciplinary CKD education) to evaluate the effectiveness of CKD education on the progression of renal function. The primary end-point will be the doubling tine estimated GFR, development of end-stage renal disease and all cause mortality. The non-CKD group of community will also follow up for urine and blood test for renal function, to determine the incidence and risk factors of new-onset renal disease. The accomplishment of this study will retard renal progression, improve community health and establish a model in preventing the chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* All CKD patients older than 18 y/o.

Exclusion Criteria:

* Refusal to participate in the trial
Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical Stimulation (TES) is a viable adjunctive treatment of substance use treatments.

A Randomized Controlled Trial with block randomization. Inpatient subjects actively seeking substance abuse treatment at the Carrier Clinic who are diagnosed with a substance use disorder, including alcohol use disorder, tobacco use disorder, polysubstance use disorder, or other substance use disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Be able to provide informed consent, assessed by the study clinician
2. Be able to speak, read and write fluently in English, assessed by the study clinician
3. Be committed to completion of the study. The subject will need to attest to availability for 10 to 15 treatments over a 5 to 8 day period for the treatment protocol.
4. Be adults over age 18 and under age 65
5. Be actively receiving substance use treatment for a substance use disorder

Exclusion Criteria:

1. Pregnant or at risk of becoming pregnant
2. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk
Outcomes of Emotion Regulation Therapy in Young Autistic Adults

This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.

Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder
* Ages 18-40
* Estimated full-scale IQ ≥ 80
* T score \> 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)
* Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)

Exclusion Criteria:

* Intellectual disability (estimated full scale IQ\<80
* History of a significant head injury (severe concussion, hospitalization)
* History of neurosurgery
* History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder
* A current major medical condition (e.g. cancer, heart failure)
* Current substance use (determined by urine screen done to all participants before each MRI scan)
* In-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other MRI contraindications
* Pregnancy
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.

Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

Adverse events collection will be covered in Adverse Events section.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Men and women ≥ 50 years of age.
* Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)
* BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye

Exclusion Criteria:

* Only one functional eye
* Presence of CNV with an origin other than wAMD
* Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins
High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia

This study will be conducted to investigate High-intensity laser therapy improves pain, health status and quality of life in women with fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

1. WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between \> 3-6/19 and SSS \> 9/12
2. symptoms have been present at a similar level for at least 3 months
3. the patient does not have another disorder that would otherwise sufficiently explain the pain
4. generalized pain, defined as pain in at least four of five regions, is present

Exclusion Criteria:

* uncontrolled diabetes
* known history of cancer
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.

The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.

This is an open, randomized 2-way crossover study in 12 healthy volunteers. Subjects will receive single oral 20 mg doses of nitisinone administrated as one 20 mg capsule or as two 10 mg capsules of Orfadin. There will be a 3-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers between 18-55 years of age, inclusive.
* BMI between 18,5-30,0 kg/m2, inclusive.

Exclusion Criteria:

* Subjects with current keratopathy, or other abnormalities found by slit-lamp examination.
* Subjects who are heavy smokers or consume more than 5 cups of coffee per day.
* Subjects with history of drug and/or alcohol abuse or a positive drug screen or alcohol breath test.
* Subjects with positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
* Subjects who were enrolled in another concurrent clinical study or intake of an investigational medicinal product within three months prior to inclusion in this study.
* Subjects who donate more than 50 mL of blood within 60 days prior to drug administration or donate more than 1,5 liters of blood in the 10 months prior to first drug administration.
* Female subjects that are pregnant or breastfeeding.
* Female subjects of childbearing potential and all male subjects must be willing to use effective forms of contraception.
Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD

Despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ASCVD), they are generally underrepresented in cardiovascular prevention programmes. The aim of this study is to examine the effects of an integrated exercise and cardiovascular health education programme (HE programme) on community-dwelling older adults at risk of ASCVD.

The study is a two-arm randomized controlled trial. (1) The control group will mainly receive a basic lifestyle modification talk, a lecture video and governmental education leaflets. (2) The experimental group will receive an integrated exercise and health education programme (HE programme) based on self-efficacy theory. Physical activity level, exercise self-efficacy and ASCVD risk profile including blood pressure, cardiac endurance, fasting blood glucose, fasting blood lipids, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 12, Week 24 and Week 36.

Eligibility Criteria:
Inclusion Criteria:

* Chinese adults ≧60 years old
* Having at least one ASCVD risk factor
* Pass the cardiovascular fitness evaluation
* Able to write and read Chinese, and communicate in Cantonese;
* Possess a mobile phone and able to make use of the phone in reading short messages

Exclusion Criteria:

* Visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder
* Having a history of attending similar cardiovascular prevention program
* Having a previous history of coronary heart disease or stroke
Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic

Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years from 18 to 80 years with an ASA (American Society of Anesthesiologists) physical status I-II
* elective hand ambulatory surgery with a maximum duration of 30 minutes involving the median nerve and performed with elbow nerve blocks

Exclusion Criteria:

* pregnant or lactating women,
* contra-indication to regional anesthesia
* diabetes mellitus,
* effective anticoagulation or antiplatelet therapy, laboratory evidence of abnormal bleeding
* neurological disease ( including carpal tunnel syndrome or neuromuscular disease detected by preoperative neurological examination in the median nerve)
* infection at the puncture site
* contra-indication to the administration of lidocaine, notably allergy
* contra-indication to the administration of lidocaine with epinephrine
* not speaking French

Exclusion from the study:

* patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

Primary Objective:

(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).

Secondary Objective:

To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.

Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.

Blood specimens will be taken:

* before starting treatment (cohort 1 and 2)
* after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
* within one month following 1st treatment of HER2 targeted treatment (cohort 1)
* approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)

Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.

   OR

   - Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
2. Patient must be female and aged 18 years or over.
3. Patient must provide written informed consent.

Exclusion Criteria:

1. Patients who do not fulfil the inclusion criteria mentioned above
Tailored Case Management for Diabetes and Hypertension

Diabetes and hypertension co-exist in approximately 10 million people in the USA and constitute severe risk factors for the development of such complications as heart and kidney disease. The investigators propose a randomized controlled trial in patients of community primary care practices to study a tailored telephone-administered behavioral intervention to improve control of blood pressure and blood sugar in patients with both hypertension and diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other month about ways to improve blood pressure and blood sugar control will bring their blood pressure under control when compared to patients who talk with the nurse only about general health issues. If successful in improving control of these diseases this intervention can easily be adopted in other community primary care practices to lessen the burden of diabetes and hypertension in the USA.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled and receiving primary care at one of 9 participating clinics in North Carolina
* Diagnosis of diabetes as determined by billing data
* Taking medication for diabetes
* Diagnosis of hypertension as determined by billing data
* Taking medication for hypertension
* Most recent (within one year) Hemoglobin A1c \>= 7.5%

Exclusion Criteria:

* Active psychosis
* Hospitalization for stroke, myocardial infarction (MI), or coronary artery revascularization in the past 6 months
* Type I diabetes
* Does not speak English
* No access to a telephone
* Institution-dwelling or receiving comprehensive professional home health care
* Hearing or speech inadequate for long interactive phone conversations
* Terminal illness or active treatment for cancer
* Cognitive impairment too severe to understand instructions
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.

External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.

More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.

Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.


Eligibility Criteria:
Inclusion Criteria:

* Mitral valve prolapse diagnosed in echocardiography
* Signed written consent
* Affiliation to social security
* No contraindication to MRI or exercise ECG
* Age above 18

Exclusion Criteria:

* Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
* Prior MRI with contrast within the last month
* Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
* Contraindication to exercise ECG: severe handicap, poor physical capacity
* Contraindication to MRI: implantable device, claustrophobia, metal debris
* Renal insufficiency with creatinine clearance \<30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent
* Pregnant or breast-feeding women
* Minors \<18 years old
* Mental illness or incapacity with incapacity to obtain informed consent
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

* Other severe diseases